Devices
FDA has cleared an Innovative Health Solutions de novo marketing request for the IB-Stim, the first medical device to aid in reducing functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS) when combined with other therapies for IBS. “This device offers a safe
Drugs
Motif Bio says FDA is requiring an additional clinical trial before it can approve the company’s NDA for iclaprim, indicated for treating acute bacterial skin and skin structure infections. The agency expressed its position at a recent Type A meeting about a complete response letter that was issued in
Drugs
The Justice Department says Insys Therapeutics is settling separate civil and criminal investigations into illegal promotion of its Subsys opioid painkiller with a payment of $225 million. A department news release says the company will plead guilty to five counts of mail fraud and pay a $2 million fine and
Drugs
FDA has announced that later this month generic drug applicants will be able to submit pre-assigned ANDA number requests through CDER’s NextGen Portal. For sponsors already having a CDER NextGen Portal account, the account will be automatically updated with this pre-assigned ANDA number request functionality. To create
Devices
FDA has cleared an Akonni Biosystems 510(k) for its TruDiagnosis System, a compact point-of-service molecular diagnostic device which includes the TruDx 2000 Imager and the TruArray consumable test kit. The saliva test is intended to identify genetic signatures associated with patient metabolization of the drug Coumadin, which
Drugs
FDA has published a draft guidance, Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment, to assist sponsors in the clinical development of drugs to treat nonalcoholic steatohepatitis (NASH) with compensated cirrhosis. The document contains the agency’s current recommendations on the important components of a drug development program for
Drugs
FDA is issuing a draft guidance, Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs, to recommend approaches that NDA and BLA clinical trial sponsors can take to broaden eligibility criteria, when scientifically and clinically appropriate, and increase enrollment of underrepresented populations in their trials.
Devices
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) says doctors should not use paclitaxel drug-coated balloons or drug-eluting stents in routine treatment of patients with intermittent claudication until further notice, as the potential mortality risk outweighs the benefits. An agency medical device alert says use of the
Drugs
FDA has accepted a Celgene NDA for ozanimod, indicated for treating patients with relapsing forms of multiple sclerosis (RMS). The oral, sphingosine 1-phosphate (S1P) receptor modulator binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). The submission is based on data from the SUNBEAM and
Biologics
Responding to an FDA 5/28 Notice of Violation indicating that R3 Stem Cell, Scottsdale, AZ, was promoting regenerative stem cell therapies without an approved BLA, the company says it is reviewing its Web site and operations and is unaware of any safety issues resulting from stem cell contamination. “R3
Drugs
FDA has granted Palatin Technologies an orphan drug designation for PL-8177 for treating non-infectious intermediate, posterior, pan and chronic anterior uveitis. Non-infectious uveitis is a group of inflammatory diseases that produces swelling and destroys eye tissue and can result in vision loss, according to the company. PL-
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’