Drugs
FDA has given ERX Pharmaceuticals approval to move to the next level in its Phase 1 study evaluating its ERX1000 leptin sensitizer in treating obesity. The company says ERX1000 “has already demonstrated proof-of-concept in first-in-human studies in obese subjects, having been generally well tolerated at doses
Drugs
Genmab and Seagen have submitted a BLA seeking accelerated approval for tisotumab vedotin, indicated for treating patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin is an investigational antibody-drug conjugate directed to tissue factor, a cell-surface protein expressed on multiple solid
Drugs
An FDA review of a Web site and YouTube channel maintained by Clarke Pharmaceuticals, Webster, TX, found the firm is marketing several unapproved drugs, according to a 2/2 Warning Letter. The letter quotes claims from the firm’s Web site that establish the products are intended for use in
Drugs
FDA has approved Allergan’s Botox for treating detrusor (bladder muscle) overactivity associated with a neurologic condition in pediatric patients aged five years and older who have an inadequate response, or are intolerant, to anticholinergic medications. Allergan says that neurogenic detrusor overactivity occurs when the spinal cord and bladder are
Drugs
A group of Democrats on the House Oversight Committee are urging FDA to remove the in-person dispensing requirement for medical abortion drug mifepristone. Last month, the U.S. Supreme Court in a 6-3 split on ideological lines granted an FDA request to reinstate a federal requirement that women
Devices
FDA has cleared an Ava 510(k) for its wearable Fertility Tracker to aid women in ovulation prediction and facilitating conception. To gain FDA clearance, Ava says it submitted multiple performance tests, including a prospective clinical trial demonstrating that the device accurately predicted the day of ovulation. “Results demonstrated that
Drugs
A 5/10-5/15/20 FDA inspection at Allay Pharmaceuticals, Hialeah, FL, found significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals. A 1/27 Warning Letter also says an unidentified tablet product is adulterated for failing to conform to compendial standards for strength, quality, or purity.
Biologics
Freeline Therapeutics says it has modified its clinical development plan for its adeno-associated virus vector-mediated gene therapy FLT180a program for Hemophilia B to address FDA feedback related to the characterization and comparability of the investigational drug product used in its Phase 1/2 B-AMAZE trial that was
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Allay Pharmaceuticals, Hialeah, FL (1/27) FDA inspected the firm 5/2020 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish adequate written
Devices
FDA says it is monitoring clinical experience with ventilator splitters (multiplexing ventilator tubing connectors) in situations in which no alternatives for invasive ventilatory support are available. Splitters are intended to divide the gas flow from a single mechanical ventilator to deliver a tidal volume to more than one patient and
Drugs
The American Society of Clinical Oncology and Friends of Cancer Research are recommending ways to further efforts to broaden eligibility criteria in cancer clinical trials. In a statement, the two groups say their goal is to make clinical trials more accessible to patients. The joint recommendations are contained in a
Drugs
FDA says its testing of hand sanitizer manufactured by ShangRao Chunyu Technology Co., Jiangxi, China, which was detained at the border and prevented from entering the U.S., found that the product was labeled to contain 75% of the ethanol active ingredient but contained an average of only 58% ethanol.
Drugs
The House Select Subcommittee on the Coronavirus Crisis says it has uncovered additional evidence of Trump administration political meddling in coronavirus guidance, testing, and treatments. In a statement (contains links to documents and letters), subcommittee chairman James Clyburn (D-SC) says the Trump administration: * pressed FDA commissioner Stephen Hahn to
FDA Policy/General
FDA says it has created a Web page listing clinical field studies that are investigating animal cells, tissues, and cell- and tissue-based products (ACTPs) in veterinary patients. “The Web page provides animal owners, veterinarians, researchers, and the public with information on clinical field studies that are being investigated for
Devices
A new Medical Imaging & Technology Alliance (MITA) white paper, “Understanding Accountability in Medical Device Servicing,” calls on FDA to do more to hold third-party medical device servicing businesses accountable. The document gives an overview of the types of organizations and entities that perform medical device servicing and the
Drugs
CDER Office of Medical Policy (OMP) director Jacqueline Corrigan-Curay has accepted a detail to the Office of the Center Director as deputy director for operations, effective 2/14. While acting in this position, Corrigan-Curay will continue in her role as OMP director. Corrigan-Curay’s temporary move is
Drugs
The U.S. Court of Appeals for the Federal Circuit, the nation’s highest patent court, has agreed to reconsider a 10/2020 ruling that Teva says would enable innovator drug companies to block low-cost generic competition. Bloomberg Law reports an appeals court panel voted 2-1 to reopen
Drugs
A Hogan Lovells white paper, “The False Claims Act Guide: 2020 and the Road Ahead,” says that a federal directive to prioritize the investigation of coronavirus-related fraud, the unprecedented amount of federal stimulus payments, and the transition to a new administration are creating a climate in which False Claims
Biologics
Despite an all-hands-on-deck approach to address Covid-19 issues in 2020, CBER was also able to squeeze out its new CBER Advanced Technologies Team (CATT) to “address the need for a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality biologics,” according to Center
Devices
CDRH Office of Neurological and Physical Medicine Devices director Carlos Pena has left the agency to develop the newly established Office of Regulatory Services at Jacobs Institute in Buffalo, NY. The institute says its mission is to “accelerate the development of next-generation technologies in vascular medicine through collisions of
Devices
FDA has granted Roche a breakthrough device designation for its Elecsys GDF-15 assay as a companion diagnostic (CDx) in cancer treatment. The in vitro diagnostic immunoassay is intended to measure Growth Differentiation Factor-15 (GDF-15) in cachectic patients 18 years of age and older with solid tumors for
Drugs
Supernus Pharmaceuticals has resubmitted its NDA for SPN-812 for treating attention deficit/hyperactivity disorder (ADHD) in pediatric patients. In 11/2020, FDA issued a complete response letter, citing Supernus’ in-house laboratory that conducts analytical testing, which recently moved to a new location. In the NDA resubmission Supernus says