Does President Donald Trump's extensive conversation with the CEO of Pfizer Inc. to get the company to hold off on midyear list price increases constitute government interference with prescription drug prices? Read More
As expected, the "radical cure" malaria drug tafenoquine from Glaxosmithkline plc (GSK) sailed through a meeting of the FDA's Antimicrobial Drugs Advisory Committee, with panelists voting 13-0 in favor of recommending its approval based on efficacy and 12-1 for marketing clearance based on safety. Read More
DUBLIN – Immatics Biotechnologies GmbH is pocketing $54 million up front and could earn up to $1.65 billion more in development, regulatory and commercial milestones from a three-product immuno-oncology research collaboration and license agreement with Genmab A/S. The two companies will pool their respective capabilities in cancer target discovery, T-cell receptor (TCR) engineering and antibody engineering to develop bispecific protein-based therapeutics that will target both intracellular tumor-associated peptides (Tumaps) and T cells. Read More
Shares of Zogenix Inc. (NASDAQ:ZGNX) climbed 20.7 percent to close at $55.90 on Thursday after a second pivotal study of ZX-008 (fenfluramine) showed the drug maintaining its ability to diminish seizures among young people with rare and severe epilepsy type Dravet syndrome, even when added to standard-of-care therapy. Participants achieved a 54.7 percent greater reduction in mean monthly convulsive seizures vs. placebo during the phase III trial and remained free of heart valve damage, easing safety concerns raised by fenfluramine in an earlier chapter of its use. (See BioWorld, Oct. 2, 2017.) Read More
TOULOUSE, France - The terms of Brexit remain shrouded and uncertain, but scientists across the EU are – regretfully – preparing for the inevitable schism. Read More
The House Appropriations Committee voted July 11 to boost funding at the NIH by $1.25 billion to a total of $38.3 billion, but the Senate Appropriations Committee had already proposed a $2 billion increase. The two chambers have fewer than 80 days in the current fiscal year to resolve their differences in funding for the affected agencies as the midterm elections encroach on an already contentious dialogue between Democrats and Republicans. Read More
Antoxerene Inc., of Lafayette, N.Y., a portfolio company of Ichor Therapeutics Inc., said it launched a joint venture with Juvenescence Ltd., called Foxbio Inc., which will develop Antoxerene's collection of small molecules targeting senescent cells. Read More
The FDA formed a new Drug Shortages Task Force to seek long-term solutions to the underlying causes of drug shortages in the U.S. Led by Keagan Lenihan, the FDA's associate commissioner for strategic initiatives, the task force will include senior leaders from the FDA, the Centers for Medicare and Medicaid Services and the Department of Veterans Affairs. Read More
Sirona Biochem Corp., of Vancouver, British Columbia, and partner Jiangsu Wanbang Biopharmaceuticals Co. Ltd., of Xuzhou, China, said a $500,000 milestone payment to Wanbang was triggered by China's CNDA approval of a clinical trial application to start testing of SGLT2 inhibitor TFC-039 in type 2 diabetes. Read More
