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Solventum

Thermo Fisher Scientific to Acquire Solventum’s Purification & Filtration Business for ~$4.1B

Shots: Thermo Fisher has entered into definitive agreement with Solventum to acquire its purification & filtration business for ~$4.1B in cash, adding value to its upstream and downstream biologics development & manufacturing Transaction is expected to close by the end of 2025, pending regulatory approval & customary closing conditions Solventum's purification and filtration unit…

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Merck

Merck Reports the US FDA’s sBLA Acceptance of Neoadjuvant Keytruda with Priority Review for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots: The US FDA has accepted sBLA & granted priority review to neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy ± cisplatin & then as a single agent to treat operable LA-HNSCC (PDUFA: Jun 23, 2025) sBLA was based on P-III (KEYNOTE-689) trial data assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by…

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Takeda & BridGene Biosciences

Takeda Partners with BridGene Biosciences to Identify Novel Small Molecules in Immunology and Neurology

Shots: Takeda has entered into strategic collaboration & licensing agreement with BridGene bioscience to identify novel small molecules in immunology & neurology As per the terms, Takeda will gain exclusive rights to develop & commercialize products arising from the deal in exchange for $46M including upfront & preclinical milestone, plus additional ~$770M in clinical…

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Gilead

Gilead Reports the EMA’s MAA and EU-M4all Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk

Shots: The EMA has accepted MAA & EU-M4all as well as granted priority review to lenacapavir (HIV-1 capsid inhibitor) for PrEP in humans at risk of HIV; MAA will be applicable in 30 EEA states (incl. Norway, Iceland & Liechtenstein) MAA was based on P-III (PURPOSE 1 & PURPOSE 2) trials assessing lenacapavir (SC;…

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summit therapeutics &pfizer

Summit Therapeutics Partners with Pfizer to Assess Ivonescimab in Combination with Pfizer’s ADCs for Various Solid Tumor Settings

Shots: Summit has entered into a clinical trial collaboration with Pfizer to assess safety & anti-tumor activity of ivonescimab with multiple Pfizer’s vedotin ADCs in solid tumors; trials are expected to initiate in mid-2025 As per the deal, Summit will supply ivonescimab for proposed trials & Pfizer will handle operations, with both firms jointly…

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Regeneron

Regeneron Presents P-I/II (CHORD) Trial Data of DB-OTO for Profound Genetic Hearing Loss at Association for Research in Otolaryngology 2025

Shots: Ongoing P-I/II (CHORD) trial assessed DB-OTO (intracochlear) in 12 pts (10mos.-16yrs.) with hearing loss due to variation in OTOF gene, where 9 pts received it in 1 ear, while 3 received it in both; pts enrolment (<18yrs.) ongoing in the US, UK & Spain At 48 wks., first subject (10mos. old) showed improved…

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Formycon Reports the MHRA’s Approval of FYB203 (Biosimilar, Eylea) as Ahzantive

Shots: Following the EC approval, Formycon & Klinge Biopharma have reported the UK MHRA’s approval of FYB203, biosimilar of Eylea (aflibercept), under the brand name: Ahzantive The biosimilar is intended to treat Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases incl. Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal…

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Boehringer Ingelheim

Boehringer Ingelheim Introduces Vaxxitek HVT+IBD+H5 Vaccine Against Marek’s Disease, Infectious Bursal Disease and H5 Avian Influenza

Shots: BI has launched Vaxxitek HVT+IBD+H5, a trivalent poultry vaccine against marek’s disease, infectious bursal disease & H5 avian influenza; commercially available in Egypt by Feb 2025 Trivalent vaccine uses BI's COBRA tech to create unique antigen for protection against prevalent H5 clades & is administered at the hatchery for early chick protection to avoid…

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