Drugs & Medical Devices Archives - Page 78 of 83

Valeant Strikes Collaboration Deal with AstraZeneca over Experimental Psoriasis Drug

Staff - September 1, 2015

The terms of the agreement include Valeant paying AstraZeneca $100 million up front, adding another $170 million depending on pre-launch benchmarks, as well as up to $175 million depending upon sales benchmarks. After the product’s launch, the two companies will share profits. Valeant will handle the regulatory submission processes and the associated costs. In return, Valeant will retain the commercialization rights to brodalumab in all markets except in Japan and some Asian countries, where Amgen, the originator of the drug, had made a pre-existing agreement with Japanese biotech firm Kyowa Hakko Kirin.

Judge Dismisses Part of Plavix Multidistrict False Claims Lawsuit

Staff - August 25, 2015

Judge Freda Wolfson of the U.S. District of New Jersey has granted some relief for drugmakers Bristol-Myers Squibb and Sanofi-Aventis in a complicated multidistrict whistleblower lawsuit against the two companies over marketing claims involving the blood-thinning medication Plavix. Wolfson granted motions to dismiss several claims made by former Sanofi sales representative Elisa Dickson, alleging that

FTC Urges FDA to Re-evaluate Homeopathic Product Regulation

Staff - August 25, 2015

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.

GSK Sells Rights to Autoimmune Drug to Novartis for up to $1 Billion

Staff - August 23, 2015

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 Buys Sprout Pharmaceuticals, Maker of Just-Approved Female Libido Medication

Staff - August 20, 2015

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.

“Female Viagra” Drug, Flibanserin Approved by FDA on Third Attempt

Staff - August 19, 2015

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.

Duodenoscope Sterilization a Focus as FDA Warns Three Device Makers

Staff - August 18, 2015

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.

Three More Birth-Defect Lawsuits add to GSK’s Zofran Tally as MDL Deadline Approaches

Staff - August 16, 2015

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.”

FDA Warns Drugmaker Duchesnay over Kim Kardashian Instagram Post

Staff - August 14, 2015

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.

Medtronic Issues Recall for Newly-Approved Heart Device

Staff - August 8, 2015

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

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