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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Clover’s SCB-1019 RSV Revaccination Study Clears U.S. IND; FDA Approves AMVUTTRA for ATTR-CM CV Risk Reduction; Pembrolizumab Combo Greenlit for HER2+ Gastric/GEJ Cancer; TREMFYA Becomes First IL-23 Inhibitor Approved for Crohn’s; FDA OKs GOZELLIX for Prostate Cancer Imaging

Clover’s RSV Vaccine Candidate SCB-1019 Gains U.S. IND Clearance for Revaccination Study Clover Biopharmaceuticals, Ltd. has received FDA clearance for its Investigational New Drug (IND) application and has initiated a Phase I revaccination clinical trial for SCB-1019, its non-adjuvanted bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine. The trial, now enrolling participants, aims to assess the safety, reactogenicity, and immunogenicity of SCB-1019, which is based on Clover’s proprietary Trimer-Tag vaccine technology platform. The study includes up to 160 older adults (ages 60-85) who were previously vaccinated with GSK’s RSV vaccine (AREXVY) at ...

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CTEXLI Approved for Cerebrotendinous Xanthomatosis; SIGX1094 Wins Fast Track for Diffuse Gastric Cancer; Bavarian Nordic’s Chikungunya Vaccine Cleared for Ages 12+; UX111 Gene Therapy Gains Priority Review for Sanfilippo Syndrome; SUBLOCADE Label Update Approved

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EU Approves Galderma’s NEMLUVIO for Atopic Dermatitis and Prurigo Nodularis; GSK’s Penmenvy Wins FDA Nod; Ono Pharmaceuticals’ ROMVIMZA Gets Green Light from FDA for Symptomatic TGCT; Bristol Myers Squibb Updates on RELATIVITY-098 Phase III Trial Findings; FDA Expands Label for Astellas’ IZERVAY in Geographic Atrophy Treatment

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Parkinson’s and Tuberculosis Share a Common Protein That Could Provide Better Drugs for Both

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Biochips in Healthcare: 8 Groundbreaking Applications Shaping the Industry

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ORLYNVAH – The First Oral Penem in the US Market: A New Era in UTI Treatment

Widespread Usage of HPV Vaccine Reduces Cervical Cancers and Precancers

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FDA Grants Orphan Status to MDL-101 for LAMA2-CMD; Pfizer’s ABRYSVO Approved for High-Risk Adults (18-59); KIND’s AND017 Gains Orphan Designation for Sickle Cell Disease; HiberCell’s HC-7366 Fast-Tracked for AML; ORLYNVAH Approved for Uncomplicated UTIs

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Gilead and Merck Announce Encouraging Phase II Results of Islatravir and Lenacapavir Combo; REGENXBIO Highlights Positive Data from Phase II ABBV-RGX-314 Wet AMD Study at AAO 2024; FDA Greenlights Astellas’ VYLOY for Advanced Gastric and GEJ Cancer Therapy; Merck’s CAPVAXIVE Vaccine Yields Strong Immune Response in Adults Vulnerable to Pneumococcal Disease; FDA Postpones LUMAKRAS Colorectal Cancer Verdict to Early 2025

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Helicobacter pylori Infections Treatment: Emerging Molecular Targets

Nonalcoholic steatohepatitis Treatment Landscape Which Pipeline Therapy Will Steal the Spotlight

Nonalcoholic Steatohepatitis Treatment Market: Which Pipeline Therapy Will Steal the Spotlight?

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Merck’s WINREVAIR™ EU Approval; BALVERSA for Urothelial Carcinoma; Novartis and Versant’s Borealis Launched; Moderna’s RSV mRESVIA® EU Approval; FDA Nods RYBREVANT® and LAZCLUZE™ for EGFR-mutated Lung Cancer

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Guard Medical Announced FDA 510(k) Clearance; PROCEPT BioRobotics Announced FDA Clearance; GE HealthCare Announced MASTER Trial Results; CollPlant and Stratasys Announced Pre-clinical Study; GE HealthCare Announced Collaboration to Investigate MRI Techniques; NOWDiagnostics’ Syphilis Test Received De Novo Marketing Authorization

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MIMEDX Launches HELIOGENTM Fibrillar Collagen Matrix; DocGo Launches Mobile X-ray Program; Labcrop’s FDA De Novo Marketing Authorization; Inspire Medical Systems Receives FDA Approval; Alcyone Therapeutics Announces Continued Enrollment Approval from the FDA; Lunit’s AI for Tuberculosis Detection

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CEPI Grants $41.3 Million to Valneva; Innovent Achieves Phase III Success for Mazdutide; GSK’s BLENREP Combination Therapies EMA Review Application; Darolutamide Phase III ARANOTE Trial; Roche’s SUSVIMO Shows Long-Term Efficacy

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Vaccine Adjuvants: Enhancing Immunity in the Fight Against Diseases

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Moderna’s Phase III Trials for Dual Influenza and COVID-19 Vaccine; Almirall’s Klisyri FDA Approval; Lilly’s Tirzepatide MASH Trial; Cycle Pharmaceuticals Acquisition of Vanda Pharmaceuticals; Ipsen’s Iqirvo FDA Approval

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