News Wire

Eli Lilly and Company has announced that its phase 3 JUNIPER study evaluating abemaciclib (Verzenio), a cyclin-dependent kinase (CDK) 4 and CDK6 inhibitor, as monotherapy in KRAS-mutated, advanced non–small-lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS). However, an…
The FDA has granted an orphan drug designation for DSP-7888 (Boston Biomedical, Inc.), an investigational cancer peptide vaccine, for the treatment of brain cancer. This is the second orphan drug designation for DSP-7888 this year. The first was granted in June 2017 for myelodysplastic syndrome. DSP-7888…
Pfizer has announced that it is reviewing strategic alternatives for its Consumer Healthcare business. A range of options will be considered, including a full or partial separation of the Consumer Healthcare business from Pfizer through a spin-off, sale, or other transaction, and Pfizer may ultimately…
The FDA has approved the first extended-release, intra-articular injection for osteoarthritis knee pain. Ttriamcinolone acetonide extended-release injectable suspension (Zilretta, Flexion Therapeutics, Inc.) is a nonopioid medicine that provides pain relief over 12 weeks. Zilretta employs proprietary…
The FDA has approved a new treatment option for patients who have been diagnosed with moderate-to-severe central sleep apnea. The Remedē System (Respicardia Inc.) is an implantable device that stimulates a nerve located in the chest that is responsible for sending signals to the diaphragm to stimulate…
The SenTiva implantable generator and Vagus Nerve Stimulation (VNS) Therapy Programming System (LivaNova USA) have received FDA approval for the treatment of patients with drug-resistant epilepsy. SenTiva is the smallest and lightest responsive therapy for epilepsy, LivaNova says. The new VNS Therapy…
The FDA has granted a breakthrough therapy designation to osimertinib (Tagrisso, AstraZeneca) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non–small-cell lung cancer (NSCLC). The FDA granted the designation based on data from the…
The FDA has approved the first Zika virus detection test for use in screening the nation’s blood supply. The cobas Zika test (Roche Molecular Systems, Inc.) is a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole…
Limited benefit health plans are bad for the insurance market and even worse for beneficiaries, argues Katherine Hempstead on the Health Affairs blog site. Such insurance packages do not have to offer the benefits mandated by the ACA. Hempstead, who directs the Robert Wood Johnson Foundation’s work…
A new-generation DNA-based Zika vaccine demonstrated both safety and ability to elicit an immune response against Zika in humans in a phase 1 clinical trial conducted through a partnership among the Perelman School of Medicine at the University of Pennsylvania, Inovio Pharmaceuticals, GeneOne Life Science,…
A U.S. appeals court has thrown out a ban on the sale of the cholesterol-lowering drug alirocumab (Praluent, Sanofi SA/Regeneron Pharmaceuticals) and ordered a new trial in the case that led to the ban, Reuters reports. The ruling from the U.S. Court of Appeals for the Federal Circuit in Washington,…
Scientists have pioneered a method to detect antibiotic susceptibility for urinary tract infections in less than 30 minutes, potentially enabling patients to be diagnosed and prescribed effective treatments during a single clinical visit. Urinary tract infections account for almost 8 million primary…
Breast cancer mortality rates dropped by 39% from 1989 through 2015, according to a study in CA: A Cancer Journal for Clinicians. Researchers estimate that 322,600 deaths were averted as a result. The declines were attributed to increased mammography screenings and better treatments. There is still…
Twelve cancers associated with obesity increased by 7% from 2005 to 2014, according to the CDC. They accounted for 40% of all cancer diagnoses in 2014, although the overall rate of new cancer diagnoses started falling in the 1990s. The 12 cancers associated with obesity are: adenocarcinoma of the esophagus,…
The FDA has approved Mylan's glatiramer acetate injection, the generic version of Copaxone (Teva) for the treatment of patients with relapsing forms of multiple sclerosis (MS). Mylan will begin shipping imminently. Mylan's abbreviated new drug applications (ANDAs) were approved for two versions of glatiramer…

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