- Is ketamine the best hope for curing major depression? (bloomberg.com)
Food and Drug Administration hasn’t approved ketamine for the treatment of mood disorders, but… studies show that it can quickly alleviate severe depression. There’s no regulation to stop doctors like Brooks from administering ketamine for nonapproved uses—a practice known as "off-label" treatment—"For patients who are suicidal…they can get relief within an hour or two,"…
- For a Rare Disease, Drug Trials Scramble for Patients (wsj.com)
Companies vie for enrollees amid questions that trials will siphon participants away from each other…After years of effort, scientists and families of young patients with the genetic condition Niemann-Pick Type C are in a position to which any rare-disease community aspires: the prospect of not one, not two, but three companies launching clinical trials to develop therapies…the flurry of commercial interest has sparked an urgent debate. Can the community support more than one trial at the same time?
- F.D.A. Approves Addyi, a Libido Pill for Women (nytimes.com)FDA approves first treatment for sexual desire disorder (fda.gov)
first prescription drug to enhance women’s sexual drive won regulatory approval …victory for a lobbying campaign that had accused the Food and Drug Administration of gender bias for ignoring the sexual needs of women…Addyi (flibanserin) — is actually the first drug approved to treat a flagging or absent libido for either sex. Advocates who pressed for approval…Even the Score, said that a drug to improve women’s sex lives was long overdue… National Consumers League..the campaign behind Addyi … made a mockery of the system that regulates pharmaceuticals..
- Drug execs behind female libido pill have run afoul of FDA (apnews.myway.com)
small drugmaker…may succeed…in winning approval for the first drug to boost women's sexual desire…team that founded Sprout Pharmaceuticals is not new to the..business …previous company, Slate Pharmaceuticals, sold an implantable testosterone pellet.. ran afoul of federal rules,… FDA sent Slate an 11-page warning letter…"I can't remember seeing a warning letter with so many examples of misbranding in it," said Fugh-Berman, who … signed a petition urging the FDA to reject Addyi (flibanserin)
- Another outbreak from tainted scopes suspected at an L.A.-area hospital (latimes.com)
Huntington Memorial Hospital..it had alerted health authorities about a potential link between patients who have a pseudomonas bacteria and the Olympus Corp. duodenoscopes used to treat them… Federal regulators have attributed this to a design flaw that makes the tip of these instruments hard to clean even when following the manufacturers' guidelines.
- Amgen pays $71 mln to settle Enbrel, Aranesp marketing case (reuters.com)
Amgen Inc has reached a $71 million settlement ...to resolve claims that the biotechnology company promoted its popular Enbrel and Aranesp drugs for uses not approved by the federal Food and Drug Administration… Amgen violated state consumer protection laws by marketing both drugs for off-label uses, through its promotion of Enbrel to treat mild plaque psoriasis and Aranesp to treat anemia caused by cancer.
- FDA approves use of opioid painkiller in 11-16 year olds (reuters.com)CDER Conversation: Pediatric pain management options (fda.gov)
Food and Drug Administration has approved the use of opioid painkiller OxyContin in patients aged 11 to 16 who have not benefited enough from alternatives….warnings and precautions for pediatric patients are the same as those for adults...
- Valeant Nears $1 Billion Deal for Maker of Women’s Libido Drug (wsj.com)
Valeant Pharmaceuticals International Inc. is nearing a deal to pay $1 billion for the closely held company (Sprout Pharmaceuticals Inc) that just won approval to sell the first drug that aims to boost a woman’s libido,..Valeant would pay all cash, one $500 million installment upfront and one next year,..Valeant would also take on all of Sprout’s 25 employees, including its leadership team, as they complete preparations to begin sales of the drug in October,…
- AbbVie buys special review voucher for $350 million (reuters.com)
AbbVie Inc has bought a (FDA) priority review voucher from United Therapeutics Corp for $350 million that will allow it to accelerate the review process for one of its drugs…pediatric disease priority review voucher…eligible to have one of its drugs reviewed in six months, compared to the standard 10 months...AbbVie did not disclose its plans for the voucher...
- Raleigh’s Sprout Pharmaceuticals awaits FDA ruling on female libido drug (newsobserver.com)
Sprout Pharmaceuticals is a small drug company with a potentially very big drug – the world’s first pill to boost women’s sex drive….Food and Drug Administration is expected to announce Tuesday whether it has approved Sprout’s drug, Addyi (flibanserin), ..plans to market as the "little pink pill"… Interest in Sprout’s libido pill is expected to run so high that, to curb potential misuse, Sprout has promised the FDA it won’t advertise the drug for 18 months on TV and radio.