The magazine said the disruptors carry the “spirit of medical inquiry into the current age” and noted the company’s industry disruption. With around one in three Americans skipping medications because of cost, Oshmyansky was moved to find a solution. D Magazine profiled the practicing radiologist and his incredible career (including his academic progression as a literal child prodigy) last year. After several fast starts and other entrepreneurial endeavors, Oshmyasnky sent a cold email to Dallas Mavericks owner and “Shark Tank” star Mark Cuban, who responded, and the two began to build a business.

The company works directly with drug manufacturers to deliver medications directly to consumers, cutting out intermediaries like inefficient and opaque pharmacy benefit managers. The result is selling medicines at a fraction of the cost. Newsweek highlighted the cholesterol medication Rosuvastatin, which sells for $5.10 on the company’s site and more than $110 at other pharmacies.

The company offers more than 1,200 on its online pharmacy, and the response has been robust. 1.3 million people created accounts in the company’s first 10 months, and sales topped $25 million in the first nine months. The company puts its pricing formula on the website, selling the drugs at cost plus a 15 percent markup for operating expenses and $8 for pharmacy and shipping fees.

More recently, the company has started working with insurance companies and employers by working with a transparent manager to allow companies to subsidize their employees’ pharmacy costs by working with Cost Plus. The company also has a pharmaceutical finish and fill facility in Deep Ellum that manufactures medications that are not profitable or in short supply.

Newsweek reports that next month, the company will sell its first biosimilar drug, Yusimry, an alternative to Humira, one of the bestselling medications of all time that treats several immune disorders. It will offer the medicine for $559.27, less than a tenth of the cost of Humira. Upon the announcement, Cuban tweeted: “The game has just changed.”

Newsweek’s list included everything from Magic Mushrooms and $1 Hearing Aids to improving women’s health. See all the below:

• Jeeshan Chowdhury, Founder and CEO, Journey Colab
•  Narjust Florez, Thoracic Oncologist, Dana-Farber Brigham Cancer Center; Founder, Florez Lab
•  Kate Ryder, Founder and CEO, Maven
•  Alex Oshmyansky & Mark Cuban, Co-founders, Mark Cuban Cost Plus Drug Co.
•  Polina Lishko, Professor of Cell Biology and Physiology, Washington University, St. Louis
•  Saad Bhamla, Assistant Professor, Biomolecular Engineering, Georgia Institute of Technology
•  Anna Lee, Co-Founder/Head of Engineering, Lioness
•  Eddie Chang, Neurosurgeon, University of California San Francisco
•  Mary Lou, Jepsen Founder, Openwater

You can read about the Medical Marvels here.

The post <i>Newsweek</i> Calls Mark Cuban Cost Plus Drug Co. a ‘Medical Marvel’ appeared first on D Magazine.

Reata was founded in 2002 by Huff, a corporate securities lawyer who found his way into pharmaceuticals looking for more meaning in his career. He was recruited to work for a startup biotech company in Boston and eventually took it public—”One of the dumbest things I have ever done,” he half-jokes—before moving back to Texas. He got connected to research happening at UT Southwestern, which eventually led to Reata.

The ups and downs of the pharmaceutical industry are all part of the business, says Huff, Reata’s chairman and president, especially when the company is venturing into novel areas of medicine. “We are out tromping into areas no one has explored before,” he says. “It gives you the potential to have a very meaningful impact.”

After years of research to develop an experimental pill for a rare genetic kidney disease, the FDA rejected the treatment, called bardoxolone methyl, in 2021. This was 11 weeks after the FDA voted against the pill being used to treat Alport Syndrome, a genetic condition that causes kidney disease, loss of hearing, and eye abnormalities and for which there is no cure. In May, Reata announced that it was officially halting the development of the drug.

“It was devastating for us, but we managed through the year,” Huff says. “We suffered a big loss.”

Many biotech companies fail, but after Blackstone Group invested $350 million, there were high hopes for the treatment. After going public in 2016, Reata raised $505 million from a stock sale in 2019.

The company followed its announcement about bardoxolone methyl by preparing to go to market with a Friedrich’s ataxia treatment called Skyclarys, which received FDA approval in March for patients over 16.

Friedrich’s ataxia is a rare inherited neuromuscular condition that develops in children and worsens over time. It can cause slurred speech, fatigue, trouble walking, loss of reflexes, hearing loss, vision loss, and more. Huff compared it to ALS. It develops in children and adolescents, leads to wheelchair use by the late teens or 20s, and most people with it die in their 30s. In the U.S., 5,000 people have been diagnosed with the disease. It has no cure.

The approval of Skyclarys represents a significant step forward in the treatment of Friedreich’s ataxia, providing physicians with the first disease-specific treatment option approved for patients living with this ultra-rare and progressive disease,” says Dr. Susan Perlman, a clinical neurology professor at UCLA.

Skyclarys is the first treatment to show any clinical benefit for these patients, slowing the progression of the disease. After nine years of development, Huff says the team popped some champagne when the FDA approved the drug. ‘Very few companies make the transition to commercial enterprise with a truly novel biology with high clinical impact on desperately ill patients,” Huff says.

Reata’s approval to go to market with Skyclarys meant the drug research company had to become Reata, the commercial pharmaceutical firm. So the company kicked into gear to determine how to commercialize, manufacture, assure the quality, and sell the drug. “We are in heavy execution mode for the launch,” Huff says.

To help connect potential patients and their prescribing physicians to Reata’s treatments, the company has developed a concierge service called Reach as a patient resource to help providers learn about the medication, provide a care navigator to improve access, connect with a specialty pharmacy, and discuss affordability options.

Reata announced that it would charge $370,000 for Skyclarys, but out-of-pocket costs are expected to be nominal due to insurance and assistance programs. About 500 patients have already signed up to take the drug, Huff says.

One part of this journey that has made it especially rewarding, he adds, has been getting connected with the Friedrich’s Ataxia Research Alliance, one of the most organized patient organizations he has ever seen. Huff says it was FARA who approached Reata about developing a treatment for the condition.

“The entire Friedreich’s ataxia community including patients, clinicians, scientists, pharmaceutical companies, government agencies, and others, have worked collaboratively for decades to enable therapeutic development for this debilitating disease,” says Jen Farmer, CEO at Friedreich’s Ataxia Research Alliance. “Today, we celebrate the impact of an engaged patient community, and we are grateful to the FDA and Reata for working together on the approval of Skyclarys, the first therapy approved in the United States for adult and adolescent patients aged 16 years and older with Friedreich’s ataxia.”

As Reata works on manufacturing and distribution, the company is also focusing on the international market, where it will seek approval from international regulatory bodies.

Huff says that Skyclarys might only be the beginning for this avenue of treatment, as it can improve the function of a cell’s mitochondria—a significant factor in fighting other neurological conditions like Alzheimer’s, ALS, and Huntingdon’s disease. “There are many follow-on developmental opportunities,” Huff says. “We are expanding our pipeline with the same science.”

The post From Devastation to Popping Champagne: Reata Pharmaceuticals’ Roller Coaster Year appeared first on D Magazine.

Reata was founded in 2002 by Huff, a corporate securities lawyer who found his way into pharmaceuticals looking for more meaning in his career. He was recruited to work for a startup biotech company in Boston and eventually took it public—”One of the dumbest things I have ever done,” he half-jokes—before moving back to Texas. He got connected to research happening at UT Southwestern, which eventually led to Reata.

The ups and downs of the pharmaceutical industry are all part of the business, says Huff, Reata’s chairman and president, especially when the company is venturing into novel areas of medicine. “We are out tromping into areas no one has explored before,” he says. “It gives you the potential to have a very meaningful impact.”

After years of research to develop an experimental pill for a rare genetic kidney disease, the FDA rejected the treatment, called bardoxolone methyl, in 2021. This was 11 weeks after the FDA voted against the pill being used to treat Alport Syndrome, a genetic condition that causes kidney disease, loss of hearing, and eye abnormalities and for which there is no cure. In May, Reata announced that it was officially halting the development of the drug.

“It was devastating for us, but we managed through the year,” Huff says. “We suffered a big loss.”

Many biotech companies fail, but after Blackstone Group invested $350 million, there were high hopes for the treatment. After going public in 2016, Reata raised $505 million from a stock sale in 2019.

The company followed its announcement about bardoxolone methyl by preparing to go to market with a Friedrich’s ataxia treatment called Skyclarys, which received FDA approval in March for patients over 16.

Friedrich’s ataxia is a rare inherited neuromuscular condition that develops in children and worsens over time. It can cause slurred speech, fatigue, trouble walking, loss of reflexes, hearing loss, vision loss, and more. Huff compared it to ALS. It develops in children and adolescents, leads to wheelchair use by the late teens or 20s, and most people with it die in their 30s. In the U.S., 5,000 people have been diagnosed with the disease. It has no cure.

The approval of Skyclarys represents a significant step forward in the treatment of Friedreich’s ataxia, providing physicians with the first disease-specific treatment option approved for patients living with this ultra-rare and progressive disease,” says Dr. Susan Perlman, a clinical neurology professor at UCLA.

Skyclarys is the first treatment to show any clinical benefit for these patients, slowing the progression of the disease. After nine years of development, Huff says the team popped some champagne when the FDA approved the drug. ‘Very few companies make the transition to commercial enterprise with a truly novel biology with high clinical impact on desperately ill patients,” Huff says.

Reata’s approval to go to market with Skyclarys meant the drug research company had to become Reata, the commercial pharmaceutical firm. So the company kicked into gear to determine how to commercialize, manufacture, assure the quality, and sell the drug. “We are in heavy execution mode for the launch,” Huff says.

To help connect potential patients and their prescribing physicians to Reata’s treatments, the company has developed a concierge service called Reach as a patient resource to help providers learn about the medication, provide a care navigator to improve access, connect with a specialty pharmacy, and discuss affordability options.

Reata announced that it would charge $370,000 for Skyclarys, but out-of-pocket costs are expected to be nominal due to insurance and assistance programs. About 500 patients have already signed up to take the drug, Huff says.

One part of this journey that has made it especially rewarding, he adds, has been getting connected with the Friedrich’s Ataxia Research Alliance, one of the most organized patient organizations he has ever seen. Huff says it was FARA who approached Reata about developing a treatment for the condition.

“The entire Friedreich’s ataxia community including patients, clinicians, scientists, pharmaceutical companies, government agencies, and others, have worked collaboratively for decades to enable therapeutic development for this debilitating disease,” says Jen Farmer, CEO at Friedreich’s Ataxia Research Alliance. “Today, we celebrate the impact of an engaged patient community, and we are grateful to the FDA and Reata for working together on the approval of Skyclarys, the first therapy approved in the United States for adult and adolescent patients aged 16 years and older with Friedreich’s ataxia.”

As Reata works on manufacturing and distribution, the company is also focusing on the international market, where it will seek approval from international regulatory bodies.

Huff says that Skyclarys might only be the beginning for this avenue of treatment, as it can improve the function of a cell’s mitochondria—a significant factor in fighting other neurological conditions like Alzheimer’s, ALS, and Huntingdon’s disease. “There are many follow-on developmental opportunities,” Huff says. “We are expanding our pipeline with the same science.”

The post Texas Is Likely to Expand Medicinal Marijuana Laws, But Access Is Still an Issue appeared first on D Magazine.

Reata was founded in 2002 by Huff, a corporate securities lawyer who found his way into pharmaceuticals looking for more meaning in his career. He was recruited to work for a startup biotech company in Boston and eventually took it public—”One of the dumbest things I have ever done,” he half-jokes—before moving back to Texas. He got connected to research happening at UT Southwestern, which eventually led to Reata.

The ups and downs of the pharmaceutical industry are all part of the business, says Huff, Reata’s chairman and president, especially when the company is venturing into novel areas of medicine. “We are out tromping into areas no one has explored before,” he says. “It gives you the potential to have a very meaningful impact.”

After years of research to develop an experimental pill for a rare genetic kidney disease, the FDA rejected the treatment, called bardoxolone methyl, in 2021. This was 11 weeks after the FDA voted against the pill being used to treat Alport Syndrome, a genetic condition that causes kidney disease, loss of hearing, and eye abnormalities and for which there is no cure. In May, Reata announced that it was officially halting the development of the drug.

“It was devastating for us, but we managed through the year,” Huff says. “We suffered a big loss.”

Many biotech companies fail, but after Blackstone Group invested $350 million, there were high hopes for the treatment. After going public in 2016, Reata raised $505 million from a stock sale in 2019.

The company followed its announcement about bardoxolone methyl by preparing to go to market with a Friedrich’s ataxia treatment called Skyclarys, which received FDA approval in March for patients over 16.

Friedrich’s ataxia is a rare inherited neuromuscular condition that develops in children and worsens over time. It can cause slurred speech, fatigue, trouble walking, loss of reflexes, hearing loss, vision loss, and more. Huff compared it to ALS. It develops in children and adolescents, leads to wheelchair use by the late teens or 20s, and most people with it die in their 30s. In the U.S., 5,000 people have been diagnosed with the disease. It has no cure.

The approval of Skyclarys represents a significant step forward in the treatment of Friedreich’s ataxia, providing physicians with the first disease-specific treatment option approved for patients living with this ultra-rare and progressive disease,” says Dr. Susan Perlman, a clinical neurology professor at UCLA.

Skyclarys is the first treatment to show any clinical benefit for these patients, slowing the progression of the disease. After nine years of development, Huff says the team popped some champagne when the FDA approved the drug. ‘Very few companies make the transition to commercial enterprise with a truly novel biology with high clinical impact on desperately ill patients,” Huff says.

Reata’s approval to go to market with Skyclarys meant the drug research company had to become Reata, the commercial pharmaceutical firm. So the company kicked into gear to determine how to commercialize, manufacture, assure the quality, and sell the drug. “We are in heavy execution mode for the launch,” Huff says.

To help connect potential patients and their prescribing physicians to Reata’s treatments, the company has developed a concierge service called Reach as a patient resource to help providers learn about the medication, provide a care navigator to improve access, connect with a specialty pharmacy, and discuss affordability options.

Reata announced that it would charge $370,000 for Skyclarys, but out-of-pocket costs are expected to be nominal due to insurance and assistance programs. About 500 patients have already signed up to take the drug, Huff says.

One part of this journey that has made it especially rewarding, he adds, has been getting connected with the Friedrich’s Ataxia Research Alliance, one of the most organized patient organizations he has ever seen. Huff says it was FARA who approached Reata about developing a treatment for the condition.

“The entire Friedreich’s ataxia community including patients, clinicians, scientists, pharmaceutical companies, government agencies, and others, have worked collaboratively for decades to enable therapeutic development for this debilitating disease,” says Jen Farmer, CEO at Friedreich’s Ataxia Research Alliance. “Today, we celebrate the impact of an engaged patient community, and we are grateful to the FDA and Reata for working together on the approval of Skyclarys, the first therapy approved in the United States for adult and adolescent patients aged 16 years and older with Friedreich’s ataxia.”

As Reata works on manufacturing and distribution, the company is also focusing on the international market, where it will seek approval from international regulatory bodies.

Huff says that Skyclarys might only be the beginning for this avenue of treatment, as it can improve the function of a cell’s mitochondria—a significant factor in fighting other neurological conditions like Alzheimer’s, ALS, and Huntingdon’s disease. “There are many follow-on developmental opportunities,” Huff says. “We are expanding our pipeline with the same science.”

The post Signify Health CEO Kyle Armbrester on What’s Next After CVS’ $8 Billion Acquisition appeared first on D Magazine.

Reata was founded in 2002 by Huff, a corporate securities lawyer who found his way into pharmaceuticals looking for more meaning in his career. He was recruited to work for a startup biotech company in Boston and eventually took it public—”One of the dumbest things I have ever done,” he half-jokes—before moving back to Texas. He got connected to research happening at UT Southwestern, which eventually led to Reata.

The ups and downs of the pharmaceutical industry are all part of the business, says Huff, Reata’s chairman and president, especially when the company is venturing into novel areas of medicine. “We are out tromping into areas no one has explored before,” he says. “It gives you the potential to have a very meaningful impact.”

After years of research to develop an experimental pill for a rare genetic kidney disease, the FDA rejected the treatment, called bardoxolone methyl, in 2021. This was 11 weeks after the FDA voted against the pill being used to treat Alport Syndrome, a genetic condition that causes kidney disease, loss of hearing, and eye abnormalities and for which there is no cure. In May, Reata announced that it was officially halting the development of the drug.

“It was devastating for us, but we managed through the year,” Huff says. “We suffered a big loss.”

Many biotech companies fail, but after Blackstone Group invested $350 million, there were high hopes for the treatment. After going public in 2016, Reata raised $505 million from a stock sale in 2019.

The company followed its announcement about bardoxolone methyl by preparing to go to market with a Friedrich’s ataxia treatment called Skyclarys, which received FDA approval in March for patients over 16.

Friedrich’s ataxia is a rare inherited neuromuscular condition that develops in children and worsens over time. It can cause slurred speech, fatigue, trouble walking, loss of reflexes, hearing loss, vision loss, and more. Huff compared it to ALS. It develops in children and adolescents, leads to wheelchair use by the late teens or 20s, and most people with it die in their 30s. In the U.S., 5,000 people have been diagnosed with the disease. It has no cure.

The approval of Skyclarys represents a significant step forward in the treatment of Friedreich’s ataxia, providing physicians with the first disease-specific treatment option approved for patients living with this ultra-rare and progressive disease,” says Dr. Susan Perlman, a clinical neurology professor at UCLA.

Skyclarys is the first treatment to show any clinical benefit for these patients, slowing the progression of the disease. After nine years of development, Huff says the team popped some champagne when the FDA approved the drug. ‘Very few companies make the transition to commercial enterprise with a truly novel biology with high clinical impact on desperately ill patients,” Huff says.

Reata’s approval to go to market with Skyclarys meant the drug research company had to become Reata, the commercial pharmaceutical firm. So the company kicked into gear to determine how to commercialize, manufacture, assure the quality, and sell the drug. “We are in heavy execution mode for the launch,” Huff says.

To help connect potential patients and their prescribing physicians to Reata’s treatments, the company has developed a concierge service called Reach as a patient resource to help providers learn about the medication, provide a care navigator to improve access, connect with a specialty pharmacy, and discuss affordability options.

Reata announced that it would charge $370,000 for Skyclarys, but out-of-pocket costs are expected to be nominal due to insurance and assistance programs. About 500 patients have already signed up to take the drug, Huff says.

One part of this journey that has made it especially rewarding, he adds, has been getting connected with the Friedrich’s Ataxia Research Alliance, one of the most organized patient organizations he has ever seen. Huff says it was FARA who approached Reata about developing a treatment for the condition.

“The entire Friedreich’s ataxia community including patients, clinicians, scientists, pharmaceutical companies, government agencies, and others, have worked collaboratively for decades to enable therapeutic development for this debilitating disease,” says Jen Farmer, CEO at Friedreich’s Ataxia Research Alliance. “Today, we celebrate the impact of an engaged patient community, and we are grateful to the FDA and Reata for working together on the approval of Skyclarys, the first therapy approved in the United States for adult and adolescent patients aged 16 years and older with Friedreich’s ataxia.”

As Reata works on manufacturing and distribution, the company is also focusing on the international market, where it will seek approval from international regulatory bodies.

Huff says that Skyclarys might only be the beginning for this avenue of treatment, as it can improve the function of a cell’s mitochondria—a significant factor in fighting other neurological conditions like Alzheimer’s, ALS, and Huntingdon’s disease. “There are many follow-on developmental opportunities,” Huff says. “We are expanding our pipeline with the same science.”

The post Texas Pharmacists Want to Keep Their Expanded Vaccination Capabilities appeared first on D Magazine.

Reata was founded in 2002 by Huff, a corporate securities lawyer who found his way into pharmaceuticals looking for more meaning in his career. He was recruited to work for a startup biotech company in Boston and eventually took it public—”One of the dumbest things I have ever done,” he half-jokes—before moving back to Texas. He got connected to research happening at UT Southwestern, which eventually led to Reata.

The ups and downs of the pharmaceutical industry are all part of the business, says Huff, Reata’s chairman and president, especially when the company is venturing into novel areas of medicine. “We are out tromping into areas no one has explored before,” he says. “It gives you the potential to have a very meaningful impact.”

After years of research to develop an experimental pill for a rare genetic kidney disease, the FDA rejected the treatment, called bardoxolone methyl, in 2021. This was 11 weeks after the FDA voted against the pill being used to treat Alport Syndrome, a genetic condition that causes kidney disease, loss of hearing, and eye abnormalities and for which there is no cure. In May, Reata announced that it was officially halting the development of the drug.

“It was devastating for us, but we managed through the year,” Huff says. “We suffered a big loss.”

Many biotech companies fail, but after Blackstone Group invested $350 million, there were high hopes for the treatment. After going public in 2016, Reata raised $505 million from a stock sale in 2019.

The company followed its announcement about bardoxolone methyl by preparing to go to market with a Friedrich’s ataxia treatment called Skyclarys, which received FDA approval in March for patients over 16.

Friedrich’s ataxia is a rare inherited neuromuscular condition that develops in children and worsens over time. It can cause slurred speech, fatigue, trouble walking, loss of reflexes, hearing loss, vision loss, and more. Huff compared it to ALS. It develops in children and adolescents, leads to wheelchair use by the late teens or 20s, and most people with it die in their 30s. In the U.S., 5,000 people have been diagnosed with the disease. It has no cure.

The approval of Skyclarys represents a significant step forward in the treatment of Friedreich’s ataxia, providing physicians with the first disease-specific treatment option approved for patients living with this ultra-rare and progressive disease,” says Dr. Susan Perlman, a clinical neurology professor at UCLA.

Skyclarys is the first treatment to show any clinical benefit for these patients, slowing the progression of the disease. After nine years of development, Huff says the team popped some champagne when the FDA approved the drug. ‘Very few companies make the transition to commercial enterprise with a truly novel biology with high clinical impact on desperately ill patients,” Huff says.

Reata’s approval to go to market with Skyclarys meant the drug research company had to become Reata, the commercial pharmaceutical firm. So the company kicked into gear to determine how to commercialize, manufacture, assure the quality, and sell the drug. “We are in heavy execution mode for the launch,” Huff says.

To help connect potential patients and their prescribing physicians to Reata’s treatments, the company has developed a concierge service called Reach as a patient resource to help providers learn about the medication, provide a care navigator to improve access, connect with a specialty pharmacy, and discuss affordability options.

Reata announced that it would charge $370,000 for Skyclarys, but out-of-pocket costs are expected to be nominal due to insurance and assistance programs. About 500 patients have already signed up to take the drug, Huff says.

One part of this journey that has made it especially rewarding, he adds, has been getting connected with the Friedrich’s Ataxia Research Alliance, one of the most organized patient organizations he has ever seen. Huff says it was FARA who approached Reata about developing a treatment for the condition.

“The entire Friedreich’s ataxia community including patients, clinicians, scientists, pharmaceutical companies, government agencies, and others, have worked collaboratively for decades to enable therapeutic development for this debilitating disease,” says Jen Farmer, CEO at Friedreich’s Ataxia Research Alliance. “Today, we celebrate the impact of an engaged patient community, and we are grateful to the FDA and Reata for working together on the approval of Skyclarys, the first therapy approved in the United States for adult and adolescent patients aged 16 years and older with Friedreich’s ataxia.”

As Reata works on manufacturing and distribution, the company is also focusing on the international market, where it will seek approval from international regulatory bodies.

Huff says that Skyclarys might only be the beginning for this avenue of treatment, as it can improve the function of a cell’s mitochondria—a significant factor in fighting other neurological conditions like Alzheimer’s, ALS, and Huntingdon’s disease. “There are many follow-on developmental opportunities,” Huff says. “We are expanding our pipeline with the same science.”

The post Mark Cuban: Business Is How We Teach Washington What Works appeared first on D Magazine.

Reata was founded in 2002 by Huff, a corporate securities lawyer who found his way into pharmaceuticals looking for more meaning in his career. He was recruited to work for a startup biotech company in Boston and eventually took it public—”One of the dumbest things I have ever done,” he half-jokes—before moving back to Texas. He got connected to research happening at UT Southwestern, which eventually led to Reata.

The ups and downs of the pharmaceutical industry are all part of the business, says Huff, Reata’s chairman and president, especially when the company is venturing into novel areas of medicine. “We are out tromping into areas no one has explored before,” he says. “It gives you the potential to have a very meaningful impact.”

After years of research to develop an experimental pill for a rare genetic kidney disease, the FDA rejected the treatment, called bardoxolone methyl, in 2021. This was 11 weeks after the FDA voted against the pill being used to treat Alport Syndrome, a genetic condition that causes kidney disease, loss of hearing, and eye abnormalities and for which there is no cure. In May, Reata announced that it was officially halting the development of the drug.

“It was devastating for us, but we managed through the year,” Huff says. “We suffered a big loss.”

Many biotech companies fail, but after Blackstone Group invested $350 million, there were high hopes for the treatment. After going public in 2016, Reata raised $505 million from a stock sale in 2019.

The company followed its announcement about bardoxolone methyl by preparing to go to market with a Friedrich’s ataxia treatment called Skyclarys, which received FDA approval in March for patients over 16.

Friedrich’s ataxia is a rare inherited neuromuscular condition that develops in children and worsens over time. It can cause slurred speech, fatigue, trouble walking, loss of reflexes, hearing loss, vision loss, and more. Huff compared it to ALS. It develops in children and adolescents, leads to wheelchair use by the late teens or 20s, and most people with it die in their 30s. In the U.S., 5,000 people have been diagnosed with the disease. It has no cure.

The approval of Skyclarys represents a significant step forward in the treatment of Friedreich’s ataxia, providing physicians with the first disease-specific treatment option approved for patients living with this ultra-rare and progressive disease,” says Dr. Susan Perlman, a clinical neurology professor at UCLA.

Skyclarys is the first treatment to show any clinical benefit for these patients, slowing the progression of the disease. After nine years of development, Huff says the team popped some champagne when the FDA approved the drug. ‘Very few companies make the transition to commercial enterprise with a truly novel biology with high clinical impact on desperately ill patients,” Huff says.

Reata’s approval to go to market with Skyclarys meant the drug research company had to become Reata, the commercial pharmaceutical firm. So the company kicked into gear to determine how to commercialize, manufacture, assure the quality, and sell the drug. “We are in heavy execution mode for the launch,” Huff says.

To help connect potential patients and their prescribing physicians to Reata’s treatments, the company has developed a concierge service called Reach as a patient resource to help providers learn about the medication, provide a care navigator to improve access, connect with a specialty pharmacy, and discuss affordability options.

Reata announced that it would charge $370,000 for Skyclarys, but out-of-pocket costs are expected to be nominal due to insurance and assistance programs. About 500 patients have already signed up to take the drug, Huff says.

One part of this journey that has made it especially rewarding, he adds, has been getting connected with the Friedrich’s Ataxia Research Alliance, one of the most organized patient organizations he has ever seen. Huff says it was FARA who approached Reata about developing a treatment for the condition.

“The entire Friedreich’s ataxia community including patients, clinicians, scientists, pharmaceutical companies, government agencies, and others, have worked collaboratively for decades to enable therapeutic development for this debilitating disease,” says Jen Farmer, CEO at Friedreich’s Ataxia Research Alliance. “Today, we celebrate the impact of an engaged patient community, and we are grateful to the FDA and Reata for working together on the approval of Skyclarys, the first therapy approved in the United States for adult and adolescent patients aged 16 years and older with Friedreich’s ataxia.”

As Reata works on manufacturing and distribution, the company is also focusing on the international market, where it will seek approval from international regulatory bodies.

Huff says that Skyclarys might only be the beginning for this avenue of treatment, as it can improve the function of a cell’s mitochondria—a significant factor in fighting other neurological conditions like Alzheimer’s, ALS, and Huntingdon’s disease. “There are many follow-on developmental opportunities,” Huff says. “We are expanding our pipeline with the same science.”

The post Mark Cuban’s Drug Company Has Entered the Employer Market appeared first on D Magazine.

Reata was founded in 2002 by Huff, a corporate securities lawyer who found his way into pharmaceuticals looking for more meaning in his career. He was recruited to work for a startup biotech company in Boston and eventually took it public—”One of the dumbest things I have ever done,” he half-jokes—before moving back to Texas. He got connected to research happening at UT Southwestern, which eventually led to Reata.

The ups and downs of the pharmaceutical industry are all part of the business, says Huff, Reata’s chairman and president, especially when the company is venturing into novel areas of medicine. “We are out tromping into areas no one has explored before,” he says. “It gives you the potential to have a very meaningful impact.”

After years of research to develop an experimental pill for a rare genetic kidney disease, the FDA rejected the treatment, called bardoxolone methyl, in 2021. This was 11 weeks after the FDA voted against the pill being used to treat Alport Syndrome, a genetic condition that causes kidney disease, loss of hearing, and eye abnormalities and for which there is no cure. In May, Reata announced that it was officially halting the development of the drug.

“It was devastating for us, but we managed through the year,” Huff says. “We suffered a big loss.”

Many biotech companies fail, but after Blackstone Group invested $350 million, there were high hopes for the treatment. After going public in 2016, Reata raised $505 million from a stock sale in 2019.

The company followed its announcement about bardoxolone methyl by preparing to go to market with a Friedrich’s ataxia treatment called Skyclarys, which received FDA approval in March for patients over 16.

Friedrich’s ataxia is a rare inherited neuromuscular condition that develops in children and worsens over time. It can cause slurred speech, fatigue, trouble walking, loss of reflexes, hearing loss, vision loss, and more. Huff compared it to ALS. It develops in children and adolescents, leads to wheelchair use by the late teens or 20s, and most people with it die in their 30s. In the U.S., 5,000 people have been diagnosed with the disease. It has no cure.

The approval of Skyclarys represents a significant step forward in the treatment of Friedreich’s ataxia, providing physicians with the first disease-specific treatment option approved for patients living with this ultra-rare and progressive disease,” says Dr. Susan Perlman, a clinical neurology professor at UCLA.

Skyclarys is the first treatment to show any clinical benefit for these patients, slowing the progression of the disease. After nine years of development, Huff says the team popped some champagne when the FDA approved the drug. ‘Very few companies make the transition to commercial enterprise with a truly novel biology with high clinical impact on desperately ill patients,” Huff says.

Reata’s approval to go to market with Skyclarys meant the drug research company had to become Reata, the commercial pharmaceutical firm. So the company kicked into gear to determine how to commercialize, manufacture, assure the quality, and sell the drug. “We are in heavy execution mode for the launch,” Huff says.

To help connect potential patients and their prescribing physicians to Reata’s treatments, the company has developed a concierge service called Reach as a patient resource to help providers learn about the medication, provide a care navigator to improve access, connect with a specialty pharmacy, and discuss affordability options.

Reata announced that it would charge $370,000 for Skyclarys, but out-of-pocket costs are expected to be nominal due to insurance and assistance programs. About 500 patients have already signed up to take the drug, Huff says.

One part of this journey that has made it especially rewarding, he adds, has been getting connected with the Friedrich’s Ataxia Research Alliance, one of the most organized patient organizations he has ever seen. Huff says it was FARA who approached Reata about developing a treatment for the condition.

“The entire Friedreich’s ataxia community including patients, clinicians, scientists, pharmaceutical companies, government agencies, and others, have worked collaboratively for decades to enable therapeutic development for this debilitating disease,” says Jen Farmer, CEO at Friedreich’s Ataxia Research Alliance. “Today, we celebrate the impact of an engaged patient community, and we are grateful to the FDA and Reata for working together on the approval of Skyclarys, the first therapy approved in the United States for adult and adolescent patients aged 16 years and older with Friedreich’s ataxia.”

As Reata works on manufacturing and distribution, the company is also focusing on the international market, where it will seek approval from international regulatory bodies.

Huff says that Skyclarys might only be the beginning for this avenue of treatment, as it can improve the function of a cell’s mitochondria—a significant factor in fighting other neurological conditions like Alzheimer’s, ALS, and Huntingdon’s disease. “There are many follow-on developmental opportunities,” Huff says. “We are expanding our pipeline with the same science.”

The post Meet North Texas’ Award-Winning Pharmacy Influencer appeared first on D Magazine.

Reata was founded in 2002 by Huff, a corporate securities lawyer who found his way into pharmaceuticals looking for more meaning in his career. He was recruited to work for a startup biotech company in Boston and eventually took it public—”One of the dumbest things I have ever done,” he half-jokes—before moving back to Texas. He got connected to research happening at UT Southwestern, which eventually led to Reata.

The ups and downs of the pharmaceutical industry are all part of the business, says Huff, Reata’s chairman and president, especially when the company is venturing into novel areas of medicine. “We are out tromping into areas no one has explored before,” he says. “It gives you the potential to have a very meaningful impact.”

After years of research to develop an experimental pill for a rare genetic kidney disease, the FDA rejected the treatment, called bardoxolone methyl, in 2021. This was 11 weeks after the FDA voted against the pill being used to treat Alport Syndrome, a genetic condition that causes kidney disease, loss of hearing, and eye abnormalities and for which there is no cure. In May, Reata announced that it was officially halting the development of the drug.

“It was devastating for us, but we managed through the year,” Huff says. “We suffered a big loss.”

Many biotech companies fail, but after Blackstone Group invested $350 million, there were high hopes for the treatment. After going public in 2016, Reata raised $505 million from a stock sale in 2019.

The company followed its announcement about bardoxolone methyl by preparing to go to market with a Friedrich’s ataxia treatment called Skyclarys, which received FDA approval in March for patients over 16.

Friedrich’s ataxia is a rare inherited neuromuscular condition that develops in children and worsens over time. It can cause slurred speech, fatigue, trouble walking, loss of reflexes, hearing loss, vision loss, and more. Huff compared it to ALS. It develops in children and adolescents, leads to wheelchair use by the late teens or 20s, and most people with it die in their 30s. In the U.S., 5,000 people have been diagnosed with the disease. It has no cure.

The approval of Skyclarys represents a significant step forward in the treatment of Friedreich’s ataxia, providing physicians with the first disease-specific treatment option approved for patients living with this ultra-rare and progressive disease,” says Dr. Susan Perlman, a clinical neurology professor at UCLA.

Skyclarys is the first treatment to show any clinical benefit for these patients, slowing the progression of the disease. After nine years of development, Huff says the team popped some champagne when the FDA approved the drug. ‘Very few companies make the transition to commercial enterprise with a truly novel biology with high clinical impact on desperately ill patients,” Huff says.

Reata’s approval to go to market with Skyclarys meant the drug research company had to become Reata, the commercial pharmaceutical firm. So the company kicked into gear to determine how to commercialize, manufacture, assure the quality, and sell the drug. “We are in heavy execution mode for the launch,” Huff says.

To help connect potential patients and their prescribing physicians to Reata’s treatments, the company has developed a concierge service called Reach as a patient resource to help providers learn about the medication, provide a care navigator to improve access, connect with a specialty pharmacy, and discuss affordability options.

Reata announced that it would charge $370,000 for Skyclarys, but out-of-pocket costs are expected to be nominal due to insurance and assistance programs. About 500 patients have already signed up to take the drug, Huff says.

One part of this journey that has made it especially rewarding, he adds, has been getting connected with the Friedrich’s Ataxia Research Alliance, one of the most organized patient organizations he has ever seen. Huff says it was FARA who approached Reata about developing a treatment for the condition.

“The entire Friedreich’s ataxia community including patients, clinicians, scientists, pharmaceutical companies, government agencies, and others, have worked collaboratively for decades to enable therapeutic development for this debilitating disease,” says Jen Farmer, CEO at Friedreich’s Ataxia Research Alliance. “Today, we celebrate the impact of an engaged patient community, and we are grateful to the FDA and Reata for working together on the approval of Skyclarys, the first therapy approved in the United States for adult and adolescent patients aged 16 years and older with Friedreich’s ataxia.”

As Reata works on manufacturing and distribution, the company is also focusing on the international market, where it will seek approval from international regulatory bodies.

Huff says that Skyclarys might only be the beginning for this avenue of treatment, as it can improve the function of a cell’s mitochondria—a significant factor in fighting other neurological conditions like Alzheimer’s, ALS, and Huntingdon’s disease. “There are many follow-on developmental opportunities,” Huff says. “We are expanding our pipeline with the same science.”

The post St. Vincent de Paul and the Power of Free Medicine appeared first on D Magazine.

Reata was founded in 2002 by Huff, a corporate securities lawyer who found his way into pharmaceuticals looking for more meaning in his career. He was recruited to work for a startup biotech company in Boston and eventually took it public—”One of the dumbest things I have ever done,” he half-jokes—before moving back to Texas. He got connected to research happening at UT Southwestern, which eventually led to Reata.

The ups and downs of the pharmaceutical industry are all part of the business, says Huff, Reata’s chairman and president, especially when the company is venturing into novel areas of medicine. “We are out tromping into areas no one has explored before,” he says. “It gives you the potential to have a very meaningful impact.”

After years of research to develop an experimental pill for a rare genetic kidney disease, the FDA rejected the treatment, called bardoxolone methyl, in 2021. This was 11 weeks after the FDA voted against the pill being used to treat Alport Syndrome, a genetic condition that causes kidney disease, loss of hearing, and eye abnormalities and for which there is no cure. In May, Reata announced that it was officially halting the development of the drug.

“It was devastating for us, but we managed through the year,” Huff says. “We suffered a big loss.”

Many biotech companies fail, but after Blackstone Group invested $350 million, there were high hopes for the treatment. After going public in 2016, Reata raised $505 million from a stock sale in 2019.

The company followed its announcement about bardoxolone methyl by preparing to go to market with a Friedrich’s ataxia treatment called Skyclarys, which received FDA approval in March for patients over 16.

Friedrich’s ataxia is a rare inherited neuromuscular condition that develops in children and worsens over time. It can cause slurred speech, fatigue, trouble walking, loss of reflexes, hearing loss, vision loss, and more. Huff compared it to ALS. It develops in children and adolescents, leads to wheelchair use by the late teens or 20s, and most people with it die in their 30s. In the U.S., 5,000 people have been diagnosed with the disease. It has no cure.

The approval of Skyclarys represents a significant step forward in the treatment of Friedreich’s ataxia, providing physicians with the first disease-specific treatment option approved for patients living with this ultra-rare and progressive disease,” says Dr. Susan Perlman, a clinical neurology professor at UCLA.

Skyclarys is the first treatment to show any clinical benefit for these patients, slowing the progression of the disease. After nine years of development, Huff says the team popped some champagne when the FDA approved the drug. ‘Very few companies make the transition to commercial enterprise with a truly novel biology with high clinical impact on desperately ill patients,” Huff says.

Reata’s approval to go to market with Skyclarys meant the drug research company had to become Reata, the commercial pharmaceutical firm. So the company kicked into gear to determine how to commercialize, manufacture, assure the quality, and sell the drug. “We are in heavy execution mode for the launch,” Huff says.

To help connect potential patients and their prescribing physicians to Reata’s treatments, the company has developed a concierge service called Reach as a patient resource to help providers learn about the medication, provide a care navigator to improve access, connect with a specialty pharmacy, and discuss affordability options.

Reata announced that it would charge $370,000 for Skyclarys, but out-of-pocket costs are expected to be nominal due to insurance and assistance programs. About 500 patients have already signed up to take the drug, Huff says.

One part of this journey that has made it especially rewarding, he adds, has been getting connected with the Friedrich’s Ataxia Research Alliance, one of the most organized patient organizations he has ever seen. Huff says it was FARA who approached Reata about developing a treatment for the condition.

“The entire Friedreich’s ataxia community including patients, clinicians, scientists, pharmaceutical companies, government agencies, and others, have worked collaboratively for decades to enable therapeutic development for this debilitating disease,” says Jen Farmer, CEO at Friedreich’s Ataxia Research Alliance. “Today, we celebrate the impact of an engaged patient community, and we are grateful to the FDA and Reata for working together on the approval of Skyclarys, the first therapy approved in the United States for adult and adolescent patients aged 16 years and older with Friedreich’s ataxia.”

As Reata works on manufacturing and distribution, the company is also focusing on the international market, where it will seek approval from international regulatory bodies.

Huff says that Skyclarys might only be the beginning for this avenue of treatment, as it can improve the function of a cell’s mitochondria—a significant factor in fighting other neurological conditions like Alzheimer’s, ALS, and Huntingdon’s disease. “There are many follow-on developmental opportunities,” Huff says. “We are expanding our pipeline with the same science.”

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Reata was founded in 2002 by Huff, a corporate securities lawyer who found his way into pharmaceuticals looking for more meaning in his career. He was recruited to work for a startup biotech company in Boston and eventually took it public—”One of the dumbest things I have ever done,” he half-jokes—before moving back to Texas. He got connected to research happening at UT Southwestern, which eventually led to Reata.

The ups and downs of the pharmaceutical industry are all part of the business, says Huff, Reata’s chairman and president, especially when the company is venturing into novel areas of medicine. “We are out tromping into areas no one has explored before,” he says. “It gives you the potential to have a very meaningful impact.”

After years of research to develop an experimental pill for a rare genetic kidney disease, the FDA rejected the treatment, called bardoxolone methyl, in 2021. This was 11 weeks after the FDA voted against the pill being used to treat Alport Syndrome, a genetic condition that causes kidney disease, loss of hearing, and eye abnormalities and for which there is no cure. In May, Reata announced that it was officially halting the development of the drug.

“It was devastating for us, but we managed through the year,” Huff says. “We suffered a big loss.”

Many biotech companies fail, but after Blackstone Group invested $350 million, there were high hopes for the treatment. After going public in 2016, Reata raised $505 million from a stock sale in 2019.

The company followed its announcement about bardoxolone methyl by preparing to go to market with a Friedrich’s ataxia treatment called Skyclarys, which received FDA approval in March for patients over 16.

Friedrich’s ataxia is a rare inherited neuromuscular condition that develops in children and worsens over time. It can cause slurred speech, fatigue, trouble walking, loss of reflexes, hearing loss, vision loss, and more. Huff compared it to ALS. It develops in children and adolescents, leads to wheelchair use by the late teens or 20s, and most people with it die in their 30s. In the U.S., 5,000 people have been diagnosed with the disease. It has no cure.

The approval of Skyclarys represents a significant step forward in the treatment of Friedreich’s ataxia, providing physicians with the first disease-specific treatment option approved for patients living with this ultra-rare and progressive disease,” says Dr. Susan Perlman, a clinical neurology professor at UCLA.

Skyclarys is the first treatment to show any clinical benefit for these patients, slowing the progression of the disease. After nine years of development, Huff says the team popped some champagne when the FDA approved the drug. ‘Very few companies make the transition to commercial enterprise with a truly novel biology with high clinical impact on desperately ill patients,” Huff says.

Reata’s approval to go to market with Skyclarys meant the drug research company had to become Reata, the commercial pharmaceutical firm. So the company kicked into gear to determine how to commercialize, manufacture, assure the quality, and sell the drug. “We are in heavy execution mode for the launch,” Huff says.

To help connect potential patients and their prescribing physicians to Reata’s treatments, the company has developed a concierge service called Reach as a patient resource to help providers learn about the medication, provide a care navigator to improve access, connect with a specialty pharmacy, and discuss affordability options.

Reata announced that it would charge $370,000 for Skyclarys, but out-of-pocket costs are expected to be nominal due to insurance and assistance programs. About 500 patients have already signed up to take the drug, Huff says.

One part of this journey that has made it especially rewarding, he adds, has been getting connected with the Friedrich’s Ataxia Research Alliance, one of the most organized patient organizations he has ever seen. Huff says it was FARA who approached Reata about developing a treatment for the condition.

“The entire Friedreich’s ataxia community including patients, clinicians, scientists, pharmaceutical companies, government agencies, and others, have worked collaboratively for decades to enable therapeutic development for this debilitating disease,” says Jen Farmer, CEO at Friedreich’s Ataxia Research Alliance. “Today, we celebrate the impact of an engaged patient community, and we are grateful to the FDA and Reata for working together on the approval of Skyclarys, the first therapy approved in the United States for adult and adolescent patients aged 16 years and older with Friedreich’s ataxia.”

As Reata works on manufacturing and distribution, the company is also focusing on the international market, where it will seek approval from international regulatory bodies.

Huff says that Skyclarys might only be the beginning for this avenue of treatment, as it can improve the function of a cell’s mitochondria—a significant factor in fighting other neurological conditions like Alzheimer’s, ALS, and Huntingdon’s disease. “There are many follow-on developmental opportunities,” Huff says. “We are expanding our pipeline with the same science.”

The post Why Mark Cuban Put His Name on a Drug Company appeared first on D Magazine.

Reata was founded in 2002 by Huff, a corporate securities lawyer who found his way into pharmaceuticals looking for more meaning in his career. He was recruited to work for a startup biotech company in Boston and eventually took it public—”One of the dumbest things I have ever done,” he half-jokes—before moving back to Texas. He got connected to research happening at UT Southwestern, which eventually led to Reata.

The ups and downs of the pharmaceutical industry are all part of the business, says Huff, Reata’s chairman and president, especially when the company is venturing into novel areas of medicine. “We are out tromping into areas no one has explored before,” he says. “It gives you the potential to have a very meaningful impact.”

After years of research to develop an experimental pill for a rare genetic kidney disease, the FDA rejected the treatment, called bardoxolone methyl, in 2021. This was 11 weeks after the FDA voted against the pill being used to treat Alport Syndrome, a genetic condition that causes kidney disease, loss of hearing, and eye abnormalities and for which there is no cure. In May, Reata announced that it was officially halting the development of the drug.

“It was devastating for us, but we managed through the year,” Huff says. “We suffered a big loss.”

Many biotech companies fail, but after Blackstone Group invested $350 million, there were high hopes for the treatment. After going public in 2016, Reata raised $505 million from a stock sale in 2019.

The company followed its announcement about bardoxolone methyl by preparing to go to market with a Friedrich’s ataxia treatment called Skyclarys, which received FDA approval in March for patients over 16.

Friedrich’s ataxia is a rare inherited neuromuscular condition that develops in children and worsens over time. It can cause slurred speech, fatigue, trouble walking, loss of reflexes, hearing loss, vision loss, and more. Huff compared it to ALS. It develops in children and adolescents, leads to wheelchair use by the late teens or 20s, and most people with it die in their 30s. In the U.S., 5,000 people have been diagnosed with the disease. It has no cure.

The approval of Skyclarys represents a significant step forward in the treatment of Friedreich’s ataxia, providing physicians with the first disease-specific treatment option approved for patients living with this ultra-rare and progressive disease,” says Dr. Susan Perlman, a clinical neurology professor at UCLA.

Skyclarys is the first treatment to show any clinical benefit for these patients, slowing the progression of the disease. After nine years of development, Huff says the team popped some champagne when the FDA approved the drug. ‘Very few companies make the transition to commercial enterprise with a truly novel biology with high clinical impact on desperately ill patients,” Huff says.

Reata’s approval to go to market with Skyclarys meant the drug research company had to become Reata, the commercial pharmaceutical firm. So the company kicked into gear to determine how to commercialize, manufacture, assure the quality, and sell the drug. “We are in heavy execution mode for the launch,” Huff says.

To help connect potential patients and their prescribing physicians to Reata’s treatments, the company has developed a concierge service called Reach as a patient resource to help providers learn about the medication, provide a care navigator to improve access, connect with a specialty pharmacy, and discuss affordability options.

Reata announced that it would charge $370,000 for Skyclarys, but out-of-pocket costs are expected to be nominal due to insurance and assistance programs. About 500 patients have already signed up to take the drug, Huff says.

One part of this journey that has made it especially rewarding, he adds, has been getting connected with the Friedrich’s Ataxia Research Alliance, one of the most organized patient organizations he has ever seen. Huff says it was FARA who approached Reata about developing a treatment for the condition.

“The entire Friedreich’s ataxia community including patients, clinicians, scientists, pharmaceutical companies, government agencies, and others, have worked collaboratively for decades to enable therapeutic development for this debilitating disease,” says Jen Farmer, CEO at Friedreich’s Ataxia Research Alliance. “Today, we celebrate the impact of an engaged patient community, and we are grateful to the FDA and Reata for working together on the approval of Skyclarys, the first therapy approved in the United States for adult and adolescent patients aged 16 years and older with Friedreich’s ataxia.”

As Reata works on manufacturing and distribution, the company is also focusing on the international market, where it will seek approval from international regulatory bodies.

Huff says that Skyclarys might only be the beginning for this avenue of treatment, as it can improve the function of a cell’s mitochondria—a significant factor in fighting other neurological conditions like Alzheimer’s, ALS, and Huntingdon’s disease. “There are many follow-on developmental opportunities,” Huff says. “We are expanding our pipeline with the same science.”

The post When Will Texas Physicians Be Able to Dispense Medication? appeared first on D Magazine.