FDA Policy/General
Federal Register notice: CDER is proposing to refuse to approve a Lexicon Pharmaceuticals NDA for sotagliflozin oral tablets, 200 milligrams (mg) and 400 mg, in its present form. The notice summarizes the grounds for the Center’s proposal and offers Lexicon an opportunity to request a hearing. Sanofi-aventis, Lexicon’
FDA Policy/General
Federal Register notice: FDA has announced a 4/6 Medical Devices Advisory Committee’s Circulatory System Devices Panel meeting. Panel members are scheduled to review a TransMedics PMA for its Organ Care System (OCS) Heart, a portable extracorporeal heart perfusion and monitoring system for the resuscitation, preservation, and assessment of
Drugs
The Government Accountability Office (GAO) says FDA needs to use lessons it has learned during the Covid-19 pandemic to improve its foreign drug inspection program, including efforts to identify alternative mechanisms to satisfy foreign inspection requirements and ways to address its growing backlog of inspections. In testimony prepared for
Devices
FDA says its review of a Web site maintained by Orvic, doing business as Webstore-USAVan Nuys, CA, determined that the firm is marketing an unapproved Covid-19 serology test that is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of Covid-19, and thus is legally
Drugs
An independent data safety monitoring board has recommended that the VIR-7831 arm of the National Institute of Health’s Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV) Phase 3 trial be closed to enrollment due to questions about the magnitude of the drug’s potential benefit. Vir Biotechnology and
Drugs
FDA says it is aware that many patients, families, and others in the amyotrophic lateral sclerosis (ALS) community have had high hopes for BrainStorm Cell Therapeutics’ NurOwn therapy. An agency online notice says that with the recent completion of a Phase 3 trial comparing NurOwn to placebo, “it has become
Drugs
FDA has accepted for priority review an On Target Laboratories NDA for pafolacianine sodium injection as an adjunct for identifying ovarian cancer during surgery. The company says that many cancers, including over 95% of ovarian cancers, over-express folate receptors to enable the uptake of folic acid. Pafolacianine sodium injection
Devices
FDA has cleared an Asensus Surgical 510(k) for the Senhance Surgical System and its use in general surgery procedures. “Senhance goes beyond the typical surgical robotic systems, providing surgical assurance through haptic feedback, eye-tracking camera control, and 3D visualization, and is the first platform to offer 3 mm
Devices
FDA says it has notified 25 companies they should stop producing and issuing “FDA registration certificates” that deceptively indicate FDA approval, clearance, or authorization for medical devices. CDRH Office of Regulatory Programs director Sean Boyd says the agency has seen an increase in the number of companies selling medical devices
FDA Policy/General
As a follow-up to its 9/2019 Technology Modernization Action Plan, that laid out a foundation for modernizing the agency’s technical structure and signaled the development of its ongoing strategy concerning data management and data itself, the agency has now released a Data Modernization Action Plan. An online
Biologics
Shanghai Junshi Biosciences and Coherus Biosciences have begun a rolling BLA submission for toripalimab for treating recurrent or metastatic nasopharyngeal carcinoma (NPC). Toripalimab is the first anti-PD-1 monoclonal antibody developed and approved in China that has made it to a BLA submission in the U.S., the companies
Biologics
The National Institutes of Health (NIH) has stopped a clinical trial evaluating Covid-19 convalescent plasma in treating emergency department patients who developed mild to moderate Covid-19 symptoms. The NIH decision was recommended by the trial’s independent data and safety monitoring board, which recently examined the second planned
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Current Good Manufacturing Practice for Finished Pharmaceuticals, Including Medical Gases, and Active Pharmaceutical Ingredients (APIs) — 21 CFR Parts 210 and 211 and 21 U.S.C 351(a)(2)(B)” (OMB Control Number 0910-0139). The collection
Drugs
An 8/4-8/13/20 FDA bioresearch monitoring program inspection at KDunn and Associates, doing business as HealthQuilt, Houston, TX, found objectionable conditions in the company’s work as the sponsor of a clinical investigation into a Covid-19 investigational drug. A 2/16 Warning Letter says specific objectionable
Drugs
FibroGen and partner AstraZeneca say FDA is requiring its Cardiovascular and Renal Drugs Advisory Committee to review their NDA for roxadustat for treating anemia caused by chronic kidney disease (CKD). FDA accepted the NDA 2/2020 and gave it a review action target date of 12/2020, which was extended
Drugs
Drug companies are pressing FDA to find ways to resolve the inspection backlog that has occurred due to Covid 19. Politico reports in an online post that between 3/2020 and 9/2020 FDA inspected just three overseas plants (well below the 600-plus visited in each of the prior
Drugs
Merck has withdrawn a Keytruda (pembrolizumab) indication for treating patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The withdrawal is part of an FDA effort to clean up products/indications on the
Drugs
FDA has approved revisions to the labeling for ViiV’s Triumeq (abacavir/dolutegravir/lamivudine) and Dovato (dolutegravir/lamivudine) to include dosing in patients with creatinine clearance between 30 and 49 mL per min. An agency notice says that drug interaction information for Triumeq and riociguat also was included in the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Generic Clearance for Data To Support Cross-Center Collaboration for Social Behavioral Sciences Associated with Disease Prevention, Treatment, and the Safety, Efficacy, and Usage of FDA Regulated Products.” Under the collection, FDA is seeking to conduct qualitative
Devices
The Department of Justice says global medical technology company Bioventus is paying over $3.6 million to resolve allegations that it violated the False Claims Act by submitting improperly completed certificates of medical necessity for medically unnecessary devices from 10/1/12 through 12/31/18. A department statement says
Devices
FDA has cleared Neurolief’s Relivion system, the first non-invasive, multi-channel brain neuromodulation system for at-home treatment of acute migraine. The company says that Relivion, worn as a headset, demonstrated statistically significant efficacy in providing complete freedom of migraine symptoms within two hours after treatment. The agency’
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: HealthQuilt, Houston, TX (2/16) FDA inspected the firm 8/4-8/13/2020 under its bioresearch monitoring program inspection and cited