HHS Watchdog To Review FDA’s Approval Of Aduhelm
The Department of Health and Human Services Office of Inspector General is set to review the process by which the Food and Drug Administration approved Biogen's Alzheimer's drug. Separately, Congress is set to try to fix medical waste and cost issues caused by distributing drugs in over-large vials.
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Watchdog Will Review FDA Approval Of Biogen's Alzheimer's Drug
The federal watchdog at the Department of Health and Human Services will review the process used by the Food and Drug Administration to approve the Alzheimer’s drug sold by Biogen, which has caused unprecedented controversy over regulatory standards. Specifically, the HHS Office of Inspector General will examine the accelerated approval pathway that the FDA increasingly uses to speed approvals for medicines to treat serious conditions and fill an unmet medical need. This was the pathway used by the agency two months ago when it OK’d the Aduhelm treatment for Alzheimer’s. (Silverman, 8/4)
In other pharmaceutical and biotech news —
Modern Healthcare:
Congress Eyes Crackdown Large, Wasteful Drug Vials
Imagine cracking open a vial of a $1,000 chemotherapy drug and injecting it into a cancer patient She only needs 1.3 milligrams but the vial contains double that amount. What happens to the rest? Oftentimes, it gets thrown in the trash. Patients, Medicare and private insurance foot the full bill anyway. Congress is set to crack down on the practice, which is the result of drug companies packaging expensive physician-administered drugs in single-use vials that are too large for the typical patient. (Hellmann, 8/4)
Stat:
Seeking Slice Of ARPA-H Pie, Patient Advocates Descend On Washington
President Biden’s vision for an ambitious new government research center is never quite the same. He’s said it will focus on diabetes and Alzheimer’s. He told a prominent ALS advocate that the agency would focus on his disease, too. Once, he mentioned obesity. And, of course, there is his most common refrain: that the new research branch will “end cancer as we know it.” The shifting vision is creating a lobbying frenzy among patient advocacy groups frustrated with the pace of research, all now scrambling to ensure they benefit from the gold rush of new research dollars and high-profile attention. (Facher, 8/5)
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Bayer Inks A $1.5 Billion Deal For A Biotech With A Proprietary Drug Discovery Platform
In a bid to quickly broaden its drug discovery abilities, Bayer (BAYRY) has reached a deal to acquire Vividion Therapeutics for $1.5 billion, the third time in two years the company has bought a small biotech with proprietary technology for uncovering medicines. Unlike the two earlier acquisitions, which gave Bayer entree to potential gene and cell therapies, the focus of this latest acquisition is primarily on oncology and immunology, although that can be expanded to other therapeutic areas. (Silverman, 8/5)
San Francisco Chronicle:
San Mateo County Sues McKinsey, Says Consulting Giant Fueled Opioid Crisis That Hurt Residents
San Mateo County has sued consulting giant McKinsey & Company, Inc. in federal court for what it says was the company’s role in helping opioid manufacturers boost sales in the county. The suit alleges that McKinsey’s work with Purdue Pharma, which manufacturers the opioid painkiller OxyContin, helped it to “turbocharge” sales of the drugs by advising Purdue to aggressively market the drug to certain doctors resulting in it being over prescribed. (DiFeliciantonio, 8/4)
The Wall Street Journal:
Former Theranos Patients Can Testify At Elizabeth Holmes Trial, Judge Rules
Former Theranos Inc. patients will be allowed to testify at the criminal fraud trial of the defunct blood-testing startup’s founder, Elizabeth Holmes, a federal judge ruled Wednesday. The decision by U.S. District Judge Edward Davila blocked a last-ditch attempt by Ms. Holmes to keep jurors from hearing the stories of patients who say they received inaccurate results from Theranos tests. (Randazzo, 8/4)
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Athira Cited Altered Studies In $15 Million NIH Grant Application
Biotech company Athira Pharma, which is in turmoil after its chief executive was found to have published research containing altered images, now faces a new concern: It cited the allegedly doctored papers in a federal grant application. This creates the potential for the government or whistleblowers to pursue legal action to force the company to repay not only the $15 million it received to fund its work but also additional penalties. (Goldhill, 8/5)
CBS News:
Tech Advances Offer New Tools In The Fight Against Skin Cancer
This year, it's estimated that more than 100,000 Americans will be diagnosed with melanoma, the most serious form of skin cancer. But there's encouraging news in the battle against the disease, in the form of revolutionary new ways to screen for it. One innovation is an oddly shaped machine that has 92 cameras. Dr. Allan Halpern, chief of dermatology at Memorial Sloan Kettering Cancer Center, showed CBS News how it works: The cameras shoot simultaneously, and within minutes, a software program builds a three-dimensional image of the patient's body in precise detail. (Lapook, 8/4)
Stat:
With A Nudge From AI, Ketamine Emerges As Potential Rare Disease Drug
In the seven difficult years since their son Mateo was diagnosed with a rare disease, Victoria Malvagno and Frank Solorzano have been waiting for medicine to catch up with their lives. Doctors tested Mateo for hundreds of conditions before they finally determined he was one of only a few hundred people in the world with a neurodevelopmental condition called ADNP syndrome. Even with a diagnosis in hand, just getting through each day has been a full-time job. Mateo communicates mostly nonverbally, and his parents must constantly be on alert to make sure he doesn’t hurt himself. For years, they have muddled through managing his many symptoms piecemeal, because there’s no treatment approved for the rare genetic disease. (Palmer, 8/5)
