Drugs
FDA has approved a class-wide labeling change for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids
Drugs
Metabolic Therapy, Austin, TX, has submitted a citizen petition asking that FDA amend the OTC External Analgesic Drug Products monograph for active ingredients to indicate that melatonin and inositol hexaphosphate are safe and effective for external analgesic drug products. The petition says the monograph should indicate that topical external analgesic
Drugs
FDA has approved a Merck supplemental NDA for Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score of 50% or more)
Drugs
FDA has released a draft guidance on “Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment” that is intended to assist sponsors in developing such drugs. The document addresses the agency’s current thinking regarding the overall clinical development program, with a focus on Phase 3
Drugs
FDA is advancing a planned direct-to-consumer (DTC) advertising study by seeking OMB approval to research the growing use of animation in prescription drug advertising and promotional activities and whether such use minimizes risk or inflates efficacy perceptions. A just-posted notice seeks comments on the proposed research that
Drugs
FDA has placed a clinical hold on an Inovio Pharmaceuticals proposed Phase 3 clinical program for VGX-3100, requesting additional data to support the shelf-life of the newly designed and manufactured disposable parts of the Cellectra 5PSP immunotherapy delivery device. The company says it is working with the agency
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
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
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
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
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
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
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
Drugs
Lachman Consultants says that three issues that drive drug companies crazy currently are (1) getting resolution of compliance status after inspection or re-inspection; (2) getting a straight answer from FDA; and (3) what to do about maximum daily exposure issues relative to the inactive ingredient database. “Most of the
Drugs
Former FDA associate commissioner Peter Pitts says that FDA could follow principles to improve drug labeling in a way that would make it easier for doctors to determine if off-label prescribing would be good for their patients. Writing in a Forbes online post, he notes that drug companies continue
Drugs
A just-released FDA-483 details observations from a 6/1-6/10 inspection of Akorn Pharmaceuticals, Decatur, IL. Specific observations included: * failing to record and justify deviations from written production and process control procedures; * failing to fully follow responsibilities and procedures applicable to the quality control unit; * failing to
Drugs
Is something amiss at CDER in the wake of last month’s controversial approval of Sarepta Therapeutics’ Duchenne muscular dystrophy drug Exondys 51 (eteplirsen)? One may suspect this after CDER Office of New Drugs director John Jenkins took an unprecedented opportunity to criticize (see presentation) the drug’s development and
Drugs
Attorney James Beck (Reed Smith) says the 3rd Circuit Court of Appeals properly rejected the Sheller law firm’s appeal of a lower court decision saying it lacked standing to sue FDA to compel the agency to approve its citizen petition on Risperdal use in children. Writing in a Drug