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Tuesday, October 20, 2026

Tag: pipeline

Alvotech announces FDA acceptance of Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio®

REYKJAVIK, Iceland, June 08, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) lyophilized vial for intravenous administration.

Novartis to highlight Rhapsido® data across multiple immune-mediated diseases at EAACI Congress 2026

Basel, June 8th, 2026 – Novartis will present data from 10 abstracts at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2026, spanning Rhapsido®  (remibrutinib) clinical trial results and real-world evidence on patient burden and treatment experience. Highlights include two late-breaking oral presentations; the Phase III RemIND trial for Rhapsido in chronic inducible urticaria (CIndU) and extension data from the Phase IIIb REMIXED trial in chronic spontaneous urticaria (CSU).

“The Rhapsido presentations at EAACI 2026 expand our understanding of BTK inhibition across multiple immune-mediated diseases and provide evidence of its potential to make a meaningful impact for patients who continue to face significant burden and limited treatment options,” said Angelika Jahreis, Global Head, Immunology Development, Novartis. “Novartis will present Rhapsido data from a long-term extension trial in chronic spontaneous urticaria, Phase III data in three types of chronic inducible urticaria, and early Phase II dose-response analysis for food allergy – together providing scientific evidence for its impact across numerous diseases.”

Abstracts accepted by EAACI include: 

GNI Group to Acquire Ayumi Pharmaceutical Holdings, Expanding Its Position as a Global Biopharmaceutical Company

Transaction Establishes a Large-Scale Pharmaceutical Platform in Japan and Strengthens Commercial Capabilities Across Key Therapeutic Areas
Transaction Establishes a Large-Scale Pharmaceutical Platform in Japan and Strengthens Commercial Capabilities Across Key Therapeutic Areas

LENZ Therapeutics Announces Everest Medicines Acquired Rights to Develop and Commercialize VIZZ® (LNZ100) in Greater China

The New Drug Application for LNZ100 in China was submitted September 2025 with approval anticipated in Q1 2027
The New Drug Application for LNZ100 in China was submitted September 2025 with approval anticipated in Q1 2027

AMGEN PRESENTS NEW DATA ACROSS ITS CARDIOMETABOLIC PORTFOLIO AT AMERICAN DIABETES ASSOCIATION 86TH SCIENTIFIC SESSIONS

VESALIUS-CV Subgroup Results Show Repatha® Reduces Risk of First Major Cardiovascular Events by 29% in People Living with High-Risk DiabetesNew Real-World Data Highlight Treatment...

Head-to-head Study Validates the Clinical Advantage of New-generation Biased GLP-1: Ecnoglutide Delivers 35% Greater Weight Loss than Semaglutide

NEW ORLEANS, June 7, 2026 /PRNewswire/ -- Hangzhou Sciwind Biosciences Co., Ltd. ("Sciwind Biosciences"), a commercial-stage biopharmaceutical company focused on discovering and developing innovative...

Head-to-head Study Validates the Clinical Advantage of New-generation Biased GLP-1: Ecnoglutide Delivers 35% Greater Weight Loss than Semaglutide

NEW ORLEANS, June 8, 2026 /PRNewswire/ -- Hangzhou Sciwind Biosciences Co., Ltd. ("Sciwind Biosciences"), a commercial-stage biopharmaceutical company focused on discovering and developing innovative...

Bronstein, Gewirtz & Grossman LLC Urges Badger Meter, Inc. Investors to Act: Class Action Filed Alleging Investor Harm

NEW YORK, June 7, 2026 /PRNewswire/ -- Bronstein, Gewirtz & Grossman, LLC, a nationally recognized investor-rights law firm, announces that a class action lawsuit...

ROSEN, A LEADING INVESTOR RIGHTS LAW FIRM, Encourages Badger Meter, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action – BMI

NEW YORK, June 06, 2026 (GLOBE NEWSWIRE) --

WHY: Rosen Law Firm, a global investor rights law firm, announces a class action lawsuit on behalf of purchasers of common stock of Badger Meter, Inc. (NYSE: BMI) between April 18, 2024 and April 16, 2026, inclusive (the “Class Period”). A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than August 3, 2026.

Real-World Evidence of Eversense 365 Presented at ADA Demonstrating Strong Performance and Patient Impact in Both Open and Closed Loop Systems

Eversense 365 delivered favorable glucometrics compared to other open and closed loop systems, validating the one-year CGM’s differentiated approach and high performance 

Cullinan Therapeutics Presents Initial Clinical Data for CLN-978, a CD19xCD3 T Cell Engager, at the EULAR 2026 Congress

Clinical benefit, including remissions, demonstrated in both systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) patients following a single target dose of CLN-978 

Ractigen Therapeutics Announces ADA 2026 Late-Breaking Presentation Highlighting saRNA as a New Frontier in Obesity Control

Breakthrough preclinical data demonstrate that LiCO-saUcp1 effectively turns white fat into calorie-burning brown fat, driving massive fat loss while fully preserving lean muscle mass...

Data at ADA 2026 Highlights Key Findings from Clinical and Real‑World Studies of MannKind’s Afrezza® (Inhaled Insulin) Across Pediatric Care, Pregnancy, and Use with...

Data at ADA 2026 Highlights Key Findings from Clinical and Real‑World Studies of Afrezza® (Inhaled Insulin) Across Pediatric Care, Pregnancy, and AID Use

Ambrosia Biosciences Announces Preclinical Data Supporting Differentiated Profile of AMB-702, its Novel Small Molecule GLP-1 Receptor Agonist Development Candidate

AMB-702 demonstrates superior target coverage and efficacy in lean non-human primates The dataset was shared as part of a poster presentation at the American Diabetes...

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