Tag: FDA

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 […]

Biotech, Industry

Genetic Engineering Across the Tree of Life

September 21, 2020

Via: Genetic Engineering and Biotechnology News

Industrial bioengineering is now using genetically modified microbes to produce a wide array of products at industrial scale, including everything from biofuels to nutraceuticals such as resveratrol. But despite the diversity of output, the primary organisms producing them are modified […]

Clinical Trials, Research and Development

Scientists Solve High-Resolution Structure of Psychedelic Drugs Bound to Serotonin Receptors

September 18, 2020

Via: Genetic Engineering and Biotechnology News

Psychedelic drugs such as LSD, psilocybin, and mescaline cause severe and often long-lasting hallucinations, but they also show great potential in treating a number of serious psychiatric conditions, such as major depressive disorder. The results of new research headed by […]

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


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


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, 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 […]

Cell and Gene Therapy, Industry

Gene therapy: Novel targets for congenital blindness

September 2, 2020

Via: ScienceDaily

As many as 40,000 people in Germany suffer from retinitis pigmentosa. This hereditary disorder is characterized by loss of photoreceptors in the retina, and can be caused by mutations in many different genes. Depending on the nature of the underlying […]

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 […]