Drugs
FDA has approved AstraZeneca’s Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization for heart failure. Previously, Farxiga, which is a sodium-glucose co-transporter 2 inhibitor, was approved to improve glycemic control in adults with
Devices
Attorneys Benjamin Zigarelli and Elizabeth Conti (Mintz) say it is unlikely that the relaxed enforcement of medical devices during the Covid-19 pandemic is likely to become permanent following the crisis. “The FDA policies reducing certain regulatory strictures clearly state that such targeted enforcement discretion is temporary and will end
Drugs
FDA has granted Cabaletta Bio fast track status for DSG3-CAART (Desmoglein 3 Chimeric Auto-Antibody Receptor T cells) for treating mucosal pemphigus vulgaris (mPV). The therapy is designed for improving healing of mucosal blisters in patients with mPV, the company says. It targets B cells that express pathogenic autoantibodies
Drugs
FDA has extended by three months its review of a Bristol Myers Squibb BLA for lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for treating adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies. After the BLA was
Drugs
FDA has approved a Novartis Pharmaceuticals NDA for Tabrecta (capmatinib) for treating adult patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body. “Tabrecta is the first FDA-approved therapy to treat NSCLC with specific mutations (those that lead to mesenchymal-epithelial transition
Devices
FDA has cleared a HeadsafeIP 510(k) for its Nurochek system for brain assessment in patients aged 14 years and older. The portable visual evoked potential (VEP) testing system is intended for use at the point-of-care to provide an objective measure of brain function, according to the company.
Drugs
The Association for Accessible Medicines says that by updating the Purple Book, FDA is “increasing transparency for patients, providers, payers, manufacturers, and other stakeholders. This will help close educational and regulatory gaps, and it will improve patient access and adoption of lower-cost FDA-approved biosimilars.” The association’s comment
FDA Policy/General
Public health officials and former FDAers are expressing concern that by hastily allowing unproven coronavirus antibody tests on the market and by authorizing emergency use of hydroxychloroquine FDA is risking losing its hard-won credibility as the gold standard for world health agencies. An in-depth McClatchy News article says
Drugs
TherapeuticsMD is petitioning FDA to not receive or approve any marketing application that references its Imvexxy (estradiol vaginal inserts) unless the application is submitted as a 505(j) ANDA and the ANDA product is manufactured qualitatively the same as Imvexxy, including the teardrop shape. Alternatively, the petition says, the generic
Drugs
Retired CDER Division of Psychiatric Products director Thomas Laughren says a trend of increasing placebo response in trials of schizophrenia drugs should be “alarming not only to pharmaceutical companies and regulators but also to clinicians, the academic community, and of course patients and their families.” In a commentary on an
Devices
FDA has issued an immediately-in-effect guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act During the Covid-19 Public Health Emergency, to implement the medical device notification requirement that was included in
Devices
A 10/28-10/31/19 FDA inspection at Bedfont Scientific, Kent, UK, found Quality System Regulation violations in the firm’s manufacturing of carbon monoxide gas analyzers. A just-released 2/12 Warning Letter lists the specific violations as: * failing to establish and maintain procedures for validating the device
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Bedfont Scientific, Kent, United Kingdom (2/12): FDA inspected the company 10/2019 and cited GMP issues with its carbon monoxide gas analyzers. For example, Bedfont failed to establish
Devices
FDA has revised a 3/26 guidance entitled “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency” to articulate changes to requirements for serology (antibody) tests. Under this revised policy (see earlier story), the agency says antibody test commercial manufacturers will need to submit emergency use authorization requests,
Biologics
Pfizer and BioNTech have announced that the first participants have been dosed in the U.S. in a Phase 1/2 clinical trial for their BNT162 vaccine program to prevent Covid-19. As part of their global development program, the first cohort in Germany were dosed last week. The Phase
Devices
An 8/27-8/30/19 FDA inspection at Philosys Co. Ltd., Gunsan-si, Korea, found Medical Device Reporting (MDR) Regulation violations in the firm’s manufacturing of self-monitoring blood glucose test systems. A just-released 1/14 Warning Letter says the inspection also revealed several “nonconformances” that were
Drugs
A 10/15-10/22/19 FDA inspection at Shriram Institute for Industrial Research, Delhi, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients (API) in its work as a contract testing laboratory. A 4/15
Drugs
The Alliance for Aging Research says it is encouraged that FDA is continuing to urge industry and other stakeholders to enroll diverse populations in their clinical trials, and especially older adults. Commenting on an agency draft guidance on inclusion of older adults in cancer clinical trials, the alliance says the
Drugs
Taiho Oncology is asking FDA not to permit companies to carve out of the approved Lonsurf (trifluridine and tipiracil) labeling the language that relates to dose reduction in severely renally impaired patients. “The carving out of dose reductions in severely renally impaired patients will result in labeling that will present
Biologics
The CBER Office of Compliance and Biologics Quality says its review of a BrioMD Web site shows that it is marketing “perivascular cells” or “perivascular cellular therapy” for treatment of respiratory conditions, immunologic and autoimmune diseases, neurologic conditions, and musculoskeletal conditions. A 4/28 Notice of Violation says the Hattiesburg,
Drugs
Some 56 pro-life and other advocacy groups are urging FDA to seize the Web site domains for AidAccess, Rablon, and any other entities illegally prescribing and/or selling mifepristone in the U.S. “We urge FDA to protect women from the distributors of abortion-inducing drugs who place lives
Drugs
FDA has accepted a Lipocine IND to begin a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148, an oral prodrug of bioidentical testosterone, for treating liver cirrhosis in adult males. The planned study is a prospective, multi-center, randomized, placebo-controlled 52-week trial