U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light—more than double the previous year—while the figure also rose in the European Union, according to a Reuters report. The E.U. recommended 92 new drugs, including generics, up from 81, and China laid out…
Less than one week after it scored approval from the FDA for Glatopa (glatiramer acetate injection), a generic version of Teva’s multiple sclerosis drug Copaxone, Novartis may be looking to sell off its generics subsidiary Sandoz, BioSpace reports. Citing unnamed sources “familiar with the matter,”…
Increased reimbursements under Medicare Part B overall could offset potential losses for hospitals under changes to the 340B discount program, according to a new analysis. FierceHealthcare reports that consulting firm Avalere Health analyzed hospital-level data from the Centers for Medicare and Medicaid…
The FDA has granted a breakthrough therapy designation to voxelotor (previously called GBT440, Global Blood Therapeutics) for the treatment of sickle cell disease (SCD). Voxelotor is being developed as a disease-modifying therapy for SCD. The breakthrough therapy designation for voxelotor was based…
FDA Commissioner Scott Gottlieb, MD, criticized pharmacy benefit managers, health insurers, and drug-makers Wednesday for “Kabuki drug-pricing constructs” that profit the industry at the expense of consumers, Reuters reported. The comments, made at a conference organized by a leading U.S. health…
In an update on pharmaceutical pipeline projects tucked inside its financial results, FierceBiotech reports, Swiss drugmaker Roche announced that it was pulling the plug on several early- and late-stage candidates. The casualties: Lampalizumab (RG7417), a phase 3 drug that last fall failed two tests:…
CMS’s Patients Over Paperwork program aims to lessen the regulatory burden on physicians. CMS administrator Seema Verma likens the effort to scraping off old layers of paint before repainting a house, reports MedPage Today. She said that requirements concerning what and how much information physicians…
A U.S. charity offering assistance to patients for their out-of-pocket drug costs has sued the federal government over restrictions on its ability to communicate with drug-makers who donate to it, according to a Reuters report. The charity, Patient Services, Inc. (PSI), filed the lawsuit in federal…
One hundred years ago, the deadliest influenza pandemic of all time made a ravaging march across the globe. The "Spanish" flu of 1918-19 infected an estimated one-third of the world's population and killed between 50 million and 100 million people, modern epidemiologists estimate. That raises the inevitable…
Commercially insured patients in health plans with value-based contracts for diabetes, high cholesterol, and human immunodeficiency virus medicines in the past two years had copays that averaged 28% lower for those medicines compared to patients in other plans, according to an analysis from the Pharmaceutical…
The FDA has sent a complete response letter to Braeburn Pharmaceuticals regarding its new drug application for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD). The FDA has requested additional information in order…
The FDA has approved Biktarvy (Gilead Sciences, Inc.), a once-daily, single-tablet regimen for the treatment of HIV-1 infection that includes 50 mg of bictegravir, 200 mg of emtricitabine, and 25 mg of tenofovir alafenamide. Bictegravir is a novel, unboosted integrase strand transfer inhibitor (INSTI),…
Workers would be allowed to band together to buy health insurance under a proposed rule released by the Department of Labor, The Hill reported. The proposal was issued in response to an executive order by President Trump, which would allow associations of workers to purchase cheaper health insurance…
Nearly one in five health employees (18%) said they would be willing to sell confidential data to unauthorized parties, according to a new survey from consultant Accenture. The survey of 912 employees of provider and payer organizations in the United States and Canada found that the respondents willing…
New clinical decision support software designed to analyze computed tomography (CT) results may speed treatment by notifying providers of a potential stroke in their patients. The FDA has permitted marketing of Viz.AI Contact (Viz.AI), a computer-aided triage software application that uses an artificial…
