PFIZER INC.

U.S. government offers another round of free COVID tests by end of September, available at COVIDTests.gov. Over 900 million tests have been distributed. At-home tests provide results within 30 minutes. Vaccines, including strain-specific formulations, are also available.

Pfizer withdraws all lots of Oxbryta (voxelotor) for sickle cell disease due to clinical data indicating higher risks. The company is discontinuing clinical trials and advising patients to consult their physicians for alternative treatments.

Generative AI, paired with data analytics, accelerates project execution for companies, as highlighted in the 2024 MIT Sloan Master of Business Analytics Capstone Project. This trend contrasts with 'legacy machine learning,' which enables precision but lacks speed. Projects involving life sciences, insurance, telecommunications, and retail sectors demonstrate generative AI's potential to expedite drug development, customer response, and internal communication. Additionally, the integration of generative AI aims to improve workforce management and accuracy in various business processes.

EMA's CHMP recommends approval of marstacimab in EU for preventing bleeding in severe hemophilia A or B without inhibitors. European Commission to review, with final decision expected soon. If approved, Pfizer's treatment, Hympavzi, will be available as a 150 mg subcutaneous injection. CHMP's positive opinion supported by Phase 3 BASIS trial data showing marstacimab significantly reduced bleed rates in patients without inhibitors.

Biohaven, after a phase 3 trial failure in 2022, continued developing troriluzole, a prodrug of riluzole, focusing on type 3 spinocerebellar ataxia. In 2023, the FDA refused to file a new drug application due to the earlier trial failure, prompting Biohaven to design a new 'real-world' trial. Recent results show troriluzole slowed disease progression by 50-70% over 3 years compared to external controls, leading Biohaven to plan resubmission to the FDA for all SCA genotypes by year-end.

Ideaya Biosciences announced positive phase 2 data for darovasertib in neoadjuvant uveal melanoma, showing 49% tumor shrinkage and 61% eye preservation. The FDA Type C meeting supported eye preservation and time to vision loss as primary endpoints, paving the way for a potential registrational phase 3 trial.

The U.S. general anesthesia drugs market is projected to grow from USD 1.98 Billion in 2024 to USD 2.56 Billion by 2033, driven by increasing surgical procedures, technological advancements, and regulatory updates. Key segments include propofol, intravenous drugs, knee and hip replacements, and hospitals, with ambulatory surgical centers expected to grow fastest. Major players include GE Healthcare, Pfizer, and Hospira Inc.

Cognitive Research Corporation (CRC) adds Dr. Albena Patroneva, Dr. Mark Versavel, Dr. Sandeep Vaishnavi, and Dr. Djouher Hough to its medical leadership team, enhancing expertise in neurology, psychiatry, analgesia, and psychedelic research.

Oncolytics Biotech Inc. advances pelareorep therapy, showing significant survival benefits in breast cancer patients. Other biotech companies like Nurix, Incyte, Regeneron, and Foghorn also report promising developments in cancer treatments.

Basilea Pharmaceutica Ltd initiated the FAST-IC phase 3 study to evaluate fosmanogepix, a novel antifungal, against standard-of-care treatment in invasive candidiasis. Fosmanogepix, with a novel mechanism of action, is available in intravenous and oral formulations and has shown efficacy against various Candida species, including multi-drug-resistant strains. The study aims to enroll 450 patients and is managed by PSI CRO AG.