Drugs
FDA has accepted for review an Ironwood Pharmaceuticals and Allergan supplemental NDA for a 72 mcg dose of linaclotide for use in treating adults with chronic idiopathic constipation (CIC). The submission is based on efficacy and safety data from a double-blind, placebo-controlled Phase 3 clinical trial involving 1,
Devices
FDA has cleared a Sandstone Diagnostics 510(k) for its Trak Male Fertility Testing System, an at-home diagnostic for couples to measure semen quality at home as they try to conceive. The device uses centrifugal force to isolate and quantify sperm cells using specially designed disposable cartridges, according to
Drugs
Sen. Dan Coats (R-IN) has introduced S. 2998, the Ensuring Patient Access to Critical Breakthrough Products Act, to “establish a program to accelerate transitional coverage and payment for new technologies that offer breakthroughs for serious illnesses affecting Medicare beneficiaries.” In a statement, the senator says that “researchers and entrepreneurs
Devices
Baxter says that unauthorized third-party services who refurbish, recondition, rebuild, remarket, remanufacture, and service medical devices “generally lack the product and process knowledge and controls of the original equipment manufacturer. Unauthorized service activities, therefore, may create significant risks for patients, despite the best intentions and efforts of the third-
FDA Policy/General
Federal Register Notification of withdrawal: FDA is withdrawing approval of five NADAs and an ANADA. This action is being taken at the sponsors’ request because these products are no longer manufactured or marketed. These are Cross Vetpharm’s Sulfa-Nox Liquid, Sulfa-Nox Concentrate, Erythromycin Medicated Premix, Purina Sulfa, Supersweet
Drugs
A joint meeting by FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee has voted 14 to 3 to support approval of Teva’s Vantrela ER (hydrocodone bitartrate extended-release tablets) for managing pain severe enough to require long-term opioid treatment
Devices
FDA has given Invacare information on additional steps the company must take to meet design control requirements at its Taylor Street facility in Elyria, OH. The company reported in an SEC filing that FDA clarified its requirement for Invacare to complete the remediation of certain design history files referenced in
Devices
Researchers at the Department of Energy’s Lawrence Berkeley National Laboratory are helping to develop and test materials for a new device that can be inserted into a vein to soak up, like a sponge, tumor-fighting drugs before they can widely circulate in the bloodstream and cause side effects.
Drugs
The Justice Department says that Genentech and OSI Pharmaceuticals, who are co-promoting the cancer drug Tarceva, have agreed to pay $67 million to resolve a whistleblower’s False Claims Act allegations that they made misleading statements about the drug’s effectiveness. A department statement says the allegations claimed that
Devices
Members of the FDA Circulatory System Devices Panel met 6/2-6/3 to discuss and make recommendations about aerosolized transmission of nontuberculous mycobacteria (NTM) from contaminated water inside heater-cooler devices into the operating room environment and sterile field and ultimately into patients undergoing open chest surgical procedures. A
Devices
Attorney John Sullivan, writing in a Drug & Device Law blog post, praises a Minnesota state court decision that all claims in a suit against Medtronic are preempted by federal regulations. The case involved allegations that the plaintiff had complications from a pain pump implant. The suit alleged a number
FDA Policy/General
Federal Register Notice: FDA seeks comments on the estimated reporting, recordkeeping, and third-party disclosure burden associated with the Mammography Quality Standards Act requirements. Comments should be submitted by 8/8. To view notice, click here.
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Biogen Idec Hemophilia Inc.’s Alprolix is 2,223 days for extending patents which claim the human biological product. Alprolix is a recombinant DNA derived, coagulation Factor IX concentrate indicated in adults and children with hemophilia B for controlling
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Biogen Idec Hemophilia Inc.’s Eloctate is 1,695 days for extending patents which claim the human biological product. Eloctate is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency)
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee 7/26 from 1 p.m. to 3:30 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD.
Drugs
A Northern California federal judge has tossed out a Merck $200 million jury verdict against Gilead Sciences after finding misconduct by the company and one of its expert witnesses. The case, Gilead Sciences v. Merck & Co., involved assertions by Merck that two of its patents cover sofosbuvir, and that
FDA Policy/General
Federal Register Final rule: FDA is amending the animal drug regulations to reflect application-related actions for NADAs and ANADAs during March and April. These are Elanco Animal Health’s Imprestor, Aratana Therapeutics’ Galliprant, and Eco’s Aivlosin mediated article. The agency is also informing the public of the availability
Drugs
FDA has granted Remedy Pharmaceuticals a fast track designation for its investigational drug Cirara and its use in treating large hemispheric infarctions (LHI). The company is planning a Phase 3 trial called CHARM (Cirara in large Hemispheric infarction Analyzing modified Rankin & Mortality) in patients with LHI, a disease associated
Devices
Reps. Michael Fitzpatrick (R-PA) and Louise Slaughter (D-NY) have introduced two bills to improve medical device safety and allow those harmed by devices to seek legal recourse. Fitzpatrick has been an outspoken advocate for FDA and medical device reform and continues to call for an Energy & Commerce
Devices
A 11/30-15-1/21/16 FDA inspection at Spectranetics Corp., Colorado Springs, CO, found Quality System Regulation and other violations in the firm’s manufacturing of lead management disposable catheter lines, including laser sheath device products, specifically the GlideLight and SLS II sheaths. A 5/23 Warning Letter
Drugs
Sarepta Therapeutics and its eteplirsen for treating Duchenne muscular dystrophy received a shot in the arm 6/6 when, in an apparent compromise with FDA, the company agreed to an agency request that it provide dystrophin data, as measured by western blot, from biopsies already obtained from an ongoing confirmatory
Drugs
With the number of shipments of FDA-regulated products into the U.S. more than doubling from 15 million to more than 34 million in the past decade, the agency is implementing initiatives to keep pace, according to deputy commissioner for global regulatory operations and policy Howard Sklamberg. Writing in