FDA
Alnylam Pharmaceuticals issued a proxy filing ahead of its May 18, 2022, Annual Meeting of Stockholders to inform stockholders of several items they can vote on at the end of the meeting.
FEATURED STORIES
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
The U.S. FDA cites concerns regarding clinical data for ChemoCentryx’s investigational rare autoimmune disease therapy avacopan. Shares in the company plunged 46.5% lower following the release of the document.
Please check out the biopharma industry’s COVID-19 stories that are trending for May 4, 2021.
Sarepta Therapeutics announced Monday that its next-generation PPMO candidate, SRP-5051, showed promise in a Phase II trial when used as a treatment for Duchenne muscular dystrophy in patients amenable to exon 51 skipping.
The U.S. FDA is expected to give the go-ahead for Pfizer and BioNTech’s COVID-19 vaccine for adolescents ages 12 and older within the week.
The U.S. FDA approved Chiesi Global Rare Diseases’ Ferriprox for treatment of transfusional iron overload caused by sickle cell disease (SCD) or other anemias in adults and children ages three years and older. This approval expands the use of the drug for patients with SCD or other anemias.
Roivant Sciences is combining with Montes Archimedes Acquisition Corp (MAAC). Once the deal is closed, outstanding shares and warrants of MAAC will be traded for newly issued shares and warrants of the company.
The regulatory nod marks the first time the FDA approved an SGLT2 inhibitor for the treatment of CKD regardless of diabetes status.
The U.S. FDA has released a Complete Response Letter (CRL) following its review of LEO Pharma’s tralokinumab. Further data on a device component is the issue brought to light by the recently completed Biologics License Application (BLA) review.
The U.S. FDA says it is unable to approve Biogen supplemental Biologic License Application (sBLA) for subcutaneously delivered TYSABRI® for the treatment of relapsing multiple sclerosis (MS), at least while the sBLA remains in its present form.
The FDA is threatening Acceleron with a $10,000 fine or criminal prosecution, charging the company with failure to post a summary of study data on its cancer combo dalantercept and axitinib in the ClinicalTrials.gov online database.