FDA: Page 24
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Sarah Silbiger via Getty Images
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 -
Chip Somodevilla via Getty Images
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 -
Sarah Silbiger via Getty Images
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 -
David Paul Morris via Getty Images
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 -
Getty Images: Edited by BioPharma Dive
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 -
Courtesy of Eli Lilly
Coronavirus variants threaten to undermine another Lilly COVID-19 drug
One month after Lilly's first coronavirus antibody was pulled from market, the U.S. government stopped distributing its other treatment in two states.
By Ben Fidler • May 24, 2021 -
Sarah Silbiger via Getty Images
FDA seeking more consistency from cell, gene therapy developers, top official says
Several drugmakers have recently faced development delays after the FDA's asked for more information on how they measure the potency of their products.
By Ned Pagliarulo • May 19, 2021 -
Erik S. Lesser via Getty Images
Merck, with new breast cancer data, aims to rebound from FDA rejection
Study results could address concerns raised by FDA advisers who recently voted against approval of Keytruda in patients with early-stage breast cancer.
By Ben Fidler • May 13, 2021 -
Sarah Silbiger via Getty Images
Heron, on third attempt, secures FDA approval for non-opioid painkiller
The San Diego-based biotech's drug, which will now be sold as Zynrelef, had perviously been rejected by the agency in 2019 and 2020.
By Kristin Jensen • May 13, 2021 -
Sarah Silbiger via Getty Images
FDA unexpectedly grounds a gene therapy for a rare heart disease
Rocket Pharma's Danon disease treatment — key to the company's quiet rise over the past year — is the latest gene therapy to be put on hold by the agency. Executives predict only a short delay, however.
By Ben Fidler • May 11, 2021 -
Sean Gallup via Getty Images
FDA authorizes Pfizer's coronavirus vaccine for younger teens
The emergency clearance greatly expands the pool of people who can be vaccinated in the U.S. just as some states begin to report waning demand.
By Ned Pagliarulo • May 10, 2021 -
Courtesy of BioNTech
Pfizer, BioNTech are first to seek full FDA approval of a coronavirus vaccine
The milestone filing could pave the way for the shot's use beyond the pandemic and give employers the legal heft to require vaccination, a key step toward herd immunity in the U.S.
By Jonathan Gardner • May 7, 2021
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