Six months after a merger deal fell through, leaving the company to face possible bankruptcy, Therapeuticsmd Inc. agreed to license U.S. commercialization rights for its women’s health care products to Australian firm Mayne Pharma Group Ltd. in exchange for $140 million up front plus milestone and royalty payments. Read More
Twelve months after a single shot of Valneva SE’s chikungunya vaccine, positive antibody persistence was found, threatening a deadly disease that has long resisted treatment. The new data are derived from a study of 363 healthy adult participants that followed them from month 6 after vaccination to month 12. Nearly all, 99%, kept their neutralizing antibody titers for 12 months beyond the seroresponse threshold of 150, which hit the primary endpoint and the antibody level agreed with regulators as endpoint under the accelerated approval pathway. Read More
Following the tone set in an October U.S. FDA Oncologic Drugs Advisory Committee meeting, the agency has issued a complete response letter (CRL) to Y-mabs Therapeutics Inc.’s BLA for Omblastys (131I-omburtamab) to treat central nervous system/leptomeningeal metastasis arising from neuroblastoma. Read More
The age-old separation of dentistry from medicine is deeply embedded in education and professional practice. Given the great advances in both disciplines in recent decades, there is a reasonable argument to be made for maintaining the divide. Read More
Investigators at the University of Bristol and Biognos AB have identified a structural feature that distinguished the deadly coronavirus strains from harmless, common cold-causing variants. The findings, which were published in the Nov. 23, 2022, issue of Science Advances, could form the basis of universal COVID antivirals, putting an end to the endless race to deal with new variants that has so far been a necessity. Read More
We wrapped up 2022 and are preparing for 2023 on this BioWorld Insider podcast. Staff writer Lee Landenberger talked to four CEOs, visionaries of companies producing new science and drug development. The CEOs offered their insights into what happened this year and looked at the challenges and opportunities for next year. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anaptysbio, Altamira, Anavex, EIP, H. Lundbeck, Mirati, Ondine, Otsuka, Qilu, SK, Theratechnologies, Urogen, Vanda, Vaxxinity, Ventyx. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beam, Eqrx, GSK, Hoth, PTC, Rigel, Y-Mabs. Read More
