Biologics
FDA has lifted clinical holds against Bluebird Bio’s Phase 1/2 (HGB-206) and Phase 3 (HGB-210) studies of LentiGlobin gene therapy for sickle cell disease. The agency also lifted holds against the company’s Phase 3 Northstar-2 (HGB-207) and Northstar-3 (HGB-212) studies of
Biologics
FDA has approved a ProMetic Biotherapeutics BLA for Ryplazim (plasminogen, human-tmvh) for treating patients with plasminogen deficiency Type 1 (hypoplasminogenemia), a disorder that can impair normal tissue and organ function and may lead to blindness. Those with the disease lack a protein called plasminogen, which helps the body break
FDA Policy/General
Some Software Functions Exempted from Device Definition 6/4/2021 Federal Register final rule: FDA is amending medical device classification regulations to exclude certain software functions from the definition of a device as mandated by the 21st Century Cures Act’s medical software provisions. The Cures Act amended the definition
FDA Policy/General
Arena Pharmaceuticals GmbH and Roivant Sciences have entered into a development, marketing and supply agreement for nelotanserin, Arena’s inverse agonist of the 5-HT2A receptor. The agreement will give exclusive worldwide rights to develop and commercialize nelotanserin to Roivant. Roivant says it will begin additional Phase 2 clinical trials
FDA Policy/General
Federal Register notice: FDA is making available a revised draft guidance entitled Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act. The document discusses key terms used to define suspect product, such as “illegitimate,” “counterfeit,” “diverted,” “stolen,” “fraudulent transaction,” and “unfit for
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers. The document is intended to address questions about product identifiers that are required to be affixed to, or imprinted on, packages and homogenous cases of certain drug
FDA Policy/General
Federal Register notice: FDA is making available a final guide entitled Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification. The document is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and specific scenarios that could significantly increase
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act. The document recommends drug distribution security requirements for building an electronic, interoperable system to identify and trace certain prescription drugs at the package level
FDA Policy/General
FDA acting commissioner Janet Woodcock is scheduled to testify 6/10 before the Senate Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies to address the administration’s budget proposal for the agency. It proposes an 8% ($477 million) boost under a $6.5 billion fiscal year
Devices
FDA has cleared an Edwards Lifesciences 510(k) for its Acumen Hypotension Prediction Index (HPI) software with the Acumen IQ finger cuff. The device uses machine learning to alert clinicians about the likelihood a patient is trending toward hypotension. Previously, the software was only available for patients using an invasive
Drugs
FDA has approved a Novo Nordisk NDA for Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in overweight adults with at least one weight-related condition (such as high blood pressure, Type 2 diabetes, or high cholesterol). The approval recommends the drug’s use in addition
Drugs
FDA has approved a Chimerix NDA for Tembexa (brincidofovir) for treating smallpox. “Although naturally occurring smallpox no longer exists, concerns about potential uses of variola virus as a bioweapon has made smallpox drug development an important component of the U.S. medical countermeasures response,” an FDA release says. Because smallpox
Biologics
FDA has issued a clinical hold on a Ortho Regenerative Technologies Phase 1-2 clinical trial for Ortho-R, a drug/biologic combination product candidate used as an adjunct to standard of care surgery in rotator cuff tear repair. The agency hold is related to a request for additional chemistry,
Drugs
FDA has finalized two guidances and published two draft guidances to help ensure that prescription drugs are identified and traced properly as they move through the supply chain. An agency online notice says the documents provide agency recommendations for how to comply with applicable Drug Supply Chain Security Act (DSCSA)
FDA Policy/General
Former FDA principal deputy commissioner Amy Abernethy has joined Alphabet’s Verily as president of its clinical research business. The company says Abernethy will lead its “planned expansion into a full-scale clinical evidence generation platform supporting a broad range of clinical trials and real-world evidence (RWE) studies.” Abernethy
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations. The document provides recommendations for consistent in vitro testing of oral drug products to demonstrate their suitability to be administered via enteral tube. To view
Drugs
FDA has accepted a PharmaEssentia USA resubmission of a BLA seeking approval for ropeginterferon alfa-2b-njft to treat polycythemia vera (PV), a rare blood cancer. The agency assigned a six-month review timeframe with a PDUFA action date of 11/13. FDA has granted ropeginterferon alfa-2b-njft orphan
Biologics
FDA says there continues to be broad marketing of unapproved products containing regenerative medicine therapies that are intended to treat or cure a wide range of diseases or medical conditions. In an online information sheet for patients and consumers, the agency says such products require FDA approval or licensure to
Devices
FDA has cleared a Medtronic 510(k) for patient-specific UNiD Rods for use with its CD Horizon, Solera, Voyager and Infinity OCT spinal systems. The rods are designed for each patient and industrially pre-bent prior to surgery to accurately match an artificial intelligence (AI)-driven pre-operative surgical
Drugs
FDA has granted priority review for an Amryt NDA for oleogel-S10 to treat epidermolysis bullosa. The agency previously granted the treatment fast track designation and rare pediatric disease designation. Amryt says oleogel-S10 is a potential treatment for the cutaneous manifestations of junctional and dystrophic epidermolysis bullosa, a rare
Drugs
Dermavant Sciences has submitted an NDA for tapinarof for treating mild, moderate and severe plaque psoriasis in adult patients. The submission for the therapeutic aryl hydrocarbon receptor modulating agent is based on data from two Phase 3 studies (PSOARING 1 and PSOARING 2) and interim results from PSOARING 3, a
Biologics
The 11th Circuit Court of Appeals has upheld a Florida federal court decision to grant summary judgment to FDA in its suit alleging that US Stem Cell Clinic, its parent company, and its chief scientific officer are providing stem cell procedures that violate the Federal Food, Drug, and Cosmetic Act.