Trump's plan to address high drug prices could be pharma-friendly | FDA grants approval to Lannett's ANDA for Sandoz's Symmetrel equivalent | Expanded use of Ipsen's Dysport approved by FDA
June 19, 2017
FDLI SmartBrief
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Drugs & Biologics
Trump's plan to address high drug prices could be pharma-friendly
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.
Politico (6/16),  The Hill (6/17) 
FDA grants approval to Lannett's ANDA for Sandoz's Symmetrel equivalent
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.
Seeking Alpha (free registration) (6/16) 
Expanded use of Ipsen's Dysport approved by FDA
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.
Seeking Alpha (free registration) (6/16) 
Cerveau's IND for tau PET tracer wins FDA approval
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.
Drug Delivery Business News (6/16),  Reuters (6/16) 
Retinal stem cell therapy drug from ReNeuron wins FDA nod
ReNeuron Group's retinal stem cell therapy candidate in a cryopreserved formulation has been approved by the FDA.
Reuters (6/19) 
Global Focus
BioMarin's manufacturing plant in Ireland approved by FDA
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.
European Pharmaceutical Review (U.K.) (6/16) 
Food & Dietary Supplements
Undeclared milk allergen prompts recall of poultry, beef products
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.
Food Poisoning Bulletin (6/16) 
Medical Devices
US lawmakers call for reconsideration of India's cardiac stent price cap
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.
Reuters (6/19) 
FDA OKs Bayer's Betaseron autoinjector, companion app
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.
PMLive (U.K.) (6/19) 
Case presentation shows positive results for Neovasc's transcatheter device
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.
Cardiovascular Business online (6/16) 
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