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NEWS

Metsera Declares Novo Nordisk’s ~$9B Acquisition Proposal a Superior Offer to Pfizer Merger Agreement

Shots: Metsera has declared Novo Nordisk’s unsolicited ~$9B acquisition proposal, valuing shares up to $77.75, as a “Superior Company Proposal” than its existing Pfizer Merger Agreement The 2-step proposal incl. an initial $56.5/share cash payment & issuance of non-voting preferred stock for 50% of Metsera’s share capital, followed by a CVR of ~$21.25/share in cash…
October 31, 2025

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Phibro Animal Health Unveils Restoris Piezoelectric Dental Gel for Dogs in the US

Shots: Phibro Animal Health has launched Restoris piezoelectric dental gel for the treatment & support of long-term oral health in dogs with periodontal disease in the US Laboratory & clinical studies showed Restoris reduced periodontal pocket depth & promoted alveolar bone regeneration around treated teeth within 30 days Restoris is applied into periodontal pockets via…
October 31, 2025

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NEWS

BioMarin Reports the US FDA’s sBLA Acceptance & Priority Review of Palynziq (Pegvaliase-pqpz) to Treat Phenylketonuria

Shots: The US FDA has accepted sBLA & granted priority review to Palynziq for the treatment of adolescents (12-17yrs.) with phenylketonuria (PDUFA: Feb 28, 2026) sBLA was supported by the P-III (PEGASUS) trial comparing Palynziq to diet alone in 55 adolescents with phenylketonuria, which showed reduced blood phenylalanine (Phe); results were presented at ICIEM’25 Palynziq…
October 31, 2025

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Daiichi Sankyo
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Daiichi Sankyo Reports the Health Canada’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Shots: Health Canada has approved Enhertu monotx. for adult with inoperable HR+, HER2-low/ultralow MBC who have received ≥1 endocrine therapy (ET) & are ineligible for ET as the next line of therapy Approval was based on the P-III (DESTINY-Breast06) trial (N=866) assessing Enhertu (5.4mg/kg) vs CT (capecitabine/paclitaxel/nab-paclitaxel) in HR+, HER2-low (n=713) & ultralow (n=152) pts Trial showed improved PFS…
October 31, 2025

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NEWS

Boehringer Ingelheim Licenses an Autoimmune Disease Therapy from Kyowa Kirin for ~$744.4M

Shots: BI has licensed a pre-clinical small molecule program from Kyowa Kirin to develop it as a potential treatment for autoimmune diseases As per the deal, BI will receive exclusive rights to develop the small molecule program globally, expanding BI’s inflammatory pipeline In contrast, Kyowa Kirin will receive up to €640M (~$744.4M), incl. an upfront payment, development,…
October 30, 2025

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Celltrion
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The FDA Grants Interchangeability Designation to Celltrion’s Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

Shots: The US FDA has granted interchangeable designation to Stoboclo & Osenvelt, biosimilar versions of Prolia & Xgeva (denosumab), respectively, for all approved indications of the reference product Designation was based on extensive data, incl. analytical data demonstrating similarity of Stoboclo & Osenvelt with reference product & P-III trial results in postmenopausal women with osteoporosis, which showed comparable…
October 30, 2025

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NEWS

ModeX Therapeutics (OPKO Health) Enters $1B+ Deal with Regeneron to Develop Multispecific Antibodies for Select Therapeutic Indications

Shots: ModeX & Regeneron entered into a license & collaboration agreement to develop multispecific antibodies across cancer and metabolic, combining ModeX’s MSTAR platform with Regeneron’s antibody binders Regeneron will fund & lead all development & commercialization in exchange for $7M upfront, plus future product selection, clinical, regulatory, & commercial milestones over $200M per molecule, with…
October 30, 2025

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Merck
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Merck Receives EC’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots: The EC has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC tumors expressing PD-L1 (CPS ≥1) across all 30 EEA states Approval was based on P-III (KEYNOTE-689) trial assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15…
October 30, 2025

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Fresenius Kabi
NEWS

Fresenius Kabi’s Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva) Receives FDA’s Interchangeable Designation

Shots: The US FDA has granted interchangeable designation to Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab), respectively, for the treatment of bone & skeletal disorders Conexxence treats adults at high fracture risk, incl. pts with osteoporosis, pts on long-term glucocorticoid therapy or certain cancer treatments affecting bone density Bomyntra prevents SREs in adults with bone-involved malignancies…
October 30, 2025

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