Biologics
Merck has exercised its option to join with Moderna to develop and commercialize a personalized cancer vaccine currently being evaluated in combination with Merck’s Keytruda (pembrolizumab), an anti-PD-1 therapy, as adjuvant treatment for patients with high-risk melanoma in a Moderna Phase 2 trial. A Merck statement
Devices
Jiangsu Well Biotech (Jiang Su Sheng, China) has recalled its Covid-19 Ag Rapid Test Devices because they were distributed without authorization, clearance, or approval from FDA. The company has not provided the agency with validation data to demonstrate the test’s performance is accurate, which could contribute to potential
Devices
FDA says CDRH has launched its Total Product Life Cycle Advisory Program (TAP) pilot intended to “de-risk the medical device valley of death by providing industry with earlier and more frequent interactions with CDRH, more strategic input from stakeholders, and proactive, strategic advice from CDRH to spur more rapid
Drugs
A 4/12-4/27 FDA inspection at the Legacy Pharmaceutical Packaging drug manufacturing facility in Earth City, MO, identified significant violations of current good manufacturing practice (CGMP) regulations. A 10/3 Warning Letter says the specific violation was failing to thoroughly investigate any unexplained discrepancy or failure of a
Devices
FDA has extended by one month to 11/25 the deadline for comments on its draft guidance intended to help ensure that information is available to patients and healthcare professionals about the benefits and risks of LASIK devices that are used in vision correction. The Broken Eyes patient group tells
Drugs
The Washington DC District Court has ruled against FDA in granting summary judgment to plaintiff Melinta Therapeutics that suspends the approval of a generic version of the company’s Minocin (minocycline), which treats bacterial infections, manufactured by Nexus Pharmaceuticals. In seeking FDA approval of its ANDA in 2020, a required
Drugs
CDER says it is proposing to refuse to approve a Vanda Pharmaceuticals sNDA for a new indication for its Hetlioz (tasimelteon). A Federal Register notice says Hetlioz is currently indicated to treat non-24-hour sleep-wake disorder. Vanda is seeking a new indication for treating jet lag disorder. The
Drugs
The Outsourcing Facilities Association (OFA), which represents FDA-registered 503B outsourcing facilities that compound medications, and FDA have reached a settlement agreement to compel the agency to “promptly review long-pending nominations for active pharmaceutical ingredients (API)” for use by such outsourcing facilities. In its complaint, OFA said that despite
Devices
Three Hyman, Phelps & McNamara attorneys and the firm’s medical device regulatory expert say the FDA 9/28 final Clinical Decision Support (CDS) Software Guidance “represents a marked change in approach from prior drafts and foreseeably will result in the regulation of many types of CDS that were previously
Drugs
FDA investigators have found additional quality issues at the Lilly Branchburg, NJ, drug manufacturing facility, according to a Reuters exclusive story based on an FDA-483 obtained through a Freedom of Information request. The report says the new FDA-483 comes three years after the agency began documenting quality control
Drugs
FDA has accepted for priority review a Gilead Sciences supplemental BLA for Trodelv (sacituzumab govitecan-hziy) for treating adult patients with unresectable locally advanced or metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer who have received endocrine-based therapy and at least two additional systemic
Drugs
A 4/18-4/19 FDA inspection at the Eksa Mills drug manufacturing facility in Zaragoza, Puebla, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/5 Warning Letter says specific violations were: * failing to clean, maintain, and, as appropriate for the nature
FDA Policy/General
Federal Register: FDA has announced that it has revoked an emergency use authorization issued to Laboratorio Clinico Toledo, Puerto Rico, for its Laboratorio Clinico Toledo SARS– CoV–2 Assay. The company told FDA that it is no longer using the test in its Covid-19 testing. To view the notice,
Drugs
Regeneron Pharmaceuticals and Sanofi say they will seek FDA approval next year for Dupixent (dupilumab) and its use in treating children with active eosinophilic esophagitis (EoE) after announcing positive results from a Phase 3 trial. EoE affects a child’s ability to eat, according to the companies, adding that common
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Facility Readiness: Goal Date Decisions Under GDUFA.” The document tells applicants how FDA will use information about a facility’s readiness for inspection as certified on Form FDA 356h to set a goal date for an original ANDA. To
Drugs
FDA has issued Supernus Pharmaceuticals a complete response letter on its NDA for SPN-830 (apomorphine) infusion device for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease. The letter requests “additional information and analysis related to the infusion device and drug product across several areas of
Drugs
Merck is reporting positive top-line results from a pivotal Phase 3 trial (STELLAR) evaluating the safety and efficacy of sotatercept, an investigational activin receptor Type IIA-Fc fusion protein being studied as an add-on therapy for treating pulmonary arterial hypertension. The company says the trial met its primary
FDA Policy/General
Federal Register notice: FDA has announced the fee rate for using a priority review voucher for fiscal year 2023. The vouchers are awarded to the sponsors of certain tropical disease, rare pediatric disease, or material threat medical countermeasure product applications. The amount of the fee is $1,524,039. To
FDA Policy/General
Federal Register notice: FDA is making available final guidances entitled “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act” and “Procedures for Handling Post-Approval Studies Imposed by PMA [Premarket Approval Application] Order.” The documents are intended to increase transparency to stakeholders on FDA’s approach
Drugs
FDA has approved scPharmaceuticals’ Furoscix (furosemide injection), described as a proprietary formulation of furosemide delivered via an on-body infusor for treating congestion due to fluid overload in adults with New York Heart Association Class 2/3 chronic heart failure. The company says Furoscix is the first FDA-approved subcutaneous
Devices
Zeiss Medical Technology has gained 510(k) clearance for MTLawton, disposable bipolar forceps made from a copper-base alloy that potentially reduce tissue adhesion and subsequent charring during dissection of tissue. Zeiss Medical says the forceps also feature an extended shaft to reduce visual restrictions in the surgical field. and
Devices
FDA has cleared a Copan Diagnostics 510(k) for its Colibrí, a semi-automated pre-analytical processor that is part of the company’s WASPLab laboratory automation system. The in vitro automated specimen workup platform is designed to prepare tests for antibiotic susceptibility testing. It comprises the Colibrí Vision System