Drugs
The Washington Post reports that Pfizer researchers found in 2015 that its blockbuster rheumatoid arthritis drug Enbrel (etanercept) appeared to reduce the risk of Alzheimer’s disease. However, the newspaper says, the company made a decision during three years of internal review that Enbrel did not show promise for Alzheimer’
Devices
FDA has cleared a ReWalk Robotics 510(k) for the ReStore soft exo-suit system for use in treating stroke survivors with mobility challenges. The device comprises a soft, garment-like design which connects to a lightweight waist pack and mechanical cables that help lift a patient’s affected leg
Biologics
Georgia State University law professor Yaniv Heled says a new FDA guidance explaining how drug manufacturers can develop follow-on biologics is a good step toward lowering drug costs, but may not be enough to make a real difference. Writing online for The Conversation, Heled explains why biologics are so
Drugs
Mallinckrodt (formerly Questcor Pharmaceuticals) says it expects to pay $15.4 million under an agreement in principle it has reached to resolve False Claims Act allegations that it used a foundation as a conduit to pay kickbacks in connection with its drug H.P. Acthar Gel from 2010 through 2014.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of 2/15/2007,” (OMB Control Number 0910-0775). To view the notice, click here.
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
Biologics
A Florida federal court has granted the federal government’s motion for summary judgment against U.S. Stem Cell Clinic and its chief scientific officer for adulterating and misbranding a stem cell drug product made from a patient’s adipose tissue. The Justice Department initiated legal action against the clinic
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
Devices
FDA has cleared a Misonix 510(k) for Nexus, an ultrasonic surgical platform. The company says its next-generation integrated device combines all the features of Misonix’s existing features, including BoneScalpel, SonicOne and Sonastar, into an integrated platform that will also serve to power future options. Nexus is driven
FDA Policy/General
The House Appropriations Committee has marked-up and passed the fiscal year 2020 Agriculture/FDA appropriations bill that would provide the agency with an increase in budget authority of 6% ($184 million) over 2019 levels. A House combined press release and statement said: “The FDA receives a total of $3.
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
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. ActiveHerb Technology, San Diego, CA (5/15): FDA inspected the firm 9/2018 and determined that it was selling unapproved new drugs that were misbranded. FDA documented the firm’
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.
FDA Policy/General
Federal Register notice: FDA has permitted the redemption of a priority review voucher associated with the recent approval of a Novartis NDA for Mayzent (siponimod) tablets, indicated for treating adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. To view
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
FDA Policy/General
FDA chief of staff Lauren Silvis has announced her departure from the agency later this month. She became chief of staff to former commissioner Scott Gottlieb 4/2017 after serving two years as CDRH deputy Center director for policy. Prior to joining FDA in 2015, she was a partner at
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