Drugs
Novo Nordisk says its diabetes drug Victoza (liraglutide) injection 1.2 mg or 1.8 mg reduced the risk of cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by 13% vs placebo in a recent trial involving 9,340 adults. “Victoza is the only approved
Drugs
FDA has strengthened an existing warning about the risk of acute kidney injury for Type 2 diabetes medicines canagliflozin (Janssen’s Invokana and Invokamet) and dapagliflozin (AstraZeneca’s Farxiga and Xigduo XR). “Based on recent reports, we have revised the warnings in the drug labels to include information about acute
Drugs
The Washington Legal Foundation says that many state attorneys general view drug companies as “their own private cash cow.” A Legal Opinion Letter by two Arnold & Porter attorneys outlines a recent South Carolina Supreme Court decision against Janssen over its Risperdal marketing. In 2003, FDA required all drugs in
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment. It provides recommendations to industry for designing a nonclinical development program to support approval of drugs to treat osteoporosis. It also discusses the nonclinical development of biopharmaceuticals (e.g.
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Arthritis Advisory Committee 7/12, from 7:30 a.m. to 5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss
Devices
Haemonetics has recalled three lots of its Leukotrap RC System with RC2D Filter due to reports that white blood cell counts were higher than expected during collection. The device is a closed system for collecting one unit of whole blood and the pre-storage leukoreduction of packed red blood cells
Drugs
Teva Pharmaceuticals has suspended marketing of its battery-powered Zecuity (sumatriptan iontophoretic transdermal system) patch, indicated for treating acute migraines, while FDA and the company investigate reports of serious burns and potential permanent scarring in product users. A recall has also been initiated, according to the company. Earlier this month,
Drugs
FDA has released a draft guidance on “Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment” that provides recommendations for designing a nonclinical development program to support approval for such drugs. “In addition to the pharmacology and toxicology studies required to support development of a new drug or biologic, long-term
Drugs
House Energy and Commerce Committee chairman Fred Upton (R-MI) and ranking member Frank Pallone, Jr. (D-NJ) have introduced The FDA Cross-Center Collaboration Act of 2016, legislation to encourage collaboration between product centers at the agency. The bill would require FDA to establish one or more “Intercenter Institutes”
Drugs
Former Insys Therapeutics district manager Jonathan Roper and former sales rep Fernando Serrano have been arrested and charged with two counts each of violating the anti-kickback statute involving the painkiller Subsys (fentanyl). After their arrest, they were brought before U.S. magistrate judge Kevin N. Fox in Manhattan. The
Devices
FDA has cleared a Masimo 510(k) for its O3 regional oximetry. Regional oximetry, also referred to as tissue or cerebral oximetry, may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain due to various factors,
Drugs
FDA has issued KemPharm a complete response letter for its NDA for Apadaz (benzhydrocodone and acetaminophen), an investigational abuse-deterrent product candidate for the short-term management of acute pain. The letter is in response to an NDA amendment that the company filed last week (see story) that seeks to
FDA Policy/General
Paradigm Spine has agreed to pay the U.S. government $585,000 to resolve allegations under the False Claims Act that it caused health care providers to submit false claims to Medicare and other federal health care programs by marketing the company’s coflex-F device for unapproved uses, according
Drugs
FDA has approved a ViiV Healthcare supplemental NDA for dolutegravir 10mg and 25mg oral tablets, reducing the weight limit from at least 40kg to at least 30kg, in ages six to less than 12 years old, for the treatment of HIV-1 in children and adolescents. Dolutegravir is indicated for
Drugs
A 6/10 FDA public meeting on the potential development of a user fee program for over-the-counter (OTC) monograph drugs drew criticism from some stakeholders who called for the agency to be more transparent and upfront on what kind of program it is seeking. FDA presenters provided no
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Dissemination of Patient-Specific Information from Devices by Device Manufacturers. The agency intends to facilitate the appropriate and responsible dissemination of patient-specific information recorded, stored, processed, retrieved, and/or derived from medical devices from manufacturers to patients. The
FDA Policy/General
Federal Register Notice: FDA is making a draft guidance available for industry entitled Oncology Drugs for Companion Animals. It provides recommendations for sponsors of investigational oncology drugs for use in companion animals (e.g., dogs, cats, and horses), discusses the contents of a NADA for certain oncology drugs, and provides
FDA Policy/General
Federal Register Notice: FDA will hold a meeting 7/13 of the Arthritis Advisory Committee, from 7:30 a.m. to 5 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss a
FDA Policy/General
Federal Register Notice: FDA's Dermatologic and Ophthalmic Drugs Advisory Committee will meet 7/19, from 8 a.m. to 5 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss a
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Celgene Corp.'s Pomalyst (pomalidomide) is 3,716 days for extending a patent which claims the human drug product. Pomalyst is indicated for treating patients with multiple myeloma who have received at least two prior therapies including lenalidomide
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Human Genome Sciences, Inc.'s Tanzeum is 3,014 days for extending a patent which claims the human biological product. Tanzeum is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type
FDA Policy/General
Federal Register Notice: FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. The agency is also requesting nominations for voting and/or nonvoting consumer representatives to serve