FDA
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
FEATURED STORIES
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Less than two weeks after Ginkgo Bioworks announced a merger with SPAC Soaring Eagle Acquisition Corp., it announced a collaboration partnership with Biogen.
Two of Merck’s Phase III pediatric trials show 15-valent pneumococcal conjugate vaccine, V114, may be safe and effective in healthy children.
Eli Lilly’s SURPASS-4 trial program shows tirzepatide, significantly reduced blood glucose levels and body weight better than insulin glargine in adult patients with type 2 diabetes.
The House Select Subcommittee on the Coronavirus Crisis questioned executives from Emergent BioSolutions as part of a congressional probe.
Shares of Voyager Therapeutics fell in aftermarket trading after its CEO and CMO announced plans to depart the company following clinical setbacks with a Parkinson’s disease program.
Several biopharmaceutical companies have submitted NDAs to the U.S. FDA covering treatment indications ranging from an opioid overdose, bipolar disorder and rare disease.
X-Vax Technology is ready to submit an IND application to the U.S. FDA for its experimental herpes vaccine against HSV-1 and -2. Here’s what you need to know.
The FDA further delays Iovance’s filing for its TIL therapy as it requests additional data on the treatment’s potency assays.
FDA says it is possible booster shots would be necessary for fully vaccinated individuals within a year even though vaccines are highly effective at COVID-19 prevention.
BMS inked a collaboration agreement with Exscientia that can leverage AI to speed the discovery of drug candidates in therapeutic areas, including oncology and immunology.