Rep. Duncan Hunter, R-Calif., is expected to introduce a bill this week that would exclude e-cigarettes and vaping devices from FDA review and authorization before being brought to market, repealing former President Barack Obama's "Deeming Rule" that considers the items to be tobacco products and subject to the same regulations as cigarettes. A separate bill that is expected to be attached as a rider to Trump's spending bill would exempt thousands of vaping devices already on the market from FDA oversight.
An artificial womb developed at Children's Hospital of Philadelphia allowed premature lambs to survive and mature normally outside the mother's womb for about a month, according to a report in Nature Communications. The device, which may allow very premature babies to survive, is made up of a clear plastic bag filled with synthetic amniotic fluid and is attached to an external machine that provides nutrition and oxygen and removes carbon dioxide.
Scientists analyzed the genomes of 1,346 dogs representing 161 breeds, compared 150,000 spots on each genome, and developed a graph that shows the breeds' relative connections. Nearly all the breeds could be categorized into one of 23 clades, and the findings, published in Cell Reports, could help veterinarians better understand the role of genetics in shared conditions.
The FDA has granted approval to Regeneron Pharmaceuticals and Sanofi's new supplemental biologics license application for a once-a-month dosing option for their cholesterol drug Praluent, or alirocumab, in a 300-mg injection. Praluent is an adjunct treatment, to be used with diet and a maximally tolerated statin drug, to address heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease in adults who need additional lowering of their LDL cholesterol.
Fresenius SE & Co. KGaA unit Fresenius Kabi agreed to purchase Merck KGaA's biosimilar unit for approximately $185.2 million upfront and up to approximately $544.7 million in milestones, plus royalties on sales. Fresenius will also acquire generic drugmaker Akorn for about $4.3 billion.
The European Commission has granted full marketing authorization to AstraZeneca's once-daily Tagrisso 40- and 80-mg tablets as a treatment for adult patients with epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer. The approval was based on late-stage trial data.
A large financing round has raised $15 million for San Diego-based Forge Therapeutics. The proceeds will be used to advance the company's gram-negative antibiotics program and will allow it to move out of its incubator space at Johnson & Johnson's JLABS.
BIO, the Renewable Fuels Association and other biofuel groups issued a statement in response to oral arguments presented to a federal appeals court regarding the petition to review the Renewable Volume Obligations for 2014-16. The groups said the proceedings strengthened their opinion that "renewable fuel targets for 2014 through 2016 were legally and factually indefensible, as well as wholly inconsistent with Congressional intent behind the Renewable Fuel Standard program."
Four online advisory letters and 14 warning letters were issued by the FDA to US-based firms for marketing and selling more than 65 products with claims that they could cure, prevent or reverse cancer, although the claims are not proven and the products have not gotten the approval of the FDA. The agency gave the companies 15 days to respond with plans on how they will address their violations, and companies that do not comply face product seizure and criminal prosecution that could result in a year in federal prison and a fine of either $100,000 or twice the company's gain on the fraudulent products.
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