Drugs
FDA and the European Medicines Agency (EMA) are establishing a joint cluster on rare diseases to share scientific evaluation of various aspects of drug development for rare diseases. A document on terms of reference for the cluster says that the aspects include selection and validation of trial endpoints, potential trial
Drugs
Janssen Research & Development has submitted a supplemental NDA for Imbruvica (ibrutinib) for treating patients with marginal zone lymphoma (MZL) who require systemic therapy. The filing is based on data from an open-label Phase 2 trial called PCYC-1121 that evaluated the therapy in MZL patients who have received
Drugs
After an FDA Office of Criminal Investigations probe, federal prosecutors have charged a Hoover, AL man with receiving and reselling misbranded male enhancement drugs from China that could cause serious side effects in men taking medications containing nitrates. Nabil Chagri has been charged with one count of receiving and selling
Drugs
U.S. senator Tom Cotton (R-AK) has introduced the Safely Advancing Valuable and Inexpensive New Generic Solutions Act, a bill that would require FDA to expedite the review process for both the first and the second introduced generic competitors to a brand name drug. The agency would also be
Drugs
FDA has approved a Janssen Biotech BLA for Stelara (ustekinumab) for treating moderately to severely active Crohn’s disease in adults (18 years or older) who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor blocker, or who failed
Drugs
Eisai Inc. has submitted a supplemental NDA for Fycompa (perampanel) seeking monotherapy use for treating partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. Currently, the drug is approved as an add-on therapy in combination with another antiepileptic drug.
Drugs
GENERAL Comments Extended on Advisory Committee Appearances Guide Federal Register Notice: FDA has extended the comment period until 11/26 for a guidance on “Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees.” The extension is being granted due to errors displayed on the FDA
Drugs
Wells Pharmacy Network has recalled all sterile human and veterinary products prepared since February due to an FDA concern over a lack of sterility assurance. “Administration of a drug product intended to be sterile that has microbial contamination may result in infections that may be serious and life-threatening,” an
Drugs
Teva Pharmaceutical Industries has reported statistically significant results in a second Phase 3 registration trial involving SD-809 (deutetrabenazine) and its use for treating tardive dyskinesia. Teva expects to submit an NDA by the end of the year. In the AIM-TD trial, the primary endpoint was change in Abnormal
Drugs
FDA has issued a guidance, Self-Identification of Generic Drug Facilities, Sites, and Organizations, to inform them about complying with the self-identification requirement in the Generic Drug User Fee Amendments of 2012 (GDUFA). Under that law, the document says, human generic drug facilities, sites, and organizations are required to
Drugs
Attorney Alexander Varond (Hyman, Phelps & McNamara) says that efforts are underway to reauthorize the FDA rare pediatric disease priority review voucher program that is set to expire 10/1. But it is not clear that those efforts will succeed in time, he writes in his firm’s FDA Law
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) for clinical pharmacology review of NMEs, NDAs, and BLAs. The document and its attachments establish good review practices for the three categories of reviews and is one in a series of MAPPs intended to document good review practices for review
Drugs
FDA is interested in providing technical expertise on legislation that could curb brand name drug companies’ efforts to block or delay generic drug entry into the market, but it says any measure should be crafted with care to avoid any unintended consequences. During a Senate appropriations subcommittee hearing 9/21,
Drugs
An 8/17-21/15 FDA inspection at Hebei Yuxing Bio-Engineering Co., Hebei, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients, according to a 9/6 Warning Letter. Specific violations noted included: * failure to have laboratory control records that include complete data derived from
Drugs
CDER has issued a Manual of Policy and Procedures (MAPP) for its Office of Surveillance and Epidemiology (OSE) with the procedures for sharing non-public information on pending proposed drug proprietary names. The procedures are to be used by the OSE Division of Medication Error Prevention and Analysis and the
Drugs
UK researchers say there is strong evidence that much of the information on adverse events remains unpublished and that the number and range of adverse events is higher in unpublished than in published versions of the same study. Writing in the open-source journal PLOS Medicine, the authors say their
Drugs
FDA has approved a Janssen Pharmaceuticals supplemental NDA for Invokamet XR (canagliflozin and metformin hydrochloride) for first-line use as an adjunct to diet and exercise to improve blood glucose control in adults with Type 2 diabetes when treatment with the two medications is appropriate. The new indication aligns with
Drugs
Members of 16 public health, patient advocacy, health professional, and disease organizations are voicing concerns about proposed legislation that they say will weaken drug safety protections and make it easier for potentially dangerous drugs to get into the wrong hands. Members of the Patients’ Alliance for Drug Safety Protections say
Drugs
FDA has accepted for review a TherapeuticsMD NDA for Yuvvexy, an investigational bio-identical 17β-estradiol vaginal softgel capsule for treating moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy in postmenopausal women. The agency has set a user fee review target date of
Drugs
FDA has released a draft guidance on “FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary” that is intended to clarify how it applies factors in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh
Drugs
FDA has issued for comment a draft guidance, Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices, to assist drug sponsors and medical device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who seek to coordinate development of the products such
Drugs
Alcon has petitioned FDA to change the bioequivalence testing requirements for any ANDA that cites its Durezol (difluprednate ophthalmic emulsion, 0.05%) as the reference-listed drug and also revise the product-specific bioequivalence draft guidance for difluprednate ophthalmic emulsion. “Petitioners believe that only in vivo pharmacokinetic testing or comparative