PipelineReview.com1d
Merck Announces Decision to Stop Phase 3 HYPERION Trial Evaluating WINREVAIR™ (sotatercept-csrk) Early and Move to Final Analysis
Robust evidence of the clinical benefit of WINREVAIR demonstrated in the STELLAR and ZENITH studies resulted in a loss of clinical equipoise in the HYPERION ...
PipelineReview.com1d
Shionogi Announces Positive Results from Phase 2 Trial of Respiratory Syncytial Virus Oral Antiviral Candidate S-337395
S-337395 is an investigational oral antiviral candidate for RSV infection that inhibits the activity of the L protein, which is essential for virus replication. 1,2 Furthermore, this drug has received ...
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Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain
JOURNAVX is the first and only approved non-opioid oral pain signal inhibitor and the first new class of pain medicine approved in more than 20 years -- ...
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Gameto Announces FDA IND Clearance for Fertilo, the First iPSC-Based Therapy to Enter U.S. Phase 3 Clinical Trials
AUSTIN, TX, USA I January 30, 2025 I Gameto, a clinical-stage biotech company developing iPSC-based therapies for women’s health, today announced that the ...
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Tubulis Announces First Patient Dosed in Phase I/IIa Trial Evaluating ADC TUB-030 in Advanced Solid Tumors
MUNICH, Germany I January 30, 2025 I Tubulis announced today that its second drug candidate, TUB-030, has entered clinical evaluation with successful dosing ...
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U.S. FDA approves Celltrion’s AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA®
JERSEY CITY, NJ, USA I January 30, 2025 I Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved AVTOZMA® (CT-P47, ...
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Ethris Presents Positive Topline Phase 1 Data with mRNA Lead Candidate ETH47 for Uncontrolled Asthma
MUNICH, Germany I January 30, 2025 I Ethris GmbH, a leading biotechnology company pioneering next-generation RNA therapeutics and vaccines, today announced ...
PipelineReview.com3d
Vincerx Pharma, Inc. and Oqory, Inc. Highlight Promising Data for Oqory’s TROP2 Antibody Drug Conjugate, OQY-3258
SAN MATEO, CA, USA I January 29, 2025 I Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting ...
PipelineReview.com4d
Herantis Pharma: encouraging pharmacokinetic data and first subject with Parkinson’s disease dosed in the Phase 1b trial
I Herantis Pharma Plc ("Herantis"), a company developing disease-modifying therapies for Parkinson’s disease, is pleased to announce an ...
PipelineReview.com4d
ILiAD and hVIVO Sign LOI for Pivotal Phase 3 Trial of BPZE1 Pertussis Vaccine Following FDA Meeting
Trial anticipated for H2 2025 to evaluate most advanced next generation intranasal pertussis vaccine for whooping cough ...
PipelineReview.com4d
miRecule and GBI Biomanufacturing Announce Strategic Partnership to Advance Development of Antibody RNA Conjugate (ARC) Therapies
PLANTATION, FL, and GAITHERSBURG, MD, USA I January 28, 2025 I miRecule, a biotechnology company pioneering RNA therapies, and GBI Biomanufacturing, a ...