CHICAGO – A week after he talked with BioWorld Today about his success in helping pharmaceutical firms backfill their dwindling pipelines with promising, early stage deals, Avalon Ventures partner Jay Lichter disclosed a multi-company arrangement designed to do just that in a big way for GlaxoSmithKline plc.
CHICAGO – Officials from the China Food and Drug Administration (CFDA) stammered through a question-and-answer period in which the audience sought the agency's definition of an "innovative" drug, its stance on orphan therapies and its policy with regard to biosimilars, during the first day of the BIO 2013 International Convention here.
Vertex Pharmaceuticals Inc.'s approach to cystic fibrosis (CF) – pairing the approved therapy Kalydeco (ivacaftor) as a "potentiator" with another compound, VX-661, as a "corrector" – gained market-pleasing, top-line, Phase II proof that sent the stock on a skyward ride.
Cancer Prevention Pharmaceuticals Inc. (CPP) is trying out its tumor-blocking approach in colon adenomas by way of a Phase III trial in a collaborative effort with the National Cancer Institute (NCI) that will enroll 1,340 survivors.
The FDA's Pulmonary-Allergy Drugs Advisory Committee gave its blessing to inhaled Breo (fluticasone furoate [FF]/vilanterol [VI]), the combination corticosteroid and long-acting beta2 agonist (LABA) for chronic obstructive pulmonary disease (COPD) from GlaxoSmithKline plc and Theravance Inc., though voting across several categories was mixed.
Disappointing, but hardly a message of doom: Such was the general view – and the opinion of the company – on Allergan Inc.'s complete response letter (CRL) for Levadex, an orally inhaled formulation of the intravenous migraine drug dihydroergotamine (DHE).
When it comes to getting venture capital (VC) deals done, the science and the financial terms naturally take center stage, but the personalities of the players need to mesh, too, for the best outcomes.
Word from the FDA that Acadia Pharmaceuticals Inc. will not need another Phase III trial in order to ask for approval of the oral tablet pimavanserin for Parkinson's disease psychosis (PDP) moved the likely launch date up about nine months, analysts estimated, and made at least some investors more sanguine about the chances for market clearance in Alzheimer's disease psychosis (ADP).
Backed by $16 million from investors that include Pfizer Inc.'s venture arm, a new orphan drug accelerator called Cydan LLC aims to spin out as many as five new companies in the first four years.
Analysts took as less serious one of two primary endpoints that fostamatinib, the oral spleen tyrosine kinase (syk) inhibitor for rheumatoid arthritis (RA), missed in Phase III trial, and focused skeptically instead on the successfully reached goal in the study, known as OSKIRA-1.
