Drugs
FDA has approved a Merck NDA for Zinplava (bezlotoxumab) injection 25 mg/mL, indicated for reducing recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment and are at high risk for CDI recurrence. The company notes that the therapy
Devices
FDA has cleared an Ortho Clinical Diagnostics 510(k) for the Ortho Vision Max, an automated blood analyzer for high-volume transfusion medicine laboratories. The device was developed for labs conducting greater than 50 types and screens per day, and it also supports more complex immunohematology testing, such as serial
Devices
FDA is urging the public and industry insiders to report regulatory misconduct against medical device manufacturers or individuals marketing medical devices who may be violating the law. Reporting these allegations “can help the FDA identify the potential risks to patients and determine whether further investigation is warranted, as well as
Drugs
GlaxoSmithKline has submitted a BLA for its Shingrix vaccine and its use for preventing herpes zoster (shingles) in people aged 50 years and older. The submission is based on data from a Phase 3 clinical trial program which showed that by reducing the incidence of shingles, the candidate vaccine also
Drugs
DEVICES FDA Guide on Medical Device Software Federal Register Notice: FDA has made available a draft guidance on “Software as a Medical Device (SaMD): Clinical Evaluation.” The document was prepared under the auspices of the International Medical Device Regulators Forum, formerly the Global Harmonization Task Force. It focuses on the
FDA Policy/General
Alere shareholders have voted to approve the company’s acquisition by Abbott for $5.8 billion. Alere said that more than 98% of the votes cast at a special meeting voted in favor of the acquisition. Chicago mayor Rahm Emanuel reportedly is supporting an ordinance that would require pharmaceutical sales
Devices
FDA and CMS have announced that their ongoing medical device “parallel review” pilot program will be fully implemented and extended indefinitely. Parallel reviews allow both agencies to review information about a medical device concurrently, rather than sequentially, while continuing to make their premarket review and coverage decisions consistent with their
Devices
Sen. Al Franken (D-MN) continues to monitor FDA’s handling of late medical device adverse events from manufacturers amid a growing controversy that new reporting mechanisms and guidelines are needed. A recent Minneapolis Star Tribune article revealed the agency’s use of a “retrospective summary reporting” program, under which
Drugs
FDA has approved an Astellas Pharma and Pfizer supplemental NDA to change product labeling for Xtandi (enzalutamide) capsules to include new clinical data versus bicalutamide from the TERRAIN study. The data demonstrate improvement in radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (CRPC) who were
Drugs
Newron Pharmaceuticals has resubmitted an NDA for safinamide, indicated for treating patients with Parkinson’s disease. In March, FDA sent the company a Complete Response Letter, requesting “clinical evaluation of the potential effect of safinamide on behaviors relating to abuse liability and dependence/withdrawal effects” as required by CDER’s
Devices
FDA has approved a Roche PMA for the cobas MPX test for use on the cobas 6800 and 8800 Systems. The test enables donor screening laboratories to “apply the most advanced PCR-based diagnostic technology to the surveillance of donated blood and plasma in the United States, preventing the spread
FDA Policy/General
Federal Register Notice: FDA is asking for comments on a submission to OMB seeking to extend an information collection related to requirements associated with the Animal Drug User Fee cover sheet. The cover sheet is designed to collect the necessary information to determine whether a fee is required for the
Drugs
Alkermes has released positive topline results from FORWARD-5, a third Phase 3 efficacy study of ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies. The
FDA Policy/General
Federal Register Notice: FDA is asking for comments on a submission to OMB seeking to extend an information collection related to a guidance on “Dear Health Care Provider Letters: Improving Communication of Important Safety Information.” The document offers recommendations on the content and format of such letters sent by manufacturers
Drugs
Teva Pharmaceutical Industries has resubmitted an NDA for SD-809 (deutetrabenazine) for treating chorea associated with Huntington disease. The agency has set a user fee review target date of 4/3/2017. In June, FDA issued Teva a Complete Response Letter on the original submission, asking that it examine blood
Devices
Teleflex Medical has begun a Class 1 recall of its Willy Rusch Tracheostomy Tube Set which is used for cannulation of tracheotomized patients, particularly for narrow tracheostoma and narrow-lumen tracheas. A recall notice says the connector may disconnect from the tracheostomy tube during use. At this time, the cause
Drugs
FDA has granted Alexion Pharmaceuticals an orphan drug designation for ALXN1007, a novel anti-inflammatory monoclonal antibody targeting complement protein C5a for treating acute graft-versus-host disease (GVHD). Alexion says it is currently investigating ALXN1007 in patients with acute GVHD in the lower gastrointestinal tract (GI-GVHD), a severe
Devices
FDA says it is recommending that healthcare providers stop using Multidata Systems radiation therapy devices because they have not received 510(k) clearance from the agency. A notice to radiation oncologists, medical physicists, dosimetrists, and radiation therapists says that for at least two of the company’s devices, the agency
Drugs
A 2014 Georgia federal court decision gave Sandoz a win on a variety of preemption defenses in a failure-to-warn case, according to attorney John Sullivan (Cozen O’Connor). Writing in the Drug & Device Law blog, Sullivan says he only recently became aware of the case, which “hits
Drugs
FDA commissioner Robert Califf says he was right in upholding her action, and by extension CDER director Janet Woodcock also was right in overruling her subordinate Center medical officers to approve Sarepta Therapeutics’ Duchenne muscular dystrophy drug Exondys 51 (eteplirsen). Addressing the same Arlington, VA meeting of the National Organization
Drugs
Members of the FDA Bone, Reproductive, and Urologic Drugs Advisory Committee voted 14-4 on 10/19 to recommend the safety and efficacy of Serenity Pharmaceuticals’ desmopressin nasal spray, but also recommended that the company’s proposed indication be narrowed. The committee members said that the proposed indication of treating
Devices
A supplement to a 3/31 citizen petition says it provides “evidence that the resin Boston Scientific Corp. (BSC) is currently using to manufacture its transvaginal mesh product (1) is not Marlex HGX-030-01, (2) is not supported by evidence proving its safety, and (3) cannot be characterized as