Taking up the matter of Novartis AG's secukinumab, the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) provided developers of interleukin-17 (IL-17) blockers for psoriasis with an idea of how the agency might take the risk-benefit profile of the class. Read More
R-Tech Ueno Ltd., of Tokyo, started a phase I clinical trial for RTU-1096, which is a vascular adhesion protein-1 (VAP-1) inhibitor with anti-inflammatory and immunomodulatory effects. Assuming safety and tolerability are confirmed with a single dose, the company will further examine its safety, tolerability, and pharmacokinetics with repeated doses. Read More
The U.S. government is putting a hold on funding for new research projects that could enhance the pathogenicity or transmissibility of influenza, MERS or SARS viruses. It also is encouraging researchers currently conducting such gain-of-function projects – regardless of the source of their funding – to voluntarily pause their work while the National Science Advisory Board for Biosecurity and the National Research Council reassess the risks and benefits of such research. Read More
Eisai Inc., of Woodcliff Lake, N.J., said the FDA accepted for review the company's supplemental new drug application (sNDA) for its in-house-discovered AMPA receptor antagonist perampanel to treat primary generalized tonic-clonic seizures, a severe form of seizures, in patients 12 years and older. Read More
Chemocentryx Inc., of Mountain View, Calif., reported that patients taking a higher dose of vercirnon (CCX282-B, Traficet-EN) for Crohn's disease during the phase III SHEILD-4 study experienced improved response and remission rates when taking a 500-mg dose of the drug twice-daily instead of just once-daily. Read More
It's official. The board of directors at Dublin-based Shire plc agreed on Monday with Abbvie Inc. that its proposed $55 billion purchase of the Irish company is not going to happen. Now Abbvie must write a check for a $1.635 billion break-up fee. Read More
HONG KONG – Biotech stocks have generally avoided the lackluster performance that has characterized stocks in China and Hong Kong in the last quarter. A spate of acquisitions and greater investments in research and development have helped push forward an ongoing consolidation of the market and supported share prices. Read More
Regeneron Pharmaceuticals Inc. and Sanofi SA began dosing patients in the first of several planned phase III studies of the potential blockbuster dupilumab (REGN668/SAR231893). Read More
Newlink Genetics Corp., which has kept its head down and plowed forward in an approach reflective of its Ames, Iowa, heritage, earned validation of those efforts in a big way, inking an exclusive global license with Roche AG unit Genentech Inc. that could exceed $1 billion. Read More
When Celgene Corp. reported that it was shelling out a whopping $710 million up front to little known privately held Nogra Pharma Ltd. to develop and commercialize GED-0301, an oral antisense DNA oligonucleotide targeting Smad7 mRNA for the treatment of moderate to severe Crohn's disease (CD), eyebrows were raised by analysts who follow the company. Read More
LONDON – The polymerase chain reaction (PCR), one of the most important technologies in the whole of DNA science, a central technique in biochemistry and molecular biology, and the basis of a $30 billion industry, is 30 years old. Read More
Immunomedics Inc., of Morris Plains, N.J., said the EMA granted orphan drug status for its solid tumor antibody-drug conjugate (ADC), isactuzumab govitecan, or IMMU-132, to treat pancreatic cancer. Read More
