Catalyst Pharmaceuticals Inc., of Coral Gables, Fla., said it completed its rolling submission of a new drug application to the FDA for Firdapse (amifampridine phosphate) for the treatment of Lambert-Eaton myasthenic syndrome. Read More
Biodelivery Sciences International Inc., of Raleigh, N.C., appointed Joseph (Jody) M. Lockhart vice president of manufacturing and supply chain. Read More
The FDA published draft guidance for sponsors of investigational new drug application (IND) studies with recommendations for identifying and evaluating important safety information that must be submitted to the FDA and all participating investigators under the IND safety reporting regulations. Read More
Overactive bladder (OAB) and irritable bowel syndrome (IBS) aren't the sexiest indications in the drug development universe, but tens of millions of patients remain untreated or undertreated for the common, uncomfortable conditions. With that large unmet need in mind, Velicept Therapeutics Inc. recently closed the first tranche of a $21 million series B financing to advance an asset that could potentially address both. Read More
Drug- and device-makers wanting the FDA to close out concerns raised in warning letters could have a long wait. So far this year, the agency has issued 14 close-out letters to drug companies for manufacturing problems, promotion violations, and failure to pay facility fees or list products correctly. It's issued 81 closeout letters to device-makers. Read More
SHANGHAI – Astrazeneca plc, of London, is betting that a "made-in-China" label will shave years off the usual CFDA review and approval timelines that imported drugs face and will get its pipeline of therapeutics to Chinese patients much faster. Read More
Astrazeneca plc is buying 55 percent of privately held Acerta Pharma LLC, the developer of acalabrutinib, a phase III oral small-molecule Bruton's tyrosine kinase (BTK) inhibitor that it expects to transform the treatment of B-cell malignancies. Read More
Replicel Life Sciences Inc., of Vancouver, British Columbia, said the first injections of study products have been completed in a phase I trial evaluating RCS-01, its autologous cell-based skin rejuvenation product. Read More
