Devices
Former DePuy Synthes sales representative Matthew Capobianco of Winchester, MA, was arrested 6/26 on eight counts of wire fraud and one count of making false statements in a case investigating his interference with a Boston-area hospital’s sterilization processes. A government indictment contends that from 1/2016 through
FDA Policy/General
In an update, FDA commissioner Robert Califf says additional changes will be made to the agency’s new Human Foods Program (HFP) and the Office of Regulatory Affairs (ORA) to enhance coordination, prevention, and response activities across FDA. In a media statement, Califf says the changes are based on recommendations
Drugs
FDA has approved Bayer’s Ultravist (iopromide)-300 and Ultravist-370, iodine-based contrast agents for contrast-enhanced mammography. The company says the products are intended to be used to visualize known or suspected breast lesions in adults, as an adjunct to mammography or ultrasound. Bayer says the indication “aligns
Drugs
FibroGen is discontinuing its ZEPHYRUS-2 Phase 3 trial of pamrevlumab in patients with idiopathic pulmonary fibrosis after topline data from the earlier ZEPHYRIS-1 Phase 3 trial did not meet the primary or secondary endpoints. The primary endpoint was a change from baseline in forced vital capacity at week
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Psychedelic Drugs: Considerations for Clinical Investigations.” The document provides general considerations for developing psychedelic drugs for treating medical conditions such as psychiatric and substance use disorders. It also discusses considerations for clinical investigations using such drugs. To view the
Devices
ReShape Lifesciences has filed a PMA supplement for the company’s next generation Lap-Band 2.0 for long-term treatment of obesity. Lap-Band is an alternative to more invasive surgical stapling procedures such as gastric bypass or sleeve gastrectomy, according to the company. The device uses a reservoir
Drugs
FDA has approved a Pfizer NDA for Litfulo (ritlecitinib), a once-daily oral treatment for individuals 12 years of age and older with severe alopecia areata. The kinase inhibitor is designed to inhibit Janus kinase 3 and the tyrosine kinase expressed in hepatocellular carcinoma family of kinases. Approval was based
Biologics
UCB says FDA’s review of its BLA resubmission for bimekizumab for treating adults with moderate to severe plaque psoriasis has been extended for undisclosed reasons. UCB previously said it expected FDA action in the second quarter and now it expects this in the third quarter. In 5/2022, FDA
Devices
FDA has cleared a CS Medical 510(k) for its Ethos Automated Ultrasound Probe Cleaner Disinfector for use in cleaning and high-level disinfection of endocavity and surface ultrasound probes. The device uses the company’s AquaCide cleaner disinfectant to clean and disinfect each ultrasound probe in about three minutes.
Drugs
FDA has lifted a clinical hold on a Pharvaris deucrictibant clinical trial for the on-demand treatment of hereditary angioedema (HAE) attacks. There still remains a hold on a separate trial for the drug’s prophylactic treatment of HAE, which the company says it will address when it submits data
Drugs
Pfizer says it is terminating the development program for glucagon-like peptide-1 receptor agonist (GLP-1-RA) anti-diabetes candidate lotiglipron due to liver injury concerns and will instead “continue to progress one oral late-stage” GLP-1-RA candidate, danuglipron, toward further clinical development for treating adults with
Biologics
CBER director Peter Marks overrode his Center’s review team in granting the 6/22 accelerated approval of Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene therapy Elevidys, a move reminiscent of a review override (see story) almost seven years ago by then-CDER director Janet Woodcock on a Sarepta NDA
Drugs
FDA has posted a draft guidance entitled “Psychedelic Drugs: Considerations for Clinical Investigations.” The document provides general considerations to sponsors developing psychedelic drugs for treating such medical conditions as psychiatric and substance use disorders. Under the guidance, the term psychedelic is used as “shorthand to include classic psychedelics, typically understood
FDA Policy/General
The Senate Appropriations Committee 6/22 voted 28 to 0 to approve FDA’s appropriations bill, which provides the agency a $20 million increase. “More specifically, it provides an additional $7 million to conduct oversight of cosmetics for the first time ever, $3.75 million to strengthen FDA’s food
Drugs
FDA has issued Intercept Pharmaceuticals a second complete response letter on its NDA resubmission for obeticholic acid (OCA) for treating pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH). The letter told Intercept that any NDA resubmission would require, at a minimum, successful completion of the long-term outcomes phase of
FDA Policy/General
FDA has posted a final guidance entitled “Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical.” The document is intended to provide a notice of exceptions and alternatives to certain requirements
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act.” The document provides recommendations on the formal dispute resolution and administrative hearings procedures for resolving scientific and medical
Drugs
Jazz Pharmaceuticals has filed a 6/22 lawsuit in the DC federal court against FDA, seeking to reverse the 5/1 approval of Avadel CNS Pharmaceuticals’ Lumryz, a sodium oxybate drug product citing Jazz’s Xyrem as the reference-listed drug, indicated for treating cataplexy or excessive daytime sleepiness in
Devices
Centers for Medicare & Medicaid Services (CMS) has issued a proposed procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices. “The new Transitional Coverage for Emerging Technologies (TCET) pathway for Breakthrough Devices supports both improved patient care and innovation by providing a clear, transparent, and consistent coverage
Drugs
The attorneys general of 13 states are urging FDA to include the use of in-home opioid disposal products in its approach to opioid disposal. Responding to an agency request for information on in-home opioid disposal systems, the attorneys general of South Carolina, Idaho, Alabama, Indiana, Alaska, Iowa, Arkansas,
Drugs
Senator Marco Rubio has written FDA commissioner Robert Califf to question the agency’s decision to temporarily permit the importation of unapproved cisplatin, an important chemotherapy drug in short supply in the U.S., from China’s Qilu Pharmaceutical. “As the FDA works to alleviate these shortages, it must carefully
Drugs
FDA has published a draft guidance, Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug, and Cosmetic Act, with recommendations on the formal dispute resolution and administrative hearings procedures for resolving scientific and medical disputes between CDER and requestors and sponsors of