Researchers at the University of Texas at Dallas have gained new insight into sex differences in response to calcitonin gene-related peptide (CGRP) that may underlie the higher prevalence of migraine in females. Read More
Phasebio Pharmaceuticals Inc., of Malvern, Pa., priced its underwritten public offering of about 3.5 million shares at $12 each, granting underwriters a 30-day option to purchase up to an additional 537,975 shares of common stock at the public offering price. Read More
The FDA issued a safety labeling change order to Sprout Pharmaceuticals Inc., of Raleigh, N.C., for female sexual dysfunction drug Addyi (flibanserin) that requires the company to revise safety information as a result of the agency's review of postmarketing studies. Read More
89bio Ltd., of San Francisco, reported preclinical data on BIO89-100, a long-acting glycopegylated fibroblast growth factor 21 analogue, at the Annual Meeting of the European Association for the Study of the Liver in Vienna. In spontaneously diabetic obese cynomolgus monkeys, the drug produced statistically significant reductions in body weight, fasting plasma glucose, LDL cholesterol, triglycerides and hemoglobin A1c compared to the vehicle group. Read More
HONG KONG – A newly set up Japanese biotech is continuing the development of a potential first-in-class drug for the treatment of neuropathic pain associated with genetic mutations. The Kyoto-based firm, Alphanavi Pharma Co. Ltd., is a carve-out business venture from Sumitomo Dainippon Pharma Co. Ltd. Read More
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) has updated its requirements for risk management plans to be submitted with applications for new drugs and biologics. Read More
Last week, the FDA approved Dovato, the first two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received treatment for HIV. The drug combines dolutegravir, an integrase strand transfer inhibitor, and lamivudine, a nucleoside reverse transcriptase inhibitor (nuc). Read More
Arrowhead Pharmaceuticals Inc.'s plan to start an adaptive phase II/III trial in the second quarter of this year with ARO-AAT brought more attention to the busy therapeutic space around alpha-1 antitrypsin deficiency (AATD). Read More
VIENNA – One year after reporting a 75% decrease in acute intermittent porphyria (AIP) attacks from a phase I trial of its RNAi drug, givosiran, Alnylam Pharmaceuticals Inc. returned to the International Liver Congress once again, this time announcing a 74% decrease in its much larger phase III Envision trial. Read More
Johnson & Johnson (J&J) unit Janssen Pharmaceutical's accelerated approval Friday from the FDA for Balversa (erdafitinib) to treat adults with locally advanced or metastatic urothelial carcinoma (mUC) with the susceptible genetic alteration fibroblast growth factor (FGFR)3 or FGFR2 brought new attention to FGFR drug candidates, hardly in short supply. Once-daily, oral Balversa is the first FGFR kinase inhibitor to gain U.S. regulators' blessing. Read More
Shares of San Diego-based Tracon Pharmaceuticals Inc. (NASDAQ:TCON) fell 49% to 66 cents Friday as the company decided to quit testing its lead candidate, carotuximab (TRC-105), in cancer. The decision followed advice from independent experts who saw no likely benefit from combining the drug with Votrient (pazopanib, Novartis AG) in the phase III advanced angiosarcoma trial called Tappas. Read More
