Drugs
FDA says it is evaluating a DC federal court 9/2021 action remanding to the agency the Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products to either certify that it will not have a significant economic effect on small businesses or prepare a regulatory flexibility analysis. The
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Novartis’ Adakveo (crizanlizumab-tmca), indicated to reduce the frequency of vaso-occlusive crises in adults and pediatric patients with sickle cell disease. The review period is 3,152 days, which includes 2,968 days that
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Sanofi’s Dengvaxia (dengue tetravalent vaccine, live), indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. The review period is 5,710 days, which includes 5,466
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Galderma’s Aklief (trifarotene), indicated for topical treatment of acne vulgaris in patients nine years of age and older. The review period is 3,137 days, which includes 2,771 days that occurred during the
Devices
FDA has approved Insightec’s Exablate Neuro for treating advanced Parkinson’s disease patients suffering from mobility, rigidity, or dyskinesia symptoms. The company says the Exablate Neuro uses focused ultrasound waves to precisely target and ablate the globus pallidus during a pallidotomy. Insightec says the treatment is incision-less, does
Devices
FDA has designated TecTraum’s Pro2cool System as a breakthrough device. The company says Pro2cool is a “novel, non-invasive hypothermic therapy device designed to reduce the severity of concussion symptoms and allow patients to return to their pre-injury baseline sooner. The device provides localized cooling for the head
Biologics
A regional director at Ventavia Research Group, which provides Covid-19 vaccine research services to Pfizer, says she had many concerns about problems at Ventavia that she raised with FDA the same day she was fired after two weeks on the job. The whistleblower, Brook Jackson, told the BMJ (formerly
FDA Policy/General
After almost 20 years at FDA, chief scientist and Public Health Service Commissioned Corps rear admiral Denise Hinton has left the agency to serve as deputy Surgeon General under the Biden Administration. Hinton previously worked at CDER before transitions to the Office of Commissioner as chief scientist. At CDER, Hinton
Drugs
CDER says it will start issuing electronic Certificates of Pharmaceutical Product (eCPPs) 12/3 and will no longer issue or mail paper CPPs. “The change from paper to electronic certificates will improve efficiency in issuing CPPs, reducing delivery time for export certificates and decreasing impact on the environment,” CDER says
Drugs
FDA has granted fast track designation to TransThera Science’s Phase 2 product TT-00420 for treating patients with cholangiocarcinoma (CCA) who have no standard treatment options. The company says TT-00420 is a spectrum selective kinase inhibitor that is found to show high potency to a variety of clinically
Drugs
An FDA inspection in May led to a 10-item Form FDA-483 issued to Innoveix Pharmaceuticals (Addison, TX) that took issue with the firm’s GMPs for sterile drug products. For example, the agency said the firm failed to conduct media fills that closely simulate aseptic production operations under
Drugs
FDA has approved an ANI Pharmaceuticals supplemental NDA for purified cortrophin gel (repository corticotropin) for treating certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis and rheumatoid arthritis, in addition to excess urinary protein due to nephrotic syndrome. Cortrophin gel is an adrenocorticotropic hormone, also known as purified corticotropin,
Drugs
FDA has extended to 2/28/22 the PDUFA action date for Legend Biotech and Janssen’s BLA for ciltacabtagene autoleucel (cilta-cel). The companies say cilta-cel is a B-cell maturation antigen CAR-T therapy that is being investigated for treating adults with relapsed and/or refractory multiple
Devices
A 6/16-7/8 FDA inspection at CellEra, a Monroe, OH, specification developer and own-label distributor of various sterile wound dressings with drug, identified nine Quality System Regulation violations, including seven repeat violations from an earlier inspection. A 10/20 Warning Letter says the specific violations were: * failing
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Sarepta Therapeutics’ Vyondys 53 (golodirsen), indicated for treating Duchenne muscular dystrophy. The review period is 1,833 days, which includes 1,474 days that occurred during the testing phase and 359 days during the approval
FDA Policy/General
Federal Register notice: FDA has determined for patent restoration purposes the regulatory review period for Biogen’s Spinraza (nusinersen sodium), indicated for treating spinal muscular atrophy in pediatric and adult patients. The review period is 1,891 days, which includes 1,799 days that occurred during the testing phase and
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki), indicated for treating adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic
Drugs
FDA has approved Novartis’ Scemblix (asciminib) for treating chronic myeloid leukemia (CML) in two distinct indications. The company says it received accelerated approval for adult patients with Philadelphia chromosome-positive CML in chronic phase previously treated with two or more tyrosine kinase inhibitors (TKIs), based on major molecular response rate
Devices
FDA has granted breakthrough device designation to Renew Bioscience’s Cerezen device, described as a novel treatment for mild cognitive impairment due to Alzheimer’s disease and mild dementia of the Alzheimer’s type. The company says the device is a drug-free, non-invasive technology designed to improve cerebral
Drugs
Amylyx Pharmaceuticals has submitted an NDA for AMX0035 (sodium phenylbutyrate and taurursodiol), indicated for treating amyotrophic lateral sclerosis (ALS). The submission is based on data from the CENTAUR trial, a placebo-controlled study evaluating 137 people with ALS. In this study, participants receiving AMX0035 had “statistically significant slowing of functional
Drugs
FDA has accepted for review an Incyte NDA seeking approval of parsaclisib for treating patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL). The submission is based on data from three Phase 2 studies (CITADEL-203, -204 and -205) evaluating parsaclisib as a
Biologics
Ongoing safety concerns with Moderna’s Covid-19 vaccine and its potential use in adolescents has led to a filing delay for an emergency user authorization (EUA) to use a smaller dose vaccine in the pediatric population (6-11 years of age). Last month, it was reported (see story) that