FDA: Page 27
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Courtesy of BioNTech
In historic decision, FDA clears coronavirus vaccine from Pfizer, BioNTech
The vaccine was the first authorized for emergency use in the U.S. after a large study showed it to be highly protective against COVID-19, a landmark moment amid a worsening pandemic.
By Jonathan Gardner • Dec. 11, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
FDA advisers back Pfizer, BioNTech vaccine, clearing way for emergency approval
In a statement Friday, FDA Commissioner Stephen Hahn said the agency would "rapidly work toward finalization and issuance" of an authorization for the shot.
By Ned Pagliarulo • Updated Dec. 11, 2020 -
Courtesy of BioNTech
A play-by-play of the historic FDA meeting on Pfizer and BioNTech's coronavirus vaccine
A panel of vaccine and infectious disease experts met Thursday to public vet the drugmaker's study results, eventually voting 17-4 in support of the vaccine after nearly nine hours of discussion.
By Ben Fidler , Jonathan Gardner , Ned Pagliarulo • Updated Dec. 9, 2020 -
Courtesy of BioNTech
FDA scientists appear supportive of Pfizer, BioNTech's coronavirus vaccine
Agency staff didn't raise any red flags in their review of the companies' study results, documents released ahead of a key advisory committee meeting Thursday show.
By Ned Pagliarulo • Updated Dec. 8, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Regeneron COVID-19 drug, used to treat Trump, cleared for emergency use
The drug is the second antibody-based treatment to win FDA emergency authorization this month, though supplies of both are very limited.
By Ben Fidler • Nov. 22, 2020 -
Pfizer, BioNTech ask FDA for emergency approval of coronavirus vaccine
The companies expect immunizations with their shot, if approved, could begin in high-risk groups by the middle to end of December.
By Ned Pagliarulo • Updated Nov. 20, 2020 -
Permission granted by Bristol-Myers Squibb
FDA delays decision on Bristol Myers cell therapy, putting Celgene deal payouts in jeopardy
Travel restrictions have made it difficult for the regulator to inspect a plant used to make the treatment, meaning the drugmaker could miss a deadline critical to former Celgene shareholders.
By Jonathan Gardner • Nov. 17, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
FDA unexpectedly rejects Alkermes schizophrenia drug, citing manufacturing concerns
Though Alkermes believes it can quickly resolve the issues cited by the agency, the complete response letter nonetheless delays approval of a drug that's critical to the company's hopes of a turnaround.
By Kristin Jensen • Nov. 17, 2020 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Eli Lilly wins FDA emergency clearance for COVID-19 antibody drug
The regulator approved Lilly's synthetic antibody treatment for emergency use, but short supplies and logistical challenges could limit its initial impact.
By Ben Fidler • Nov. 9, 2020 -
Jacob Bell/BioPharma Dive
5 takeaways from the FDA's high-stakes meeting for Biogen's Alzheimer's drug
The expert panel's decidedly negative vote on aducanumab raised questions about the drug's future, as well as the credibility of the FDA.
By Jacob Bell , Ned Pagliarulo , Ben Fidler • Nov. 9, 2020 -
FDA advisers vote against Biogen's Alzheimer's drug, leaving its future in doubt
In a tense meeting, a group of experts found Biogen and the FDA's case for aducanumab unpersuasive, voting overwhelmingly against the drug.
By Jacob Bell , Jonathan Gardner , Ned Pagliarulo • Updated Nov. 7, 2020 -
Courtesy of BioMarin Pharmaceutical
BioMarin, stung by FDA rejection, pressed on path forward for 2 key drugs
Roctavian, the biotech's hemophilia gene therapy, was turned down by the FDA in August, while an important rare disease drug is now under review.
By Ned Pagliarulo • Nov. 6, 2020 -
Who would get Regeneron's COVID-19 antibody treatment?
The drug, now being considered for emergency clearance by the FDA, seems to work best in patients whose immune systems haven't responded to infection. Fast antibody testing, however, is spotty.
By Jonathan Gardner • Nov. 5, 2020 -
Biogen surges as FDA reviewers appear supportive of Alzheimer's drug approval
Documents made public ahead of a key advisory meeting Friday revealed an FDA more willing than expected to accept Biogen's controversial case for approval of aducanumab.
By Ned Pagliarulo , Jacob Bell • Updated Nov. 4, 2020 -
Jacob Bell/BioPharma Dive
5 takeaways from the FDA's closely watched coronavirus vaccine meeting
Experts convened by the regulators debated how much data would warrant an approval, while pressing government officials on their distribution plans.
By Ned Pagliarulo , Jonathan Gardner • Oct. 24, 2020 -
Permission granted by University of Maryland School of Medicine
AstraZeneca, J&J cleared to restart major coronavirus vaccine studies
The U.S. trial of AstraZeneca's shot has been paused over safety concerns since early September, while J&J's was halted in mid-October.
By Ned Pagliarulo • Updated Oct. 24, 2020 -
At key meeting, FDA advisors debate if early coronavirus vaccine approvals may compromise trials
An emergency clearance is expected for the first vaccine proven effective. But early availability of a shot could jeopardize ongoing studies, and may make tests of other candidates more difficult.
By Ned Pagliarulo • Oct. 23, 2020 -
Permission granted by Gilead Sciences
Gilead's Veklury becomes first FDA-approved drug for COVID-19
The U.S. regulator granted a full approval after allowing emergency use earlier this year. New results from an WHO study, however, raise questions about the drug's ultimate effectiveness.
By Ben Fidler • Updated Oct. 23, 2020 -
Lilly hires consultant to help fix issues at COVID-19 drug manufacturing plant
The New Jersey facility that ran afoul of FDA manufacturing standards is one of several Lilly is using to produce coronavirus antibody drugs.
By Kristin Jensen • Oct. 22, 2020 -
Permission granted by Robert Hood / Fred Hutchinson Cancer Research Center
Q&ACoronavirus vaccine trial leader Larry Corey on the tough FDA, policy decisions to come
The co-leader of an NIH network of coronavirus prevention studies spoke with BioPharma Dive about the FDA's big vaccine meeting this week and what will come next.
By Ben Fidler • Oct. 20, 2020 -
Pfizer won't seek FDA clearance of coronavirus vaccine until mid-November, CEO says
An unusual letter from Pfizer chief Albert Bourla confirms that the drugmaker won't file for an approval of its experimental shot, assuming positive results, before the U.S. presidential election.
By Ben Fidler • Oct. 16, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
5 questions ahead of this week's FDA meeting on coronavirus vaccines
Normally staid affairs, this Thursday's advisory committee meeting will be closely watched and could set expectations for how the FDA will approach any future vaccine approval.
By Jonathan Gardner • Oct. 16, 2020 -
FDA approves Regeneron antibody drug as first Ebola virus treatment
Research for the drug, now cleared as Inmazeb, helped Regeneron jumpstart its fast development of an antibody therapy for COVID-19.
By Ned Pagliarulo • Oct. 14, 2020 -
Alkermes' comeback bid boosted by FDA panel backing for schizophrenia drug
While the committee's votes in favor of ALKS 3831 make an approval more likely, the drug's effects on patients also taking opioids could limit its use.
By Ben Fidler • Oct. 12, 2020 -
Courtesy of Regeneron Pharmaceuticals
Regeneron follows Lilly in asking for emergency approval of COVID-19 antibody drug
The two antibody treatments are now being reviewed by the FDA, although limited supply could mean their impact won't be felt for months, even if they are cleared for use.
By Ben Fidler • Oct. 8, 2020
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