LONDON – Cases of the new variant of SARS-CoV-2, which has an unprecedented number of mutations in the spike protein that is the target of most COVID-19 vaccines, have now been reported across Europe and in Canada, following its initial detection in South Africa. Read More
While the world grapples for a clear picture of the Omicron variant and how to handle it, Moderna Inc., Biontech SE and Adagio Therapeutics Inc. stepped out with stock advances, building on momentum from the end of last week, while eyeing 2022 as a launch date against the variant. Read More
With Omicron all the COVID-19 buzz right now, the FDA’s concern that the antiviral drug molnupiravir might enhance SARS-CoV-2 evolution might take on added weight when the Antimicrobial Drugs Advisory Committee meets Nov. 30 to advise on Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s emergency use authorization (EUA) request for what could be the first take-at-home oral drug authorized to treat COVID-19 infections. Read More
Molnupiravir, the take-at-home pill from Merck & Co. Inc. hailed as a potential game-changer against COVID-19, is not as effective as previously thought, according to newly released trial data from the company. Read More
LONDON – Quell Therapeutics Ltd. has raised $156 million in an oversubscribed series B, enabling it to start a phase I/II trial of its engineered T regulatory (Treg) cell therapy for promoting long-term immune tolerance in liver transplant patients, averting the need for chronic immunosuppression.
Shares of Krystal Biotech Inc. (NASDAQ:KRYS) rocketed 121.7% higher, to $88.44 on Nov. 29, after top-line data showed its investigational gene therapy for dystrophic epidermolysis bullosa (DEB) achieved the primary endpoint of a pivotal phase III trial, healing 67% of skin wounds associated with the disease vs. placebo at six months. Read More
Ascentage Pharma Group International’s olverembatinib has received marketing approval from China’s NMPA for the treatment of patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CMP-AP) harboring a T315I mutation. Read More
Zenas Biopharma LLC in-licensed the global right to develop, manufacture, and commercialize the antibody obexelimab from Xencor Inc. to treat autoimmune diseases in a deal worth up to $480 million. Under the agreement, Monrovia, Calif.-based Xencor gained the rights to acquire additional shares in U.S. and China-based Zenas, which will bring its total equity up to 15%. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akcea, Astrazeneca, Avrobio, Cytodyn, Gilead, Hutchmed, Index, Ionis, Merck & Co., Pfizer. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Alphamab, Amivas, Beigene, J&J, Kintor, Kura, Merck & Co., Novavax, Pharmather, RDIF, Relief, Sedana, Takeda. Read More
