RNAi specialist Dicerna Pharmaceuticals Inc.'s chief operating officer, James Weissman, told BioWorld that scientists inside and outside of the company have come to believe in what's called "the X hypothesis" in hepatitis B virus (HBV). "My view, though, as a person who has been in the pharmaceutical industry for decades, is who cares, anyway?" he said – as long as the drug works. He pointed out that, with the cholesterol therapy Lipitor (atorvastatin calcium) from New York-based Pfizer Inc., where he served in business development and marketing, "everybody had a different theory for why it lowered the incidence of heart disease. Nobody knew with certainty." Read More
Shares of Agile Therapeutics Inc. (NASDAQ:AGRX) trebled Thursday, rising 223.8% to $1.20 at the market's close following a near-unanimous FDA adcom vote the day before supporting approval for the company's transdermal contraceptive patch, Twirla (levonorgestrel/ethinyl estradiol). Read More
How vulnerable is the U.S. biopharma supply if China were to halt exports of active pharmaceutical ingredients (APIs)? No one knows. "We cannot assess the extent of U.S. dependence on China," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), said in testimony to a House subcommittee Wednesday. Read More
Significant progress is being made in the development of next-generation treatments for multiple myeloma. For that reason, investors and industry analysts alike will be anxiously awaiting the abstracts for the upcoming American Society of Hematology (ASH) annual meeting. Read More
With a $17 million series A fundraiser completed, Pinteon Therapeutics Inc., of Cambridge, Mass., is keeping its eyes on the phase I trial it started in September testing PNT-001, a tau antibody that targets cis-pT231 tau, a toxic epitope that drives neurodegenerative disease. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
