R&D/Clinical Trials

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.

Supplemental Biologics License Application for lisocabtagene maraleucel (Breyanzi) seeks to expand the current indication include the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously treated with a BTKi and BCL2i.

Adalimumab-bwwd (Hadlima; Samsung Bioepis Co., Ltd. and Organon & Co.) is seeking to become the third Humira biosimilar deemed interchangeable with the reference product.

Adzynma is the first approved genetically engineered protein product for the treatment of patients with congenital thrombotic thrombocytopenic purpura.

Solomon discusses new ways that researchers are fighting against bacterial resistance to medications.