FDA
Vera Therapeutics’ atacicept, to be marketed as Trutakna, will go up against Novartis, Otsuka and possibly Vertex in the kidney disease primary IgA nephropathy after receiving an accelerated FDA approval.
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A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
When the variance can’t be modeled, even disciplined biotech investors stop deploying. Here’s the cheapest fix for biotech’s investability problem.
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The U.S. FDA approved Keytruda combined with Genentech’s Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
BioSpace takes a look at data released this week from some of the numerous ongoing clinical studies to advance potential therapies and treatment for disease. Here are some of them.
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.