NEW YORK (Reuters Health)—The investigational drug romosozumab led to gains in hip bone mineral density (BMD) that were not seen with teriparatide in older women with osteoporosis transitioning from bisphosphonate therapy in the STRUCTURE study. Amgen’s romosozumab is a monoclonal antibody that inhibits sclerosin, a negative regulator of bone formation. In addition to stimulating bone…
Senate Reauthorizes FDA to Collect Fees from Drugmakers
(Reuters)—The U.S. Senate on Thursday passed a bill allowing the Food and Drug Administration to continue collecting fees from drug companies to review new product applications. The FDA Reauthorization Act renews an existing law that expires on Sept. 30 and which provides the majority of FDA funds used to review pharmaceuticals and determine whether they…
Oversupply of Opioids after Surgery Helps Fuel Opioid Epidemic
(Reuters Health)—More than two-thirds of surgery patients in a recent study had prescription opioids left over after they recovered from their operations, and the vast majority failed to safely store or dispose of the often misused and abused pills, researchers say. “Unused opioids that have been prescribed for pain after surgery serve as an important…
U.S. Launches Opioid Fraud and Detection Unit
(Reuters)—U.S. Attorney General Jeff Sessions unveiled on Wednesday a plan to go after doctors and pharmacies suspected of healthcare fraud by over-prescribing and unbridled distribution of addictive pain medications known as opioids. In a speech at a Columbus, Ohio, police academy, Sessions said a new Opioid Fraud and Abuse Detection Unit pilot program would also…
U.S. FDA Panel Votes Against Approval of Arthritis Drug Sirukumab
(Reuters)—The benefits of Johnson and Johnson’s experimental rheumatoid arthritis drug sirukumab do not outweigh the risks, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 12-1 that the drug should not be approved, citing safety concerns, including an imbalance in the number of deaths in patients taking sirukumab…
More Than a Third of U.S. Adults Prescribed Opioids in 2015
(Reuters Health)—The U.S. needs to curb excessive opioid prescribing and improve access to pain management techniques, suggests a new government study. Researchers found that more than one third of U.S. adults were prescribed the medications in 2015 and many also misused the drugs. “A very large proportion and large number of adults use these medications…
Abatacept Approved for Adult PsA
The FDA has approved abatacept to treat adults with active psoriatic arthritis. In clinical trials, the treatment has proved effective in both intravenous and subcutaneous forms…
U.S. House Panel Spotlights Use of FDA Rules to Slow Generic Drugs
WASHINGTON (Reuters)—Republican and Democratic lawmakers on Thursday discussed ways to prevent drugmakers from using rules developed to safeguard patients to instead block the sale of cheaper medicines. The focus at a hearing, held by members of the House Judiciary Committee’s antitrust subcommittee, was on the use by some brand name drug companies of a U.S….
As Drug Prices Drop, Generics Makers Fight Back with Deals
NEW YORK (Reuters)—Generic drug makers are turning to mergers and acquisitions to shield themselves against a concerted effort by U.S. regulators to crack down on steep drug prices. Impax Laboratories Inc, Perrigo Company Plc and Alvogen Inc have been talking to advisers about strategic options for their generics businesses, ranging from acquisitions to increase scale…
U.S. Senator Expands Opioid Probe to Distributors, Drugmakers
(Reuters)—U.S. Democratic Senator Claire McCaskill on Thursday expanded an investigation into the causes of the opioid crisis plaguing the country, seeking information from four more drugmakers and three drug distributors. The top-ranking Democrat on the Senate Homeland Security and Governmental Affairs Committee is focusing on the distribution of opioids and the efforts companies made to…
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