Drugs & Medical Devices Archives - Page 82 of 88

Will Industry Ties Hamper Nominee for FDA Commissioner?

Staff - September 20, 2015

Dr. Califf, a cardiologist, has been serving as the FDA’s deputy commissioner for medical products and tobacco since he joined the agency in February, divesting interest in his pre-FDA activity. Although he has donated his proceeds from private industry to nonprofit groups since the mid-2000s, Dr. Califf has taken some form of financial support from over 20 companies according to a disclaimer added to the end of a European Heart Journal article he penned last year. His financial disclosure form for 2014 alone lists consulting fees provided to him from seven companies, and his salary at Duke was funded in part by drugmakers Merck, Novartis and Eli Lilly.

FDA Grants Bristol-Myer’s Kidney Cancer Drug ‘Breakthrough’ Status

Staff - September 17, 2015

Opdivo was first approved in Japan in July 2014 for the treatment of melanoma and nivolumab was approved by the European Commission this past July for the treatment of lung cancer. The FDA also approved Opdivo for the treatment of melanoma in December and lung cancer in March. In addition to being granted breakthrough designation prior to its two FDA approvals, it has also been given the status for the treatment of Hodgkin lymphoma.

FDA Panel Unanimously Recommends Approval for Abuse-Deterrent Painkiller Xtampza

Staff - September 14, 2015

Despite the dosing warning issued by the Food and Drug Administration (FDA) earlier last week amid concerns about the product’s labeling, an independent panel commissioned by the agency recommended approval for a experimental oral painkiller. The panel’s 23-0 vote is a major win for Massachusetts-based Collegium Pharmaceuticals, and its potential breakthrough drug marketed as Xtampza.

FDA Issues Dosing Warning for Collegium’s Experimental Painkiller

Staff - September 10, 2015

Unlike most opioid painkillers, which are either taken on an empty stomach or without regard for food intake, users must take Xtampza after eating to release the maximum effects. The FDA warned that if Xtampza is taken without food, it will lead to inadequate pain control, and contribute to abuse and overdose by users who are seeking to remedy their pain.

Appeals Court Rules for Novartis against Amgen in Biosimilar Cancer Treatment Suit

Staff - September 3, 2015

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

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.

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