Office of Management and Budget Director Mick Mulvaney and other top administration officials who met Friday
at the White House to talk about an executive order aimed at lowering prescription drug prices made minor progress on the issue, and discussions during the meeting suggest that the government's drug pricing remedy could be relatively friendly to the pharmaceutical industry. Contrary to Trump's campaign promises, the administration did not propose that the government be allowed to negotiate drug prices, or be allowed to import cheaper drugs from other countries.
Lannett's abbreviated new drug application to market its amantadine hydrochloride capsules USP, 100 mg to prevent and treat influenza A virus infection, drug-induced extrapyramidal reactions and parkinsonism was approved by the FDA. The drug is the therapeutic equivalent of Sandoz Pharmaceuticals' Symmetrel capsules.
Ipsen's Dysport, or abobotulinumtoxinA, has received FDA approval as a treatment for adult patients with lower-limb spasticity. Dysport has already been approved to treat lower-limb spasticity in pediatric patients and upper-limb spasticity in adults.
The FDA has approved the investigational new drug application filed by Cerveau Technologies for its MK-6240, a tau PET imaging agent licensed from Merck. Cerveau will work with pharmaceutical partners to assess the tracer in imaging neurofibrillary tangles in the brain.
BioMarin Pharmaceutical's manufacturing facility in Cork, Ireland, has received approval from the FDA for production of the formulated bulk substance N-acetylgalactosamine 6-sulfatase used in manufacturing Vimizim, or elosulfase alfa, as a treatment for patients with mucopolysaccharidosis IVA. The facility was licensed by the agency for bulk production, QA release, QC testing, packaging and labeling, and distribution.
Golden Platter Foods issued a recall of almost 31,760 pounds of its poultry, beef and turkey products because the batter and cracker meal used in making them may contain undeclared milk, an allergen. The affected products in the recall include eight different product varieties that bear the establishment number EST. 8813 and were shipped to institutional and retail locations in Pennsylvania, Massachusetts, New York and New Jersey.
A group of 18 US lawmakers sent a letter to India's ambassador to Washington asking the country to reconsider its price cap on cardiac stents, because the policy could hamper citizens' access to innovative medical devices and discourage medtech companies from releasing new products in India. "We are especially worried that comments by government officials signal the intention to double down on this dangerous policy and expand price cuts to other medical devices," the lawmakers wrote.
The FDA has given Bayer approval for the Betaconnect electronic autoinjector and its companion app, myBETAapp, for use in patients with multiple sclerosis. The autoinjector facilitates administration of Betaseron, while the app allows data access and sharing between patients and health care professionals because it connects with the autoinjector via Bluetooth technology.
A case presentation at the annual Transcatheter Valve Therapies conference showed positive outcomes from the use of Neovasc's experimental transcatheter device, Tiara, in treating a patient with severe heart conditions. The patient, a 79-year-old man who had poor left ventricular function, ischemic cardiomyopathy and severe mitral valve regurgitation, underwent implantation of the device and was recovering well at home seven weeks after the 30-minute procedure.
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