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.
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
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
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
Drugs
FDA is urging drug compounders not to compound drug products using any remdesivir active pharmaceutical ingredient (API) due to its complex nature that makes it challenging to compound. “Remdesivir API is complex and neither a United States Pharmacopeia monograph nor other public quality standard for the API used in FDA-
Drugs
FDA has granted Ellodi Pharmaceuticals a fast track designation for APT-1011 (fluticasone propionate) oral disintegrating tablet for treating eosinophilic esophagitis, a rare, chronic allergic inflammatory disease characterized by eosinophilic infiltration in the esophagus. The designation was granted based on data from the Phase 2b study (FLUTE) evaluating histological remission
Drugs
FDA has granted TG Therapeutics accelerated approval for Ukoniq (umbralisib), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon for treating adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen, and with relapsed or refractory follicular lymphoma
Drugs
A 12/17/20 meeting of FDA and industry representatives to negotiate the reauthorization of GDUFA covered these topics, according to a meeting summary distributed by the agency: * industry asked the agency to consider harmonizing some technical terminology related to the mid-cycle discipline review letters with a publicly-facing
Drugs
FDA reviewers are taking issue with a Merck study supporting a new indication for Keytruda (pembrolizumab) for treating patients with high-risk early-stage triple-negative breast cancer (TNBC), in combination with chemotherapy as neoadjuvant treatment, then as a single agent as adjuvant treatment after surgery. FDA briefing documents released
Drugs
Bristol-Myers Squibb 2/5 won BLA approval for (Breyanzi) lisocabtagene maraleucel (liso-cel), indicated for treating adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies. The BLA’s review was put on hold in November pending the completion of an inspection, which was
Drugs
Apotex has recalled two batches of enoxaparin sodium injection due to a packaging error resulting in some syringe barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) on the syringe barrel and vice versa.
Drugs
Three Morgan Lewis attorneys say a recent FDA guidance to facilitate the development of antisense oligonucleotide (ASO) drugs for patients with severely debilitating or life-threatening genetic disorders that are tailored to a patient’s specific genetic variant is targeted to academic investigators who may be less familiar with the
Drugs
The Clinical Trials Transformation Initiative (CTTI), a joint venture of FDA and Duke University, says it has identified eight best practices for designing and conducting Covid-19 treatment clinical trials. “While these best practices, comments, and quotes are specific to Covid-19 trials, CTTI recommends that these principles should be
Drugs
The 4th Circuit Court of Appeals has affirmed a federal district court’s summary judgment in favor of Greer Laboratories in a case in which whistleblowers said the company had sold custom mixes of allergenic extracts to doctors under an FDA general license rather than a required separate license for
Drugs
FDA’s Oncology Center of Excellence (OCE) annual report for 2020 describes OCE’s work on behalf of cancer patients affected by the Covid-19 pandemic. “OCE participated in writing a guidance emphasizing the flexibility that FDA would exercise with regard to conduct of clinical trials with decentralized trial procedures
Drugs
A decade-old, FDA-investigated case involving the unlicensed wholesale distribution of prescription drugs by Israeli citizen Boaz BenMoshe is finally coming to a close with his extradition to the U.S. and a sentencing date now scheduled for 4/1. According to the government, in 2009 BenMoshe pled guilty
Drugs
FDA says that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with Pfizer’s arthritis and ulcerative colitis drug Xeljanz (tofacitinib) and Xeljanz XR, compared to tumor necrosis factor (TNF) inhibitors. An agency drug safety communication says FDA required the
Drugs
FDA has approved a Durect NDA for Posimir (bupivacaine solution) for infiltration use in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. Approval was based on clinical trial data in patients undergoing arthroscopic