BEIJING – China will kickstart a phase III trial Feb. 3 to determine whether patients with 2019-nCoV can be treated with Gilead Sciences Inc.’s NUC inhibitor, remdesivir, which was originally developed for Ebola, four days after a U.S. patient was said to have recovered by using the drug candidate. Read More
The U.S. Department of Health and Human Services has declared a public health emergency in the U.S. over the coronavirus in part because a government diagnostic for the virus yields inconsistent results, a fact that may spur the life sciences to provide a solution. Read More
Biotech investors had every reason to feel bullish heading into the new decade. The sector had turned around in 2019 and was riding a wave of a very strong fourth-quarter performance, with the BioWorld Biopharmaceutical Index closing up 14% for the year after being underwater from April through to September. Unfortunately, those great expectations were quickly erased during J.P. Morgan Healthcare conference week (Jan. 10 – Jan. 17), which turned out to be a very low-key affair absent of any blockbuster M&A revelations. As a result, confidence has now given way to concerns about the prospects for biopharmaceutical companies going forward, particularly as unfavorable political rhetoric on drug pricing will certainly be dialed up during this election year. Read More
The FDA has issued two new approvals, one for a cell-based pandemic influenza A (H5N1) vaccine and the other is the first approval for treating peanut allergy. Read More
The National Institute of Allergy and Infectious Diseases has stopped a late-stage HIV vaccine study it sponsored after an interim review by the trial's independent data and safety monitoring board (DSMB) found the regimen failed to prevent HIV. Read More
Shares of Bridgewater, N.J.-based Insmed Inc. (NASDAQ:INSM) closed at $28.88, up $8.34, or 40.6%, on positive top-line results from the global, randomized, double-blind placebo-controlled phase II study called Willow, testing INS-1007 once daily in adults with non-cystic fibrosis bronchiectasis (NCFBE). Read More
HONG KONG – Aiming to increase the financial stability of the national health care insurance system, Japan has announced a list of 17 drugs for which prices will be reduced. Read More
PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. has filed the final module of its rolling BLA submission for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, after it showed strong survival rates in children with acute steroid-refractory graft-vs.-host disease (aGVHD). Read More
New hires and promotions in the biopharma industry, including: Boston, Bryologyx, Contrafect, Cytomx, Galecto, Generex, Inceptua, Merck, Orchard, Phoremost, Portola, Respirerx, Verona. Read More
Biopharmas raising money in public or private financings, including: Cocrystal, CTI Biopharma, Denali, Passage Bio, Revolution Medicines, Xortx. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bio-Thera, Can-Fite, Corvus, Insmed, Moleculin, Regentree, Teva, United Therapeutics, Zynerba. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agex, Anticancer, Applied Biomath, Artelo, Aspen Global, Astrazeneca, Avacta, Be Cool, Biomx, Cellink, Citius, Daewoong, Enochian, Gritstone, Inovio, Nektar, Novartis, Precigen, PTC Therapeutics, Sandoz. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aimmune, Cormedix, CTI, Glaxosmithkline, GW, Merck, Mesoblast, Resverlogix, Scancell, Seqirus, Therapeuticsmd. Read More
