FDA Recommends Approval For New Cholesterol Drug
But, the Food and Drug Administration panel also said more data are needed to examine its longterm viability as a treatment for heart attacks. Elsewhere, stakeholders await proposed rules on the 340B drug discount program, which may limit prices and provide guidance on civil damages for drugmakers.
USA Today:
FDA Panel Backs New Cholesterol Drug
Food and Drug Administration advisers Tuesday recommended that an injectable cholesterol-lowering drug be approved, but the panel of experts said more data is needed about its ability to reduce heart attacks or strokes in the long run. (Szabo and Winter, 6/9)
The Associated Press:
FDA Panel Backs First-In-Class Cholesterol Drug
Federal health advisers on Tuesday recommended approval for a highly anticipated cholesterol drug from Sanofi and Regeneron Pharmaceuticals, but with the caveat that more data is needed about its long-term ability to reduce heart attacks. The expert panel recommended by a 13-3 vote that the Food and Drug Administration approve the injectable drug, called Praluent. (Perrone, 6/9)
CQ Healthbeat:
Draft Rule On Civil Penalties For 340B Drug Program Nears Release
The first of two proposed measures related to the 340 drug discount program could be released soon. The Office of Management and Budget has completed its review of a proposed rule. Drugmakers and hospital groups have for years been at odds about the operation of the 340B program, designed originally with an aim of helping provide medicines to people lacking insurance. The proposed rule expected to be unveiled soon addresses civil penalties for drugmakers and ceiling prices for the program. The Health Resources and Services Administration, which oversees the 340B program, also submitted a broad proposed guidance document for OMB review last month. That remains under review, according to the OMB web site. (Young, 6/9)
Reuters:
Drug Switch Study Bolsters Case For Copies Of Biotech Medicine
New clinical data has bolstered the case for using cheaper copies of expensive biotech drugs by showing that patients with rheumatic diseases can be safely and effectively switched from original-brand medicine to a lower-cost version. While the first copies of a blockbuster antibody drug for rheumatoid arthritis are now on sale in Europe, such so-called biosimilars have so far been used mainly in new patients, given doubts about how existing patients might react to a switch. (6/9)
The Wall Street Journal:
Hysterectomy Device Will Be Covered By Insurer Despite Danger Of Uterine Cancer’s Spread
Health Care Service Corp., the nation’s fourth-largest health insurer, will continue to cover laparoscopic power morcellators after considering a policy that would have curbed the surgical tools used in hysterectomies, a spokeswoman said Tuesday. (Kamp, 6/9)
