As developers of similar drugs sought signs of hope – despite negative safety signals – in the otherwise-favorable top-line phase III data with transthyretin (TTR) antisense inhibitor inotersen in familial amyloid polyneuropathy (FAP), Ionis Pharmaceuticals Inc. called out during its conference call one would-be competitor's candidate by name: patisiran, the RNAi therapy from Alnylam Pharmaceuticals Inc. Read More
MMJ Phytotech Ltd., of Perth, Australia, said its Israeli subsidiary, Phytotech Therapeutics Ltd., received Helsinki and Ministry of Health approvals to conduct a phase II study of PTL-201 capsules in treating spasticity-related symptoms of multiple sclerosis (MS). Read More
LONDON – The World Health Organization (WHO) is throwing its weight into the row over medicines pricing, summoning 200 delegates from governments, industry, patients' groups and payers to exchange views at a Fair Pricing Forum and start drawing up an international plan of action to curb the cost of drugs. Read More
In the second half of the year, Minerva Neurosciences Inc. plans to initiate a single phase III trial of lead candidate MIN-101 that will enroll about 500 individuals with schizophrenia to evaluate improvement in negative symptoms. If the trial succeeds, the FDA agreed the data could form the basis – in conjunction with findings from the company's phase IIb trial – for a new drug application (NDA) submission. Read More
U.S. lawmakers are asking the Centers for Medicare & Medicaid Services (CMS) to follow the law in how it reimburses for biosimilars by reversing a policy, adopted under the Obama administration, that lumps biosimilars under one Part B payment code while giving the reference biologic a unique code. Read More
TOKYO – Astellas Pharma Inc. is streamlining its product lineup by selling off rights to 16 of its long-listed products to LTL Pharma Co. Ltd. in a deal worth ¥20.1 billion (US$177 million), a move that will enable Astellas to focus on newer and more profitable drugs. Read More
The first therapeutic monoclonal antibody (MAb) that selectively targets activated intracellular cytosolic Ras mutant proteins, which are inaccessible to current antibodies, has been developed and assessed preclinically in a new South Korean study. Read More
Henri Termeer, long-time CEO of Genzyme Corp. and arguably one of the founding fathers of the current biopharma industry, died Friday at the age of 71. Read More
Genoa Pharmaceuticals Inc., of Seattle, completed a $62 million series A financing led by F-Prime Capital Partners and Edmond de Rothschild Investment Partners. Read More
The Robert J. Margolis Center for Health Policy at Duke University is forming a consortium to address key issues in advancing value-based payment for drugs, medical devices and gene technologies. Read More
Aerie Pharmaceuticals Inc., of Irvine, Calif., said the FDA has completed its initial 60-day review of the Rhopressa NDA and determined it is complete to allow for a substantive review. Read More
