Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He... read more
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He... read more
Pfizer received a Complete Response Letter from the FDA on 4/23/18 highlighting the need for additional technical information. Though this is a setback for Pfizer's Herceptin biosimilar program,... read more
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) announced on 4/24/18 that the US Food and Drug Administration (FDA) has approved an expanded indication for Trelegy Ellipta (... read more
Celgene Corporation (NASDAQ:CELG) announced on 4/24/18 additional phase III data analyses evaluating the efficacy and safety of ozanimod, a novel, oral, selective sphingosine 1-phosphate 1 (S1P1... read more
Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing Pentarins as a new class of potent and selective cancer medicines, announced on 4/24/18 that it... read more
Surface Oncology announced on 4/23/18 the closing of its initial public offering of 7,200,000 shares of common stock at a public offering price of $15.00 per share. The gross proceeds from the... read more
Patients with relapsing remitting multiple sclerosis (RRMS) who received Sanofi Genzyme’s Lemtrada (alemtuzumab) experienced effects of treatment on disease activity that were maintained over... read more
NuProbe Global will commercialize the Harvard Wyss Institute's DNA nanotechnology-based variant-detecting method as a fast, low-cost and multiplexed molecular diagnostic for different disease... read more
GENFIT announced on 4/23/18 that the Data Safety Monitoring Board (DSMB) issued a new positive recommendation for the continuation of the RESOLVE-IT Phase 3 trial evaluating elafibranor in NASH... read more
Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), announced on 4/23/18 that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending... read more
Pfizer Inc. (NYSE:PFE) announced on 4/23/18 that it received a Complete Response Letter (CRL) from the FDA in response to the Biologics License Application for the company’s proposed trastuzumab... read more
Pfizer Inc. (NYSE: PFE) today announced that Trumenba (Meningococcal Group B Vaccine) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for active... read more
Fresenius SE ended its pending acquisition of Akorn over a probe that found problems with product development and data. Fresenius issued a statement that said it's decision was based on a number... read more
Bellicum announced on 4/20/18 the closing of its previously announced underwritten public offering of 9,200,000 shares of its common stock, including 1,200,000 shares sold pursuant to the... read more
Chemoimmunotherapy is a promising technology in the fight against cancer. Researchers at the University of Michigan Rogel Cancer Center have designed a new delivery system – a drug hidden in a... read more
Helsinn Group announced on 4/20/18 that the U.S. Food and Drug Administration (FDA) has approved the intravenous formulation of Akynzeo (NEPA, a fixed antiemetic combination of fosnetupitant,... read more
Vaxart announced on 4/20/18 that it received notification from Daiichi Sankyo Co., Ltd, that sales of Inavir, a single inhaled dose product licensed in Japan to prevent or treat influenza... read more
Veloxis Pharmaceuticals A/S announced on 4/19/18 that the U.S. Food & Drug Administration (FDA) has accepted for standard review the Company’s supplemental New Drug Application (sNDA) which... read more
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) on 4/19/18 announced the pricing of its previously announced underwritten public offering of 16,000,000 shares of its common stock, offered at a price of... read more