Drugs
FDA has approved Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Alexion’s Soliris (eculizumab) to treat specific rare diseases. An agency statement says Bkemv is approved for these Soliris indications: * treating patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis; and * treating patients with atypical hemolytic uremic
Drugs
Johnson & Johnson is reporting positive topline results from its pivotal Phase 3 MDD3001 clinical trial evaluating the efficacy and safety of seltorexant as an adjunctive treatment to baseline antidepressants in adult and elderly patients with major depressive disorder with insomnia symptoms. Seltorexant is described as a first-in-class
Drugs
FDA has granted Eli Lilly accelerated approval for Retevmo (selpercatinib) for pediatric patients two years of age and older with advanced or metastatic medullary thyroid cancer with a RET mutation, as detected by an FDA-approved test, who require systemic therapy. The therapy was also granted accelerated approval for advanced
Drugs
A CDER online post discusses the Center’s pharmaceutical quality function, saying it covers more than just a drug’s quality, including manufacturing facilities and the processes used to manufacture the drug. “Some of CDER’s pharmaceutical quality functions occur before a prescription drug is approved and reaches patients,” the
Drugs
The International Council for Harmonization (ICH) has published the M12 final guideline on drug interaction studies. The document has recommendations to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction studies during the development of a therapeutic product. The
Drugs
A 6/12-8/31/23 FDA inspection at Biomic Sciences, doing business as ION Intelligence of Nature in Charlottesville, VA, found several violations of the Federal Food, Drug, and Cosmetic Act. A just-released 5/9 Warning Letter lists violations involving adulterated human drugs, drug CGMP (current good manufacturing
Drugs
Teva says an FDA recommendation for a unique manufacturing treatment for the cholesterol drug ezetimibe (Zetia) is inconsistent with the agency’s and other health authorities’ past regulatory treatment of the product and is “unwarranted.” The company’s analysis is in a comment letter for the FDA docket on a
Drugs
FDA has published for public comment the International Council for Harmonization M14 guidance, General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines. The document recommends international standards for, and promotes harmonization of, the general principles on planning, designing, and
Drugs
FDA has published a draft guidance, Platform Technology Designation Program for Drug Development, with details about the implementation of the platform technology designation program that was enacted as part of the 2023 Consolidated Appropriations Act. The agency says the document outlines eligibility factors for receiving a platform technology designation, how
Drugs
Senators Cory Booker (D-NJ) and Elizabeth Warren (D-MA) are calling on the Department of Justice (DoJ) to rescind its Office of Legal Counsel’s 2019 opinion on FDA jurisdiction over execution drugs and allow the agency to regulate the products. “The DoJ under the current Administration has reversed
Drugs
Pfizer’s Hospira drug unit is recalling (Class 1) several lots of buprenorphine HCl injection Carpuject units and labetalol HCl injection Carpuject units due to the potential for incomplete crimp seals. A recall notice says one customer complaint has been received on one leaking unit. “In the event that impacted
Drugs
FDA has cited Laurus Labs (Hyderabad, India) over GMP deficiencies following a 12/2023 inspection at the firm’s active pharmaceutical ingredient (API) manufacturing facility in Andhra Pradesh, India. During the inspection, the agency says in a just-posted untitled letter that it determined that the firm’s quality unit
Drugs
FDA has denied an Ipsen Pharmaceuticals 10/15/2019 petition asking that the agency take specific actions on any ANDA that references Ipsen’s Somatuline Depot (lanreotide acetate) subcutaneous solution. The FDA 5/21 response says Ipsen asked that FDA require: * ANDA applicants referencing Somatuline Depot to demonstrate bioequivalence through
Drugs
The FY 2023 GDUFA Science and Research Report says FDA awarded eight new grants and 12 new contracts during the fiscal year for innovative extramural research projects relevant to generic drugs. The agency also used its internal resources and expertise to conduct over 70 research projects designed to facilitate generic
Biologics
Responding to a question posed during a 5/23 hearing held by the House Energy and Commerce Committee Health Subcommittee, CDER director Patrizia Cavazzoni said FDA would benefit from having the authority to order mandatory recall of harmful drugs. “We have that authority for lettuce, but not for drugs,” she
Drugs
FDA has granted Theriva Biologics a fast-track designation for its lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma. VCN-01 is described by the company as a systemically administered oncolytic adenovirus
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says there are four key, open FDA Reauthorization Act (FDARA) implementation issues that FDA should address. In its comment letter submitted to the docket for the Pediatric Oncology Subcommittee 5/22 meeting to discuss perspectives relating to implementation of FDARA, PhRMA identifies the
Drugs
Vyaire Medical is recalling (Class 1) its Twin Tube sample lines, which are used on the Vyntus CPX Cardiopulmonary Exercise Test, due to the potential for the nozzle separating during patient use. The tubes connect to the device’s dead volume trap adapter, which allows the continuous collection of gas
Drugs
Otsuka Pharmaceutical has terminated its development of the novel compound AVP-786 as a potential treatment for patients with agitation associated with dementia due to Alzheimer’s disease. The decision was based on results from a Phase 3 program that showed no statistically significant difference was observed between AVP-786
Drugs
FDA medical reviewers say there was an increased risk of hypoglycemia in patients with Type 1 diabetes taking Novo Nordisk’s Awiqli (insulin icodec) once-weekly insulin. The reviewers’ comments are in a briefing document released in advance of a 5/24 meeting of the agency’s Endocrinologic and Metabolic
Drugs
After a nine-year career at FDA, Oncology Drugs Division director Harpreet Singh has left the agency to join Precision for Medicine as chief medical officer, responsible for medical strategy and oversight. “The wealth of experience that Dr. Singh brings to Precision from over a decade of experience at the
Drugs
Public Citizen is suing FDA in DC federal court to force the agency to act on a six-year-old petition seeking revised labeling for selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) to warn of serious side effect risks. A Public Citizen statement says the revised