Morning Briefing
Summaries of health policy coverage from major news organizations
Third US Recipient Of Aeson Artificial Heart Is The First-Ever Woman
Reuters: French Company Carmat Announces First Implant Of Its Artificial Heart In A Woman
French artificial heartmaker Carmat (ALCAR.PA) announced on Tuesday that it had carried out the first implant of its Aeson artificial heart in a woman. The company said the procedure had been performed at the UofL Health - Jewish Hospital by University of Louisville physicians in the United States. "This third implant in the U.S. was a landmark event not only because it allowed us to finalize the enrollment of the first cohort of patients of the EFS (early feasibility study), but very importantly because it is the first time ever that our device has helped a woman suffering from heart failure," Carmat CEO Stephane Piat said in a statement. (9/21)
In pharmaceutical industry news —
Stat: Beyondspring Lung Cancer Study Results Trigger Debate
Beyondspring’s stock price tripled in August after the New York drug maker said its experimental treatment helped patients with advanced lung cancer live longer. But detailed results presented Monday revealed issues with the conduct and analysis of the clinical trial — leaving the company’s claim of a survival benefit open for debate. (Feuerstein, 9/20)
Stat: European Commission Seeks To Intervene In Illumina's Acquisition Of Grail
In an unusual step, the European Commission plans to intervene in the recent merger between Illumina (ILMN) and Grail because regulators were unable to finish reviewing the deal before it was completed, raising concerns that competition in the market for DNA sequencing tests will now be damaged. The move comes one month after Illumina stunned regulators by announcing it had closed its $8 billion acquisition, even though the EC had opened an investigation only weeks earlier at the prompting of France and five other European Union member states. In the U.S., the Federal Trade Commission had already filed a complaint last March to block the deal. (Silverman, 9/20)
FiercePharma: Good Ad Or Bad Ad? FDA Quiz Reminds Docs About Its Bad Ad Program To Police Problematic Advertising
True or false: Pharmaceutical companies are required to send drug ads to the FDA for approval before they're used. It’s false—but you'd already know that if you took the FDA’s new interactive quiz to help promote its Bad Ad program. Now in its 12th year, the FDA's Bad Ad program is promoting itself to healthcare providers to determine false or misleading advertising and report it to the FDA for review. The FDA’s Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) oversees the program. (Bulik, 9/20)
