LONDON (Reuters)—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. The European Union (EU) recommended 92 new drugs, including generics, up from 81; and China laid out plans to speed up approvals in what…
Flimsy Evidence Behind Many FDA Approvals
(Reuters Health)—Many drugs granted accelerated approval by the U.S. Food and Drug Administration (FDA) lack clear evidence of safety and effectiveness, and the same is true for most high-risk medical devices, according to two new reports in JAMA, online Aug. 15. The Accelerated Approval pathway makes potentially promising investigational medicines available for use before the…
New Test Yields Rapid Infliximab Drug Concentrations
NEW YORK (Reuters Health)—A new test provides rapid infliximab drug concentrations that enable immediate dosing adjustments, researchers from Belgium report. “With this rapid test, our biggest wish is to persuade physicians to now perform and use infliximab measurements also in their own daily clinical practice, as many practical and organizational issues that went along with…
U.S. Probes Contracts Between Drugmakers, Pharmacy Benefit Managers
(Reuters)—The U.S. Attorney’s Office for the Southern District of New York is investigating contracts between drugmakers and companies that manage prescription benefits, according to regulatory filings. Federal prosecutors have approached at least three companies, including Johnson & Johnson, Merck & Co. and Endo International Plc., demanding information about their contracts with pharmacy benefit managers. Pharmacy…
Europe Launches New Fast Approval Scheme for Promising Drugs
LONDON (Reuters)—European regulators launched a new scheme on Monday to speed the approval of promising new drugs that address unmet medical needs by offering enhanced support to medicine developers as they work on clinical trials. The European Medicines Agency‘s (EMA) initiative called PRIME, which stands for PRIority MEdicines, is the latest example of regulators on…
FDA Update: Infliximab Biosimilar Garners Support & Fibromyalgia Drug Receives Fast Track
Recently, an FDA committee announced support for the approval of CT-P13, an infliximab biosimilar. The FDA has also fast tracked the development of a fibromyalgia treatment designed for multiple symptoms…
Newly Released Documents Show Profit-Seeking Behind Price Hikes at Turing, Valeant
WASHINGTON/NEW YORK (Reuters)—A decision by Turing Pharmaceuticals to raise the price of a lifesaving drug by 5,000% drove up some patient co-pays to as high as $16,000, according to excerpts of documents that congressional committee members released on Tuesday. The excerpts, which are highlighted in memos released by Democrats on the powerful U.S. House of…
GSK, Astra, J&J Link with Universities in New Drug Research Fund
LONDON (Reuters)—GlaxoSmithKline, AstraZeneca and Johnson & Johnson have joined with three leading British universities to create a new 40 million pounds ($57 million) fund backing early drug research. The Apollo Therapeutics Fund, which aims to improve the speed and potential of university research being translated into new medicines, is a further example of a trend…
Drug Approvals Top 2014 High, but R&D Returns Still Struggle
LONDON (Reuters)—The number of new drugs approved in the U.S. this year has already topped last year’s 18-year high, yet large pharmaceutical companies are still struggling to get a decent return on their research dollars. In fact, returns on research and development (R&D) spending by the world’s top drug makers have fallen to just 4.2%,…
FDA’s ‘Breakthrough Drug’ Terminology Confuses the Public
NEW YORK (Reuters Health)—What the Food and Drug Administration calls a ‘breakthrough’ drug is often not the same as what a layperson would call a breakthrough, a new study shows. The FDA uses the term more often, and for smaller advances, than people use it colloquially, and this may lead patients to have unwarranted confidence…