(Reuters)—Valeant Pharmaceuticals International Inc.’s experimental drug to treat psoriasis should be approved as long as certain measures are put in place to mitigate the risk of suicide, an advisory committee to the U.S. Food and Drug Administration concluded on Tuesday. The FDA is not obliged to follow the advice of its advisory committees but typically…
Articles by Natasha Yetman
U.S. Antitrust Officials Poised to Block Anthem, Aetna Deals
NEW YORK (Reuters)—U.S. antitrust officials are poised to file lawsuits to block Anthem Inc’s acquisition of Cigna Corp., as well as Aetna Inc.’s takeover of Humana Inc., a person familiar with the matter tells Reuters. Antitrust regulators have been scrutinizing the deals and looking at the potential for higher prices if the insurance market consolidates…
Women on Osteoporosis Drugs Still Need Bone Density Screenings
(Reuters Health)—Women with osteoporosis who take bisphosphonates to help avoid fractures still need to have their bone density monitored, a Canadian study suggests. Researchers who studied more than 6,600 women taking osteoporosis drugs found that for nearly one in five, bone mineral density at the hip actually decreased after the women started taking the medication….
FDA Panel Supports Novartis Biosimilar of Etanercept
(Reuters)—Novartis AG’s cheaper version of Amgen Inc.’s arthritis drug etanercept (Enbrel) is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 20–0 that there is no clinically meaningful difference between Novartis’s drug, a biologic made…
FDA Panel Backs Amgen Biosimilar of Humira
(Reuters)—Amgen Inc.’s cheaper version of AbbVie’s top-selling arthritis drug adalimumab (Humira) is highly similar to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The panel voted 26–0 that the drug, ABP 501, which was studied in rheumatoid arthritis and plaque psoriasis, was similar in…
Prescription-Drug Monitoring Saves Lives, Could Save More
(Reuters Health)—State programs that monitor narcotic prescriptions help prevent 10 opioid-overdose deaths a day in the U.S., yet improvements could save another two people a day, a new study finds. States with the most robust programs—ones that tracked a greater number of potentially addictive medications and updated their databases at least weekly—saw the biggest drops…
U.S. Justice Department Has Concerns about Aetna-Humana Deal
(Reuters)—The U.S. Department of Justice has significant concerns about Aetna Inc.’s proposed acquisition of health insurer Humana Inc., a source familiar with the situation said on Thursday, and shares of Humana fell more than 11%. Aetna’s purchase of Humana would combine two of the largest providers of Medicare Advantage plans for elderly people, and investors…
FDA Staff Says Amgen Biosimilar ‘Highly Similar’ to AbbVie’s Humira
(Reuters)—Amgen Inc’s biosimilar form of AbbVie Inc.’s adalimumab (Humira) arthritis drug, the world’s top-selling medicine, is similarly potent and safe as the original product, according to a preliminary review by staff members of the U.S. Food and Drug Administration (FDA). The assessment precedes an all-day meeting on Tuesday of an independent panel of medical advisers…
U.S. Judge Cuts $500 Million Verdict over Johnson & Johnson Hip Implants
NEW YORK (Reuters)—A U.S. judge has slashed a $500 million verdict against Johnson and Johnson and its DePuy unit over allegedly defective metal-on-metal Pinnacle hip implants to approximately $151 million. On Tuesday, U.S. District Judge Ed Kinkeade in the Northern District of Texas says he was compelled to reduce the verdict under a Texas state…
GI Side Effects Leading Reason for Bisphosphonate Nonadherence
NEW YORK (Reuters Health)—Gastrointestinal side effects are the most common reason osteoporotic women cite for nonadherence to oral bisphosphonate therapy, according to a new survey. “Our findings highlight the importance of low tolerability to nonadherence with osteoporosis therapy and underlines patients’ poor awareness and suboptimal physicians’ involvement in conveying the importance of this therapy,” Dr….
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