Although huge strides have been made with antiretroviral therapy (ART) and prevention since HIV was first reported 42 years ago, there is still not an effective preventive vaccine or a scalable cure for those living with HIV. But broadly neutralizing antibodies (bNAbs) look to be a further step down the pathway to a cure, speakers said during the International AIDS Society meeting held July 23 to 26 in Brisbane, Australia. Read More
A British billionaire who’s the founder and principal owner of the Tavistock Group, an international private investment fund with a portfolio that includes biotech companies, was arrested July 26 on multiple criminal charges of U.S. securities fraud, along with two private pilots whom allegedly received insider tips from him in lieu of a formal retirement plan. Read More
Japanese pharmaceutical company Astellas Pharma Inc. is scouting for more novel targeted protein degrader (TPD) therapeutics, having added a research and licensing deal with Peptidream Inc. to its shopping cart filled with TPD promises. Read More
The U.S. Federal Trade Commission (FTC) has been exceptionally active in the mergers and acquisitions space for the past 18 months, but Congress might soon amplify these agencies’ ability to suppress these transactions. Sen. Amy Klobuchar (D-Minn.), who chairs the competition subcommittee of the Senate Judiciary Committee, said in a recent hearing that vertical mergers have flown largely off the enforcement radar, a problem that Congress could address by several means, including by providing the FTC with a heftier budget to pursue these cases. Read More
Following a comment-and-review process waylaid by the COVID-19 pandemic, the U.S. FTC is finalizing its revised guides on the use of endorsements and testimonials in advertising. Read More
Public companies registered with the U.S. SEC will soon have to disclose material cybersecurity incidents and annually report material information regarding their cybersecurity risk management, strategy and governance. Read More
A lot of biosimilar sponsors and wannabes are watching as the biosimilar competition in the U.S. unfolds to challenge the all-time biggest-selling drug, Humira from Abbvie Inc. In this episode, BioWorld Regulatory Editor Mari Serebrov and Tom Newcomer, vice president and head of U.S. market access at Samsung Bioepis, discuss the biosimilars landscape. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ascletis, Compass Pathways, Elevar, Epsilogen, Gilead Sciences, Hoth, Immuron, Intrommune, Mindbio, Moonlake Immunotherapeutics, Remegen, Stoke, Third Harmonic. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Alexion, Calibr, ICER, IMV, Infinity, Mei, Nexo, Novartis, Orchard, Vantage. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied, Avenue, Boehringer Ingelheim, Eli Lilly, Larimar, Mirum, Pfizer, Sinopharm, Tarsus, Viiv Healthcare. Read More
