Drugs
FDA has granted orphan drug designation to Senhwa Biosciences’ silmiasertib, a casein kinase 2 inhibitor, to treat patients with medulloblastoma. The company says silmitasertib is a small molecule drug that targets the CK2 pathway. In addition to medulloblastoma, it is being investigated for tolerability and efficacy in Covid-19, along
Drugs
A 3/1-3/26/21 FDA inspection at Spartan Chemical Company, Maumee, OH, found significant violations of current good manufacturing practice (CGMP) regulations. A 12/15/21 Warning Letter says specific violations were: * failing to establish adequate written procedures for production and process control designed to assure that the
Drugs
Taro Pharmaceuticals USA is recalling one lot of clobetasol propionate ointment, 0.5%, packaged in 60 g tubes, due to the presence of Ralstonia pickettii. The company says it discovered the microbial contamination through routine testing. Some 96 units of the affected lot were distributed to two wholesale distributors between
Drugs
FDA has approved Viiv’s Apretude (cabotegravir extended-release injectable suspension) for use in some at-risk adults and adolescents for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually-acquired HIV. It is the first approved injectable PrEP drug. An agency statement says Apretude is given first as
Drugs
FDA says Viona Pharmaceuticals has recalled 33 lots of metformin HCl extended-release tablets 750 mg having valid shelf life due to an out-of-specification result observed for the product that detected N-nitrosodimethylamine. An agency notice says the product was manufactured by Cadila Healthcare Limited, Ahmedabad, India, for
Drugs
FDA has approved a new indication and dosage form for Janssen’s Xarelto (rivaroxaban). An agency statement says the new indication is to prevent blood clots in pediatric patients age 2 and older with congenital heart disease after the Fontan open-heart surgical procedure. The agency also approved Xarelto as
Drugs
FDA has approved Xeris Biopharma’s Recorlev (levoketoconazole) to treat endogenous hypercortisolemia in adults with Cushing’s syndrome who aren’t eligible for surgery or haven’t responded to surgery. Fierce Pharma reports the company obtained the drug in 2021 through its acquisition of rare disease company Stonebridge Biopharma. The
Drugs
FDA has granted Eisai and Biogen a fast track designation for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for treating early Alzheimer’s disease. In 9/2021, Eisai initiated a rolling BLA submission under the accelerated approval pathway based on clinical, biomarker and safety data from a Phase
Drugs
UroGen Pharma has licensed to Allergan the worldwide rights to UroGen’s RTGel delivery system technology for use with neurotoxins. RTGel has thermo-sensitive properties that enable it to convert from a liquid state when cold, into a gel once it reaches body temperature, which allows increased “residence time” for
Drugs
New York University bioethics professor Arthur Caplan says that among all the efforts to increase clinical trial diversity, what’s missing is a clear explanation of why it is so important. In a Stat First Opinion post, Caplan reviews some recent announcements from FDA and other stakeholders calling for greater
Drugs
CDER has ramped up its enforcement of ClinicalTrials.gov compliance, specifically registration and the results reporting requirements. Speaking during a virtual Food and Drug Law Institute conference 12/9, CDER Office of Compliance director Donald Ashley said ClinicalTrials.gov compliance continues to be an area of “focused attention for CDER”
Drugs
FDA researchers are working with industry and clinicians to determine the best way to apply modeling information to improve pediatric dose selection for renally eliminated drugs in the pediatric patient population. A new CDER Web posting notes recent research findings that renal function models and equations are “valuable tools for
Drugs
FDA has updated the “List of Off-Patent, Off-Exclusivity Drugs Without an Approved Generic” to include approved NDAs for drug products that are not protected by patents or exclusivities at the time of the update and for which the agency has not approved an ANDA referencing the NDA product.
Drugs
Biogen says it will submit to FDA in 3/2022 a final clinical trial protocol for a required post-marketing trial of its controversial Alzheimer’s drug Aduhelm (aducanumab). Aduhelm was granted accelerated approval earlier this year amid a firestorm of criticism over the agency’s use of the pathway
Drugs
FDA has denied a 7/19 petition submitted by Buchanan Ingersoll Rooney asking that the agency: * review the basis for submission of an ANDA by Eugia Pharma Specialties; * determine that the ANDA should have been filed as a 505(b)(2) NDA; * conclude that FDA should have issued a refuse-
Drugs
The development of checkpoint inhibitors needs more coordination and collaboration and less competition. That’s the view of FDA Oncology Center of Excellence director Richard Pazdur and chief of medical oncology Julia Beaver, writing in the New England Journal of Medicine. Checkpoint inhibitors are a type of immunotherapy that works
Drugs
In denying a Par Sterile Products 11/8 petition involving an Eagle Pharmaceuticals ANDA for vasopressin citing Vasostrict as the reference-listed drug, FDA says it will refer the matter to the Federal Trade Commission to investigate a potential anti-competitive business practice. FDA says that while it denied the
Drugs
FDA has released a draft guidance entitled Inspection of Injectable Products for Visible Particulates. The document addresses the development and implementation of a “holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective actions designed to assess, correct,
Drugs
FDA has modified a Risk Evaluation and Mitigation Strategies (REMS) program for mifepristone, a drug used in early abortion and miscarriage care. While the agency did determine that the REMS continues to be necessary to ensure that the benefits of the drug outweigh its risks, it also concluded that it
Drugs
An FDA 12/7/20-1/20/21 inspection at Dental Technologies, Lincolnwood, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and Quality System (QS) regulations for medical devices. An 11/30 Warning Letter identifies the specific violations as: * failing to thoroughly investigate any
Drugs
Citizens Against Government Waste health and science policy director Elizabeth Wright says the Biden administration’s Build Back Better Act includes provisions from the Elijah E. Cummings Lower Drug Costs Now Act that will hurt the generic drug industry. In an Inside Sources article reprinted by the American Institute for
Drugs
Commenting on an International Council for Harmonization (ICH) draft guidance, Q13 Continuous Manufacturing of Drug Substances and Drug Products, the United States Pharmacopeia asks how the ICH guidance, when finalized, will affect an FDA draft guidance on quality considerations for continuous manufacturing. In its comment letter, Lilly says it has