News Wire

FDA chief Scott Gottlieb called for help from the insurance and PBM industries in August, asking them to play a part in solving the opioid crisis, the deadliest drug overdose crisis in American history. Gottlieb called for a meeting in September. That meeting took place September 6, but the FDA is downplaying…
The FDA has announced what its commissioner called “a major new set of policies” aimed at making it easier to bring generic competition to a category of branded medications known as complex drugs. Such products include high-cost medicines like metered-dose asthma inhalers and some injectable drugs,…
The FDA has granted a breakthrough therapy designation to brentuximab vedotin (Adcetris, Seattle Genetics, Inc.) in combination with chemotherapy for the firstline treatment of patients with advanced classical Hodgkin’s lymphoma. Positive topline results of the phase 3 ECHELON-1 clinical trial were…
Merck has become the latest pharmaceutical company to abandon development of potential new treatments for hepatitis C virus (HCV) infection in an increasingly crowded market. Merck elected to discontinue the development of the investigational combination regimens MK-3682B (grazoprevir/ruzasvir/ uprifosbuvir)…
Faulty pacemakers and implantable defibrillators that malfunctioned and needed to be replaced cost Medicare about $1.5 billion from 2005 through 2014, the New York Times reports. And that’s a conservative estimate that doesn’t include the out-of-pocket costs for this care, estimated to be at least…
The FDA has approved abemaciclib (Verzenio, Eli Lilly and Company) to treat adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after endocrine therapy. Abemaciclib is approved to be given in…
A new formulation of insulin aspart injection (Fiasp, Novo Nordisk) has received FDA approval. Fiasp 100 units/mL is a fast-acting mealtime insulin indicated to improve glycemic control in adults with type-1 and type-2 diabetes. Fiasp can be dosed at the beginning of a meal or within 20 minutes after…
The settlement of a court battle means that the launch of Amgen’s biosimilar version of adalimumab (Humira, AbbVie) will be delayed in the United States by more than five years. The two companies announced that they have reached a global settlement to resolve all pending litigation regarding the Amgen…
One out of five adults report that they have personally experienced a medical error, according to a national survey released by the Institute for Healthcare Improvement/National Patient Safety Foundation (IHI/NPSF) Lucian Leape Institute and NORC at the University of Chicago.  Although the vast…
The FDA has approved the first continuous glucose monitoring system that will allow adults to make diabetes treatment decisions without taking a blood sample from the fingertip, often called a “fingerstick.” The FreeStyle Libre Flash Glucose Monitoring System (Abbott Diabetes Care Inc.) reduces…
There’s a strong moral and ethical case for organizations to address doctor burnout, but there’s also a financial case to be made as well, according to a study in JAMA Internal Medicine. “Evidence suggests that improvement is possible, investment is justified, and return on investment measurable.”…
The FDA has declined to approve Rexista, Intellipharmaceutics International’s new abuse-deterrent formulation of extended-release oxycodone, until additional studies are performed, the company announced. The FDA issued a complete response letter (CRL) in relation to Intellipharmaceutics’ new drug…
The FDA has approved nivolumab injection (Opdivo, Bristol-Myers Squibb) for intravenous use for the treatment of patients with hepatocellular carcinoma (HCC) who have been treated previously with sorafenib (Nexavar, Bayer HealthCare). Accelerated approval for this indication was granted based on tumor…
Pembrolizumab (Keytruda, Merck) has received a new FDA approval for the treatment of certain patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.  The new indication covers patients whose tumors express programmed death ligand-1 (PD-L1) with…
Aegerion Pharmaceuticals Inc. will plead guilty to two misdemeanors and pay $40.1 million to resolve investigations into its marketing and sales of the expensive cholesterol drug lomitapide (Juxtapid), according to a Reuters report. The settlements will resolve long-running investigations into Aegerion,…

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