Novartis AG’s FDA go-ahead for Leqvio (inclisiran), the first and only small interfering RNA therapy to lower LDL-C, “should come as a relief, given fears that the pandemic could again limit FDA's ability to conduct manufacturing-site inspections,” Jefferies analyst Peter Welford said. PCSK9-targeting Leqvio’s Dec. 22 approval, which came slightly ahead of the Jan. 1, 2022, PDUFA date, landed after a complete response letter about a year ago, citing unresolved facility inspection-related conditions. The drug is dosed twice per year, unlike competitors in the space. Read More
The FDA went from zero to two oral antivirals to treat COVID-19 in the space of two days, granting emergency use authorizations last week to Pfizer Inc.’s Paxlovid and Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s molnupiravir. Both five-day regimens are authorized for use, within five days of COVID-19 symptom onset, in individuals at high risk of progressing to severe disease, including hospitalization and death. Read More
DUBLIN – ITM Isotope Technologies Munich (ITM) SE has secured its first radiopharmaceutical licensing deal in China, a pact with Grand Pharmaceutical Group Ltd. involving two radiopharmaceutical candidates, as well as a companion diagnostic for one of them. Read More
Top-line results from Bridgebio Pharma Inc.’s ongoing phase III study of acoramidis are no holiday gift for the company. The clinical trial for treating symptomatic transthyretin amyloid cardiomyopathy missed its primary endpoint. The Palo Alto, Calif.-based company’s stock (NASDAQ:BBIO) plunged on the news as shares closed 72% lower Dec. 27 at $11.38 each. Read More
RTW Investments LP-backed Ji Xing Pharmaceuticals Ltd. has acquired greater China rights to Cytokinetics Inc.’s omecamtiv mecarbil in a deal worth up to $400 million. Read More
LONDON – A suite of papers rushed through peer review and published in Nature late on Dec. 23, 2021 contain data indicating approved monoclonal antibody drugs designed to neutralize SARS-COV-2 have substantially weaker activity against the Omicron variant. Read More
Biopharma is getting another reprieve, as Canada once again delays the implementation of major changes to its Patented Medicines Regulations. Set to take effect Jan. 1, the implementation of the drug pricing changes has now been pushed back to July 1. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agenus, Akston, Alphamab, Amo, Bausch, Medicenna, Mereo, Moleculin, Nervgen, Redx, Vallon. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accutar, Aimmune, Allarity, Alnylam, Arcutis, Bioarctic, Celularity, Daiichi, Eisai, Fluoguide, GSK, I-Mab, Innovent, Irlab, Lion, Merck, Novartis, Radius, Syndax. Read More
