Drugs
FDA has accepted for review a Celgene and Acceleron BLA for luspatercept, an investigational erythroid maturation agent for treating adult patients with very low to intermediate-risk myelodysplastic syndromes (MDS)-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions, and for treating adult patients with beta-
Drugs
An 11/13-12/10/18 FDA inspection at the Kingston Pharma drug manufacturing facility in Massena, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and misbranding violations. A 5/14 Warning Letter says specific violations were: * failing to establish adequate written responsibilities and
Drugs
FDA has approved a W. L. Gore PMA for the GORE CardioForm ASD Occluder for the percutaneous closure of ostium secundum atrial septal defects. Approval was supported by data collected from the pivotal Gore ASSURED clinical study, which demonstrated 100% closure success at a six-month evaluation in patients with
Drugs
A presentation by staff from FDA and Harvard Medical School on “Medical Product Safety: Ten Years of the U.S. Sentinel System” gives the history and operations of the Sentinel System. FDA uses Sentinel to: (1) evaluate safety signals identified during the premarket review of new drug applications; (2) evaluate
Drugs
A 9/11-9/17/18 and 3/19/19 FDA inspection at ActiveHerb Technology, San Diego, CA, found that the firm is selling unapproved new drugs that are misbranded. A 5/15 Warning Letter lists 13 products the company markets that FDA considers to be drugs because they are
Drugs
Boehringer Ingelheim says its experience as the only biosimilar sponsor to have publicly announced conducting a switching study, to support an interchangeability designation for its biosimilar Cyltezo (adalimumab-adbm), shows that the FDA pathway for biosimilars and interchangeable biologics “is working well as it is currently designed.” Commenting on an
Drugs
FDA’s Oncology Center of Excellence has unveiled a new drug expanded access pilot program to help oncology health care professionals seeking access to unapproved therapies for patients with cancer. A new call center called Project Facilitate will be a single point of contact where FDA oncology staff will help
Drugs
Federal Register notice: FDA has withdrawn the approval of five ANDAs for products containing pemoline. The application holders requested their withdrawal and have waived their opportunity for a hearing. To view the notice, click here.
Drugs
FDA has issued a safety alert on the dietary supplement ingredient due to its potential to cause a miscarriage or harm fetal development. According to data reviewed by the agency, including a recent report by the National Institute of Health’s National Toxicology Program, consumption of vinpocetine is associated with
Drugs
FDA needs to be more transparent and announce when companies submit NDAs to the agency, according to Center for Science in the Public Interest and former associate commissioner Peter Lurie. Reacting to new FDA research on NDA notifications published in JAMA-Internal Medicine, Lurie says it makes “no sense for
Drugs
Generic drug maker Heritage Pharmaceuticals has been charged for conspiring with its competitors to fix prices, rig bids, and allocate customers, according to the Justice Department. According to the government, from about 4/2014 to 12/2015, “Heritage participated in a criminal antitrust conspiracy with other companies and individuals engaged
Drugs
FDA has approved a Merck NDA for a new indication for Zerbaxa (ceftolozane and tazobactam) for treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. The drug was initially approved in 2014 to treat complicated intra-abdominal infections and for complicated
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) has issued Vivus an untitled letter over false and misleading claims made on its Web page for weight-loss drug Qsymia (phentermine and topiramate extended-release) capsules. According to the letter, the page makes false/misleading claims and representations about the drug’
Drugs
Novis PR has recalled five lots of PexGen DMX, 16 oz, liquid cough syrup due to incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states that children six to under two years of age should receive one teaspoonful every four hours (not
Drugs
FDA and precision medicine technology company COTA, Inc. have a two-year research collaboration agreement (RCA) to establish a study protocol with an initial focus on breast cancer. Operating under FDA’s regulatory science research Information Exchange and Data Transformation (INFORMED) Program, the RCA is intended to provide the agency
Drugs
CDER Office of Surveillance and Epidemiology director Gerald Dal Pan says that although the number of reports to the FDA Adverse Event Reporting System (FAERS) reached a record of more than two million in 2018, that does not suggest that FDA-approved drugs have become riskier. In a CDER Conversation:
Drugs
FDA has announced a 7/17 public workshop entitled “Improving the Implementation of Risk-Based Monitoring (RBM) Approaches of Clinical Investigations.” The workshop is intended to capture stakeholder experiences with risk-based approaches to monitoring of clinical investigations and gather stakeholder input on opportunities to further implement risk-based approaches
Drugs
FDA has approved an Astellas Pharma supplemental NDA to update the U.S. product labeling for Xospata (gilteritinib) to include final analysis data from the ADMIRAL trial. The data demonstrated improvement in overall survival in patients treated with gilteritinib monotherapy versus salvage chemotherapy in adult patients with relapsed or refractory
Drugs
Five FDAers working in various CDER positions involving cancer drugs and treatment say the agency is working to help resolve a problem that occurs when patients and their families don’t understand information they are given about a cancer diagnosis and treatment options. Writing in an open-source article in
Drugs
The Justice Department says Almirall (formerly Aqua Pharmaceuticals) will pay $3.5 million to resolve a whistleblower’s allegations that it used illegal kickbacks to incentivize doctors to prescribe the company’s dermatology drugs. A department statement says the settlement resolves allegations that between 2012 and 2017 Aqua knowingly paid
Drugs
Epizyme has submitted an NDA seeking accelerated approval of tazemetostat for treating patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. The company describes Tazemetostat is an oral, first-in-class, EZH2 inhibitor that it discovered and is developing for various cancers and treatment settings. The
Drugs
GlaxoSmithKline says a draft FDA guidance on quality considerations for continuous manufacturing is “a good first step toward establishing current Good Manufacturing Practices around emerging continuous manufacturing technology.” The company says it expects that once the International Conference on Harmonization Q13 guideline on continuous manufacturing of drug substances and drug