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Merus
NEWS

Genmab to Acquire Merus for ~$8B

Shots: Genmab has entered into a transaction agreement to acquire Merus, incl. its lead asset petosemtamab, expanding its late-stage pipeline & accelerating Genmab’s shift to a wholly owned model As per the deal, Genmab will acquire Merus for $97 per share in an all-cash transaction, representing the deal value of ~$8B, with closing expected in the…
September 29, 2025

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NEWS

Amneal Pharmaceuticals Reports the US FDA’s BLA Filing for Biosimilar Candidate to Xolair (Omalizumab)

Shots: The US FDA has received a BLA for a biosimilar candidate to Novartis’ Xolair (omalizumab), developed by Kashiv BioSciences Additionally, Amneal expects to incur a $22.5M R&D milestone charge in Q3’25 instead of Q4 due to the earlier BLA filing & holds exclusive US commercialization rights for the product pending regulatory approval Xolair is…
September 29, 2025

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Regeneron New
NEWS

Regeneron’s Evkeeza Receives the US FDA’s Approval to Treat Homozygous Familial Hypercholesterolemia in Younger Patients

Shots: The US FDA has approved label expansion to Evkeeza (evinacumab-dgnb) as an adj. to diet, exercise & other lipid-lowering therapies for the treatment of children (1 to <5yrs.) with homozygous familial hypercholesterolemia (HoFH) Approval was supported by efficacy & safety results in 6 children with HoFH (incl. PK data from 4) who participated in…
September 29, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Sep 22, 2025 – Sep 26, 2025)  

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A and Biosimilars. Check out our full report below:   Roche Reports P-III (evERA Breast Cancer) Trial Data on Giredestrant + Everolimus for ER-Positive Breast Cancer Read More: Roche BMS Reports the P-III (EXCALIBER-RRMM) Trial Data of Iberdomide Regimen to Treat…
September 26, 2025

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Intellia Therapeutics
NEWS

Intellia Reports Long-Term P-I Trial Data of Nexiguran Ziclumeran for Hereditary ATTR Amyloidosis with Polyneuropathy (ATTRv-PN)

Shots: Intellia has reported P-I trial data assessing nexiguran ziclumeran (nex-z) in ATTRv-PN; results were presented at the International ATTR Amyloidosis Meeting 2025 & published in The NEJM Single dose of nex-z achieved mean TTR reductions of 92% at 24mos. & 90% in 12 pts followed for 36mos. At 24mos., 13/18 pts met ≥4-point mNIS+7 improvement, incl.…
September 26, 2025

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NEWS

HemoSonics Secures the US FDA’s 510(k) Clearance for Quantra Hemostasis System in Obstetric Procedures

Shots: The US FDA has granted 510(k) clearance to Quantra Hemostasis System with QStat Cartridge, expanding its use in peripartum obstetric procedures to help manage postpartum hemorrhage Quantra is a cartridge-based viscoelastic testing system that uses SEER Sonorheometry tech to provide fast, point-of-care whole-blood coagulation analysis in <15min., enabling individualized & evidence-based decisions, along with…
September 26, 2025

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Eli lilly
NEWS

Eli Lilly’s Inluriyo (Imlunestrant) Receives the US FDA’s Approval for ESR1-mutated Breast Cancer

Shots: FDA approved Inluriyo (200mg; PO) for treating adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after ≥1L of endocrine therapy; US availability expected in the coming wks. Approval was based on P-III (EMBER-3) trial (N=874: 32% in 1L & 64% in 2L treatment post progression) assessing Inluriyo ± abemaciclib vs fulvestrant/exemestane…
September 26, 2025

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