NEWS

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…

February 26, 2025

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…

February 26, 2025

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;…

February 25, 2025

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…

February 25, 2025

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…

February 25, 2025

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…

February 25, 2025

Sandoz Launches Pyzchiva (Biosimilar, Ustekinumab-ttwe) in the US for Chronic Inflammatory Diseases

Shots: 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…

February 25, 2025

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…

February 25, 2025

Takeda Reports EMA Approval for Additional SC Administration Option of Takhzyro (lanadelumab) for Patients aged ≥12 with Recurrent HAE

Shots: Takeda reported the EMA's approval of an additional 2 mL pre-filled pen option for Takhzyro (lanadelumab) for patients aged ≥12 with Recurrent hereditary angioedema (HAE) Currently Takhzyro is approved in 150 mg and 300 mg pre-filled syringes and 300 mg vial. The new approval is for a 300 mg pre-filled pen (2 mL…

February 25, 2025

Innovent Reports the NMPA’s NDA Acceptance & Priority Review of Neoadjuvant Ipilimumab + Sintilimab for Colon Cancer

Shots: China’s NMPA has accepted NDA & granted priority review to ipilimumab (IBI310) + sintilimab as neoadj. treatment of operable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer Submission was based on P-III (NeoShot) trial assessing safety & efficacy of ipilimumab + sintilimab vs direct radical surgery in MSI-H/dMMR colon cancer pts …

February 24, 2025

NEWS

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)

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

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

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

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

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

Sandoz Launches Pyzchiva (Biosimilar, Ustekinumab-ttwe) in the US for Chronic Inflammatory Diseases

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

Takeda Reports EMA Approval for Additional SC Administration Option of Takhzyro (lanadelumab) for Patients aged ≥12 with Recurrent HAE

Innovent Reports the NMPA’s NDA Acceptance & Priority Review of Neoadjuvant Ipilimumab + Sintilimab for Colon Cancer

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