NEWS

Johnson & Johnson Reports Clinical Findings on Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG) at AAN 2026

Shots: J&J has reported data from the P-III (Vivacity-MG3) trial assessing Imaavy + SoC (n=77) vs PBO + SoC (n=76) in gMG pts (N=199; 153 were Ab +ve), plus from an ongoing OLE trial. Also, enrolment is ongoing in the EPIC trial of Imaavy against efgartigimod The 24wk. Post-hoc analysis data showed adults receiving Imaavy…

2 hours ago

Regeneron Reports the US FDA Accelerated Approval of Otarmeni (lunsotogene parvec-cwha) in Genetic Hearing Loss

Shots: Otarmeni was approved under CNPV for pediatric & adult pts with sev. to profound and profound sensorineural hearing loss due to biallelic OTOF gene variants, with preserved outer hair cell function & no prior cochlear implant. It will be provided free of charge in the US by Regeneron Approval was based on the P-I/II…

3 hours ago

Novo Nordisk Reports the P-IIIa (PIONEER TEENS) Trial on Oral Semaglutide for Paediatric Patients with Type 2 Diabetes

Shots: Novo Nordisk has reported the P-IIIa (PIONEER TEENS) trial assessing oral semaglutide (3, 7 or 14mg, QD) vs PBO, on top of background treatment with metformin, basal insulin, or both, in 132 pts (10-17yrs.) with type 2 diabetes Trial showed superior HbA1c reduction vs PBO, lowering blood sugar by 0.83% at 26wks., with a…

21 hours ago

DemeRx Reports the US FDA IND Application Acceptance to Advance DMX-1001 for Alcohol Use Disorder

Shots: The US FDA has accepted IND application of DMX-1001 (oral noribogaine) for the treatment of alcohol use disorder (AUD) DemeRx completed a MAD trial of DMX-1001 in healthy volunteers, demonstrating safety, tolerability, & PK supportive of P-II in AUD. The company plans to initiate a P-II trial of DMX-1001 in AUD in 2027 Noribogaine…

22 hours ago

Regeneron and Sanofi Report the US FDA Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Shots: FDA has approved Dupixent to treat CSU pts (age 2-11yrs.), who were symptomatic despite H1 antihistamine treatment based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program, & P-III (CUPIDKids) trial Study A & C assessed Dupixent + SoC antihistamines (loading dose then 300mg Q2W; pts weighing <60kg received 200mg) vs PBO…

23 hours ago

Merck Partners with Google Cloud in ~$1B Deal to Build AI-Enabled Enterprise Platform

Shots: Merck partnered with Google Cloud in a multi-year deal worth up to $1B to deploy an AI-driven agentic platform across R&D, manufacturing, commercial, and corporate functions The collaboration will integrate advanced AI tools, incl. Gemini Enterprise, to enhance productivity, digitize data, & support Merck’s global workforce of ~75,000 employees The partnership aims to accelerate…

1 day ago

AstraZeneca Reports the P-III (I CAN) Trial Data on Ultomiris for IgA Nephropathy

Shots: AstraZeneca has reported the global P-III (I CAN/ALXN1210-IgAN-320) trial assessing Ultomiris (IV) vs PBO in ~510 adults with IgAN who are at risk of disease progression Trial met its 1EP of reduced proteinuria based on 24-hr. UPCR at 34wks., with effect seen as early as 10wks., while the 1EP of change in eGFR will be…

1 day ago

Utepreva Launches Utepreva Endometrial Sampler to Support Early Diagnosis of Endometrial Cancer

Shots: Utepreva has launched the Utepreva Endometrial Sampler, a single-use device designed to improve tissue capture & enable early diagnostic evaluation of endometrial cancer, with availability expected in Oct 2026 The device combines three mechanisms for single-pass sampling: a sponge tip absorbs tissue & fluid, a plunger-driven suction aspirates cells & prevents loss, & the…

1 day ago

Amneal Pharmaceuticals to Acquire Kashiv Biosciences for ~$1.1B

Shots: Amneal Pharmaceuticals has entered into a definitive agreement to acquire 100% of Kashiv BioSciences, accelerating its biosimilar pipeline & strengthening US commercial position As per the deal, Amneal will acquire Kashiv for $375M cash & $375M equity at closing, plus up to ~$350M in regulatory milestone payments, potential royalties tied to commercial milestones, &…

2 days ago

Regeneron Reports P-III (NIMBLE) Trial Data on Cemdisiran for Generalized Myasthenia Gravis (gMG)

Shots: The Regeneron's P-III (NIMBLE) trial enrolled adults with symptomatic gMG & anti-AChR antibodies, randomizing them to either cemdisiran monotx. (600mg, SC, Q12W), pozelimab monotx. (200 mg, Q4W), cemdi-poze (200mg each, Q4W), or PBO (Q4W) cemdisiran (Q12W; n=64) vs PBO (n=59) improved gMG within 2wks., sustained to Wk. 24; MG-ADL (1EP) improved by 4.5 vs…

2 days ago

NEWS

Johnson & Johnson Reports Clinical Findings on Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG) at AAN 2026

Regeneron Reports the US FDA Accelerated Approval of Otarmeni (lunsotogene parvec-cwha) in Genetic Hearing Loss

Novo Nordisk Reports the P-IIIa (PIONEER TEENS) Trial on Oral Semaglutide for Paediatric Patients with Type 2 Diabetes

DemeRx Reports the US FDA IND Application Acceptance to Advance DMX-1001 for Alcohol Use Disorder

Regeneron and Sanofi Report the US FDA Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Merck Partners with Google Cloud in ~$1B Deal to Build AI-Enabled Enterprise Platform

AstraZeneca Reports the P-III (I CAN) Trial Data on Ultomiris for IgA Nephropathy

Utepreva Launches Utepreva Endometrial Sampler to Support Early Diagnosis of Endometrial Cancer

Amneal Pharmaceuticals to Acquire Kashiv Biosciences for ~$1.1B

Regeneron Reports P-III (NIMBLE) Trial Data on Cemdisiran for Generalized Myasthenia Gravis (gMG)

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