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Accelerated approval brings BIO members’ breakthrough cancer treatments to patients facing unmet need—here are three recent examples. Plus, a Purdue University official explains why a plan to use Bayh-Dole to control prices will harm innovation. (627 words, 3 minutes, 8 seconds) |
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Accelerated approval brings new cancer treatments to patients |
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Accelerated approval is accelerating the war against cancer, as the Food and Drug Administration (FDA) recently gave the nod to three new treatments meeting urgent unmet needs.
FDA grants accelerated approval to drugs meeting “surrogate endpoints that can reasonably predict whether a treatment will result in clinical benefit, such as tumor shrinkage,” according to BIO. “The pathway has successfully sped up the development of new medicines for people with life-threatening conditions and few treatment options.”
3 BIO member companies recently announced accelerated approval for breakthrough cancer drugs: - Amgen’s IMDELLTRA tripled life expectancy against the “persistently deadly” small cell lung cancer. The drug “activates the patient's own T cells” in patients who “have exhausted other options,” The New York Times reported Thursday.
- Bristol Myers Squibb’s Breyanzi, a CAR T cell therapy “for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy,” BMS announced Wednesday. “Historically, FL has been considered an incurable disease, and patients frequently relapse following front-line therapy, with prognosis worsening after each subsequent relapse.”
- AstraZeneca’s Enhertu, which “significantly outperformed standard chemotherapy at extending the time before tumor progression or death among patients with HR-positive, HER2-low metastatic breast cancer who had tried at least one prior line of endocrine therapy,” explained Fierce Pharma in April.
Why it matters: 1 in 5 people alive today will develop cancer in their lifetimes, with as many as 35 million cases expected to be diagnosed in 2050, according to recent American Cancer Society data.
The bottom line: “The facts clearly show the accelerated approval pathway is providing new hope and meaningful new treatments for patients to fight their disease,” according to BIO. More reading: BIO President & CEO John F. Crowley spoke at a panel organized by The Hill, The Future of Cancer Care, where he talked about incredible cancer innovations and the importance of policy to advance these cures—read more and watch highlights at Bio.News. |
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Bayh-Dole price control plan will kill tech transfer, says Purdue official |
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The technology transfer system that enables academic research to drive innovation is endangered by efforts to abuse the Bayh-Dole Act for drug price controls, writes Purdue University’s head of commercialization.
The 1980 Bayh-Dole Act allows universities and small businesses to own and commercialize inventions made with federal funding. The government can “march in” and give licensing rights to a third party—in limited circumstances—if the IP holder does not commercialize an invention that could benefit society.
The threat: The National Institute of Standards and Technology (NIST) is attempting to use the Bayh-Dole Act to “march in” and control drug prices—something BIO, bipartisan lawmakers, and American voters oppose.
Why it matters: Bayh-Dole has enabled “hundreds of breakthrough medicines and vaccines” and biotech for agriculture, writes Purdue’s Brooke Beier, who leads the university’s commercialization efforts. “If the government can arbitrarily impose upon this intellectual property, investors will hesitate to fund companies that attempt to commercialize federally funded research.”
The impact: “At Purdue, university research has led to the creation of over 350 innovative start-ups, which together have raised hundreds of millions of dollars and support good-paying jobs across Indiana and the nation,” Beier explains.
The big picture: “Under the proposed framework, dominant companies, less capitalized competitors, or even foreign rivals like China could petition the government to march in and forcibly relicense the valuable IP of small firms,” she continues.
What’s next: After receiving comments on the proposal, NIST will soon decide on policy. “For the sake of Indiana and the country at large, let’s hope common sense prevails and the administration jettisons this misguided march-in effort,” Beier concludes. |
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