The Caribena brand of Maradol papayas has been recalled by the FDA after being linked to a salmonella outbreak in 12 states. The papayas come from Mexico and go through Texas, and the FDA is looking into whether other brands are also involved in the outbreak.
Six public health groups have filed motions in federal district courts in the District of Columbia and Alabama to intervene in two lawsuits filed by the Cigar Association of America and Cyclops Vapor 2 against the FDA and its regulation requiring warnings on e-cigarettes and cigars and mandating that the products be subject to FDA approval. The motion filed by the American Cancer Society Cancer Action Network, American Academy of Pediatrics, American Heart Association, American Lung Association and the Campaign for Tobacco-Free Kids Truth Initiative said that rolling back the rule would have a "direct adverse effect on public health, particularly among youth."
Forget the mood rings. The Massachusetts Institute of Technology Media Lab's spinout mPath has created a wearable device that can determine the exact moment a wearer is experiencing certain subconscious emotions. The MOXO wearable was originally developed to study the stress levels of children who have autism. Now, Denver-based mPath is using the sensor to help bring market research insights to companies to help improve their product offerings. Read the story.
A round of Series C financing led by Tiger Partners and Forbion Capital Partners pulled in $30 million for Exosome Diagnostics. The proceeds will be used for a rapid commercial expansion of the ExoDx Prostate (IntelliScore) test, as well as to commercialize oncological diagnostics, develop tests for other applications, conduct investigations into new technologies and expand the company's companion diagnostics and instrumentation arms.
Bristol-Myers Squibb's supplemental biologics license application for a new dosing regimen of Opdivo -- 480 mg infused for 30 minutes every four weeks -- for all monotherapy indications has been accepted for review by the FDA with an action date of March 5, 2018.
Nektar Therapeutics' NKTR-358 for immune system imbalance in patients with multiple autoimmune diseases will be co-developed by Eli Lilly and Co. in an agreement worth up to $400 million. In preclinical trials, the drug candidate demonstrated profound effects on regulatory T cells and suppressed inflammation in multiple models.
Parkinson's disease drug firm NeuroDerm has been acquired by Mitsubishi Tanabe Pharma for $1.1 billion. NeuroDerm has a pipeline of subcutaneously administered drug candidates indicated for treatment of patients who no longer respond to oral levodopa therapy.
The comment period for the Environmental Protection Agency's proposed Renewable Fuel Standard for 2017 and requirements for biomass-based diesel for 2019 is open until Aug. 31. The proposed standard would set the 2018 RFS level for conventional biofuel at 15 billion gallons and lower the cellulosic biofuel requirement to 238 million gallons. The minimum biomass-based diesel volume requirement for 2019 would remain at 2.1 billion gallons.
Perrigo's Testosterone Topical Solution 30mg/1.5mL, for use as a replacement therapy in males with conditions related to deficiency or absence of endogenous testosterone, has been launched. Perrigo's solution is a generic version of Eli Lilly and Co.'s Axiron Topical Solution.
The European Medicines Agency has accepted into its PRIME priority medicines program Tocagen's high-grade glioma drug Toca 511, or vocimagene amiretrorepvec, which will fast-track the drug's review process in Europe. The drug candidate is in an ongoing midstage trial
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