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…

ByRidhi RastogiSeptember 29, 2025

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…

ByRidhi RastogiSeptember 29, 2025

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…

ByRidhi RastogiSeptember 26, 2025

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.…

ByRidhi RastogiSeptember 26, 2025

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…

ByRidhi RastogiSeptember 26, 2025

NEWS

Evaxion Licenses EVX-B3 Vaccine Candidate to Merck

Shots: Evaxion has granted Merck the rights to EVX-B3, a preclinical vaccine candidate under their Sep 2024 option & license agreement As per the deal, Merck will assume full responsibility & costs of further development of EVX-B3 in exchange for $7.5M upfront & ~$592M in development, regulatory & sales milestones, with net sales-based royalties EVX-B3…

ByRidhi RastogiSeptember 26, 2025

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…

ByRidhi RastogiSeptember 26, 2025

NEWS

Crinetics Pharmaceuticals Reports the US FDA’s Approval of Palsonify (Paltusotine) for Acromegaly

Shots: The US FDA has approved Palsonify for 1L treatment of adults with acromegaly who are ineligible for or inadequately respond to surgery; commercially available in the US by Oct 2025 & MAA under EMA's review, with CHMP opinion expected in H1’26 Approval was based on 2 P-III (PATHFNDR-2 & PATHFNDR-1) trials assessing Palsonify vs PBO…

ByRidhi RastogiSeptember 26, 2025

NEWS

Eli Lilly Reports Kisunla (Donanemab) Approval in the EU to Treat Early Symptomatic Alzheimer’s Disease

Shots: The EC has approved Kisunla to treat early symptomatic Alzheimer’s disease in adults with mild impairment or dementia & confirmed amyloid pathology who are ApoE4 heterozygotes or non-carriers Approval was based on P-III (TRAILBLAZER-ALZ 2) study (n=1736, ≥18mos.) & P-IIIb (TRAILBLAZER-ALZ 6) trial (n=843, 60-85yrs.) assessing Kisunla (QM) vs PBO in AD pts The TRAILBLAZER-ALZ 2 trial showed…

ByRidhi RastogiSeptember 26, 2025

NEWS

Acadia Pharmaceuticals Reports Topline P-III (COMPASS PWS) Trial Data of Carbetocin for Hyperphagia in Prader-Willi Syndrome

Shots: Acadia Pharmaceuticals has reported topline P-III (COMPASS PWS) trial data of carbetocin (ACP-101; intranasal) in pts with hyperphagia in Prader-Willi syndrome The global trial evaluated carbetocin (3.2mg, TID) vs PBO for 12wks. in 175 pts (5 to 30yrs) with Prader-Willi syndrome & failed to meet its 1EP of change in HQ-CT alongside any 2EP Additionally,…

ByRidhi RastogiSeptember 25, 2025

Ridhi Rastogi

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

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

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

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

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

Evaxion Licenses EVX-B3 Vaccine Candidate to Merck

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

Crinetics Pharmaceuticals Reports the US FDA’s Approval of Palsonify (Paltusotine) for Acromegaly

Eli Lilly Reports Kisunla (Donanemab) Approval in the EU to Treat Early Symptomatic Alzheimer’s Disease

Acadia Pharmaceuticals Reports Topline P-III (COMPASS PWS) Trial Data of Carbetocin for Hyperphagia in Prader-Willi Syndrome

Contact US

FOLLOW US