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Category: Regulations


Cell and Gene Therapy, FDA, Industry, Regulations

FDA decision on Bristol Myers cell therapy could come down to the wire

September 22, 2020

Via: Biopharma Dive

Celgene gained rights to ide-cel through a 2018 deal with Bluebird bio, the experimental therapy’s original developer. When Bristol-Myers made its bid to buy Celgene, the two sides couldn’t agree to the long-term value of ide-cel, the now-approved multiple sclerosis […]


Cell and Gene Therapy, FDA, Industry, Regulations

Emmecell exits stealth mode as FDA greenlights clinical trials of cornea cell therapy

September 22, 2020

Via: FierceBiotech

Corneal transplantation can help people who are losing their sight thanks to degenerating corneas, but it’s “probably the most aggressive surgery” that already highly trained corneal specialists do, said Roger Goldberg, M.D., a retinal surgeon. “It’s not a decision they […]


FDA, Regulations

FDA Clears IND Application for Vaxart Oral COVID-19 Vaccine

September 16, 2020

Via: Contract Pharma

The U.S. Food and Drug Administration (FDA) has completed its review of Vaxart Inc.’s Investigational New Drug (IND) application for its Phase 1 clinical trial evaluating its oral COVID-19 vaccine candidate. “Our goal is to deliver the best, most elegant […]


FDA, News, Regulations

Trump health officials prepare to distribute coronavirus vaccine within 24 hours of OK from FDA

September 16, 2020

Via: CNBC

The U.S. government plans to transport a coronavirus vaccine to distribution sites across the U.S. within 24 hours after the Food and Drug Administration grants an emergency authorization or approval, senior administration officials said Wednesday. The government will use medical […]


FDA, Regulations

FDA ticks off list of grievances over California drug repackager’s quality issues in warning letter

September 11, 2020

Via: FiercePharma

Unlike drugmakers that make their meds in-house, a cottage industry of repackagers exists to resell premade drugs with shiny new labels. But what happens when one of those companies fails at its primary job: safely repackaging drugs? A California firm […]


FDA, Regulations

FDA chief says he has ‘no intention’ of overruling career staff on coronavirus vaccine decision

September 10, 2020

Via: CNBC

The head of the Food and Drug Administration on Thursday said he has “no intention” of overruling career scientists at the agency on an approval of a coronavirus vaccine even though he has the authority. FDA Commissioner Stephen Hahn said […]


FDA, News, Pricing, Regulations

Democratic senators grill U.S. health officials on Trump interference in coronavirus vaccine process

September 9, 2020

Via: CNBC

Democratic senators on Wednesday grilled U.S. health officials about whether President Donald Trump is interfering in the development of potential coronavirus vaccines. National Institutes of Health Director Dr. Francis Collins and U.S. Surgeon General Dr. Jerome Adams testified before the […]


FDA, Industry, Regulations, Vaccines

FDA Action Alert: Possible COVID-19 Action and Mallinckrodt’s Terlipressin

September 8, 2020

Via: BioSpace

It’s entirely possible that what we will be seeing most from the U.S. Food and Drug Administration (FDA) for the month of September is related to treatments and vaccines for COVID-19. In general, the vaccines probably will not have actionable […]


FDA, Manufacturing, Regulations, Research and Development

FDA scolds Mylan for ‘repeated’ manufacturing problems

September 4, 2020

Via: Biopharma Dive

Before legal troubles and a challenging generics market wiped out much of its value, Mylan was an industry titan with a glowing manufacturing record to match. “There was a time, of course, that the very thought of Mylan receiving an […]


FDA, Regulations

How COVID-19 is Changing FDA Approval and Clearance Processes

September 1, 2020

Via: BioSpace

The COVID-19 pandemic is changing the FDA irrevocably, resulting in a more dynamic, streamlined FDA that is more willing to embrace digital technology, according to panelists at the recent OC LIFe (Lifesciences Innovators Forum) virtual presentation, “COVID-19: Changes In FDA […]


FDA, Industry, Regulations, Vaccines

FDA Clears SPI’s Ebselen for Phase II COVID-19 Trials

August 31, 2020

Via: Contract Pharma

Sound Pharmaceuticals, Inc. (SPI) received clearance from the FDA to begin two Phase 2 studies of ebselen (SPI-1005) in COVID-19 patients. SPI-1005 is a novel anti-inflammatory drug which was recently shown to inhibit nCoV2 activity and viral replication. The two […]


FDA, Regulations

FDA Approves New Rapid Coronavirus Test

August 27, 2020

Via: Drugs.com

The first rapid coronavirus test that doesn’t need any special computer equipment to produce results was approved by the U.S. Food and Drug Administration on Wednesday. Made by Abbott Laboratories, the 15-minute test will sell for $5, giving it an […]