Ionis’ Olezarsen sNDA Secures the US FDA Priority Review for Severe Hypertriglyceridemia
Ionis Pharmaceuticals received FDA acceptance of its supplemental NDA for olezarsen and a priority‑review designation, with a PDUFA action date of June 30, 2026. The decision is backed by two Phase III CORE studies—CORE (n=617) and CORE2 (n=446)—that evaluated once‑monthly subcutaneous doses of 50 mg or 80 mg in adults with severe hypertriglyceridemia. Both trials demonstrated a placebo‑adjusted triglyceride reduction of roughly 72%, an 85% drop in acute pancreatitis events, and about 90% of treated patients achieving triglyceride levels below 500 mg/dL. Results were published in The New England Journal of Medicine.
Bayer Reports P-III (PEACE-3) Trial Data on Xofigo Combination for Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Bone Metastases
Bayer announced that its phase‑III PEACE‑3 trial demonstrated a statistically significant overall‑survival benefit for the combination of Xofigo (radium‑223) and enzalutamide versus enzalutamide alone in patients with metastatic castration‑resistant prostate cancer (mCRPC) and bone metastases. Median overall survival extended to...
Post-Conference Highlights | 2026 ViVE | Feb 22–25 | Los Angeles, CA
ViVE 2026 in Los Angeles marked a decisive shift from digital ambition to operational accountability across the health ecosystem. Leaders emphasized that AI adoption now hinges on governance, measurable ROI, and clinician trust, while interoperability is being treated as core...
Cara Medical Reports 510(k) Clearance of CARA System for Noninvasive Cardiac Conduction System Visualization
Cara Medical announced that the U.S. FDA granted 510(k) clearance for its CARA System, a non‑invasive solution that creates patient‑specific 3‑D visualizations of the cardiac conduction system using CTA data. The platform pairs the CARA Metis™ Simulator for pre‑procedural mapping...
GSK Reports the NMPA’s NDA Acceptance with Priority Review of Linerixibat for Cholestatic Pruritus
GlaxoSmithKline announced that China’s National Medical Products Administration has accepted the New Drug Application for linerixibat and placed it under priority review for treating cholestatic pruritus in primary biliary cholangitis (PBC). The filing is backed by the Phase III GLISTEN trial,...
Merck Animal Health’s Numelvi Secures the FDA Approval for Control of Pruritus Associated with Allergic Dermatitis in Dogs
Merck Animal Health announced that the U.S. FDA has approved Numelvi (atinvicitinib) for controlling pruritus linked to allergic dermatitis in dogs six months and older, with commercial availability slated for spring 2026. Numelvi is a second‑generation JAK inhibitor that demonstrates...
Argenx Reports Topline P-III (ADAPT OCULUS) Trial Data on Vyvgart in Ocular Myasthenia Gravis (MG)
argenx announced topline Phase III ADAPT OCULUS data for Vyvgart (efgartigimod alfa + hyaluronidase‑qvfc) in adults with ocular myasthenia gravis. The trial met its primary endpoint, delivering a 4.04‑point improvement in Myasthenia Impairment Index PRO ocular scores versus 1.99 points for placebo at...
IDEAYA Biosciences Reports the First Patient Enrolment in P-I Trial of IDE034
IDEAYA Biosciences announced the enrollment of the first patient in a Phase‑I dose‑escalation and expansion study of IDE034, a bispecific B7H3/PTK7 TOP1 antibody‑drug conjugate for solid tumours. The trial will assess safety, tolerability and pharmacokinetics of IDE034 as a monotherapy...
SteinCares Forges Licensing Agreement with Shilpa Biologicals for Biosimilars Across Latin America
SteinCares has signed a strategic licensing agreement with Shilpa Biologicals to commercialize a biosimilar across Latin America. Under the deal, SteinCares receives exclusive rights to register, market and distribute the product throughout the region, while Shilpa Biologicals will complete development...
Evolution Summit By Marcus Evans | May 7-8, 2026 | The Ritz-Carlton, Fort Lauderdale, Florida
The Evolution Summit, organized by Marcus Evans, will take place May 7‑8, 2026 at the Ritz‑Carlton in Fort Lauderdale. The invitation‑only event convenes senior clinical‑trial executives with innovative suppliers to discuss pressing challenges in clinical operations and drug development. Featured speakers include...
J&J Reports the FDA’s sBLA Submission for Imaavy to Treat Warm Autoimmune Hemolytic Anemia
Johnson & Johnson has filed a supplemental Biologics License Application (sBLA) with the U.S. FDA for Imaavy (nipocalimab‑aahu), a monoclonal antibody intended to treat warm autoimmune hemolytic anemia (wAIHA). The filing is supported by the Phase II/III ENERGY trial, which demonstrated...
Sciwind Biosciences and Pfizer China Partner to Commercialize Ecnoglutide in China
Sciwind Biosciences granted Pfizer China exclusive rights to commercialize ecnoglutide injection in Mainland China. Sciwind will keep the marketing authorization and handle R&D, registration, manufacturing, and supply, receiving up to $495 million in milestone payments. Ecnoglutide, a cAMP‑biased GLP‑1 receptor agonist,...
Sebela Pharmaceuticals Licenses Miudella to Organon in ~$532M Deal
Sebela Pharmaceuticals has licensed its hormone‑free copper intrauterine device, Miudella, to Organon for exclusive global rights. The agreement provides Sebela with a $27.5 million cash payment at closing and up to $505 million in sales‑based milestone payments, plus double‑digit royalties on net...
A New Era in Neuropsychiatry: Dr. Velichka Valcheva on GH Research’s Rapid-Acting Breakthrough, GH001
GH Research’s inhaled mebufotenin (GH001) demonstrated ultra‑rapid, profound antidepressant effects in a Phase 2b trial for treatment‑resistant depression, with 73% of patients in remission after six months versus ~11% for standard oral therapies. Early‑stage studies in postpartum depression and bipolar disorder...
Partner Therapeutics Reports P-II (eNRGy) Post-Hoc Results on Zenocutuzumab for NRG1+ NSCLC
Partner Therapeutics presented post‑hoc data from its Phase II eNRGy study of zenocutuzumab (Bizengri) in 27 patients with advanced NRG1‑positive non‑small cell lung cancer who received at least three doses beyond radiographic progression. Eight patients stayed on therapy for six months...
Vanda Pharmaceuticals Reports the US FDA’s Approval of Bysanti (Milsaperidone) for Acute Bipolar I Disorder & Schizophrenia
Vanda Pharmaceuticals announced that the U.S. FDA has approved Bysanti (milsaperidone), an active metabolite of iloperidone, as a first‑line therapy for acute manic or mixed episodes in bipolar I disorder and for schizophrenia. The approval is based on demonstrated bioequivalence...
The US FDA Accepts Roche’s Giredestrant NDA for ESR1-Mutated, ER-Positive Advanced Breast Cancer
The U.S. FDA has accepted Roche’s new drug application for giredestrant combined with everolimus to treat ER‑positive, HER2‑negative, ESR1‑mutated advanced breast cancer. Phase III evERA data show a 44% reduction in disease progression or death overall and a 62% reduction in...
Candel Therapeutics and RTW Enter Royalty Funding Agreement to Support the Launch Aglatimagene Besadenovec in Localized Prostate Cancer
Candel Therapeutics has secured a $100 million royalty‑funding agreement with RTW Investments, contingent on FDA approval of its gene‑therapy candidate aglatimagene besadenovec for intermediate‑ to high‑risk localized prostate cancer. Under the deal, RTW will receive a capped, tiered single‑digit percentage of...
NexEos Bio Receives US FDA IND Clearance to Advance NTX-1024 Into P-II/III Study for Vernal Keratoconjunctivitis
U.S. FDA has granted IND clearance for NexEos Bio’s ophthalmic solution NTX-1024, allowing the company to commence a combined Phase II/III clinical trial in vernal keratoconjunctivitis (VKC). The upcoming study will assess safety and efficacy after an open‑label investigator‑initiated trial...
Boehringer Ingelheim Secures US FDA’s EUA for NexGard and NexGard COMBO to Treat NWS
Boehringer Ingelheim received an Emergency Use Authorization (EUA) from the U.S. FDA for its NexGard chewable tablets to treat New World screwworm (NWS) infestations in dogs and puppies, and for NexGard COMBO topical solution to treat NWS in cats and...
ViiV Healthcare Reports P-III (LATITUDE) Trial of Cabenuva in Adherence-Challenged HIV Patients
ViiV Healthcare presented results from the Phase III LATITUDE trial evaluating Cabenuva, a long‑acting injectable of cabotegravir and rilpivirine, in 453 adults with adherence challenges. Among 306 virally suppressed participants, the quarterly injection reduced cumulative regimen failure to 22.8% versus...
Covetrus to Merge with Cencora’s MWI Animal Health in a $3.5B Deal
Covetrus and Cencora have signed a definitive agreement to merge Covetrus with MWI Animal Health, creating a unified animal‑health platform valued at $3.5 billion. Cencora will receive $1.25 billion in cash, $800 million of preferred equity and $1.45 billion of common equity, securing a...