Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two New Drug Applications (NDAs) for doravirine, the company’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1 infection in adults.
Novartis announced the initiation of SURPASS, a head-to-head clinical trial of Cosentyx® (secukinumab) versus proposed biosimilar adalimumab** in ankylosing spondylitis (AS). SURPASS is the first head-to-head clinical trial in AS investigating superiority of Cosentyx in slowing spinal bone damage versus proposed biosimilar adalimumab**. SURPASS is currently recruiting patients, with the 'first patient first visit' already achieved in November 2017.
Two months after expanding a licensing deal with Genentech, privately-held Arvinas LLC struck another lucrative deal with a major pharmaceutical company. Connecticut-based Arvinas inked a deal with Pfizer worth up to $830 million to develop small molecules that can degrade proteins.
Novartis’ CDK4/6 inhibitor Kisqali has picked up Breakthrough status in the US as an initial endocrine-based treatment in certain patients with breast cancer.
Scholar Rock has raised $47 million to take its treatment for spinal muscular atrophy (SMA) into the clinic. The series C tees up Scholar Rock to find out whether its myostatin blocker can best the underwhelming performance of one-time rivals from companies including Novartis.
New drug approvals all but screeched to a halt in 2016, with a measly 22 new OKs after a pair of bountiful years. But the FDA wasted no time in 2017, signing off on 12 drugs in the first quarter alone—besting its record for the same period of any year in recent history.
FLX Bio, Inc., a biopharmaceutical company focused on the discovery and development of oral small-molecule drugs to activate the immune system against cancer, today announced the completion of a $60 million Series C private financing. The financing included new investments from GV (formerly Google Ventures) and other undisclosed investors as well as existing investors including The Column Group, Kleiner Perkins, Topspin Partners and Celgene Corporation.
Roche (SIX: RO, ROG; OTCQX: RHHBY) and Ignyta, Inc. (NASDAQ: RXDX) today announced they have entered into a definitive merger agreement for Roche to fully acquire Ignyta at a price of US$ 27.00 per share in an all-cash transaction. This corresponds to a total transaction value of US$ 1.7 billion on a fully diluted basis. This price represents a premium of 74% to Ignyta’s closing price on 21 December 2017 and a premium of 71% and 89% to Ignyta’s 30-day and 90-day volume weighted average share price on 21 December 2017, respectively. The merger agreement has been unanimously approved by the boards of Ignyta and Roche.
Janssen Biotech, Inc. (Janssen) announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for apalutamide, an investigational, next-generation oral androgen receptor (AR) inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC). Currently, there are no FDA-approved treatments for patients with non-metastatic CRPC.
A new drug developed by Merck & Co and Pfizer Inc won U.S. approval on Wednesday to treat type II diabetes, the Food and Drug Administration(FDA) said, adding another competitor to a growing class of treatments.
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