NEWS

SpringWorks Therapeutics (Merck KGaA) Reports the EC’s Approval of Ogsiveo (Nirogacestat) for Desmoid Tumors

Shots: The EC has approved Ogsiveo as a monotx. for adults with progressing desmoid tumors needing systemic treatment Approval was based on global P-III (DeFi) trial (N=142) assessing Ogsiveo (150mg, BID, n=70) vs PBO (n=72) in adults with progressing desmoid tumors Trial met its 1EP with 71% reduction in risk of disease progression & showed…

August 19, 2025

SystImmune and BMS’ Izalontamab Brengitecan Secures the US FDA’s Breakthrough Therapy Designation to Treat EGFRm NSCLC

Shots: The US FDA has granted BTD to izalontamab brengitecan (iza-bren) for LA/M NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations progressing on or after EGFR TKI & Pt-based CT Designation was backed by data from 3 ongoing trials: BL-B01D1-101 & BL-B01D1-203 in China led by Sichuan Biokin, & the global BL-B01D1-LUNG-101…

August 18, 2025

Galvanize Therapeutics Enrolls First Patient in PROPEL Registry Trial of Aliya Pulsed Electric Field Ablation for Soft Tissue Lesions

Shots: Galvanize Therapeutics has enrolled the first patient in the PROPEL registry trial evaluating the Aliya Pulsed Electric Field ablation system for soft tissue lesions, including primary and metastatic lung, liver, & other organ tumors Trial will evaluate clinical application, safety, perioperative outcomes, & radiographic response of the Aliya PEF system in ~1000 pts over…

August 18, 2025

Valneva Obtains Health Canada’s Approval for Ixchiq to Prevent Chikungunya

Shots: Health Canada has approved label expansion for Ixchiq against CHIKV disease in individuals (≥12yrs.) Approval was based on a P-III trial of Ixchiq vs PBO in adolescents over 6mos., which showed a superior high & sustained immune response in 99.1% of participants; data was published in The Lancet Infectious Diseases Additionally, label extension filing…

August 18, 2025

Accord BioPharma launches Imuldosa (Biosimilar, Stelara) PFS at the lowest WAC

Shots: Accord BioPharma, a division of Intas Pharmaceuticals, has launched Imuldosa (ustekinumab-srlf), a biosimilar to Stelara The launch includes a $0 co-pay program for eligible pts with plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis Through an exclusive deal with Bio-Thera Solutions, Accord plans to introduce BAT2506, a biosimilar to Simponi, to the U.S.…

August 18, 2025

Eli Lilly Collaborates with Superluminal Medicines to Develop Small Molecule for Cardiometabolic Diseases and Obesity

Shots: Superluminal Medicines & Eli Lilly have partnered to develop small molecule therapeutics for undisclosed GPCR targets in cardiometabolic diseases & obesity, leveraging Superluminal’s drug discovery platform As per the deal, Superluminal will use its platform to discover & optimize small molecules, while Lilly will obtain exclusive rights to develop & commercialize the candidates in…

August 18, 2025

Novo Nordisk Reports the US FDA’s Approval of Wegovy for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Shots: The US FDA has approved a label extension for Wegovy to treat noncirrhotic MASH in adults with mod. to adv. liver fibrosis (F2 to F3 fibrosis) in combination with a reduced calorie diet & increased physical activity; Application submitted to EMA & PMDA in Feb & May 2025, respectively Approval was based on Part…

August 18, 2025

Precigen’s Papzimeos Receives the US FDA’s Full Approval for Recurrent Respiratory Papillomatosis

Shots: The US FDA has granted full approval to Papzimeos (zopapogene imadenovec-drba) for adults with recurrent respiratory papillomatosis (RRP), even though its BLA was originally submitted under the accelerated approval pathway Approval was based on a P-I/II trial meeting its 1EP of safety as well as efficacy & showed 51% pts (18/35) achieving CR with…

August 18, 2025

Sanofi’s Rilzabrutinib Secures the EMA’s Orphan Drug Designation to Treat IgG4-Related Disease

Shots: The EMA has granted ODD to rilzabrutinib for the treatment of IgG4-related disease (IgG4-RD) Rilzabrutinib (PO) is being evaluated in a P-II trial for IgG4-RD with glucocorticoids vs glucocorticoids alone, showing reduced flares, improved disease markers, & steroid sparing over 52 weeks; data presented at EULAR 2025 Rilzabrutinib, a reversible covalent BTK inhibitor, is…

August 14, 2025

PetPace Launches Epilepsy Insights Module for Canine Seizure Monitoring

Shots: PetPace has launched an Epilepsy Insights module to deliver low-latency, data-driven insights on epileptic events in dogs; available for beta testing in dogs with a confirmed epilepsy diagnosis The Epilepsy Insights module is powered by the PetPace smart collar & uses AI as well as ML to manage canine epilepsy through continuous monitoring & automated…

August 14, 2025

NEWS

SpringWorks Therapeutics (Merck KGaA) Reports the EC’s Approval of Ogsiveo (Nirogacestat) for Desmoid Tumors

SystImmune and BMS’ Izalontamab Brengitecan Secures the US FDA’s Breakthrough Therapy Designation to Treat EGFRm NSCLC

Galvanize Therapeutics Enrolls First Patient in PROPEL Registry Trial of Aliya Pulsed Electric Field Ablation for Soft Tissue Lesions

Valneva Obtains Health Canada’s Approval for Ixchiq to Prevent Chikungunya

Accord BioPharma launches Imuldosa (Biosimilar, Stelara) PFS at the lowest WAC

Eli Lilly Collaborates with Superluminal Medicines to Develop Small Molecule for Cardiometabolic Diseases and Obesity

Novo Nordisk Reports the US FDA’s Approval of Wegovy for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Precigen’s Papzimeos Receives the US FDA’s Full Approval for Recurrent Respiratory Papillomatosis

PetPace Launches Epilepsy Insights Module for Canine Seizure Monitoring

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