Drugs
FDA is asking Eisai to withdraw its weight-loss drug Belviq (lorcaserin) and Belviq XR from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. An agency drug safety communication says Eisai has submitted a request to voluntarily withdraw the drug. The agency says
Drugs
Florida federal judge Paul G. Byron has sentenced Barry Clint Wright (Monroe, NC) to seven years in federal prison for introducing unapproved and misbranded drugs into interstate commerce with the intent to defraud or mislead. Wright pleaded guilty to the charges 11/1/2019. According to the government, Wright sold
Drugs
The Federal Trade Commission sued two companies to stop them from falsely claiming that their pills are scientifically proven to alleviate joint pain by growing new bone and cartilage. The joint complaint is against ZyCal Bioceuticals, that has marketed a line of joint pain relief products under the brand name
Drugs
CDER has launched its new Controlled Substances Program (CSP) that encompasses the controlled substances staff and controlled substances initiatives. An internal staff memo says the CSP was established to coordinate CDER activities and emerging issues around controlled substances including prescription opioids, benzodiazepines, and stimulants. The memo says the CSP will
Drugs
The FDA Office of Clinical Pharmacology (OCP) says its 2019 annual report and the annual report of the Division of Applied Regulatory Science (DARS) are now available. In an online notice, OCP says it is a “dynamic, purpose-driven organization dedicated to promoting and protecting global public health through the
Drugs
Attorney Curtis Dombeck (SheppardMullins) says a 2/10 Federal Circuit Court of Appeals decision has revised the country of origin determination for drugs to be purchased by U.S. government entities. Dombeck writes in an FDA Law Update Blog that the case involved an Acetris Health drug where the active
Drugs
Writing in an Annals of Pharmacotherapy editorial, University of Connecticut professor C. Michael White says FDA should act to eliminate the differing rules for completing INDs, different inspection rates, and different inspection intensities that advantage foreign clinical trial sites. “It is a threat to U.S. competitiveness and the quality
Drugs
Merck says that its Phase 3 KEYNOTE-355 trial investigating anti-PD therapy Keytruda (pembrolizumab) in combination with chemotherapy met one of its dual primary endpoints of progression-free survival (PFS) in patients with metastatic triple-negative breast cancer whose tumors expressed PD-L1. An interim analysis found that first-
Drugs
A 2/3-2/11 FDA inspection at the Lupin Pithampur Unit 1 facility closed with two observations on the FDA-483. India online Web site Equity Bulls did not say what the specific observations were. In recent months, Lupin has had inspection issues at its Andhra Pradesh facility, at
Drugs
FDA has released the FDA-483 issued following a 10/8-11/19/19 inspection at SCA Pharmaceuticals, a Windsor, CT, outsourcing facility. The two inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of
Drugs
FDA has announced a 4/20-21 workshop entitled “The 12th Annual Sentinel Initiative Public Workshop.” The active medical product surveillance system was established under the FDA Amendments Act of 2007. The workshop, which is being conducted by the Robert J. Margolis, MD, Center for Health Policy, will discuss recent
Drugs
Trevena has resubmitted its NDA for oliceridine for managing moderate-to-severe acute pain. The company expects a six-month review by FDA. The submission is based on the outcome and final minutes of a Type A meeting with FDA, which was conducted to obtain clarity on a 2018 complete
Drugs
Pfizer and Astellas Pharma report that the Phase 3 PROSPER trial demonstrated a statistically significant improvement in overall survival (OS) in men with non-metastatic castration-resistant prostate cancer who were treated with Xtandi (enzalutamide) plus androgen deprivation therapy (ADT) versus placebo plus ADT. OS was a key secondary endpoint
Drugs
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Marco Pharma, Roseburg, OR (1/10) FDA inspected the firm 5/2019 and found serious GMP violations for dietary supplements. For example,
Biologics
Senior CBER officials and executives from BrainStorm Cell Therapeutics have agreed on a potential regulatory pathway for the company’s NurOwn (autologous MSC-NTF cells) to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). The company says that repeated intrathecal administration of NurOwn is currently being evaluated in
Drugs
FDA has placed a clinical hold on a LogicBio Therapeutics IND for LB-001 for treating methylmalonic acidemia (MMA) pending resolution of certain clinical and nonclinical questions. The company says it submitted the IND 1/2020 to support the initiation of a Phase 1/2 clinical trial in patients with
Drugs
The Washington Legal Foundation (WLF) is asking the 9th Circuit Court of Appeals to enjoin a California law that would presume that every drug company patent settlement is unlawful if it gives a generic manufacturer “anything of value,” including an “exclusive license,” and postpones generic market entry for even a
Drugs
Since its founding in 2015, the FDA Office of Pharmaceutical Quality (OPQ) has worked to “assure that all drugs marketed in the U.S. meet quality standards so that every dose is safe and effective, and free of contamination and defects.” In its 2019 annual report, OPQ says it has
Drugs
FDA has lifted its clinical hold on a Marker Therapeutics planned clinical trial investigating the safety and efficacy of its novel MultiTAA T-cell therapy in patients with post-transplant acute myeloid leukemia. The hold was initiated 11/12/19 when FDA requested additional information and technical specifications for two
Drugs
The Physicians Committee for Responsible Medicine says FDA should require that all product packaging and labeling for erectile dysfunction drugs disclose information on the role of cardiovascular disease in erectile dysfunction and the role of diet and lifestyle in cardiovascular health. The committee’s petition suggests wording that should be
Drugs
Eli Lilly says it does not plan to pursue an NDA submission for solanezumab for treating patients with dominantly inherited Alzheimer’s disease, also known as autosomal dominant Alzheimer’s disease, based on recent clinical trial results. The company says that an analysis performed by Washington University School of Medicine
Drugs
FDA has accepted for review a Janssen Pharmaceutical supplemental BLA for Darzalex (daratumumab) for use in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone for relapsed/refractory multiple myeloma. The submission is supported by data from the Phase 3 CANDOR study, which compared treatment with the triple therapy to carfilzomib