Anti-infective

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PolyPid's D-PLEX100 meets Phase III endpoints this time around, significantly reducing surgical point infections in abdominal colorectal surgery, and is set for a US approval submission early next year.

The company will ramp up manufacturing of its Jynneos vaccine to meet demand in worst-affected African countries and stockpiling richer nations.  

2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.  

Tarsus Pharmaceuticals is putting more sales and marketing heft behind its novel eyelid disease therapy, Xdemvy, to capitalize on a solid start in a previously untapped market.    

The commercial implications of the miss are hard to call, but separate trials could offer hope.    

The specialist pharma company hopes demand for mpox vaccines will help establish its vaccine platform, but cash and investor confidence remain in short supply.

Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.

An academic study of GLP-1 agonist showed promise in patients with the painful skin condition but with no signs that the Danish drugmaker will pursue the indication, smaller players in the space may be interested.

Serum Institute is working on an mpox vaccine while other Indian firms are weighing options after the WHO sounded an alert and a new case was reported in neighboring Pakistan. Scrip looks at factors that could favor development and/or manufacture of an mpox vaccine at Indian majors.

Discontinuation of the AML study created concern about potential readthrough to a pivotal MDS trial, but the company and analysts pointed out differences in the diseases.

Francesco Hofmann, head of R&D at the mid-sized French group, tells Scrip that its strategy of not playing in the spaces that are dominated by big pharma is paying off.

Nemluvio is a first-in-class IL-31 inhibitor that the US FDA approved for prurigo nodularis.

Second quarter revenues are up but RSV jab woes drag on the company’s stock.    

In this week's podcast edition of Five Must-Know Things: Narasimhan plays the long game; Merck & Co’s RSV contender; Mounjaro’s China approval; the mid-cap rising stars; and AI could add billions in drug revenues.

Beyfortus was a minimal contributor in Sanofi’s second quarter, which beat consensus and prompted an earnings guidance boost, but the RSV antibody’s sales should surge in Q3 and Q4.

A Phase IV study showed that ViiV’s Dovato was non-inferior to Gilead’s Biktarvy on efficacy and produced less weight gain.

 Phase IIb/III trial testing Merck’s prophylactic monoclonal antibody clesrovimab met the primary safety and efficacy endpoints to protect infants from RSV, but the market is competitive. 

Chairman Sir Nigel Rudd said re-registering as a private company is necessary to provide Destiny Pharma with a realistic chance of securing the capital required to progress XF-73 Nasal through clinical trials, without which “liquidation of the company is the most likely alternative.”

In this week's podcast edition of Five Must-Know Things: US approval for Lilly’s Alzheimer's contender; the challenges and rewards of late-stage ADCs; Eisai regains control of ADC from BMS; RSV vaccine developers hit by declining expectations; and an interview with Amgen’s Ian Thompson.