The $3 billion industry has increasingly drawn the attention of both regulators. Among the questions the FDA brought up in the request for comment involve consumer and health provider attitudes towards homeopathic products, requests for data sources regarding the safety of the products, and what kind of measures could be implemented to improve the clarity of the CPG’s standard, among others.
While the timing of the purchase is ideal in many respects for Novartis considering its portfolio and the pending loss of the gilenya patent, it is also timing that has some in the industry questioning the deal. Ocrelizumab is about two years ahead in development compared to ofatumumab, having completed two successful late-stage studies in June.
Valeant’s purchase of Sprout will include $500 million cash up front as well as $500 million when the deal is closed, which is expected to be in early 2016. In addition, Valeant has agreed to give Sprout a portion of future revenues if certain milestones are met, although neither party would discuss specifics. Sprout CEO Cindy Whitehead will join Valeant and lead the division responsible for Addyi.
Unlike its counterpart medications for male erectile dysfunction like Viagra or Cialis, Addyi will not be taken on an “as needed” basis. Citing differences in sexual function between men and women, clinical sex therapist Judy Kuriansky said, “Women’s sexuality is very complicated. It’s not a matter of just taking that pill, by the way, and then all of a sudden the lights go on.” Kuriansky added, “You have to feel good about your body. You have to feel good about yourself. You have to feel the guy really loves you. It’s complex.
The regulator sent the letters to the Olympus, Fujifilm, and Pentax as part of an effort to fight against a wave of deadly bacterial infections attributed to the insufficient cleaning and sterilization of the devices. Duodenoscopes are reusable flexible tubes that go down the throat in order to treat gastrointestinal tract ailments.
The lawsuits accuse GSK of “off-label” marketing, that is, it is prescribed for ailments (pregnancy) that is not mentioned in the drug’s official FDA labeling. Zofran’s 1991 FDA approval was for “treatment of nausea and vomiting related to chemotherapy and surgery.” According to San Francisco attorney Rachel Abrams, speaking at a bar conference in the city regarding the lawsuits, “If they’re marketing and pushing a drug for a certain indication, and don’t have FDA approval for that indication, that’s a problem for GSK in and of itself.”
Indeed the social media age has brought a new wrinkle in the FDA’s regulatory agenda. Social media marketing schemes are often designed to appear casual and conversational, as if friends are discussing an issue over coffee. While certainly not illegal and for the most part, and a useful form of advertisement, FDA risk statements rarely fit within 144 character-limit social-media parameters.
Leading medical device manufacturer Medtronic has issued its second recall in as many weeks involving recently developed technology. Coming off of the European recall of its MiniMed 640 insulin pump last week, which is scheduled for a Pre-Market Approval (PMA) review in the U.S. later this year, the company has recalled nearly 7,000 EnVeo R
In the wake of a buying and selling frenzy, Irish drugmaker Allergan has been subpoenaed by the Department of Justice (DOJ) over antitrust concerns regarding the pricing of its generic drugs. Last week, the company announced a $40.5 billion selloff of its generics unit to the global generic market leader, Israeli-based Teva Pharmaceuticals. That deal
7/29/2015 Minnesota-based device giant Medtronic has issued letters to nearly 2,000 owners of the MiniMed 640 and 620 insulin pumps in Europe, warning them of a potential glitch in the reading mechanism. According to the letter, there is an error with the Bolus Wizard screen, causing it to not time-out and instead giving an outdated