Drugs
Vifor says it strongly disagrees with portions of an FDA 5/26/21 response to a 4/19/16 citizen petition in which the company sought new chemical entity exclusivity for its Velphoro (sucroferric oxyhydroxide). In an 8/3 petition, the company says that by the time of FDA’s
Drugs
A Florida federal judge sentenced two people to prison terms 8/11 in connection with their participation in a conspiracy to falsify data related to clinical drug trials. A Department of Justice statement says the defendants worked for Tellus Clinical Research. Nurse practitioner Eduardo Navarro, a sub-investigator, was sentenced
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) plus Eisai’s Lenvima (lenvatinib) for first-line treatment of adult patients with advanced renal cell carcinoma. Merck says the approval was based on results from the pivotal Phase 3 CLEAR study in which the two drugs together demonstrated significant improvements versus sunitinib
Drugs
FDA has granted orphan drug designation to Allogene Therapeutics’ ALLO-715 to treat multiple myeloma. A company statement says initial results from the Phase 1 UNIVERSAL study of ALLO-715 in relapsed/refractory multiple myeloma demonstrated that an allogeneic CAR T therapy directed at B-cell maturation antigen can achieve
Drugs
FDA has approved a Jazz Pharmaceuticals NDA for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for treating idiopathic hypersomnia in adults. Idiopathic hypersomnia is a debilitating neurologic sleep disorder characterized by chronic excessive daytime sleepiness. In addition to excessive daytime sleepiness, symptoms may include severe sleep inertia or
Drugs
An FDA complete response letter for the FibroGen NDA for roxadustat to treat anemia of chronic kidney disease says the agency will not approve the NDA in its present form and requests additional clinical study before resubmission. The company says it and its partner, AstraZeneca, will be discussing next steps
Drugs
SterRx has recalled three lots of sodium bicarbonate in 5% dextrose injection 150mEq per 1,000 mL due to waterborne microbial contamination. Intravenous administration of contaminated product “could result in site specific infections as well as serious systemic infections which may be life-threatening,” a recall notice says. To date,
Drugs
FDA has granted Lantern Pharma an orphan drug designation for LP-184 and its use in treating pancreatic cancer. The company says that the next generation alkylating agent works by damaging DNA in cancer cells that over-express certain biomarkers or that harbor mutations in DNA repair pathways. The therapy
Drugs
The Court of Appeals for the Federal Circuit has affirmed an earlier ruling that Teva’s sale of carvedilol induced infringement of a GlaxoSmithKline method-of-treatment patent, even though the Teva product was approved and labeled only for non-infringing uses. A Patentlyo post (contains link to decision) says
Drugs
A 3/22-3/26 FDA inspection at BBC Group, Pumei Town, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/4 Warning Letter says specific violations were: * failing to exercise appropriate controls over computer or related systems to assure that only authorized
Drugs
A 3/1-3/5 FDA inspection at Sanit Technologies (Durisan), Sarasota, FL, a drug manufacturing facility, found current good manufacturing practice (CGMP) regulation violations for finished drugs. A 7/27 Warning Letter says the specific violation was: * the firm’s quality control unit failed to exercise its responsibility to
Drugs
KVK Tech has recalled two lots of atovaquone oral suspension, USP 750 mg/5mL based on customer complaints of unusual grittiness in the product, which the company has determined was most probably caused by prolonged exposure to extremely cold weather during shipment. Atovaquone is indicated to treat pneumocystis jiroveci pneumonia,
Drugs
Attorney Patricia Kaufman says a new FDA final rule amending the “intended use” regulations for drugs and medical devices “may come as a disappointment to those who were hoping that FDA would provide more clarity in its regulations regarding permissible activities. However, it is not surprising that FDA is rejecting
Drugs
Axsome Therapeutics is warning investors of a potential review delay for its NDA for AXS-05 (dextromethorphan bupropion) for treating major depressive disorder (MDD). “As part of the ongoing review of our NDA for AXS-05, the FDA recently notified us that they have identified deficiencies that preclude labeling discussions
Drugs
FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation will host a two-day (9/1-2) virtual public workshop entitled “Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design.” The workshop is intended to discuss opportunities for leveraging complex and innovative trial designs,
Drugs
Acer Therapeutics and Relief Therapeutics have submitted an NDA for ACER-001 (sodium phenylbutyrate) for treating urea cycle disorders (UCDs). The companies describe ACER-001 as a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase,
Drugs
FDA’s recent “intended use” rule and accompanying FDA preamble and response to comments offer important advertising and promotion guidance for pharmaceutical and medical device industries, such as the agency clarifying that it will not determine a firm’s intent regarding off-label use based solely on its knowledge that
Drugs
FDA has issued a final guidance entitled Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials. The document provides recommendations on using such endpoints in clinical trials for nonmetastatic castration-resistant prostate cancer product development programs. For example, it recommends that: * Sponsors should establish the
Drugs
FDA has issued a final guidance entitled Development and Submission of Near Infrared Analytical Procedures. The document provides recommendations to applicants to aid the development, validation, and use of near infrared (NIR)-based analytical procedures in evaluating the identity, strength, quality, purity, and potency of drug substances and drug products.
Drugs
FDA has issued Spectrum Pharmaceuticals a complete response letter on its BLA for Rolontis (eflapegrastim), citing deficiencies related to manufacturing and stating that a reinspection will be necessary to complete its review. The company is seeking an indication for treating neutropenia in patients receiving myelosuppressive anti-cancer drugs. Spectrum says
Drugs
Researchers from several academic medical centers and other sites say there is no evidence to support an FDA class warning for suicidality in newer anti-seizure drugs. “Without the evidence to support it,” says Thomas Jefferson University professor Michael Sperling, one of the study authors, “the net effect of such
Drugs
FDA has granted Apexigen an orphan drug designation for APX005M (sotigalimab) for treating soft tissue sarcoma. Sotigalimab is described by the company as a CD40 agonist monoclonal antibody “with unique epitope specificity and Fc receptor engagement for optimal therapeutic effect and tolerability. In an ongoing Phase 2 clinical trial, sotigalimab