Drugs
FDA has issued Coherus BioSciences a complete response letter on its BLA for a biosimilar copy of Amgen’s Neulasta (pegfilgrastim), indicated for reducing the duration of neutropenia (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with neutropenia in adult patients treated
Drugs
Gilead Sciences has submitted an NDA for a once-daily single tablet regimen containing bictegravir (50 mg), an investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) for treating HIV-1 infection in adults. The drug product has demonstrated high rates of virologic suppression and no treatment-
Drugs
FDA has accepted for review a Synergy Pharmaceuticals supplemental NDA for Trulance (plecanatide) for treating adults with irritable bowel syndrome with constipation. The user fee review target date is 1/24/2018. Trulance is currently approved for treating adults with chronic idiopathic constipation. The submission is based on data from
Drugs
Eli Lilly says it is planning a BLA before year-end after reporting positive results from three Phase 3 studies of galcanezumab, an investigational treatment for preventing episodic and chronic migraine, including data on several key secondary endpoints for galcanezumab compared to placebo at both studied doses. Data from EVOLVE-
Drugs
Public Citizen senior advisor Sidney Wolfe is criticizing FDA for originally approving Endo Pharmaceuticals’ controversial pain drug Opana ER (oxymorphone hydrochloride extended release) while condemning the company for being defiant in announcing that it is reviewing the agency’s request (see earlier story) to remove the product from the market.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection reinstatement for “Electronic Products OMB Control Number 0910–0025.” The notice applies to requirements to establish and carry out an electronic product radiation control program, including the development, issuance, and administration of performance standards to control the emission of
FDA Policy/General
Federal Register notice: FDA has announced a 6/26 Science Board meeting. Panel members will be given an update on FDA’s biotechnology activities related to plant-derived food and animals, and will hear a report from the National Antibiotic Resistance Monitoring System Review Subcommittee. To view the notice, click
FDA Policy/General
DEVICES FDA has approved a Qiagen PMA supplement for QuantiFeron-TB Gold Plus, a fourth-generation blood test for detecting latent tuberculosis (TB) infection. The device adds the company’s proprietary CD8+ technology to “offer the ability to capture a much broader picture of an individual’s immune response to
Drugs
Pediatric Oncology Meeting Planned for 6/21-22 Federal Register notice: FDA announces a 6/21-22 Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting. 06/8/2017 FDA Vaccines Panel Meeting to Review Hep B Vaccine Federal Register notice: FDA announces a 7/28 Vaccines and Related
Devices
In response to a request for comment on activists’ complaints yesterday that Bayer had not begun a promised study on patient experience with its controversial Essure permanent contraceptive implant, FDA told FDA Webview 6/8 that it approved the study plan 9/2/2016, and Bayer has since begun the
Devices
Since it is well established that FDA Warning Letters do not represent final agency action, in his five-page order, Nunley, an Obama appointee, declined to address these allegations and instead focused on EMED’s claims of irreparable harm if RMS sales in California were not stopped. He found the
Biologics
OncBioMune Pharmaceuticals has submitted to FDA a Phase 2 clinical trial protocol for ProscaVax, a novel therapeutic cancer vaccine for early stage prostate cancer. In the trial, ProscaVax will be evaluated for safety, tolerability and efficacy as a treatment for patients with a new disease diagnosis and who have chosen
Drugs
FDA has granted an OncoSec Medical an orphan drug designation for ImmunoPulse IL-12 (tavokinogene telsaplasmid) for treating unresectable metastatic melanoma. OncoSec is beginning a pivotal trial called PISCES trial to evaluate the safety and efficacy of ImmunoPulse IL-12 and pembrolizumab (Merck’s Keytruda) in patients with metastatic melanoma
FDA Policy/General
Federal Register notice: FDA has determined that it is necessary for manufacturers of certain reusable medical devices to include in their premarket notifications (510(k)s) instructions for use which have been validated and validation data on cleaning, disinfection, and sterilization. The notice includes a list of the reusable devices
Drugs
FDA has approved a Teva Pharmaceuticals ANDA for the first generic copy of Gilead’s Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg) for treating HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-
Devices
As required by the 21st Century Cures Act, FDA has published a list of reusable medical devices which must include in their 510(k) submissions instructions for use that have been validated and validation data regarding cleaning, disinfection, and sterilization, for which a substantial equivalence determination may be based. The
Devices
Clinical pathologist and medical microbiologist Diane Alame says that poor monitoring of the safety of medical processes is a major problem in the nation’s medical system. Writing in a Stat online opinion piece, Alame discusses the “superbug outbreak involving duodenoscopes that seriously sickened 350 people and killed at least
FDA Policy/General
Federal Register notice: CBER, National Institutes of Health and National Institute of Allergy and Infectious Diseases are announcing a 7/10 public workshop entitled “Bacteriophage Therapy: Scientific and Regulatory Issues.” The workshop is intended to exchange information with the medical and scientific community about the regulatory and scientific issues associated
Drugs
The 21st Century Cures Act added a new section to the Federal Food, Drug, and Cosmetic Act on Qualification of Drug Development Tools that established an updated multi-stage process for drug development tool qualification. In an online notice, FDA says the process includes three submission milestones — Letter of Intent,
Devices
FDA has cleared a Thornhill Medical 510(k) for the Moves SLC Portable Emergency Life Support System to expand the device’s capabilities to include pediatric settings, expanded patient monitoring modes, new ventilator modes, and a remote monitoring and control interface. The company describes the device as the “world’s
FDA Policy/General
Federal Register notice: FDA has announced a 7/12 Oncologic Drugs Advisory Committee meeting. The panel intends to discuss a Novartis BLA for tisagenlecleucel-T suspension for intravenous use and indicated for treating pediatric and young adult patients three to 25 years of age with relapsed/refractory B-cell acute
Devices
Members of a 37,000-member advocacy group say that the number of women harmed by Bayer Healthcare’s Essure sterilization coil continue to grow while FDA efforts to inform them of the risks are not working. The Philadelphia Inquirer reports that the Essure Problems Facebook group says that in