Six months after a merger deal fell through, leaving the company to face possibly 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. The deal will allow Therapeuticsmd to clear its debt and continue operations as a royalty company. Mayne, meanwhile, adds three approved products to its women’s health portfolio, which includes birth control Nextstellis (drospirenone + estetrol).

Valneva posts positive chikungunya vaccine data

Twelve months after a single shot of Valneva SE’s chikungunya vaccine, positive antibody persistence was found, threatening a deadly disease. The 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 the endpoint under the accelerated approval pathway. The antibody level confirmed data that had been found in a previous study of the vaccine. Valneva now plans to complete its rolling BLA submission to the U.S. FDA before 2022 ends. Chikungunya is transmitted by mosquitoes and carries high morbidity.

After a brutal adcom, Y-mabs gets an anticipated CRL

Following the tone set in an October U.S. FDA Oncologic Drugs Advisory Committee meeting, the agency issued a complete response letter to Y-mabs Therapeutics Inc.’s BLA for Omblastys (131I-omburtamab) to treat the CNS/leptomeningeal metastasis arising from neuroblastoma. The company said the agency noted it could not approve the BLA in its current form and wants to talk about designing another clinical trial for the therapy. The adcom was asked if the company had provided sufficient evidence to conclude the therapy improves overall survival and 16 of the panel voted no, while none voted yes and there were no abstentions. Y-mabs said it’s assessing the omburtamab program.

Keystone Bio linking oral health with systemic benefit

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. But there is also growing evidence about the links between oral and systemic health that suggests a contrary position. Keystone Bio Inc. is among a small clutch of firms probing the effects of a particular oral pathogen on chronic inflammatory disease. If it’s successful, it could have a profound bearing on how we manage risk for conditions like cardiovascular disease, cardiometabolic syndrome and even Alzheimer’s disease

Conserved binding pocket is net positive for deadly coronavirus strains

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 BioWorld Insider Podcast: Looking ahead to 2023, CEOs contemplate the new normal

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.

Also in the news

Altamira, Amgen, Anaptysbio, Anavex, Aridis, Aum, Bactobio, Baudax, Beam, Bright Minds, Coya, EIP, Eqrx, GSK, Hoth, Karyopharm, Mirati, Nuvectis, Ondine, Otsuka, Qilu, PTC, Pyxis, Rigel, Roche, SK, Theratechnologies, Tonix, Urogen, Vanda, Vaxxinity, Ventyx, Y-Mabs