FDA: Page 27
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In a first, FDA approves an 'interchangeable' biosimilar for diabetes
An injectable insulin from Viatris has become the first-ever biosimilar product that can be directly substituted for a marketed biologic, a long-awaited decision that could put pricing pressure on other diabetes drugs.
By Jonathan Gardner • July 29, 2021 -
Merck rebounds to win a milestone immunotherapy approval in early breast cancer
The FDA reversed an earlier decision to make Keytruda the first immunotherapy available for patients with early-stage breast cancer and also gave the drugmaker a full approval in advanced disease.
By Ben Fidler • July 27, 2021 -
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Bristol Myers withdraws Opdivo in liver cancer as fallout from FDA meeting continues
With the decision by Bristol Myers, each of the two accelerated cancer drug approvals an FDA advisory panel voted to overturn in April have now been voluntary withdrawals.
By Ben Fidler • July 26, 2021 -
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Ardelyx latest biotech surprised by unexpected FDA criticism of drug application
The FDA cited problems with Ardelyx's case for its kidney disease drug just weeks before an approval deadline — feedback one analyst described as "troubling" evidence of FDA inconsistency.
By Ben Fidler • July 20, 2021 -
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Merck to take on Pfizer with FDA OK of next-gen pneumonia vaccine
Approval of Merck's shot sets the stage for the two large pharmas to compete for market share with new pneumococcal vaccines that are meant to improve on older versions.
By Jonathan Gardner • July 19, 2021 -
FDA advisers push back on FibroGen anemia drug
Safety worries led to a near-unanimous vote against roxadustat in kidney disease patients, dimming the approval chances of what would be the first pill to boost red blood cells.
By Jonathan Gardner • July 16, 2021 -
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FDA flags rare side effect in new warning on J&J's coronavirus vaccine
The agency said the benefits of vaccination with J&J's shot still "clearly outweigh" the risks, which now include very rare cases of an immune-driven condition known as Guillain-Barré.
By Jonathan Gardner • July 12, 2021 -
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FDA, under fire for Alzheimer's drug approval, seeks investigation of review process
Janet Woodcock, the agency's acting head, asked the HHS inspector general to investigate contacts between Biogen executives and FDA staff as criticism mounts of the regulator's handling of the controversial approval.
By Ned Pagliarulo • Updated July 9, 2021 -
Permission granted by Biogen
FDA revises labeling of Biogen's Alzheimer's drug to emphasize early treatment
Aduhelm's approval last month, already highly controversial, was made more so by the agency's decision to clear the drug for a broad group of patients. New prescribing information more closely matches clinical testing criteria.
By Ned Pagliarulo , Ben Fidler • July 8, 2021 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
5 FDA decisions to watch in the third quarter
The agency is under pressure to grant full approvals to two coronavirus vaccines and faces important questions on how to handle the next Alzheimer's drugs after Aduhelm.
By Ned Pagliarulo , Ben Fidler • July 2, 2021 -
Permission granted by Biogen
Congress pressures FDA and Biogen on Alzheimer's drug approval, price
The agency's decision-making process as well as Biogen's pricing of Aduhelm at $56,000 per year are both under the microscope as the repercussions of the controversial OK continue to be felt.
By Jonathan Gardner • June 28, 2021 -
FDA advisers vote down Incyte cancer drug as agency takes tougher line
The committee voted 13-4 to recommend the FDA wait for more clinical trial data from Incyte, which is aiming to win approval for what would be the eighth PD-1 or PD-L1 inhibitor.
By Ned Pagliarulo • June 25, 2021 -
Courtesy of Eli Lilly
Reversing course, Lilly to seek fast approval for experimental Alzheimer's drug
The drugmaker said it will file an application with the FDA later this year for accelerated approval of donanemab, a change of plans that comes weeks after the FDA's controversial clearance of Biogen's Aduhelm.
By Ned Pagliarulo • Updated June 24, 2021 -
Sarah Silbiger via Getty Images
New Alzheimer's drugsFDA documents show how controversial Alzheimer's drug decision was reached
A group of statisticians who had argued for rejection were overruled, internal memos show, as high-ranking agency officials got behind an accelerated clearance for Biogen's drug.
By Jacob Bell , Ned Pagliarulo • June 22, 2021 -
Jacob Bell/BioPharma Dive
Public Citizen calls for top FDA officials to resign following Alzheimer's drug approval
The consumer group wants Janet Woodcock, Patrizia Cavazzoni and Billy Dunn to step down over last week's controversial approval of Aduhelm, which is expected to put immense strain on healthcare budgets.
By Jacob Bell • June 16, 2021 -
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Former FDA chief Hahn joins venture firm that launched Moderna
Hahn's appointment as chief medical officer of Flagship Pioneering is another example of FDA officials joining industry after their government service. Hahn's predecessor, Scott Gottlieb, sits on Pfizer's board of directors.
By Jonathan Gardner • June 15, 2021 -
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As trials progress, FDA weighs COVID-19 vaccine authorizations for children
An advisory panel could not reach consensus on how long or large trials in young children should be. Some experts argued falling infection rates might mean vaccination of kids under 12 is unnecessary.
By Jonathan Gardner • June 11, 2021 -
Permission granted by Biogen
The FDA approved Biogen's Alzheimer's drug. The company now has years to confirm it works.
Officially, Biogen has until 2029 to complete a study confirming Aduhelm's benefit. But the agency says it hopes to push the drugmaker to finish faster.
By Ned Pagliarulo • Updated June 9, 2021 -
Permission granted by Biogen
Deep Dive // New Alzheimer's drugsIn historic move, FDA approves a closely watched and controversial Alzheimer's drug
The decision cleared the way for what many predicted would become a lucrative treatment. But a high price and controversy over whether Biogen's Aduhelm benefits patients weighed heavily on the drug's launch.
By Jacob Bell • Updated June 7, 2021 -
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Former FDA official Abernethy joins Google health spinoff
The agency's former acting CIO pushed development of real world evidence as well as improved data sharing. At Verily, she'll head up the unit's clinical research business.
By Jonathan Gardner • June 3, 2021 -
Alkermes prepares for uncertain launch as FDA finally clears schizophrenia drug
Lybalvi is meant to be as effective as marketed antipsychotics but without the weight gain patients typically experience. Alkermes will introduce the drug into a competitive market, however.
By Jacob Bell • June 1, 2021 -
Retrieved from National Cancer Institute on September 27, 2019
In first, FDA approves KRAS-blocking cancer drug from Amgen
For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers. Lumakras is the first drug proven effective.
By Ned Pagliarulo • Updated May 29, 2021 -
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FDA restricts use of Intercept drug due to liver injury risk
An investigation linked the drug to severe injuries in about two dozen patients, leading the agency to add a new contraindication to the label.
By Kristin Jensen • May 27, 2021 -
'A hugely consequential decision:' How Biogen's Alzheimer's drug came to face the FDA
The FDA's decision to approve aducanumb could have far-reaching consequences for patients, Biogen and Alzheimer's research. Here's how the drug's review came about.
By Ned Pagliarulo • May 27, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Vir, GSK win US nod for another COVID-19 antibody drug as rival falters
Vir's sotrovimab arrives months after similar treatments from Eli Lilly and Regeneron. But the therapy could still play a role due to its apparent potency against variants that have challenged Lilly's drugs.
By Ben Fidler • May 27, 2021
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