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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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Medgene has entered into an agreement with Elanco to commercialize Medgene’s highly pathogenic avian influenza (HPAI/H5N1) vaccine in the US for dairy cattle
Medgene's vaccine has met all USDA platform tech guidelines & is in final review for conditional approval, with manufacturing supply ready for deployment upon approval
HPAI vaccine is developed…
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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 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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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 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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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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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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Sandoz has launched Pyzchiva, a biosimilar version of Stelara in the US to treat mod. to sev. plaque PsO & active PsA in adults as well as pediatric pts, plus mod. to sev. active crohn’s disease & UC in adults; expected to offer interchangeability by H1'25
Launch follows Samsung’s settlement & license deal…
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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…

