Drugs
Three Syneos Health executives say there are six things FDA could do to better improve representation in clinical trials. Writing in a Stat News online opinion column, the three praise the agency’s guidances issued over the last 25 years and say the recent 4/2022 guidance is a welcome
Drugs
Two women who worked as study coordinators at Florida’s Tellus Clinical Research have pleaded guilty to participating in a conspiracy to falsify clinical trial data. The Department of Justice says Analay Rico, Fort Lauderdale, and Daylen Diaz, Miami, reached a plea agreement in which they admitted agreeing with others
Drugs
Michigan Gov. Gretchen Whitmer (D) is asking FDA commissioner Robert Califf to “remove the mifepristone Risk Evaluation and Mitigation Strategy (REMS) restrictions in order to eliminate yet another burdensome requirement that threatens timely and essential reproductive health care.” In a 7/21 letter, Whitmer says the REMS restrictions “are preventing
Drugs
FDA has published a draft guidance, Evaluation of Therapeutic Equivalence, explaining the agency’s therapeutic equivalence evaluations, including the assignment of therapeutic equivalence codes. The document says FDA’s therapeutic equivalence evaluations are listed for multisource prescription drug products approved under Section 505 of the Federal Food, Drug, and Cosmetic
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it generally supports the International Council for Harmonization (ICH) Q9(R1) draft guidance on quality risk management and recommends several revisions for clarity. “We support revision of the Q9 quality risk management guidance and FDA’s efforts to help facilitate more effective
Drugs
Former CDER staffer Jacqueline Major and colleagues at Harvard, the University of Pennsylvania, and the National Cancer Institute say the FDA Sentinel System’s electronic healthcare data may be useful for characterizing short latency cancer risk, examining cancer drug utilization and safety post-diagnosis, and conducting surveillance for acute adverse
Drugs
CDER Office of Quality Surveillance director Jennifer Maguire says FDA samples drugs for general quality surveillance and for targeted investigations in response to information about suspected quality issues with drugs on the market. In an online interview post, Maguire says the information analyzed through the drug quality sampling and testing
Drugs
FDA has told Soleno Therapeutics that a proposed change to the company’s study of DCCR (diazoxide choline) extended-release tablets for treating Prader-Willi syndrome might address the agency’s concerns about the adequacy of the overall efficacy data supporting an NDA. Soleno says the study protocol has been
Drugs
FDA has published a draft guidance, Human Prescription Drug and Biological Products—Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers—“Dose Banding”, with recommendations to assist applicants in incorporating information into proposed human prescription drug labeling under specified conditions. The document applies to
Drugs
A 1/31-2/4 FDA inspection at the Bioiberica, SAU, drug manufacturing facility in Barcelona, Spain, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A 6/30 Warning Letter says specific deviations were: * failing to establish written procedures to monitor the progress
Drugs
FDA says a review of promotional materials in ophthalmology professional journals for Imprimis Rx’s compounded Pred-Moxi-Brom (prednisolone acetate 1%, moxifloxacin 0.5%, and bromfenac 0.075%) found that they make false or misleading claims about the drug and thus misbrand the drug product. A 6/30 Warning
Drugs
FDA has lifted a clinical hold against Viking Therapeutics’ VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD), and the company says it will resume study enrollment in the coming weeks. The agency action followed its review of results from an in vivo genotoxicity study that it had requested due
Drugs
Merck says it is stopping for futility its Phase 3 LYNK-003 trial investigating Lynparza (olaparib) with or without bevacizumab for treating patients with unresectable or metastatic colorectal cancer who have not progressed following first-line induction. The stoppage was recommended by an independent data monitoring committee after they reviewed
Drugs
CDER director Patrizia Cavazzoni has appointed associate director for controlled substances Marta Sokolowska to serve as deputy Center director for substance use and behavioral health, a new position in the Center. In this new role, she will continue to oversee the Controlled Substances Program at the agency. “At a time
Drugs
The Washington Legal Foundation (WLF) says a 7/29 HHS Office of Inspector General (OIG) advisory opinion rejecting a proposal to permit pharmaceutical and medical device industry sponsorship of a continuing education program for healthcare providers “could have significant implications for how life sciences companies contribute towards continuing education programs
Drugs
Santa Monica, CA, pain specialist Gerald Sacks has agreed to pay $271,259.12 to resolve allegations that he violated the False Claims Act in connection with prescribing Purdue Pharma and Depomed medications to Medicare beneficiaries. A Department of Justice release says Sacks prescribed the medications in exchange, at least
Drugs
FDA has accepted for priority review an Apellis Pharmaceuticals NDA for intravitreal pegcetacoplan, an investigational, targeted C3 therapy for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The agency set a user fee review action target date of 11/26. GA is an advanced form of AMD
Drugs
The Alliance for Natural Health, saying it is acting on behalf of its one million consumer supporters, is calling on FDA to require manufacturers of proton pump inhibitors (PPIs) to add a Boxed Warning to the product labeling describing the link between taking PPIs and the risk of developing dementia.
Drugs
Sanofi has told Regulus Therapeutics that it is terminating a Phase 2 clinical study (HERA Study) of lademirsen (RG-012) for treating Alport syndrome after data failed to meet Sanofi’s pre-defined futility criteria. Previously, Sanofi acquired from Regulus the rights for developing and marketing RG-012. Regulus says
Drugs
Acer Therapeutics has resubmitted its NDA for ACER-001 (sodium phenylbutyrate) for oral suspension for treating patients with urea cycle disorders (UCDs). The resubmission addresses items raised by the agency in a complete response letter issued last month, which identified the company’s third-party contract packaging manufacturer as not
Drugs
Acadia Pharmaceuticals has submitted an NDA for trofinetide for treating Rett syndrome in adults and pediatric patients two years of age and older. The submission is based on data from the pivotal Phase 3 Lavender study evaluating the efficacy and safety of trofinetide versus placebo in 187 girls and young
Drugs
A group of bipartisan lawmakers is urging FDA to do more to help get therapies approved for treating amyotrophic lateral sclerosis (Lou Gehrig’s Disease). Reps. Mike Gallagher (R-WI), Anna G. Eshoo (D-CA), Brett Guthrie (R-KY), Jan Schakowsky (D-IL), Gus Bilirakis (R-FL), Mike Quigley (D-