Just weeks after seeing one late-stage candidate hit a wall in a subtype of non-small-cell lung cancer (NSCLC), Merck KGaA's EMD Serono has won accelerated approval from the FDA for another important NSCLC therapy, Tepmetko (tepotinib). Read More
Of the three companies launching IPOs Feb. 4, one struggled mightily, another posted double-digit gains while the third ended the day flat. Shares of Landos Biopharma Inc. (NASDAQ:LABP) dropped 25%, to $12 each, on their first day of trading. Sana Biotechnology Inc. (NASDAQ:SANA) had the strongest first day of trading as shares closed 40.4% higher at the close at $35.10. Sensei Biotherapeutics Inc. (NASDAQ:SNSE) saw its IPO launch roughly break even on its first day of trading, closing with only a half-point gain at $18.90. Read More
LONDON – The U.K has started the world’s first trial alternating an adenoviral vectored COVID-19 vaccine with one that delivers the virus spike protein instructions encoded in messenger RNA. The heterologous prime boost trial will recruit 820 participants into an eight-arm study comparing different combinations of the Astrazeneca plc/Oxford University and Pfizer Inc./Biontech SE vaccines, administered in a different order and at different intervals. Read More
In a task made more challenging by COVID-19, the EU and the World Health Organization are rolling out separate plans to take down cancer in Europe. The European Commission Feb. 3 announced its Europe’s Beating Cancer Plan, the first comprehensive European cancer initiative in nearly 30 years. A day later, WHO/Europe launched its United Action Against Cancer, billing it as a “pan-European cancer movement” to galvanize support and cooperation from grassroots to governments with the long-term goal of eliminating cancer as a life-threatening disease in the region. Read More
Probably no one was surprised by the FDA’s recent nod for the combination of Alameda, Calif.-based Exelixis Inc.’s tyrosine kinase inhibitor, Cabometyx (cabozantinib), which targets MET, AXL and VEGF, and PD-1 drug Opdivo (nivolumab) from Bristol Myers Squibb Co. as a first-line treatment for advanced renal cell carcinoma (RCC), but investors may feel less confident about the odds for the pairing in a competitive space. Read More
PERTH, Australia – Synthetic cannabinoid company Botanix Pharmaceuticals Ltd. announced top-line data from a phase IIa study showing that two different formulations of BTX-1801, a synthetic cannabidiol, eradicated Staphylococcus aureus (staph) in the nose, meeting study endpoints for safety and efficacy. Read More
KRAS is the most frequently mutated oncogene in solid tumors in general, and in lung tumors in particular. There are more patients whose lung tumors are driven by KRAS mutations than by ALK, Ros, Ret and TRK alterations. Combined. And after 40 years, they look to be getting a targeted therapy, or even two. Read More
U.S. FDA warning letters have been a staple of regulatory life since the late 1990s, but James Boiani, a regulatory attorney with Epstein, Becker & Green P.C., said it’s no stretch of the imagination that warning letter volumes will jump in 2021. This is to some extent because the volume of warning letters dropped significantly over the past four years, and Boiani advised that all FDA-regulated industries will see more warning letters unless they are communicative with the agency about inspectional findings. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: FDA weighing Xeljanz safety results; EMA initiates OPEN collaboration; NICE evaluating guidance processes; TGA seeking comments; USPTO extends program with Japan’s, Korea’s patent offices; NICE recommends Keytruda in NSCLC; Florida researcher indicted. Read More
New hires and promotions in the biopharma industry, including: Catamaran, Codexis, Inozyme, Merck, Microbiotica, Nkmax, Pepgen, Secarna, TCR². Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Active, Angelini, Angiotensin, Arvelle, Astrazeneca, Beximco, BMS, BNC, Connectyx, Diamond, Evotec, Famar, Gensight, Golden, Molecular Partners, Neogenomics, Novartis, Novavax, Serum Institute, Sio, Sunshine, Wuxi. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Astrazeneca, EMD, Intrommune, Karyopharm, Sinovac, Theratechnologies. Read More
