Category: FDA

MEwens
Birth-Control Recall: Pfizer has recalled about a million packs of birth-control pills on concerns that incorrect packaging could lead to unplanned pregnancies, but says it believes only 30 packs actually had the troublesome glitches, the WSJ reports. Pfizer has identified three production problems that could permit pills to be placed incorrectly in the […]

MEwens
A young patient holds Kalydeco, a cystic-fibrosis treatment from Vertex just approved by the FDA.
Certain cystic-fibrosis patients will now have an FDA-approved treatment that targets an underlying cause of their disease.
But that drug — Kalydeco, from Vertex Pharmaceuticals — won’t come cheap.
As Dow Jones Newswires reports, the annual cost will be $294,000. Vertex […]

MEwens
McNeil Oversight Changes: Johnson & Johnson is replacing two company group chairmen who had been charged with turning around the McNeil Consumer Healthcare unit after a series of recalls, the WSJ reports. Patrick Mutchler, charged with overseeing McNeil last April, is retiring and will be replaced by Roberto Marques. Meantime, the duties of […]

Laura Landro
Consumer Unit Oversight Changes: Johnson & Johnson is replacing two company group chairmen who had been charged with turning around the company’s consumer health unit after a series of recalls, the WSJ reports. Patrick Mutchler, charged with overseeing McNeil Consumer Healthcare last April, is retiring and will be replaced by Roberto Marques. […]

MEwens
Bydureon, the once-weekly injection for treating patients with type 2 diabetes, has finally won the FDA’s okay.
As Dow Jones Newswires reports, it’s been a long, bumpy road to approval for the drug’s developer, Amylin Pharmaceuticals.
(Alkermes is behind the extended-release technology used to deliver the drug, a longer-acting version of Amylin’s twice-daily Byetta.)
Amylin started […]

MEwens
Keeping Birth-Control Rule: The Obama administration refused to scrap a rule that will require most employers to offer health insurance that provides FDA-approved contraceptives with no copayments or deductibles, the WSJ reports. There is an exemption for certain employers if birth control violates their religious beliefs, and those who object but don’t qualify […]

MEwens
Seeking More Data: The FDA wants more information about an experimental diabetes drug from Bristol-Myers Squibb and AstraZeneca before considering it for approval, Dow Jones Newswires reports. The companies said the agency wants more clinical data in order to better assess the risks and benefits of dapagliflozin, which is a new type of […]

MEwens
The FDA is casting a skeptical eye on evidence backing a gel being proposed to prevent preterm birth in women with a short cervix.
As Dow Jones Newswires reports, one of the agency’s outside advisory panels is due to consider that use of the gel — already approved for certain women undergoing infertility treatments […]

MEwens
Orange Juice Worries: Coca-Cola said it found an unapproved fungicide in some of it and its competitors’ orange juice imported from Brazil, though it wouldn’t identify the brands, the WSJ reports. Coke makes Simply Orange and Minute Maid.  The FDA is testing OJ from supermarket shelves for the fungicide, but the EPA said […]

MEwens
The pharma industry has been waiting for guidance from the FDA on what is — and is not — permitted in terms of marketing online and via social media. (For example — who’s responsible for consumer Tweets about a drug?)
Hearings on the topic were held in November 2009 but so far there hasn’t […]