Drugs
Washington Legal Foundation (WLF) has filed an amicus brief calling on the U.S. Supreme Court to review and overturn a 6/2016 decision by the U.S. Court of Appeals for the Third Circuit that “requires exacting antitrust scrutiny for virtually any agreement between a brand-name drug company
Drugs
FDA has placed a clinical hold on the CARDIO-TTR study being developed by GlaxoSmithKline to evaluate Ionis Pharmaceuticals’ Ionis-TTRRX in patients with TTR (transthyreitin) amyloid cardiomyopathy. Ionis says that the hold is in place while Glaxo provides answers to FDA questions about the Phase 3 study protocol stemming
Drugs
After recent First Amendment losses, FDA has moved away from its theory of using speech by companies as evidence they may be distributing a drug for an unapproved use, according to Washington Legal Foundation chief counsel Richard Samp. Speaking at an American University College of Law seminar (video link) on
Drugs
Par Pharmaceuticals is asking FDA not to approve any ANDA for a potassium chloride oral solution drug product for use in certain pediatric patients if the proposed product contains alcohol as one of its components. The company’s 3/22 petition specifically asks that the agency: refrain from approving any
Drugs
An American College of Physicians (ACP) position paper recommends forcing drug companies to disclose their actual product and research-and-development costs and submit to price negotiation among ways to reduce the highest national spending on drugs in the advanced world. The U.S. is the only country in the
Drugs
Pew senior director for health programs Allan Coukell says that the Promise for Antibiotics and Therapeutics for Health (PATH) act is needed to help speed development of antibiotics for limited populations of patients with serious and life-threatening bacterial infections that are resistant to current treatments. Writing online in Health
Drugs
Life sciences and healthcare respondents to a Deloitte poll say that supply chain fraud increased to 35% of companies in 2016 from 31% in 2014. Overall, poll respondents from many sectors reported that for the third consecutive year, the level of supply chain fraud remained at about 30%. “From a
Drugs
A 3/9-3/12/15 FDA inspection at the Wellness Pharmacy, Winchester, Virginia, identified multiple violations in the firm’s compounding of sterile drug products. Wellness has informed FDA that it stopped producing compounded sterile drugs as of 3/12/15. A 3/23 Warning Letter from the agency
Drugs
The New England Journal of Medicine, considered by many to be the best known and most venerated such journal in the world, is now the subject of concerns that it is slipping in relevancy and reputation, according to a ProPublica report co-published with the Boston Globe The report discusses
Drugs
FDA says that a 10/6-10/30/15 Bioresearch Monitoring Program inspection of two clinical trials conducted by Dr. Cheta Nand in Richland, WA, determined that Nand “did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations. A just-released 3/10
Drugs
FDA has again changed its mind on the question of whether a biosimilar’s labeling should identify itself as a biosimilar. That’s one of the takeaways attorney James Shehan (Hyman, Phelps & McNamara) sees in the FDA 3/31 guidance on biosimilar labeling. Writing in his firm’s FDA
Drugs
New FDA warnings are being added to Type 2 diabetes medicines containing saxagliptin and alogliptin after an agency safety review found that they may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. The warnings are an extension of a 2014 drug safety
Drugs
Medical students from Harvard and Tufts and members from an activist group staged a “die-in” 4/1 in front of the Tufts Center for the Study of Drug Development (CSDD), claiming a recent study by Tufts associate professor Joseph A. DiMasi is biased. About two dozen protesters demanded that
Drugs
FDA medical reviewers did not raise any serious issues about Intercept Pharmaceuticals’ NDA for obeticholic acid (OCA) for treating primary biliary cirrhosis in combination with ursodeoxycholic acid in adults with an inadequate response to ursodeoxycholic acid or as monotherapy in patients unable to tolerate it. The reviewers’ comments were in
Drugs
FDA representation is missing from a National Cancer Institute (NCI)-created blue ribbon panel of scientific experts, cancer leaders, and patient advocates that will guide the scientific direction and goals under vice president Joe Biden’s National Cancer Moonshot Initiative. The panel will serve as a working group of the
Drugs
FDA has posted a guidance on “Contents of a Complete Submission for the Evaluation of Proprietary Names” that describes the information it uses to evaluate proposed proprietary names for drugs and biological products. The agency says the document is intended to assist industry when submitting complete submission packages used to
Drugs
FDA scientists have provided “proof-of-concept” for a technique that identifies the presence of potentially harmful contaminants in probiotics. “The technique eliminates a product’s beneficial bacteria and allows any potentially harmful contaminants in the product to grow unimpeded, allowing detection of potentially harmful contaminants using standard laboratory methods,
Drugs
Janssen Research & Development says it is discontinuing a Phase 3 development program for fulranumab in osteoarthritis pain. The decision was based on “strategic portfolio prioritization and was not based on any emerging safety concerns from the Phase 3 clinical studies with fulranumab,” it says. Additionally, affiliate Janssen Pharmaceuticals is
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) has objected to a Shionogi “Patient Co-Pay Assistance Voucher” for Ulesfia (benzyl alcohol) lotion because it omits important risk information associated with the use of Ulesfia and omits material facts. As such, the voucher misbrands Ulesfia and makes its distribution violative,
Drugs
After 25 years at FDA, CDER associate director for policy Jane Axelrad will retire effective 4/29. In total, she has 41 years of government service when counting legal and policy positions she held at the Nuclear Regulatory Commission and the Environmental Protection Agency prior to joining the agency in
Drugs
CDER Office of Compliance (OC) director Cynthia Schnedar has resigned and Office of Manufacturing Quality director Tom Cosgrove will assume the OC director role in an acting capacity on 4/4. Schnedar’s departure comes three months after she was recused from working on substantive issues relating to compliance actions
Drugs
Radius Health has submitted an NDA for abaloparatide-SC 80 mcg, an investigational, once daily treatment for postmenopausal women with osteoporosis. The submission is supported by data from an 18-month Phase 3 study called ACTIVE, which evaluated 2,463 postmenopausal women with osteoporosis. The company says the trial met