Drugs
FDA has approved Eli Lilly’s rapid-acting insulin Lyumjev (insulin lispro-aabc injection) 100 units/mL, indicated for improving glycemic control in adults with Type 1 and Type 2 diabetes, to include administration through continuous subcutaneous insulin infusion with an insulin pump. Lyumjev, a novel formulation of insulin lispro
FDA Policy/General
Former Trump administration FDA commissioner Stephen Hahn is urging more independence for the agency to prevent political interference. Hahn will likely be remembered as the most politicized commissioner in recent history and for how he sought to preserve the agency’s science-based gold standard by dismissing further White House
FDA Policy/General
FDA Implementing Fallout from Drug/Device Case 8/13/2021 Federal Register notice: FDA has announced its implementation of a decision from the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA. The 4/16 decision affirmed a district court ruling
FDA Policy/General
Quest Diagnostics has completed its acquisition of Cleveland HeartLab, which allows Quest to establish a national center of excellence focused on heart disease diagnostics within Cleveland HeartLab's existing 25,000 square-foot clinical laboratory facility in Cleveland. In connection with the acquisition, Quest and Cleveland Clinic have finalized
Drugs
After 24 years at FDA, CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger has decided to retire to spend more time with family. Joining FDA in 1997 as a medical officer at CBER, in 2003, he transitioned to CDER when regulatory authority for therapeutic biologics was transferred
FDA Policy/General
Federal Register notice: FDA is announcing the rates for prescription drug user fees for fiscal year 2022. The fee for an application requiring clinical data is $3,117,218; for an application not requiring clinical data $1,558,609, and for the prescription drug program $369,413. The fees are
Biologics
FDA has amended the emergency use authorizations (EUAs) for both Pfizer-BioNTech’s and Moderna’s Covid-19 vaccines to allow for the use of an additional dose in certain immunocompromised individuals. The expanded use specifically covers “booster” doses for solid organ transplant recipients or those who are diagnosed with
Drugs
Ipsen has withdrawn its NDA for palovarotene, indicated for preventing heterotropic ossification (new bone formation) as a potential treatment for people living with fibrodysplasia ossificans progressiva (FOP). Palovarotene is described as an oral, investigational, selective RARγ agonist. The NDA was accepted for priority review 5/28. The company says that
Devices
FDA has cleared a Syntr Health Technologies 510(k) for the SyntrFuge System and its use in surgical specialties when the transfer of harvested adipose (fat) tissue is desired. The device is intended for use in orthopedic, arthroscopic, neurosurgery, gastrointestinal, urological, general, gynecological, thoracic, laparoscopic, and plastic and reconstructive surgeries
Drugs
FDA has issued Sesen Bio a complete response letter on its BLA for Vicineum (oportuzumab monatox-qqrs) for treating bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer. The agency’s letter requested additional clinical/statistical data and analyses, in addition to citing chemistry, manufacturing and controls issues related to
FDA Policy/General
Federal Register notice: FDA has established a public docket to solicit comments on several issues related to FDA’s post-approval regulation of certain drug products approved in abbreviated applications before the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments) amended the Federal Food, Drug,
Devices
Baxter Healthcare is recalling its Dose IQ Safety Software used with the Spectrum IQ Infusion System due to a software defect (version 9.0.x) that may lead to mismatched drug information in drug libraries created using the software. “If the software’s drug identifier does not match the drug
Drugs
FDA has granted a breakthrough therapy designation to Shanghai Junshi Biosciences and Coherus BioSciences for toripalimab in combination with chemotherapy (gemcitabine and cisplatin) for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). Previously, the agency granted a similar designation for toripalimab monotherapy for patients with recurrent or
Drugs
The Cato Institute, a Libertarian think tank, says a case before the U.S. 1st Circuit Court of Appeals is again raising issues involving FDA’s “paradoxical stance” toward off-label use of drugs. A Cato online post says that while it is lawful for physicians to prescribe approved drugs
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
Devices
A CDRH report, “2018-2020 Strategic Priorities Accomplishments,” says the Center met, and in most cases exceeded, its strategic goals in the study period. The report highlights successes in four areas: * Novel Technologies: The target was for 50% of novel technology manufacturers intending to bring their devices to the U.
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
Biologics
FDA has placed a clinical hold on Bluebird Bio’s Lenti-D (elivaldogene autotemcel) after the company reported a suspected unexpected serious adverse reaction of myelodysplastic syndrome (MDS) in a trial involving the investigational gene therapy for treating cerebral adrenoleukodystrophy. The MDS event showed up in a patient in the
FDA Policy/General
Federal Register notice: FDA has announced a 10/6 Patient Engagement Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on medical device recalls. Specifically, it will address when a company may recall a device after discovering a problem on its own, or after FDA raises concerns.