Drugs
A New York federal court has dismissed for a second time a case against Bristol-Myers Squibb over its blood thinner Eliquis. The first time the case was heard, the court rejected as preempted the plaintiff’s design defect claims and said the case could be amended on non-design
Drugs
FDA Oncology Center of Excellence (OCE) director Richard Pazdur says the Center has begun coordinating clinical review of oncology products. Writing in an online American Journal of Managed Care post, Pazdur says that applications are submitted to CDER, CBER, or CDRH and, if appropriate, OCE forms a clinical review team
Biologics
Spark Therapeutics has completed a rolling BLA submission for voretigene neparvovec, an investigational, one-time gene therapy for treating patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal disease. The filing includes data from three clinical trials that enrolled 41 participants with the retinal disease, including the
Devices
FDA has cleared a Myoscience 510(k) for its iovera device for relieving pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The device uses iovera’s technology and non-systemic treatment for blocking pain signals from peripheral nerves. It uses the “body’s natural
FDA Policy/General
Federal Register notice: FDA has extended until 7/18 the comment period on a final rule that clarifies for drug and device manufacturers the agency’s interpretation and application of its existing definitions of “intended use” (see earlier story). The comment extension is related to a citizen petition from medical
Devices
AdvaMed says that the bipartisan Medical Product Review Harmonization Act of 2017 (H.R. 2474), sponsored by Reps. Mimi Walters (R-CA) and Ami Bera (D-CA), would establish an alternate review approach for a subset of moderate-risk Class 2 medical devices, making FDA review of these devices more
FDA Policy/General
The House Energy and Commerce Subcommittee on Health 5/18 marked-up and advanced the FDA Reauthorization Act (FDARA) of 2017, that would reauthorize user fee programs for five years beginning 10/1. Four amendments were passed by voice, and they were offered by: Reps. Joseph P. Kenedy, III (D-
Drugs
CDER’s Professional Affairs and Stakeholder Engagement staff is hosting a 6/15 public meeting called “Safe Use Symposium: A Focus on Reducing Preventable Harm from Drugs in the Outpatient Setting.” CDER director of professional affairs and stakeholder engagement John Whyte says in an FDA Voice blog post that those
Drugs
In a 5/15 letter to Sen. Patty Murray (D-WA), ranking Democrat on the Senate HELP Committee, HHS secretary Tom Price says the administration’s budget blueprint calls for increasing and restructuring the medical product user fee programs at FDA to be 100% user fee supported programs, with no
Devices
FDA and the Centers for Disease Control (CDC) say that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the U.S. An agency news release says the CDC recommends that parents of children younger than age 6 and currently pregnant women
FDA Policy/General
University of North Carolina researchers looking at awareness of and trust of FDA and the Centers for Disease Control (CDC) have identified some demographic variables that suggest audiences the agencies may want to target with communications aimed at improving the level of trust. Writing in the open-source journal PLOS
Devices
A comment letter signed by former FDA principal deputy commissioner Joshua Sharfstein (now a professor at Johns Hopkins University) and five other medical school professors or researchers says that drug testing assays that are Class 2 medical devices and used for employment or insurance purposes should not be permitted to
Devices
FDA has cleared a BrainCool AB 510(k) for the IQool System, intended for use for temperature reduction in adult patients when clinically indicated. The device is a “next-generation precision surface cooling system intended for temperature management with a focus on three independent anatomical zones: head/neck, thigh and
FDA Policy/General
Former FDA commissioner Robert Califf has accepted the position of vice chancellor for health data science for Duke Health. In this capacity, Califf also becomes the director of a new cross-campus center at Duke University for integrated health data science. “This center, which has not yet been formally named,
Drugs
AstraZeneca says that FDA should not approve a Teva 505(b)(2) application referencing Faslodex (fulvestrant) intramuscular injection as the listed drug and that proposes a drug product asserted to have a different formulation unless certain conditions are met. The AstraZeneca petition says FDA should require that: * the application contain
Devices
FDA has cleared an Exactech 510(k) to market the ExactechGPS Shoulder Application that combines preoperative planning with computer-assisted shoulder arthroplasty surgery. The device is designed to help surgeons understand their patient’s anatomy prior to surgery, according to the company. “In addition, ExactechGPS provides a real-time view
Drugs
Former FDA deputy commissioner for policy William Schultz says that newly confirmed agency commissioner Scott Gottlieb will need to make an early decision on whether to accept industry proposals to reduce the standards under which drugs can be advertised, standards that Schultz says have “protected patients for more than 50
Drugs
FDA has approved the expanded use of Vertex Pharmaceuticals’ Kalydeco (ivacaftor) for treating cystic fibrosis. This more than triples the number of rare gene mutations that the drug can treat, from 10 mutations to 33. The agency based its decision, in part, on laboratory testing, which it used in conjunction
Drugs
Former FDA commissioner Robert Califf has accepted the position of vice chancellor for health data science for Duke Health. In this capacity, Califf also becomes the director of a new cross-campus center at Duke University for integrated health data science. “This center, which has not yet been formally named,
Drugs
FDA has placed a Concert Pharmaceuticals study of its hair loss therapy, CTP-543, on clinical hold to allow the agency to review requested data. FDA told the company that the Phase 2a clinical trial for alopecia areata can proceed after it reviews recently completed non-clinical toxicology studies if
Drugs
FDA has granted Bayer a priority review on its NDA for copanlisib for treating relapsed or refractory follicular lymphoma (FL) patients who have received at least two prior therapies. Copanlisib is an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor that the company says has “predominant inhibitory activity against
Drugs
FDA has approved an Abon Pharmaceuticals ANDA for clofarabine injection, 20 mg/20 mL, single-use vial, a generic copy of Genzyme’s Clolar injection, indicated for treating pediatric patients one year of age and older with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. According