Drugs
FDA’s Psychopharmacologic Drugs Advisory Committee has voted 12 to 5 to recommend approval for a Titan Pharmaceuticals NDA for the probuphine implant that is designed to reduce cravings in opioid dependent patients. The agency noted that as an implantable formulation, probuphine is intended to be difficult to divert or
FDA Policy/General
FDA should adapt how it approaches pre-market regulation in order to properly address very novel areas of technology like gene editing and cell and gene therapy, according to former deputy commissioner Scott Gottlieb. His remarks were made this week at the International Society for Stem Cell Research in Berkeley,
Drugs
A 3/2-3/7/15 FDA inspection at Zhejiang Hisun Pharmaceutical Co., Zhejiang Province, China, found significant deviations from current good manufacturing practice for the manufacture of active pharmaceutical ingredients (API), according to a 12/31/15 Warning Letter. Specific deviations included: failing to prevent unauthorized access and changes
FDA Policy/General
FDA commissioner-nominee Robert Califf won an unanimous voice vote from the Senate Health, Education, Labor, and Pensions (HELP) Committee 1/12 to approve his nomination to become the next commissioner. The nomination now moves to the Senate floor for a full vote. Before the vote, HELP Committee chair Lamar
FDA Policy/General
Former CBER Office of Compliance and Biologics Quality deputy director Mark I. Schwartz has joined Hyman Phelps & McNamara after a 13-year career at the agency in escalating responsibility positions. At FDA, he oversaw two of the Office’s four divisions — Case Management and Inspections and Surveillance. His day-
Drugs
Mesoblast Ltd. says FDA has agreed to a smaller patient enrollment target for a Phase 3 trial involving MPC-150-IM in chronic heart failure (CHF), which should shorten the time to trial completion. The agreement follows a meeting last month between Mesoblast’s development and commercial partner, Teva Pharmaceutical
Devices
FDA has approved the use of Animas Corp.’s Vibe Insulin Pump and Continuous Glucose Monitoring (CGM) System for managing diabetes in children and adolescents (ages two to 17). The device allows patients and their caregivers to view glucose data and administer insulin right from the pump, making it easy
Devices
Stryker has begun a Class 1 recall of its Fuhrman Pleural and Pneumopericardial Drainage Sets because the catheter may break during insertion. The company has received two reports that the catheter included in the drainage set broke off in the pleural cavity while inserting the device into the patient, according
Biologics
The U.S. Pharmacopeial Convention (USP) is developing standards for therapeutic proteins to help manufacturers in the development and analysis of their proteins. USP’s standards for these and other biologics are based on input from global scientific experts and on specifications for FDA-approved products. Published in the United
Drugs
FDA commissioner-nominee Robert Califf says that revising advertising and promotion policies and the agency’s approach to foreign inspections will be top priorities if he is confirmed as the next commissioner. The Senate HELP Committee is scheduled to vote on his nomination 1/12. In response to questions posed
Devices
FDA has cleared a K2M Group Holdings 510(k) for the Cascadia Lateral Interbody System featuring Lamellar Titanium Technology that uses 3D printing with the goal of allowing for bony integration throughout the spinal implant. “Starting with a titanium powder, the implants are grown through the selective application of a
Drugs
The Hyman, Phelps and McNamara (HPM) law firm says FDA’s bioequivalence recommendations for generic copies of Janssen Pharmaceuticals’ Xarelto (rivaroxaban) should be re-evaluated and revised. In just-posted comments submitted on behalf of an unnamed generic drug company client, HPM says revisions to a recent draft guidance should
FDA Policy/General
BIOLOGICS Panel to Discuss 2016-2017 Influenza Vaccine Federal Register Notice: FDA’s Vaccines and Related Biological Products Advisory Committee will meet 3/4, from 8:30 a.m. to 3 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm.
FDA Policy/General
DEVICES FDA has approved the use of Animas Corp.’s Vibe Insulin Pump and Continuous Glucose Monitoring (CGM) System for managing diabetes in children and adolescents, ages two to 17. The company says the system allows patients and their caregivers to view glucose data and administer insulin right from the
Drugs
CDER has posted a revised internal procedure document on handling requests for drug proprietary name reviews. The document is required as part of FDA’s and the drug industry’s user fee agreement. To meet the review performance goals, a decision about a request for a proposed proprietary name submitted
FDA Policy/General
Federal Register Notice: FDA is making available a draft document entitled Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry. It provides establishments that make donor eligibility determinations
FDA Policy/General
Federal Register Notice: FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will meet 2/25, from 8 a.m. to 6 p.m. and 2/26, from 8 a.m. to 1 p.m. at the Hilton Washington DC North/Gaithersburg, Salons A, B, and
FDA Policy/General
Federal Register Notice: FDA is extending the comment period until 2/22 in the notice entitled “Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Availability” that appeared in the 11/23/15 Federal Register. To view this notice, click here.
Drugs
FDA commissioner nominee Robert Califf says improving clinical trial designs to understand the effects of new drugs and devices in patient subpopulations is a high priority for the agency and it will “require a comprehensive, multifaceted approach using a concept known as ‘quality by design.’” Responding to follow-up questions
Drugs
FDA has accepted a Regeneron Pharmaceuticals and Sanofi BLA for sarilumab, an investigational human monoclonal antibody that is designed to target the IL-6 receptor for treating patients with active, moderate-to-severe rheumatoid arthritis (RA). “IL-6 is the most abundant cytokine in the serum and synovial fluid of
Drugs
FDA has granted Immune Design an orphan drug designation for LV305 and G305 for treating soft tissue sarcoma. The drugs are described by the company as complementary agents that comprise CMB305, its “prime boost” cancer immunotherapy product candidate. LV305 is a hybrid vector that is designed to “target dendritic cells
Drugs
Momenta Pharmaceuticals and Mylan have entered into a collaboration agreement to develop, manufacture and commercialize six of Momenta’s current biosimilar candidates, including a version of Bristol-Myers Squibb’s Orencia (abatacept), indicated for treating rheumatoid arthritis. Under the agreement, Mylan will make an upfront $45 million cash payment to