FDA
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Contamination concerns spur FDA call for nationwide withdrawal of heartburn drug
Some pharmacies and manufacturers had already discontinued distribution of Zantac due to impurities involving a probable human carcinogen.
By Jonathan Gardner • April 01, 2020 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
Under pressure, FDA touts speedy coronavirus drug development
By redeploying staff and request "triaging," the agency says it has streamlined its process for approving use of experimental drugs for COVID-19.
By Jonathan Gardner • April 01, 2020 -
Courtesy of Bristol-Myers Squibb
With latest FDA submission, Bristol Myers keeps pace with Celgene milestones
Bristol Myers' second cancer cell therapy is now on track to be approved before the deadline set in its $74 billion acquisition of Celgene last year.
By Jonathan Gardner • March 31, 2020 -
Novartis
No sanctions for Novartis as FDA ends review of gene therapy violations
Quietly completing an inspection review, the FDA indicated it will not penalize Novartis for submitting altered data in its approval application for Zolgensma.
By Ned Pagliarulo • March 30, 2020 -
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FDA clears emergency use of malaria pills to treat COVID-19
The unusual authorization, granted by the agency over the weekend, allows the federal government to distribute millions of doses of the drug to states.
By Ned Pagliarulo • March 30, 2020 -
5 FDA approval decisions to watch in the 2nd quarter
The FDA's focus is squarely on responding to COVID-19, yet the agency continues to review new drugs for other diseases. Among them: Roche's SMA therapy risdiplam and Intercept's NASH drug.
By Jacob Bell , Ben Fidler • March 30, 2020 -
Despite another delay, Intercept says its NASH drug remains on track
The coronavirus outbreak, though, adds more uncertainty to what will be a closely watched regulatory review of Intercept's therapy.
By Ben Fidler • March 26, 2020 -
Courtesy of Bristol-Myers Squibb
Bristol Myers investors breathe easier as multiple sclerosis drug approved by FDA
Regulatory clearance for Zeposia is the first of three drug approval milestones that must be met for former Celgene shareholders to see the full value of the 2019 acquisition.
By Jonathan Gardner • March 26, 2020 -
Getty Images
In rare move, Gilead gives up 'orphan' status for experimental coronavirus drug
After sparking controversy, the biotech asked the FDA to rescind a designation designed to encourage research into therapies for rare diseases.
By Jonathan Gardner • March 25, 2020 -
Courtesy of Roche
Leukemia drug from Roche, AbbVie extends survival, study finds
Paired with chemotherapy, Venclexta succeeded in a Phase 3 acute myeloid leukemia trial just weeks after falling short in another combination study.
By Jonathan Gardner • March 23, 2020 -
Remdesivir, chloroquine move to forefront as White House tries to speed coronavirus response
Neither drug is approved for COVID-19, but officials seek to quickly study both in hopes of finding an answer for U.S. coronavirus patients.
By Jonathan Gardner • March 19, 2020 -
Jacob Bell
FDA scales back domestic inspections amid coronavirus outbreak
The agency's announcement comes a little over a week after it postponed nearly all overseas inspections, which are a critical oversight tool.
By Kristin Jensen • March 19, 2020 -
Jacob Bell / BioPharma Dive
FDA maps out plan for trials as coronavirus starts to threaten drug research
The agency is trying to get ahead of what could be widespread protocol changes to ongoing clinical trials.
By Ben Fidler • March 18, 2020 -
Regeneron and Sanofi speed Kevzara into coronavirus trials
Positive signs from a Chinese test of Roche's Actemra support the companies' decision to start studying their anti-inflammatory drug against COVID-19.
By Jonathan Gardner • March 16, 2020 -
Coronavirus spread prompts FDA to postpone nearly all overseas inspections
The agency's decision was based on U.S. government travel restrictions, but it said "alternative tools and methods" will help it maintain oversight.
By Jonathan Gardner • March 10, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from https://www.flickr.com/photos/nihgov/49565662436/in/album-72157713108522106/.
Tracking biopharma's response to the new coronavirus
The ongoing outbreak is a huge test for the biopharmaceutical industry and its ability to supply, develop, and test new drugs without disruption. Keep up with all of BioPharma Dive's coverage here.
By Jacob Bell • UPDATED: March 26, 2020 at noon -
Brian Tucker / BioPharma Dive
FDA, FTC put drugmakers on notice about tactics to block biosimilars
A joint agency meeting called out deceptive advertising and anti-competitive practices that may have kept the U.S. from catching up to Europe in establishing a market for lower-priced biologics.
By Jonathan Gardner • March 09, 2020 -
Courtesy of Centers for Disease Control and Prevention
$8.3B in coronavirus funding set in motion as federal agencies ramp up response
The bill approved by both houses of Congress provides more than $2 billion to BARDA, and requires treatments developed using taxpayer money be available to the U.S. government at a "fair and reasonable price."
By Shannon Muchmore • UPDATED: March 5, 2020 at 4:55 p.m. -
Sanofi wins US approval for myeloma drug key to its cancer ambitions
Sarclisa is the first cancer drug wholly owned by Sanofi to win an FDA OK in a decade — a milestone in the pharma's bid to play a larger role in oncology.
By Ned Pagliarulo • March 02, 2020 -
FDA seeks 'right balance' as it allows immediate use of coronavirus tests
"We are not changing our standards for issuing emergency use authorizations," said agency chief Stephen Hahn as the FDA works to expand U.S. testing.
By Susan Kelly • March 02, 2020 -
Jacob Bell
FDA reports first drug shortage due to coronavirus impact
Supplies of the drug, which the FDA did not identify, ran short as a result of issues at a site that produces the active ingredient. Other options are available, the agency said.
By Ned Pagliarulo • UPDATED: March 2, 2020 at 2:55 p.m. -
FDA pushes back decision on Zogenix epilepsy drug
Shares sank on concerns about the future of the drug designed to treat Dravet syndrome, a rare form of epilepsy.
By Kristin Jensen • Feb. 27, 2020 -
Jacob Bell / BioPharma Dive
FDA monitoring impact of coronavirus outbreak on medical product supply
The agency postponed drug and device inspections in China that were scheduled for February, limiting its oversight of a key country in the medical supply chain.
By Nick Paul Taylor • Feb. 18, 2020 -
Jacob Bell / BioPharma Dive
Cancer concerns knock Eisai's weight loss drug from market
Eisai has agreed to remove Belviq after the FDA said a post-marketing study found a "range of cancer types" appeared to develop more frequently in patients taking the drug.
By Jacob Bell • Feb. 14, 2020 -
Dollar Photo Club
Biogen dips as Alzheimer's drugs from Lilly, Roche fail again
Analysts have said that, should the DIAN-TU study miss, it may further paint Biogen's aducanumab and the positive Phase 3 data it generated as an "artifact of luck" within a series of failed amyloid-targeting drugs.
By Jacob Bell • Feb. 10, 2020
