Moderna Inc.’s phase III win with its COVID-19 vaccine candidate, mRNA-1273, lifted spirits while validating the Cambridge, Mass.-based firm’s platform, as Wall Street buzzed with comparisons between the prospects that have yielded late-stage data thus far. Read More
LONDON – A second phase III trial of Johnson & Johnson’s adenoviral-vectored COVID-19 vaccine is starting in the U.K. this week, amid concerns the positive news from the Pfizer Inc./Biontech SE vaccine study will deter volunteers from coming forward to take part. Read More
Olema Pharmaceuticals Inc., a company looking to improve on current endocrine therapies with an oral estrogen receptor antagonist and degrader of its own, has filed for a $170 million IPO on Nasdaq. The offering follows an $87.4 million series C round, closed in September and a $54 million series B financing closed not long before in July. Read More
There has been a recent renaissance in the interest in radiopharmaceuticals used for diagnostic and therapeutic applications, as well as their combined use (theranostics). A recent Canadian partnership between Admare Bioinnovations and the Centre for Probe Development and Commercialization (CPDC) aims to take advantage of the country’s expertise in the field and leverage promising radiopharmaceutical innovations into potential commercial opportunities. Read More
The FDA has issued Sanofi SA a complete response letter (CRL) regarding its complement pathway inhibitor sutimlimab, citing deficiencies found during a pre-license inspection of a third-party manufacturing facility. Read More
LONDON – Myricx Pharma Ltd. has launched with £4.5 million (US$5.9 million) seed funding to advance a new approach to targeting Myc, an oncogene that has defied long years of effort to drug it. The company will take a synthetic lethal approach, developing small-molecule inhibitors of N-myristoyltransferase to perturb pathways that Myc drives, causing cancer cell death. Read More
If the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services has its way, one of the casualties of the COVID-19 pandemic would be the in-person speaker programs many drug and device companies sponsor. The OIG issued a special fraud alert Nov. 16 questioning the need for such events in which health care professionals are often paid a hefty honorarium or fee to provide colleagues with information that’s readily available online and in the labeling of a drug or device. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Lawmakers protest latest 340B scheme; Groups make case for extending sequester moratorium; More $$ needed for global vaccine effort; Russia extends COVID-19 drug, device program. Read More
New hires and promotions in the biopharma industry, including: Arch, Athersys, Crinetics, Gossamer, Melinta, Monte Rosa, Q-State, Silo, Spark, Terns, Ziopharm. Read More
New and updated preclinical and clinical data presented by biopharma firms at The Liver Meeting of the American Association for the Study of Liver Diseases Nov. 13-16, including: Arbutus, Can-Fite, Dicerna, Gilead, Mallinckrodt, Mirum, Novo, Seal Rock, Theratechnologies, Twoxar Read More
New and updated preclinical and clinical data presented by biopharma firms at the 2020 American Heart Association Scientific Sessions Nov. 13-17, including: Acceleron, Astrazeneca, Cytokinetics, Daiichi, Myokardia, Silence. Read More
Biopharmas raising money in public or private financings, including: Bioatla, Compass, Intervenn, Kinnate, Moberg, Nereid, Oncozenge, Sigilon, Stat Codon. Read More
