Drugs
The Association for Accessible Medicines and its Biosimilars Council say they support FDA efforts to foster biosimilar competition in the interest of building a sustainable marketplace for those innovative medicines. Following an FDA 5/13 hearing on the future of insulin biosimilars, the association and council recommend that: * FDA has
Devices
FDA has approved a DT MedTech PMA for the Hintermann Series H3 Total Ankle Replacement System. The three-piece, mobile-bearing implant is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis or arthritis secondary to inflammatory
Drugs
Tempus, a precision medicine technology company, says it is launching its Tempus Integrated Molecular Evaluation (TIME) trial, at scale, which aims to increase clinical trial enrollment and participation for cancer patients who are treated in academic and community settings. The company says TIME is a proprietary platform that aims to
Devices
The National Evaluation System for health Technology Coordinating Center (NESTcc) says it is opening 12 new test cases to leverage real-world evidence and address key priorities for medical device stakeholders. A NESTcc statement says the test cases are intended to accelerate the organization’s progress and provide proof of
Devices
ECA Academy says a recent FDA Warning Letter “gives very nice insights into the state of the art regarding cleaning validation from the point of view of FDA.” The Warning Letter was issued 4/23 to Laboratoires Clarins, Pontoise, France. The ECA analysis says the agency criticized that the company
Devices
Hamilton Medical is updating all Hamilton-G5 Ventilators that contain software versions 2.60 or older to prevent the user message “panel connection lost” and the device entering an ambient state. “The user error message is due to a blocked or terminated communication between the ventilation unit processor and the
Drugs
FDA has approved an Eli Lilly BLA for Emgality (galcanezumab-gnlm) solution for injection for treating episodic cluster headache in adults. The drug was first approved 9/2018 for preventing migraine headaches in adults. The new approval was based on data from a 106-patient placebo-controlled clinical trial. “The
Drugs
HHS says it will not further renew a contract with the University of California San Francisco (UCSF) for research involving human fetal tissue from elective abortions. A department statement says, “Promoting the dignity of human life from conception to natural death is one of the very top priorities of President
Biologics
FDA has accepted for review an Enzyvant BLA for RVT-802, a novel investigational tissue-based regenerative therapy designed to treat pediatric congenital athymia, a rare and deadly condition associated with complete DiGeorge anomaly, Charge syndrome, and FoxN1 deficiency, according to the company. The agency granted a priority review and
Devices
FDA has approved a Zavation 510(k) to market the Ti3Z Interbody System, a lumbar intervertebral body fusion device. The device is indicated for spinal fusion procedures and used with autogenous bone graft in skeletally mature patients. The implants are intended for use at either one level or two contiguous
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