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Glenmark signals “very challenging” US environment but expects things to stabilize with a string of potential new launches in the wings. The impending debut of Ryaltris, among other products, and a filing for a generic rival to Flovent could add some spark to the US business.
Restructuring Updates: Homology implemented modest job cuts as it ended a gene therapy trial, while ProQR revealed its second round of layoffs this year and Synthetic Biologics shifted focus to oncolytic virus pipeline. Also, Bolt, MacroGenics and others deprioritized programs in their Q2 updates.
Deal Snapshot: Through subsidiary Immunomedics, Gilead will pay $280m up front to gain the remaining global rights to the drug, at a time when Everest’s business model has encountered some difficulties in China.
The final Phase III readout for Ilaris (canakinumab) in NSCLC, this time in the adjuvant setting, missed the primary endpoint. One more lung cancer trial is under way, a Phase II neoadjuvant study.
Analysts said that while the Phase III survival data could lead to Trodelvy’s FDA approval, it still could face competitive headwinds from AstraZeneca/Daiichi Sankyo’s Enhertu.
Viridian says Phase I/II data for its thyroid eye disease candidate outperforms Horizon’s Tepezza on multiple measures. Company plans quick advancement into Phase III for VRDN-001.
The pediatric market represents 70%-75% of the market for pneumococcal vaccines; Merck & Co.'s Vaxneuvance was already approved for infants earlier this year.
Good news in the biopharma industry and the US economy gave public drug developers the boost they needed to raise cash, including Karuna’s $750m offering. Private company financings slowed during the second week of August, but Prellis and Vector BioPharma raised venture capital.
Lead candidate NYX-2925 has failed a pair of Phase IIb studies in diabetic peripheral neuropathy and now one in fibromyalgia, leaving Aptinyx’s likely last hopes in neuropsychiatric indications.
Even as it prepares for competition from an authorized generic, Lupin expects a launch of its generic to Boehringer’s blockbuster Spiriva in the fourth quarter of FY23. It hopes the launch will help its position in the US, where it has exited low margin products amid heightened competition, leading in turn to manufacturing job losses in India
Gilead execs Jared Baeten and Tomas Cihlar talk to Scrip about how the company, still the leader in HIV, is working toward less-frequent dosing, providing PrEP for broader populations and maybe finding a cure for HIV infection.
Plus deals involving Shionogi/ Grünenthal, CR Biopharma/ImmVira, Elevation Oncology/CSPC, Everest Medicines/TTY Biopharm and Dr. Reddy’s/Slayback
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