R&D/Clinical Trials

FDA approval of bluebird bio’s Lyfgenia and Vertex Pharmaceuticals' and CRISPR Therapeutics’ Casgevy marks significant milestone in the treatment of sickle cell disease.

PREPVACC study expected to stop further HIV vaccination attempts after previously enrolling 1,500 participants in East and Southern Africa.

Migraine with comorbid obesity have been found to cause high levels of disability and are both more common in female patients.

Trial of Keytruda (pembrolizumab) plus chemotherapy and maintenance Lynparza (olaparib; AstraZeneca, MSD) for the treatment of metastatic squamous non-small cell lung cancer stopped after data did not show a survival benefit.

Fabhalta (iptacopan) is the first oral monotherapy approved by the FDA for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria.

TAR-200 has a novel targeted releasing system for the treatment of patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer who are ineligible for bladder removal surgery.

The FDA assigned a PDUFA date of April 5, 2024 for Opdivo (nivolumab) plus cisplatin-based chemotherapy for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma.

Jaypirca (pirtobrutinib) granted accelerated approval by the FDA for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously administered least two prior lines of therapy that included a BTK inhibitor and a BCL2 inhibitor.

The FDA previously granted accelerated approval to the Keytruda plus Padcev combination for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

FDA to expedite review of zotatifin plus Faslodex (fulvestrant) and Verzenio (abemaciclib) as a second- or third-line treatment for patients with estrogen receptor–positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer whose disease progressed after treatment with endocrine therapy and a CDK4/6 inhibitor.

Supplemental new drug application for roflumilast cream 0.15% to treat atopic dermatitis in patients 6 years of age and older was assigned a Prescription Drug User Fee Act target action date of July 07, 2024.

KarXT (xanomeline-trospium) is currently in development to treat schizophrenia and psychosis related to Alzheimer disease.

Vivos becomes the first company to bring to market an alternative to continuous positive airway pressure (CPAP) or surgical neurostimulation implants for patients with severe OSA.

The launch of the Elecsys HBeAg quant immunoassay adds to Roche's viral hepatitis testing portfolio.

Ogsiveo is the first and only drug approved by the FDA to treat desmoid tumors.

Trial results expected to accelerate the potential of Dupixent to become the first FDA-approved treatment for chronic obstructive pulmonary disease.

AbbVie and Genmab will share commercial responsibilities in the United States and Japan for epcoritamab-bysp (Epkinly), whereas AbbVie will be responsible for further global commercialization.

Manufacturer states that novel drug is the most advanced multi-food oral immunotherapy drug candidate currently in development.

Study aims to find ways industry gets involved in the most influential clinical trials, and how transparent these trials are.

Enzalutamide (Xtandi) from Astellas Pharma Inc. and Pfizer Inc. gets FDA approval to treat nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

Merck's pembrolizumab (Keytruda) plus fluoropyrimidine- and platinum-containing chemotherapy approved for the first-line treatment of patients with locally advanced unresectable or metastatic, HER2-negative gastric/GEJ adenocarcinoma.

Capivasertib (Truqap) plus fulvestrant (Faslodex) is a first-of-its-kind combination for HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1 or PTEN biomarker alterations.

Emerging technologies like digital twins offer supply chain efficiency solutions, allowing the industry to integrate sustainable practices while ensuring patient safety.

Repotrectinib (Augtyro) is a next-generation, potential best-in-class tyrosine kinase inhibitor approved to treat locally advanced or metastatic ROS1-positive non-small cell lung cancer.

Webinar Date/Time: Tue, Dec 12, 2023 10:00 AM EST | 9:00 AM CT | 3:00 PM GMT | 4:00 PM CET

When considering factors like disease biology and patient needs in drug discovery and development, the goal is to deliver effective and scalable treatments globally by balancing established approaches like small molecules or protein therapeutics with more complex modalities such as RNA, cell, and gene therapies.

Defencath is indicated for the prevention and treatment of catheter-related bloodstream infections in adults with kidney failure administered chronic hemodialysis via a central venous catheter.

The FDA granted accelerated approval to Aliqopa in September 2017 for the treatment of adults with relapsed follicular lymphoma previously treated with at least two prior systemic therapies.

FDA expands indications for bupivacaine liposome injectable suspension (Exparel; Pacira BioSciences, Inc.) for use in adult patients as an adductor canal block and a sciatic nerve block in the popliteal fossa.

The global market for chikungunya virus vaccines is estimated to exceed $500 million annually by 2032.