FDA
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Courtesy of Roche
First oral drug for spinal muscular atrophy approved by FDA
Approval of Evrysdi, from Roche and PTC Therapeutics, adds a third option for treating the neuromuscular disease, joining Spinraza and Zolgensma.
By Ben Fidler • Aug. 07, 2020 -
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FDA agrees to review Biogen's Alzheimer's drug
The agency's decision kicks off a historic and dramatic regulatory review, as significant lingering questions surround aducanumab's approval chances.
By Jacob Bell • Aug. 07, 2020 -
Permission granted by Veradigm
Sponsored by VeradigmAdvancing cardiac care through health information technology
A talk with the American College of Cardiology about how they are working with Health IT to deliver their guidance to the point-of-care.
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FDA rejects a peanut allergy treatment, sinking a small biotech's shares
Given the long list of requirements in the FDA's rejection letter, DBV Technologies likely has years of work ahead to win approval of Viaskin Peanut.
By Jacob Bell • Aug. 04, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49565158908/in/album-72157713108522106/.
AstraZeneca signals it won't wait for US data to seek clearance of coronavirus vaccine
The British drugmaker indicated on a conference call that data from trials already underway in the U.K., Brazil and South Africa will be sufficient to ask regulators to approve the vaccine.
By Jonathan Gardner • July 30, 2020 -
Courtesy of Bristol-Myers Squibb
Bristol Myers resubmits cancer cell therapy, lifting investors' chance at payout
A surprise refusal by the FDA in May to review Bristol Myers' application put at risk a conditional payment promised as part of the pharma's Celgene deal.
By Ben Fidler • July 29, 2020 -
Side effects don't stop FDA panel from backing GSK blood cancer drug
An approval decision on what could be a first-in-class multiple myeloma drug is due this month, but the FDA will need to weigh safety concerns against the panel's unanimous support.
By Jonathan Gardner • July 15, 2020 -
GlaxoSmithKline
FDA documents reveal doubts about GSK blood cancer drug
Eye-related side effects could derail the leading drug that homes in on a new multiple myeloma target, just as rival therapies progress toward FDA review.
By Jonathan Gardner • July 10, 2020 -
FDA plans to restart domestic inspections, depending on local coronavirus trends
The agency aims to resume some on-site surveillance the week of July 20 after shutting down non-critical inspections in March due to the COVID-19 outbreak.
By Maria Rachal • July 10, 2020 -
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Biogen submitted its Alzheimer's drug for approval. Now what?
The later-than-expected filing is just the first of many hurdles Biogen faces in trying to get aducanumab approved. Some analysts on Wall Street don't have high hopes for the drug's chances.
By Jacob Bell • July 08, 2020 -
Jacob Bell / BioPharma Dive
Merck hits rare FDA setback for cancer drug Keytruda
The regulator declined to grant a speedy approval for Keytruda and Lenvima in liver cancer, citing the recent clearance of another regimen.
By Kristin Jensen • July 08, 2020 -
5 FDA approval decisions to watch in the 3rd quarter
The next few months could bring approvals for BioMarin's hemophilia gene therapy, a spinal muscular atrophy drug from Roche and a DMD treatment from NS Pharma.
By Ned Pagliarulo , Jonathan Gardner • July 08, 2020 -
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FDA insists it 'will not cut corners' in coronavirus vaccine approvals
New guidelines released by the agency detail what reviewers will require from drugmakers before approving or making available any coronavirus vaccine.
By Ned Pagliarulo • June 30, 2020 -
Jacob Bell / BioPharma Dive
Intercept's NASH drug faces its biggest delay yet
The FDA rejected obeticholic acid, asking for more data. If the agency ends up requiring outcomes results too, it could set Intercept's approval hopes back by two years or more.
By Jacob Bell • June 29, 2020 -
Zogenix caps tumultuous ride with FDA OK for Dravet drug
The agency approved Zogenix's drug Fintepla after an earlier rejection and two delays, setting up potential commercial competition with GW Pharmaceuticals.
By Ben Fidler • UPDATED: June 27, 2020 at 11:20 a.m. -
Dufour, Tia. (2020). "White House Press Briefing" [Photograph]. Retrieved from Flickr.
Pandemic pushes FDA to 'accelerate' real-world evidence efforts, Hahn says
The agency has grappled with how to use real-world data in regulating drugs and medical devices, but is now leaning on it to update emergency use authorizations, FDA chief Stephen Hahn said.
By Maria Rachal • June 19, 2020 -
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With latest Keytruda approval, Merck beats Bristol Myers to a new immunotherapy target
The FDA decision validates a genetic cancer measure known as tumor mutational burden, which has been studied in multiple trials but previously never led to an approval.
By Ben Fidler • June 17, 2020 -
Jacob Bell / BioPharma Dive
FDA revokes emergency clearance for hydroxychloroquine, citing new data, risks
Negative results from two large studies in the U.S. and the U.K. factored into the regulator's reversal, which comes six weeks after it controversially authorized the malaria pill.
By Ned Pagliarulo • June 15, 2020 -
Jacob Bell
AstraZeneca spinout wins first FDA approval 2 years after launch
Viela Bio can now call itself a commercial-stage company, but its new drug Uplizna will compete with existing therapies in the rare neurological disease it just got approved to treat.
By Jonathan Gardner • June 12, 2020 -
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Lilly wins first-ever FDA approval for drug that can spot Alzheimer's 'tau tangles'
Tauvid, which identifies the size and spread of tau protein clusters in the brain, could help Alzheimer's researchers as they shift away from a long-dominant focus on amyloid beta.
By Jacob Bell • May 29, 2020 -
Jacob Bell / BioPharma Dive
Contaminated diabetes drugs raise red flag for FDA oversight
The Food and Drug Administration is reaching out to drug manufacturers after finding some metformin pills were contaminated with the carcinogen NDMA.
By Jacob Bell • UPDATED: May 29, 2020 at 11:03 a.m. -
Intercept shares fall as FDA again delays closely watched NASH drug
The FDA has asked for more data on obeticholic acid, which could be the first-ever marketed medicine for non-alcoholic steatohepatitis. The latest delay means the drug likely won’t be approved by the agency's June 26 deadline.
By Jonathan Gardner • May 22, 2020 -
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Sunovion crowds a new group of Parkinson's drugs, with uncertain sales prospects
Kynmobi has become the fourth drug the FDA has approved since late 2018 for the "off" episodes Parkinson's disease patients experience. The coronavirus pandemic may complicate an already challenging launch.
By Ben Fidler • May 22, 2020 -
AstraZeneca
AstraZeneca, Merck race past Clovis as PARPs break into prostate cancer
The approvals of Lynparza and Rubraca within days of one another mark the arrival of PARP inhibitors as treatments for prostate cancer — a role that could grow in the coming years.
By Ben Fidler • May 20, 2020 -
Courtesy of Bristol-Myers Squibb
Bristol Myers, trailing Merck in lung cancer, finally wins FDA OK for immunotherapy combo
The long-sought approval of Opdivo and Yervoy gives Bristol Myers an entry into the competitive first-line lung cancer drug market after years of setbacks.
By Ben Fidler • May 18, 2020
