With funding from the world's largest source of global health initiatives, the U.S., barely growing and global health development funding stagnant at around $36.4 billion annually, it has become increasingly clear to some that the time for creativity in funding public health programs is now.
Ampio Pharmaceuticals Inc. missed the primary endpoint in its second pivotal trial for Ampion, a candidate for treating osteoarthritis of the of the knee (OAK), tested under an FDA special protocol assessment (SPA).
Cancer vaccines tailored to fit tumor-specific profiles are at the heart of a new strategic collaboration and licensing deal between Merck & Co. Inc. and Moderna Therapeutics Inc., a company on which Merck is upping its bet as early clinical data begins to roll in as part of an earlier deal between the two targeting infectious disease.
Gilead Sciences Inc. landed an on-schedule FDA approval for the chronic hepatitis C virus (HCV) drug Epclusa, the first drug effective against all six major genotypes of the virus. The fixed-dose combination tablet contains both the active ingredient of Sovaldi (sofosbuvir) and the new NS5A inhibitor velpatasvir.
A serious new case of jaundice that developed during a Regulus Therapeutics Inc. study of RG-101 for the treatment of chronic hepatitis C virus (HCV) triggered the FDA to issue a verbal clinical hold on the program, sending company shares (NASDAQ:RGLS) down 49.3 percent to $2.54 on Tuesday.
A potential new tool in the war on gram-negative pathogens, The Medicines Co.’s Carbavance (meropenem-vaborbactam) met both FDA and EMA primary endpoints in a pivotal phase III trial testing the therapy in patients with complicated urinary tract infections (cUTIs).
FDA reviewers told agency advisors in briefing docs released Friday that Jardiance (empagliflozin) postmarket data show "substantial evidence" that, for certain adults with type 2 diabetes, the drug reduces the risk of cardiovascular death. They did not recommend that the advisors support label claims that the drug could reduce the risk of either hospitalization for heart failure (HF) or a composite of CV death (excluding fatal stroke) or hospitalization for HF.
IFM Therapeutics Inc. closed a $27 million series A financing led by Atlas Venture and Abingworth, with participation from Novartis AG. The Cambridge, Mass.-based company, incubated at Atlas, will use the financing to advance and expand its early stage portfolio of preclinical small-molecule modulators.
Academia's role in antibiotic development – crucial since the dawn of the antibiotic age when Oxford University purified penicillin ahead of mass production – remains just as important today. Despite the centrality of pioneering work undertaken at universities, challenges from basic training to funding crunches have left a yawning gap in some areas, contributing to a complex web of problems slowing the arrival of new antibiotics on the market.