PFIZER INC.

The global oncology precision medicine market was valued at USD 53.2 billion in 2023 and is expected to grow at a 10.4% CAGR from 2024 to 2032, driven by rising cancer incidence and increasing demand for personalized therapies. Key segments include breast cancer, oral administration, small molecules, and kinase inhibitors. North America leads in market share, with the U.S. accounting for USD 19.7 billion in 2023. Prominent companies include AbbVie, AstraZeneca, and Pfizer, with recent strategic acquisitions enhancing their oncology portfolios.

GSK sues Moderna for patent infringement on mRNA vaccine technology, claiming Moderna's COVID-19 vaccines rely on GSK's foundational patents from a team led by Christian Mandl at Novartis. GSK seeks damages and licensing fees.

The FDA has approved 64 biosimilars, including Steqeyma. Biosimilars are highly similar to FDA-approved reference products with no clinically meaningful differences. Interchangeable biosimilars meet additional requirements, allowing pharmacy-level substitution without prescriber intervention. Examples include biosimilars for Actemra, Avastin, Enbrel, and others, highlighting their safety, effectiveness, and cost-saving potential.

The October 2024 Medicinal Chemistry Symposium, hosted by Bristol Myers Squibb in Cambridge, MA, focuses on new drug discoveries. Key presentations include BMS-986408 for cancer, STX-721 for lung cancer, PF-07328948 for heart failure, and NVP-DFF332 targeting HIF-2α. Registration required by October 11, 2024.

Tulisokibart maintained clinical and endoscopic improvements in IBD patients through week 50 in phase II trial extensions, with 48% of ulcerative colitis patients and 56% of Crohn's disease patients achieving clinical remission. The drug was well-tolerated with no identified safety signals.

FDA approves Hympavzi (marstacimab, Pfizer) for routine prophylaxis in hemophilia A/B patients without factor inhibitors, targeting TFPI to increase thrombin. Hympavzi is the first non-factor, once-weekly treatment for hemophilia B in the US, reducing bleeding episodes in BASIS trial participants.

Tonix Pharmaceuticals submitted an NDA for TNX-102 SL, a non-opioid analgesic for fibromyalgia treatment, marking a potential new first-line option. Supported by Phase 3 trials, TNX-102 SL targets fibromyalgia's non-restorative sleep, showing significant pain reduction and a favorable safety profile.

Pfizer collaborates with Triana Biomedicines to discover molecular glue degraders for oncology and other disease areas, potentially generating over $1.5 billion for Triana. The partnership reflects growing interest in molecular glue technology, with other biopharma giants like Takeda, Novo Nordisk, and Genentech also forming collaborations in this space.

JAK inhibitors are key drugs for treating inflammatory diseases and cancer, with billions in revenue. They target JAK enzymes, crucial for cytokine signaling, reducing inflammation and symptoms. Approved for atopic dermatitis, ulcerative colitis, rheumatoid arthritis, psoriasis, and alopecia areata, they offer significant benefits. For cancer, they treat myelofibrosis and are being explored in combinations with immune checkpoint inhibitors. Safety concerns led to FDA and EMA restrictions, but market growth is expected due to rising autoimmune disease prevalence.

Tonix Pharmaceuticals submitted an NDA to the FDA for TNX-102 SL, a non-opioid analgesic for fibromyalgia, based on two successful Phase 3 studies showing significant pain reduction. The drug targets non-restorative sleep and has Fast Track designation, potentially expediting review. If approved, it would be the first new fibromyalgia drug in over 15 years.