Sunovion Pharmaceuticals Inc.'s $635 million buy of Cynapsus Therapeutics Inc. gained new validation with the success of a pivotal phase III trial testing the object of the deal, a sublingual version of the antiparkinsonian drug apomorphine.
Shares of Oxford, U.K.-based Summit Therapeutics plc (NASDAQ:SMMT) rose 12.9 percent to close at $13.78 Thursday on interim data showing that its Duchenne muscular dystrophy (DMD) candidate, ezutromid, appears to have helped reduce muscle fiber damage and increased levels of a protein called utrophin, seen to offer benefits in restoring and maintaining healthy muscle function.
Concerns over the clinical relevance and risk-worthiness of Puma Biotechnology Inc.'s Nerlynx (neratinib) in extended adjuvant use for women with early stage, HER2-positive breast cancer made it unlikely that the Europe's Committee for Medicinal Products for Human Use (CHMP) would support a marketing authorization application for the drug without "additional steps," Puma said.
A bumper crop of biopharma financings, highlighted by fresh fundraising at Tmunity Therapeutics Inc., Biocancell Ltd. and Ultragenyx Pharmaceutical Inc., and recently closed offerings at Beigene Ltd., Avexis Inc. and Arrowhead Pharmaceuticals Inc., highlight a strong start for the sector in 2018.
Shares of San Diego-based Vical Inc. (NASDAQ:VICL) fell 23 percent, or 43 cents, to $1.44 Monday as longtime partner Astellas Pharma Inc. took the wraps off top-line data showing that ASP-0113, a vaccine designed to prevent cytomegalovirus (CMV) disease and associated complications in hematopoietic stem cell transplant (HCT) recipients, failed to meet primary or secondary endpoints of the phase III study.
With the prospect of a U.S. federal government shutdown appearing ever more likely Friday, the potential tolls that action might take on the FDA, NIH and other federal elements crucial to industry's forward momentum became clearer in some respects, but not others.
Circle Pharma Inc., of South San Francisco, said its first collaboration with Pfizer Inc. has led to the identification of a series of bioavailable macrocyclic peptides capable of acting as potent and cell-permeable modulators of CXCR7.
SAN FRANCISCO – Exuberance over China's ascendant biopharma sector formed a near-deafening roar at the 6th Annual Wuxi Global Forum last week, where Ruyi He, chief scientist of the CFDA's Center for Drug Evaluation (CDE), spoke to the accelerating pace of the Republic's regulatory reform. In the past few years, he said, not only has the agency embraced a growing body of guidelines from its regulatory agency peers but has also gone on a hiring spree aimed at boosting efficiency at the agency, which has labored under criticism in past years. Having jumped from 600 CDE reviewers to 800 in just the last year, he said that the agency is now aiming to reach a total of 1,600 reviewers by 2020.
A Japanese cancer drug that Eiger Biopharmaceuticals Inc. hoped would help key subgroups of people with pulmonary arterial hypertension (PAH) failed to do so, missing both the primary and a key secondary endpoint of the phase II study, Liberty. The trial's failure marks the end of Eiger's pursuit of PAH with the drug, ubenimex, though it continues to test it in lymphedema.
