CHICAGO – With blocking the PD-1 pathway working so well in so many tumor types, a seemingly never-ending number of companies are taking an "if you can't beat 'em, join 'em" approach, adding their therapies to anti-PD-1/PD-L1 drugs. Read More
Ultragenyx Pharmaceutical Inc. and partner Kyowa Hakko Kirin Co. Ltd. (KHK) have won FDA approval for Crysvita (burosumab), making it the first U.S.-approved treatment for X-linked hypophosphatemia (XLH), a rare, inherited form of rickets. The chronic progressive musculoskeletal disorder is estimated to affect about 3,000 children and 9,000 adults in the U.S. Read More
GW Pharmaceuticals plc CEO Justin Gover said solid science and years of cooperating with not only the FDA but also with the Drug Enforcement Administration (DEA) allowed his firm to reach the brink of an FDA panel meeting on its cannabidiol (CBD) oral solution for types of epilepsy, potentially followed by approval in June. Read More
"The Trump administration's FY 2019 budget request for FDA is likely to be the boldest and largest funding request in recent memory, and maybe ever," Rep. Robert Aderholt (R-Ala.) said in opening the first congressional hearing on the agency's fiscal 2019 budget. Read More
SHANGHAI – Denovo Biopharma LLC, a cross-border biotech with offices in San Diego and Shanghai, has dosed the first patient in a phase III trial of DB-102 (enzastaurin) to treat diffuse large B-cell lymphoma (DLBCL). DB-102 is a serine/threonine kinase inhibitor of the PKC beta and AKT pathways. Read More
CAMBRIDGE, U.K. – They are currently relishing the challenges of academic research, but 100 early career scientists gathering in Cambridge this week need new skills if they are to fulfill their aspirations to be biotech entrepreneurs and industry leaders of tomorrow. Read More
HONG KONG – China' Luye Pharma Group Ltd. said its investigational drug with billion-dollar potential, rotigotine extended-release microspheres for injection (LY-03003), was granted the regulatory approval to enter phase III trials in China. Read More
Researchers have identified infection with Epstein-Barr virus (EBV), best known for causing mononucleosis, as a risk factor for seven autoimmune diseases. Read More
NEW DELHI – India's drug quality administration is cracking down on companies that manufacture and sell unauthorized and untested fixed-dose combination (FDC) drugs, following recent inspections that brought that issue into the spotlight. Read More
Mateon Therapeutics Inc., of South San Francisco, said it completed a private placement transaction with accredited investors for the sale of 14.625 million shares of unregistered Mateon common stock at 20 cents per share. Read More
Orphazyme A/S, of Copenhagen, Denmark, disclosed the creation of a U.S. subsidiary, based in Newton, Mass., called Orphazyme U.S. Inc., which will directly support the U.S. market and work to establish closer relationships with the medical, patient and financial communities. Read More
The U.S. Court of Appeals for the Fourth Circuit struck down a Maryland law that went into effect in October to stop generic drug price gouging. The court, in a split decision, overturned a lower court by ruling that the law is unconstitutional because it directly regulates transactions that occur outside the state. Read More
