The U.S. Court of Appeals for the Federal Circuit granted a major victory for Novartis AG, the world’s pharmaceutical market leader. The court’s three-judge panel ruled 2-1 on Wednesday, declining a petition to renew a six-month injunction filed by competitor Amgen involving the marketing of a biosimilar drug comparable to Amgen’s breakthrough cancer treatment Neupogen
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.
Borders’s death is a stark reminder that many of those who endured the 9/11 tragedy are suffering from long-term health problems. Borders was asked if she thought that the debris from the terror attack, which contained glass and other carcinogenic dust, among other dangerous particles led to her cancer. She responded, “I’m saying to myself, ‘Did this thing ignite cancer cells in me?’ I definitely believe it because I haven’t had any illnesses. I don’t have high blood pressure, high cholesterol, diabetes.”
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
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.
Calling it a “tremendous victory,” Sarah Leberstein, senior staff attorney for the National Employment Law Group said, “Paying workers less than the minimum wage for their work hours, and not paying an overtime premium after 40 hours a week benefits no one.” According to the advocacy group Caring Across Generations, domestic care is one of the U.S.’s lowest paying industry, with an average hourly wage of $9.61.
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.