BI Reports P-III (SYNCHRONIZE-2) Trial Data on Survodutide for Obesity/Overweight and Type 2 Diabetes at EASD 2026

Shots: P-III trial of survodutide (3.6 or 6mg, QW) in 755 pts, met both co-1EP using treatment-regimen & efficacy estimands. At Wk. 76, weight loss reached up to an average of 13.1% vs 3.1% with PBO, while up to 79.3% vs 32.7% pts achieved ≥5% weight loss (efficacy estimand) In 2EPs, trial showed reduced HbA1c…

ByRidhi Rastogi16 hours ago

NEWS

BMS Reports US FDA Approval of Camzyos in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The US FDA has approved Camzyos (mavacamten) for the treatment of symptomatic oHCM to improve functional capacity & symptoms in adults & pediatric pts (≥30kg) Approval was based on P-III (SCOUT-HCM) trial data assessing Camzyos (n=23) vs PBO (n=21) in 44 pts (12 to <18yrs.) with symptomatic NYHA class II-III oHCM, which met its 1EP,…

ByRidhi Rastogi17 hours ago

INSIGHTS+

Q3 2026 Biopharma Review: Mega Deals, Strategic Licensing, and a Wave of FDA Innovation

Introduction The third quarter of 2026 underscored just how rapidly the biopharma landscape is being reshaped by capital, innovation, and strategic consolidation. Across July through September, the industry saw a succession of multibillion-dollar acquisitions, high-value licensing agreements, and a broad spectrum of FDA approvals spanning oncology, rare diseases, metabolic disorders, neurology, immunology, and precision diagnostics. …

ByRidhi Rastogi18 hours ago

NEWS

Ceribell Secures FDA Clearance for Quantitative EEG Trending and Amplitude-Integrated EEG Analysis

Shots: The US FDA has granted 510(k) clearance to a new software for the Ceribell System that converts raw EEG information into simplified easy-to-read trends, helping clinicians monitor changes in brain activity The update adds Alpha-Delta Ratio & Relative Alpha trending for detecting early signs of brain distress & reduced blood flow in high-risk pts,…

ByRidhi Rastogi18 hours ago

NEWS

Roche Secures US FDA Priority Review for Fenebrutinib in both Relapsing and Primary Progressive Multiple Sclerosis

Shots: The US FDA has accepted an NDA & granted priority review to fenebrutinib for RMS & PPMS based on P-III (FENhance 1 & 2) studies & the P-III (FENtrepid) trial, respectively FENhance 1 & 2 showed fenebrutinib reduced relapses and active & chronic brain lesions vs teriflunomide, lowering ARR by 51.1% & 58.5%, respectively,…

ByRidhi Rastogi20 hours ago

NEWS

Merck Reports the P-IIb (MK-7240-012) Trial Data on Tulisokibart in Hidradenitis Suppurativa

Shots: Merck has presented the P-IIb (MK-7240-012) study data assessing tulisokibart vs PBO in pts with moderate to severe hidradenitis suppurativa at EADV’26 Trial met its 1EP, with HiSCR50 at Wk. 16 achieved by 72% pts on high-dose tulisokibart (480mg, Q2W) & 64% on medium-dose (480mg, Q4W), representing a 37% & 29% improvement over PBO…

ByRidhi Rastogi21 hours ago

NEWS

Regeneron and Sanofi Expand Immunology Alliance in a Deal Valued at ~$8B

Shots: The companies expanded their alliance to add 4 long-acting, Regeneron-invented antibodies targeting IL-13 (REGN20423), IL-4×IL-13 bispecific, IL-4 & IL-4Rα. REGN20423 is in P-I for atopic dermatitis, while the other 3 are expected to enter clinical studies in 2027 As per the expanded agreement, Regeneron & Sanofi will co-develop & co-commercialize the assets, with Regeneron…

ByRidhi Rastogi22 hours ago

NEWS

Meitheal Pharmaceuticals Reports US FDA Approval of High-Concentration Formulation of Yusimry (Biosimilar, Humira)

Shots The US FDA has approved a citrate-free, high-concentration formulation for Yusimry as an interchangeable biosimilar to Humira (adalimumab) Yusimry, a TNF blocker, is available in low and high concentration formulations via autoinjector, with the low-concentration formulation also available as a PFS Emerge Bioscience holds the approved BLA for Yusimry, while Meitheal serves as its…

ByRidhi Rastogi2 days ago

NEWS

Vanda Pharmaceuticals Reports the P-III Trial Results on Hetlioz in Delayed Sleep-Wake Phase Disorder

Shots: Vanda Pharmaceuticals has reported the P-III (VP-VEC-162-3502) trial data assessing Hetlioz (tasimelteon; 20mg, PO, QD; n=20) vs PBO (n=20) in 43 adults with Delayed Sleep-Wake Phase Disorder (DSWPD) Trial met its 1EP, showing Hetlioz (20mg) shifted the time of sleep onset 42.5 min. earlier vs 5.4 min. shift on PBO, plus in an exploratory…

ByRidhi Rastogi2 days ago

NEWS

Takeda Reports P-III (LATITUDE) Program Results on Zasocitinib for Plaque Psoriasis

Shots: Takeda has presented the P-III (LATITUDE) studies data assessing zasocitinib (TAK-279) in adults with mod. to sev. plaque psoriasis (PsO) at EADV’26 In P-III (LATITUDE Atlas) study, zasocitinib was superior to deucravacitinib across 1 & all key 2EPs, with complete skin clearance emerging as early as Wk. 8 & 36.5% vs 13.9% pts achieving…

ByRidhi Rastogi2 days ago

Ridhi Rastogi

BI Reports P-III (SYNCHRONIZE-2) Trial Data on Survodutide for Obesity/Overweight and Type 2 Diabetes at EASD 2026

BMS Reports US FDA Approval of Camzyos in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Q3 2026 Biopharma Review: Mega Deals, Strategic Licensing, and a Wave of FDA Innovation

Roche Secures US FDA Priority Review for Fenebrutinib in both Relapsing and Primary Progressive Multiple Sclerosis

Merck Reports the P-IIb (MK-7240-012) Trial Data on Tulisokibart in Hidradenitis Suppurativa

Regeneron and Sanofi Expand Immunology Alliance in a Deal Valued at ~$8B

Meitheal Pharmaceuticals Reports US FDA Approval of High-Concentration Formulation of Yusimry (Biosimilar, Humira)

Vanda Pharmaceuticals Reports the P-III Trial Results on Hetlioz in Delayed Sleep-Wake Phase Disorder

Takeda Reports P-III (LATITUDE) Program Results on Zasocitinib for Plaque Psoriasis

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