PFIZER INC.

ORIC-944 is an orally bioavailable PRC2 inhibitor designed to improve solubility and stability, with a longer half-life than EZH2 inhibitors. It reprograms AR-independent prostate tumors to AR-dependent states.

July's Molecules of the Month feature Novartis' molecular glue degrader for sickle cell disease, Pfizer's tinlorafenib for melanoma with brain metastasis, AstraZeneca's AZ-PRMT5i-1 for MTAP-deficient cancers, MTX-531 for dual EGFR/PI3K inhibition, and LifeMine Therapeutics' XC219 discovered via top-down approach. Paxalisib shows promising data in glioblastoma, and Takeda's OX2R-selective agonist offers potential in Alzheimer's disease.

Novo Nordisk launches Wegovy® in Australia for weight loss. Xbrane regains certolizumab biosimilar rights. BMS’ Opdivo® gains new NSCLC indication in Australia. Teva’s Q2 revenue grows 7%. Celltrion’s ustekinumab biosimilar approved in Canada. Zydus’ trastuzumab biosimilar approved in Mexico. PBAC agenda includes denosumab & ustekinumab biosimilars. UPC hears omalizumab patent dispute. Biogen’s Leqembi® shows Alzheimer’s benefits. Samsung Bioepis revokes Janssen’s Stelara® patent in UK. Bio-Thera/Sandoz’s bevacizumab biosimilar approved in EU. Roche’s Vabysmo® approved for RVO in EU. FDA approves J&J’s Darzalex Faspro® for multiple myeloma. Formycon’s pembrolizumab biosimilar enters Phase III. US indicts for counterfeit cancer drugs. Roche’s Vabysmo® approved for RVO in Canada. NICE against trastuzumab deruxtecan for HER2-low breast cancer. Amgen’s Xgeva® PFS approved in Korea. FDA alerts on compounded semaglutide imitations. Regeneron disclaims aflibercept patent after adverse IPR decision.

Brazil emerges as a key hub for oncology clinical trials, with Roche leading in trials for drugs like Atezolizumab and Pertuzumab. The country focuses on prevalent cancers, with NSCLC trials dominating. Phase III trials are prevalent, supported by CROs, indicating Brazil's role in global cancer research.

The global biotechnology market is projected to grow from USD 1.38 trillion in 2023 to USD 4.25 trillion by 2033, at a CAGR of 11.8%. Growth is driven by chronic disease prevalence, personalized medicine, and R&D. North America leads with a 37.79% market share in 2023, followed by Asia Pacific at 23.99%. Key applications include bio-pharmacy, which dominated in 2023, and technologies like tissue engineering and regeneration.

The recurrent glioblastoma market is projected to grow at a CAGR of 5.85% from 2024 to 2034, driven by advancements in targeted therapies, immunotherapies, and combination treatments. Key developments include targeting EGFR and VEGF pathways, CAR T-cell therapy, and integrating tumor-treating fields with traditional therapies. Leading companies like Novartis, Pfizer, and Roche are innovating treatments, with the U.S. leading in patient pool and treatment advancements.

AI is increasingly used across the drug lifecycle, from discovery to post-market surveillance, enhancing efficiency and safety. Regulatory agencies emphasize transparency and explainability in AI applications to ensure informed decision-making. Challenges include adapting regulatory frameworks for AI's evolving role, with specific actions proposed for each drug development stage. Collaboration between regulators, developers, and AI experts is crucial for leveraging AI's potential while maintaining safety standards.

Moderna's shares dropped nearly 20% after lowering its 2024 financial forecasts due to decreased COVID-19 vaccine sales, deferred government contracts, and competition. The company expects low EU sales and contract deferrals, impacting revenue. Moderna is optimistic about future growth, focusing on new vaccines and cost-cutting measures, including AI investments.

GSK raised its 2024 sales and earnings forecasts due to strong HIV and cancer drug performance, with Q2 sales up 13% to £7.88bn. Sales growth expected at 7%-9%, but vaccine sales outlook reduced. Core operating profit and EPS forecasts also increased.