The FDA and the CDC have jointly recommended a temporary pause in the further rollout of Johnson & Johnson Co.’s COVID-19 vaccine while they investigate six rare clotting cases in adults ages 18 to 48. Read More
LONDON – The U.K. is moving on to the next phase of testing mixed dosing schedules for COVID-19 vaccines, launching a study in which it will assess the effect of using Moderna Inc. or Novavax Inc.’s products as the second dose in a heterologous prime boost trial. Read More
Senti Biosciences Inc. stands to receive more than $645 million in up-front, opt-in and milestone payments through a new collaboration and option agreement with Spark Therapeutics Inc. Read More
Theseus Pharmaceuticals Inc., a startup developing new tyrosine kinase inhibitors to overcome treatment-resistant cancer mutations, has raised $100 million in a series B financing led by Foresite Capital. Co-founded at the health care investment firm Orbimed with former Ariad Pharmaceuticals Inc. scientists who pioneered the development of pan-variant kinase inhibitors, the company's lead candidate is THE-630, a next-generation pan-variant KIT inhibitor for the potential treatment of refractory gastrointestinal stromal tumors. Read More
The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee will be venturing into new territory April 15 in which it not only has to consider whether the benefit of Celltrans Inc.’s donislecel is clinically meaningful, but it also will have to define the indication. Read More
Plx Pharma Inc. is not letting out the details just yet about next quarter’s launch of liquid-filled aspirin capsule Vazalore, recently cleared by the FDA in 81-mg and 325-mg doses, but CEO Natasha Giordano said cardiologists are “essential to our strategy. We have developed very deep sales plans [that are] laser-focused.” Read More
SHANGHAI – China’s regulatory environment has evolved to encourage drug innovation, but despite remarkable progress, mounting pricing pressure from the government and a weak insurance sector remain as barriers. Read More
Speaking during the 2021 China Pharmaceutical Innovation 100 Summit, industry insiders called for more regulatory talent and even an organizational revamp to clear innovative products faster and support the global development strategies of Chinese drugmakers. Read More
PERTH, Australia – In the aftermath of the COVID-19 pandemic, Australia is shoring up its national supply of medical products and making it a national priority to drive economic recovery and ensure future resilience. The objective of the government’s modern manufacturing strategy is to build scale and capture income in high-value areas of manufacturing where Australia either has established competitive strength or emerging priorities. Read More
New hires and promotions in the biopharma industry, including: Aavantibio, Adicet, Albireo, Amarin, Amarin, Atriva, Candel, Eli Lilly, Kane, Landos, Lixte, Oncternal, Orion, Rain, Yumanity. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Association for Cancer Research Annual Meeting 2021, including: BMS, Kronos, Kymera, Medicenna, Medigene, Mei, Mersana, Mirati, Molecular Partners, Molecular Templates, Morphic, Nextcure, Nuvalent, Oasmia, Oncolytics, Oncomyx, Oncurious, Oncternal, Oric, Pharmabcine, Phio, Pieris, PMV, Puretech, Schrodinger, Seneca. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akouos, Avenue, Axcella Health, Celularity, Janssen, Kibow, Lintonpharm, Neuraptive, Novartis, RDIF, Vtv. Read More
