The Netherlands-based Synaffix BV has expanded a deal focusing on its antibody-drug conjugate (ADC) linker tech with U.S. cancer biotech Mersana Therapeutics Inc., with the revised contract potentially paying out more than $1 billion. Privately owned Synaffix is hoping to ride a wave of interest in ADC technology, which is finally coming of age more than two decades after the first drug of this type was approved. Read More
Ursula Matulonis, a co-principal investigator in the latest study with Immunogen Inc.’s antibody-drug conjugate mirvetuximab soravtansine in stubborn ovarian cancer, said the top-line data are “truly spectacular” and bring “the potential to be transformative for patients.” Read More
A divided FDA advisory committee voted 13-10 Nov. 30 that the known and potential benefits of the Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s antiviral drug, molnupiravir, outweighs its known and potential risks. If granted an emergency use authorization (EUA), molnupiravir would become the first take-at-home oral drug in the U.S. to keep mild and moderate COVID-19 infections from becoming severe in high-risk adults. Read More
While the FDA’s reaction to the results of the Nov. 30 advisory hearing for the COVID-19 therapy molnupiravir is difficult to predict, demand for rapid antigen tests may jump considerably when this or any such product is approved. That increased demand could crunch supplies of these tests due to the convergence of any such approvals, the upcoming holiday season, and the 2021-22 flu season, a convergence that could hamper efforts to roll out these new therapies. Read More
Alphamab Oncology Co. Ltd. has won conditional marketing approval from China’s NMPA for KN-035 (envafolimab), the world’s first PD-1/PD-L1 antibody to be administered by subcutaneous injection. The drug was cleared for use in treating adult patients with advanced solid tumors who have unresectable or metastatic advanced microsatellite instability-high phenotype/mismatch-repair deficiency. That includes patients with advanced colorectal cancer who have experienced disease progression after previous therapy with fluorouracil, oxaliplatin and irinotecan. Read More
Fennec Inc. received the complete response letter (CRL) it had expected from the FDA, sidelining U.S. development of Pedmark, a formulation of sodium thiosulfate for preventing ototoxicity associated with cisplatin chemotherapy in pediatric patients older than 1 month to those 18 years of age with localized, non-metastatic, solid tumors. Read More
Ildong Pharmaceutical Co. Ltd. inked a partnership with Shionogi & Co. Ltd. to co-develop S-217622, the latter’s orally administered 3CL protease inhibitor treating COVID-19 and has obtained an IND for a phase II/III trial in South Korea to enroll more than 200 patients who are asymptomatic or suffering from mild to moderate COVID-19. Read More
The U.S. SEC released guidance Nov. 29 that could impact how drug and medical device companies shape, and report, their executive compensation packages when it comes to "spring-loaded awards.” Read More
As part of its real-world evidence (RWE) program, the U.S. FDA released a draft guidance Nov. 29 on using registries to support regulatory decision-making for drugs and biological products. Read More
New hires and promotions in the biopharma industry, including: Algernon, Anaptysbio, Biostage, Bright Peak, Diamond, Forma, Metrion, Olix, Pardes, Recursion, Relief, T-knife, Viacyte, Vivacitas. Read More
