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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Oct 27, 2025 – Oct 31, 2025)

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:   Roche Reports P-III (INShore) Trial Findings on Gazyva (Obinutuzumab) for Idiopathic Nephrotic SyndromeRead More: RocheMerck Reports the P-III (LITESPARK-022) Trial Data on Welireg + Keytruda to Treat Clear…
12 hours ago0Comments

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NEWS

GlycoNex Doses Last Patient in P-III Trial of SPD8 (Biosimilar, Prolia/Xgeva) to Treat Osteoporosis

Shots:GlycoNex has dosed the last patient with SPD8, a biosimilar version of Prolia/Xgeva (denosumab), in its P-III trial for the treatment of primary osteoporosis from solid tumorsTrial will assess the PK, efficacy, & safety of SPD8 vs reference denosumab in postmenopausal women with osteoporosis; top-line results are expected in Q2’26 & data will support…
13 hours ago0Comments

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4D Molecular Therapeutics Collaborates with Otsuka Pharmaceutical to Develop and Commercialize 4D-150 in the APAC Region

Shots:4DMT has granted Otsuka exclusive rights to develop & commercialize 4D-150 for retinal vascular diseases, incl. wet age-related macular degeneration (wet AMD) & diabetic macular edema (DME) in Japan, China, Australia & other APAC markets, while retaining rights in other regionsAs per the deal, Otsuka will lead all regulatory & commercialization efforts in…
14 hours ago0Comments

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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 AgreementThe 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…
15 hours ago0Comments

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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 USLaboratory & clinical studies showed Restoris reduced periodontal pocket depth & promoted alveolar bone regeneration around treated teeth within 30 daysRestoris is applied into periodontal pockets via…
17 hours ago0Comments

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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’25Palynziq…
18 hours ago0Comments

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Daiichi Sankyo
NEWS

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 therapyApproval 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) ptsTrial showed improved PFS…
19 hours ago0Comments

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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 diseasesAs per the deal, BI will receive exclusive rights to develop the small molecule program globally, expanding BI’s inflammatory pipelineIn contrast, Kyowa Kirin will receive up to €640M (~$744.4M), incl. an upfront payment, development,…
2 days ago0Comments

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Celltrion
NEWS

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 productDesignation 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…
2 days ago0Comments

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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 bindersRegeneron will fund & lead all development & commercialization in exchange for $7M upfront, plus future product selection, clinical, regulatory, & commercial milestones over $200M per molecule, with…
2 days ago0Comments

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