Merck & Co. Inc.'s $1.05 billion acquisition of Peloton Therapeutics Inc. in 2019, a big bet on the hypoxia inducible factor-2 alpha inhibitor belzutifan, has paid off with an earlier-than-anticipated FDA approval of the drug for cancers associated with von Hippel-Lindau disease. The therapy will be marketed as Welireg. Read More
An unexpected complete response letter (CRL) from the FDA has thrown a wrench into Sesen Bio Inc.’s commercial launch plans for Vicineum (oportuzumab monatox) in high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The company, which has spent the past few months completing its commercial build phase and hiring sales reps ahead of the Aug. 18 PDUFA date, instead must now address outstanding clinical and statistical data and analyses, in addition to CMC issues, cited in the CRL. Read More
The FDA has made allowances for a third COVID-19 vaccine dose to protect certain adults with compromised immune systems. The amended emergency use authorization amendments allow for booster doses of mRNA vaccines from Pfizer Inc.-Biontech SE and Moderna Inc. Read More
The CDC’s Advisory Committee on Immunization Practices (ACIP) deliberated the matter of third COVID-19 shots, with panel members voting whether to recommend “additional doses of mRNA COVID-19 vaccines as part of a primary [two-shot] series” in certain immunocompromised patients. A work group set up by ACIP decided previously that the desirable consequences outweighed undesirable ones in such a population. Read More
Innovent Biologics Inc.’s PCSK9 inhibitor, IBI-306, intended for the treatment of heterozygous familial hypercholesterolemia (HeFH), has met its primary endpoint in a phase III study in Chinese patients. Read More
Inhaled drugs developer Vectura Group plc has accepted a takeover bid from tobacco firm Philip Morris International Inc. (PMI), a move that has sparked revulsion from health campaigners but has been supported by investors. Shares in both firms ticked up in trading on Aug. 13 after Chippenham, U.K.-based Vectura accepted a bid worth around £1.1 billion (US$1.5 billion), rejecting a rival bid from U.S.-based private equity firm Carlyle Group. Read More
PERTH, Australia – The Treasury Department is seeking feedback from industry stakeholders on its discussion paper on a patent box policy, which was first announced in the May 2021 federal budget. Read More
Clinical data in 2021 has risen by about 9.2% in comparison with the same timeframe in 2020. As of mid-August, BioWorld has tracked a total of 2,400 entries of clinical data, which is up from the 2,197 entries last year. The gap has decreased from about 26% in mid-April, suggesting a steady slowdown in activity. Read More
New hires and promotions in the biopharma industry, including: Altasciences, Anebulo, Corcept, Fibrobiologics, Freeline, Myovant, Puretech, Urovant. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atea, Azurrx, Cali, Equillium, Gigagen, Innovent, Innovation, Longeveron, Lynk, Medivir, Phasebio, Trigone, Ultimovacs, Valneva. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Chemotherapy, Ampio, Bexson, Cytocom, Fusion, Moderna, Mustang, Nyrada, RDIF, Sen-Jam, Theratechnologies. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aprea, Biontech, Cytodyn, Immune-Onc, Ipsen, Jazz, Moderna, Novatek, Pfizer, Rigel. Read More
