The FDA’s vaccine advisory committee voted 17-4 with one abstention Dec. 10 to recommend an emergency use authorization (EUA) for the Pfizer Inc./Biontech SE mRNA vaccine BNT-162b2 to prevent COVID-19 in individuals 16 and older. Read More
Gilead Sciences Inc.’s move to grab Myr GmbH for about €1.15 billion (US$1.39 billion) in cash up front, with €300 million if the latter’s Hepcludex (bulevirtide) wins FDA clearance, put chronic hepatitis delta virus (HDV) in the headlines and benefited the stock of another player in the space: Eiger Biopharmaceuticals Inc. (NASDAQ:EIGR), which closed at $10.27, up $1.51, or 17%. Read More
DUBLIN – Boehringer Ingelheim GmbH is paying up to €1.18 billion (US$1.4 billion) to acquire antibody-drug conjugate (ADC) developer NBE-Therapeutics AG. The deal includes an undisclosed up-front payment, plus development and regulatory milestones linked to the progress of NBE’s pipeline of clinical and preclinical ADC programs. Read More
Both phase III studies of ublituximab, an anti-CD20 monoclonal antibody from TG Therapeutics Inc., of New York, met their primary endpoints of significantly reducing the annualized relapse rate in multiple sclerosis (MS) patients. Company stock (NASDAQ:TGTX) received a solid bump Dec. 10 as shares closed 40.85% higher at $41.72. T Read More
Clinical-stage biopharma HBM Holdings Ltd. (also known as Harbour Biomed) debuted on the Hong Kong Stock Exchange on Dec. 10, raising HK$1.71 billion (US$220.7 million) to advance its autoimmune candidates to commercial launches in 2023. Read More
Australian biopharma Immutep Ltd. saw its stock price jump 165% Dec. 10, as the company reported that adding its eftilagimod alpha (IMP-321, “efti”) to paclitaxel resulted in what the company called a “promising and improving” trend toward increased overall survival in women with metastatic hormone receptor-driven breast cancer. Read More
BEIJING – San Diego and Hangzhou, China-based biotech Denovo Biopharma LLC closed a series D financing round to raise nearly ¥300 million (US$46 million) on Dec. 8, just six months after its $83.5 million series C round. Denovo CFO Carrie Chen told BioWorld that the proceeds will be used to “upgrade the technology platform, advance the clinical programs, expand the team and license in new assets.” Read More
Nothing much has changed since last month. This year is still, by far, the best year for financings in biopharma history, although the gap between 2020 and the next highest year has widened even more. Read More
Suzhou, China-based Kintor Pharmaceutical Ltd. said it's "actively initiating" multiregional phase II/III trials to test a combination of its angiogenesis inhibitor, GT-90001 (ascrinvacumab), and Opdivo (nivolumab) for advanced hepatocellular carcinoma (HCC) after preliminary data showed 40% of patients given the combo so far had partial remissions. Read More
HONG KONG – Partnerships are reshaping the pharmaceutical industry across Asia, said speakers during day two of the Phar-East 2020 virtual conference. While industry has “tended to have a go-at-it-alone approach,” doing all its discovery, development and commercialization work in-house, “nothing ever came in or out. I think that’s really changed in recent years,” said Kazia Therapeutics Ltd. CEO James Garner. Read More
Roche Holding AG has revealed a partnership with Moderna Inc. involving the use of the Elecsys Anti-SARS-CoV-2 S antibody test in the latter’s mRNA-1273 vaccine research trials. The news comes shortly after Roche received emergency use authorization from the U.S. FDA for the antibody test. Read More
New and updated preclinical and clinical data presented by biopharma firms at the San Antonio Breast Cancer Symposium, Dec. 8-11, including: Amunix, Astrazeneca, Athenex, Beyondspring, Bold, Briacell, Daiichi Sankyo, Eli Lilly, Evelo, Greenwich, Immutep, Infinity, Medsir, Novartis, Oncolytics, Pharmabcine. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Atox, Biogen, Diamedica, Editas, Eisai, Entera, Hoth, Lantheus, Neoleukin, Oblato, Scynexis, SOBI, Ultragenyx, X4. Read More
