Infectious Diseases

VBI Vaccines obtained FDA approval of its three-antigen hepatitis B vaccine PreHevbrio and will take on GSK’s Engerix-B and Dynavax’s Heplisav-B as CDC recommends universal HBV immunization.

GSK looks to Cabenuva to get ahead in the long-acting HIV therapy and PrEP market, but Gilead will not relinquish its lead easily.

NRx’s BriLife has demonstrated strong potential in early data from a mid-stage COVID-19 trial, spurring the company on to begin a Phase IIb/III study as soon as possible.

In this week's podcast edition of Five Must-Know Things: the prospects and plans for J&J’s pharma and oncology business; China looks more inward under new policies; an important US approval for Takeda; and Moderna’s co-founder shares tips on innovation.

Pfizer and BioNTech’s Comirnaty supply under existing agreements will continue as planned despite anticipated expansion into a new child sub-population in Europe.

The partners are halting recruitment out of “an abundance of caution,” but Gilead could decide to exit the alliance if islatravir cannot shake off safety concerns.

Regeneron is investing heavily to advance five vaccine programs with Nykode Therapeutics, the Norwegian company formerly known as Vaccibody.

Merck & Co. is looking to compete in the burgeoning long-acting HIV market, but a safety halt to a Phase II trial could disrupt those plans.

Big pharma must bet on biotech if the industry is to tackle the looming issue of superbugs, argues the Access To Medicine Foundation.

Brii’s antibody combo therapy nears approval in China, based on data from a late-stage study conducted outside the country.

Ensovibep failed to meet thresholds for continued enrollment in the large NIH Phase III trial, forcing Novartis and Molecular to home in on the early COVID-19 setting instead.

Roche has bowed out of the race to develop an oral COVID-19 therapy, leaving a lucrative but likely short-lived market for its rivals.