Clinical Trials & Research News

FDA Approved Weight-Management Treatment for Bardet–Biedl Syndrome

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The FDA recently approved the Imcivree (setmelanotide) injection as a weight-management treatment for adults and children over 6 with Bardet–Biedl Syndrome (BBS). BBS is a relatively...

Pfizer-BioNTech’s Expanding Coronavirus Vaccine FDA Approval

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Late last month, Pfizer announced its coronavirus vaccine clinical trial results, indicating that a three-dose regimen of the Pfizer-BioNTech vaccine was safe and effective for children older than 6...

Study Finds Vaccination During Pregnancy Decreases Baby’s COVID-19 Risk

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Data from a study published in February's CDC Morbidity and Mortality Weekly Report suggest that COVID-19 vaccination during pregnancy provides substantial protection for mother and baby. This...

Novartis Gains FDA Approval for Follicular Lymphoma Cell Therapy

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Novartis’s Kymriah was granted accelerated FDA approval last week after the drug’s clinical trial results demonstrated an 86% overall response rate and a high level of safety. Patients with...

Academia Partners with Pharma to Discover New SARS-CoV-2 Drug Treatments

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The National Institutes of Health (NIH) and the National Institutes of Allergy and Infectious Disease (NIAID)’s Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern program...

Coronavirus Rebound After Pfizer’s Paxlovid Oral Antiviral Drug

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On Tuesday, the CDC warned Americans about the potential for coronavirus recurrence after using Pfizer’s antiviral drug Paxlovid. CDC officials are not recommending any changes to the ordinary...

FDA Approves First Drug for Chronic Disease Eosinophilic Esophagitis

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Sanofi’s Dupixent received FDA approval for use in people suffering from eosinophilic esophagitis (EoE) after a double-blind, placebo-controlled trial proved the drug effectively reduces...

FDA Lifts Clinical Hold on Gilead’s HIV Treatment, Lenacapavir

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FDA recently lifted the clinical hold on Gilead’s investigational new drug application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis...

Bristol Myers Squibb’s Drug Effective in Plaque Psoriasis Patients

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Bristol Myers Squibb recently announced that its severe plaque psoriasis treatment,  deucravacitinib, elicited durable efficacy and a consistent safety profile in adult...

Novo Nordisk, Flagship to Develop Rare Disease Treatments

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Novo Nordisk and Flagship Pioneering recently collaborated to create a portfolio of novel research programs to develop transformation metabolic and rare disease treatments. The companies will apply...

Real-World Evidence Shows Pfizer’s Ibrance Improves Breast Cancer

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Pfizer recently presented real-world evidence demonstrating a significant benefit for patients treated with Ibrance (palbociclib) combined with an aromatase inhibitor (AI) compared to AI...

Bristol Myers Ends Clinical Program for Combination Drug Therapy

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Bristol Myers Squibb and Nektar Therapeutics recently ended the global clinical development program for their combination drug therapy, bempegaldesleukin (BEMPEG) and Opdivo (nivolumab), in renal cell...

Novartis’ Antibody Boosts Survival for Squamous Cell Carcinoma

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Novartis recently announced that its IgG4 anti-PD-1 monoclonal antibody, tislelizumab, plus chemotherapy, significantly improved overall survival (OS) compared to chemotherapy in  esophageal...

Gilead, Dragonfly to Advance Immunotherapies in Oncology

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Gilead and Dragonfly Therapeutics recently collaborated to advance several of Dragonfly’s novel natural killer (NK) cell engager-based immunotherapies for oncology and inflammation...

Roche’s Drug Improves Infants with Type 1 Spinal Muscular Atrophy

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Roche recently announced new three-year data of its study evaluating Evrysdi (risdiplam) in infants with symptomatic Type 1 spinal muscular atrophy (SMA).   The FIREFISH study evaluated the...

FDA Accepts AstraZeneca BLA for Hepatocellular Carcinoma Antibody

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FDA recently accepted AstraZeneca’s biologics license application (BLA) for its anti-CTLA4 antibody, tremelimumab, supporting the indication of a single primary dose of the drug added to Imfinzi...

Pfizer Reports Positive Phase 2 Data for Lyme Disease Vaccine

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Pfizer and Valneva recently reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15. The Phase 2 trial, VLA15-221, is the first clinical study with VLA15 that enrolled...

Sandoz Launches Generic Drug Combination for Ocular Hypertension

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Sandoz recently launched its generic drug combination eyedrop, brimonidine tartrate/ timolol maleate ophthalmic solution 0.2%/0.5%, to lower eye pressure in patients with ocular...

FDA Accepts Application for GSK’s Chronic Kidney Disease Drug

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FDA recently accepted the New Drug Application (NDA) for GSK’s daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to treat patients with anemia of chronic kidney...

Sanofi’s BTK Inhibitor Effective in Immune Thrombocytopenia Patients

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Sanofi recently announced positive results from the Phase 1/2 clinical trial evaluating its Bruton's tyrosine kinase (BTK) inhibitor, rilzabrutinib, in adults with heavily pre-treated immune...