The US and China are in talks to negotiate better access for Chinese imports of biotech crops as part of a trade deal. The discussion is nearing a deal that could see China buying more US farm biotech crops.
The Environmental Protection Agency and the Energy and Agriculture departments are scheduled to meet today to discuss President Donald Trump's planned changes to the country's biofuel laws. Trump wants to increase sales of higher-ethanol gasoline blends, count ethanol exports toward biofuel volume mandates and reduce the number of waivers that the EPA can grant small refiners.
House lawmakers approved legislation Tuesday that would allow terminally ill patients to request access to experimental drugs that have undergone early-stage clinical trials but have yet to receive approval from the FDA. The bill, which would not require pharmaceutical companies to provide the drugs, was passed by the Senate last year and now goes to President Donald Trump for his expected signature.
Revibe of Missouri, Colorado-based Front Range Kratom and Kratom Spot of California received warning letters from the FDA about selling kratom-containing, illegal, unapproved products, which the firms claim could treat opioid addiction and withdrawal, pain and cancer, as well as lower blood pressure and lessen neuron damage caused by stroke. The agency determined that kratom, which is listed as a "drug and chemical of concern" by the Drug Enforcement Administration, has similar effects to narcotics and has led to dozens of deaths.
The FDA issued warning letters to companies selling dietary supplement pills and capsules, such as Solaricare, Sunsafe Rx, Sunergetic and Advanced Skin Brightening Formula, which claim to protect against the sun. FDA Commissioner Scott Gottlieb said any ingestible sun protection product would be considered a drug, and the FDA has not approved a drug with that claim.
Sanofi's marketing application for Zynquista, or sotagliflozin, was accepted by the FDA for review. The drug is used as an add-on to insulin to help adult patients with type 1 diabetes achieve better blood sugar control.
Eli Lilly's and Co.'s Taltz, or ixekizumab, is the first medication for moderate to severe plaque psoriasis to receive FDA approval to include on its label data on psoriasis involving the genital area. The drug was previously approved as a treatment for patients with psoriatic arthritis and plaque psoriasis.
FDA Commissioner Scott Gottlieb is paving the way for drug developers to advance more gene therapies for various diseases by creating a framework that will guide gene therapy manufacturers. "The first therapeutic area we'll focus on is hemophilia, where factor production may be sufficient in some cases as a surrogate measure of benefit where a gene therapy product can potentially normalize factor production," Gottlieb said.
Mumbai, India-based Sun Pharmaceutical was granted approval by the FDA for its Yonsa, or abiraterone acetate, in combination with methylprednisolone to treat patients with metastatic castration-resistant prostate cancer. The drug will be marketed as a branded therapy.
The Department of Justice filed a civil complaint in the US District Court for the Eastern District of New York on behalf of the FDA, seeking to permanently enjoin Royal Seafood Baza and Euroline Foods for violating the Federal Food, Drug and Cosmetic Act for processing and distributing food in unsanitary conditions. The complaint says the companies, which process and distribute ready-to-eat fish, fishery products, cheese products and vegetable salads in a Staten Island, N.Y., facility that was contaminated with Listeria monocytogenes, failed to adequately implement effective sanitation controls to reduce the risk of such health hazards and comply with Current Good Manufacturing Practices requirements.