Glaxosmithkline plc (GSK) pledged $2.1 billion up front and as much as $1.2 billion in development milestone payments to take over privately held Affinivax Inc. and bring aboard the phase II-stage, next-generation, 24-valent pneumococcal vaccine candidate, AFX-3772. London-based GSK is buying all outstanding shares of Affinivax, of Cambridge, Mass., for $2.1 billion upon closing the deal in the third quarter of this year, and two potential milestone payments of $600 million to be paid if certain pediatric development goals are reached.

Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.

The U.S. FDA has rejected Verrica Pharmaceuticals Inc.’s drug-device combination to treat the viral skin disease molluscum for a third time, losing more ground to a potential rival from Novan Inc., because of continued manufacturing issues. There are no FDA-approved treatments for molluscum contagiosum, which leads to skin-colored or pink lesions and affects around 6 million people in the U.S. annually.

The U.S. FDA’s approval, in recent years, of new medicines that can fight certain drug-resistant bugs makes it possible to conduct noninferiority trials of potential antibacterial therapies in patients with infections caused by those bugs since active controls are now available.

Unveiling further positive data for SER-109 in preventing recurrent Clostridium difficile infection at Digestive Disease Week (DDW) over the weekend, Seres Therapeutics Inc. reiterated plans to file a BLA with the U.S. FDA in mid-2022. Should the FDA accept the application and grant priority review – SER-109 has breakthrough and orphan status – the medicine could be the first microbiome-based therapy to reach the market.

Respiratory syncytial virus (RSV) continues to be a tough indication. Enanta Pharmaceuticals Inc.’s phase IIb study of otherwise healthy adults treated with EDP-938, an N-protein inhibitor, missed its primary endpoint of reduction in total symptom score compared to placebo. It also missed the study’s secondary antiviral endpoints.

Shares in Bavarian Nordic A/S jumped after the company received an order of its monkeypox vaccine from an “undisclosed European country.” The order comes amid a small but growing number of cases of monkeypox in Europe, with nine reported in the U.K. and further cases in Portugal and Spain, bringing the total in the continent to more than 20.