The American Medical Association is urging the Justice Department and the Federal Trade Commission to monitor market competition and pricing for insulin, which experienced a cost increase from $4.34 to $12.92 per milliliter between 2002 and 2013, because of the negative financial impact the rising cost has on patients. "The AMA also plans to educate physicians and policymakers on ways to tackle this problem, and transparency from manufacturers and pharmacy benefit managers is a good place to start," says AMA board member William McDade.
The FDA has approved the investigational new drug application for ContraVir Pharmaceuticals' experimental drug CRV431 to treat hepatitis B virus infections, allowing the company to begin its clinical development program. The three-part trial will be conducted in the US and will test CRV431 in patients with HBV as well as in healthy volunteers.
Nightstar Therapeutics' NSR-REP1, being developed to treat choroideremia, was granted regenerative medicine advanced therapy status by the FDA.
A marketing application was filed with the FDA by Motif Bio for its infectious disease product- and fast track-tagged Gram-positive antibiotic iclaprim, being developed to treat patients with acute bacterial skin and skin structure infections.
China's State Drug Administration has given priority review status to Pharnext's new drug application for PXT3003, which is being developed for the treatment of patients with Charcot-Marie-Tooth disease type 1A. The company anticipates data from a late-stage study of the drug, which is an oral solution of baclofen, naltrexone and sorbitol, in the second half of the year.
Kellogg has issued a recall for 1.3 million cases of Honey Smacks cereal because the product is linked to a nationwide salmonella outbreak that has sickened 73 people. Affected in the recall are 15.3-ounce and 23-ounce boxes of the cereal with UPC numbers 3800039103 and 3800014810, respectively, which were shipped throughout the US and in Costa Rica, Guam, Guatemala, the Caribbean, Mexico, Tahiti and Saipan.
A draft guidance on labeling considerations for guidewires, catheters and delivery systems with lubricious coatings and another on performance-testing and labeling to be included in 510(k) submissions for intravascular guidewires have been issued by the FDA. The agency is accepting comments on the documents until Aug. 14.
The Creo Fenestrated Screw System has been launched by Globus Medical for use in treating patients who have advanced-stage tumors of the thoracolumbar spine. The screws in the system are intended to allow restoration of the structural integrity of the spine at metastatic bone disease-affected vertebral levels.
The Canadian Food Inspection Agency reported that Roundup-resistant biotech wheat developed by Monsanto was found in Alberta. Field trials of biotech wheat were previously conducted in Canada, but the wheat has not yet been approved by the CFIA.
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