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Blueprint Medicines
NEWS

Sanofi to Acquire Blueprint Medicines for ~$9.5B

Shots: Sanofi to acquire Blueprint Medicines, expanding its rare immunological disease portfolio As per the deal, Blueprint shareholders will receive $129/share in cash (~$9.1B equity value) & one non-tradeable CVR of $2 & $4 per share upon achievement of development & regulatory milestones, respectively, for BLU-808, totaling the deal value up to $9.5B on a…
June 2, 2025

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Regeneron & Sanofi
NEWS

Regeneron and Sanofi Report P-III (AERIFY-1 & AERIFY-2) Trials Data of Itepekimab for Chronic Obstructive Pulmonary Disease (COPD)

Shots: P-III (AERIFY-1 & AERIFY-2) trials assessed itepekimab (SC, Q2W or Q4W) vs PBO as an add-on therapy in pts (40-85yrs.) with mod. to sev. COPD, who haven’t smoked for ≥6mos.; data to be discussed with regulatory bodies  AERIFY-1 (n=1127) met its 1EP of reduced exacerbations, with Q2W (n=375) showing a 27% reduction at Wk.…
May 30, 2025

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GSK & Spero Therapeutics
NEWS

GSK & Spero Therapeutics Reports Early Conclusion of P-III (PIVOT-PO) Trial of Tebipenem HBr for Complicated Urinary Tract Infections (cUTIs) 

Shots: GSK & Spero Therapeutics have reported early conclusion of P-III (PIVOT-PO) trial for efficacy of tebipenem HBr to treat cUTIs, incl. pyelonephritis following IDMC recommendation based on positive interim analysis; US FDA’s filing is expected in H2’25 The P-III (PIVOT-PO) trial assessed tebipenem pivoxil HBr (600mg, PO, every 6hrs.) vs imipenem-cilastin (500mg, IV, every…
May 29, 2025

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Rezolute
NEWS

Rezolute Reports Enrollment Completion in P-III (sunRIZE) Trial of Ersodetug for Congenital Hyperinsulinism

Shots: Rezolute has completed pts enrollment in P-III (sunRIZE/RZ358-301) trial of ersodetug as an add-on treatment of hypoglycemia in congenital hyperinsulinism pts, with 62 pts enrolled, exceeding the target of 56; the US FDA’s BLA filing is expected in 2026 Trial assessed ersodetug (5 or 10mg/kg, Q2W during initial loading then Q4W for 6mos.) + SoC vs…
May 29, 2025

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GRIN Therapeutics & Angelini Pharma
NEWS

GRIN Therapeutics Collaborates with Angelini Pharma to Co-Develop and Commercialize Radiprodil for Neurological Disorders

Shots: GRIN has granted Angelini Pharma exclusive rights to commercialize radiprodil worldwide, while GRIN will retain its rights in the US, Canada, & Mexico as well as lead global development As per the deal, GRIN will get $50M upfront & ~$520M in development, regulatory & sales milestones, with net sales-based tiered royalties & payments from…
May 28, 2025

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Astrazeneca
NEWS

AstraZeneca Reports the CHMP’s Positive Opinion for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The CHMP has recommended Imfinzi as a perioperative treatment of MIBC; regulatory review is ongoing in Japan & other regions Opinion was based on the P-III (NIAGARA) trial (n=1063) MIBC pts randomized to either neoadj. Imfinzi + CT before cystectomy followed by adj. Imfinzi or neoadj. CT with no further treatment after surgery   …
May 27, 2025

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Remegen
NEWS

RemeGen’s Telitacicept Receives the NMPA’s Approval for Generalized Myasthenia Gravis (gMG)

Shots: The NMPA has approved telitacicept for the treatment of AChR antibody-positive gMG in combination with standard therapies In P-III trial for gMG, telitacicept demonstrated favorable efficacy vs PBO, with 98.1% vs 12% pts achieving ≥3-point MG-ADL reduction (-5.74 vs -0.91) as well as 87% vs 16% pts having ≥5-point QMG reduction (-8.66 vs -2.27) at…
May 27, 2025

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