Another monoclonal antibody therapy has entered the pandemic fray with the FDA granting emergency use authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg and etesevimab (JS016 or LY-CoV016) 1,400 mg as a cocktail for treating mild to moderate COVID-19 in patients aged 12 and up at high risk for progressing to severe COVID-19 and/or hospitalization. Read More
HONG KONG – Ono Pharmaceutical Co. Ltd. has agreed to pay Ribon Therapeutics Inc. as much as ¥15.4 billion (US$147.3 million) for exclusive rights to develop and commercialize the company’s phase I PARP7 inhibitor RBN-2397 for the treatment of solid tumors in Japan, South Korea, Taiwan and ASEAN countries. Read More
Under threat of emerging variants, the EU is taking to heart lessons learned so far in the global COVID-19 pandemic to accelerate the review of vaccines, improve data sharing from clinical trials and address the difficulties inherent in the mass production of vaccines that may contain up to 400 components. Read More
Biopharmaceutical companies developing cancer therapies had a productive year with about 38% of the record 53 new medicines approved by the FDA targeting oncology indications. This was one of the contributing factors for the 21% growth in the valuation of the price weighted BioWorld Cancer index in 2020. Read More
DUBLIN – Spybiotech Ltd. raised $32.5 million to move into clinical trials its first in-house vaccine program based on its Spycatcher/Spytag protein conjugation technology. The company is gearing up to start a phase I trial of a vaccine directed against cytomegalovirus (CMV) early next year. Read More
In its first decision on excessive drug pricing, the European Commission (EC) accepted a commitment Feb. 10 from Aspen Pharmacare Holdings Ltd. to immediately drop the price of six essential cancer drugs in Europe by an average of 73% and to continue to supply the drugs for at least the next five years. Read More
Panbela Therapeutics Inc. hit a speed bump with its phase I trial in the ever-challenging indication of pancreatic cancer (PC), as an independent data safety monitoring board (DSMB) recommended that dosing be held for patients until more safety information is available about polyamine analog SBP-101. Read More
Preventive medicine hasn’t always had the backing of hard data, but research into genomics at the U.S. National Institutes of Health may soon change that. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Algernon, Basilea, Celon, Galapagos, Galecto, Gamida, Gemini, Genfit, Gilead, Infant Bacterial, Protalix, Regulus, Tessa, Yumanity. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Adaptive Phage, AIM Immunetech, Astrazeneca, Biontech, Eli Lilly, I-Mab, Merck, Panbela, Pfizer, RDIF, Regeneron, Sanifit, Sanofi, Takeda, Vico. Read More
