Oxitec signed a deal with an undisclosed partner to develop a self-limiting soybean looper, or Chrysodeixis includens, which threatens a variety of crops. The company is developing biotech male insects that carry genes that kill all female offspring.
Legislation that would increase the legal age to purchase tobacco products to 21, as well as prohibit cigarette and e-cigarette marketing to youths younger than 21 and non-face-to-face sales of tobacco, was introduced by House Energy and Commerce Chairman Frank Pallone Jr., D-N.J., and Rep. Donna Shalala, D-Fla. The Reversing the Youth Tobacco Epidemic Act would also mandate the inclusion of graphic health warnings on cigarette ads and packages and make FDA cigarette sales and distribution regulations applicable to e-cigarettes and smokeless tobacco.
An animal rights organization bought a billboard ad urging President Donald Trump to cut $15 billion from the NIH's budget so that the agency will stop funding biomedical research that involves animals. If the president does the group's bidding, valuable research will grind to a halt and countless people -- as well as dogs and cats -- will die of otherwise treatable diseases, writes FBR President Matthew R. Bailey.
Scientists used an engineered version of antibodies from alpacas and chimeric antigen receptor T cells to penetrate protective barriers on solid tumors. The researchers reported in Proceedings of the National Academy of Sciences that the new cells slowed tumor growth and extended survival in mouse models of colon cancer and melanoma.
The FDA agreed that Mesoblast can file on a rolling basis a biologics license application for allogeneic cellular medicine remestemcel-L in pediatric patients with steroid-refractory acute graft-versus-host disease. In an open-label study, complete or partial response was observed in 69% of children who received the drug versus a historical control response rate of about 45%.
CRISPR Therapeutics and Vertex Pharmaceuticals' transfusion-dependent beta-thalassemia drug candidate CTX001 has received fast-track designation from the FDA. The companies launched a Phase I/II study of the drug in February.
Ultragenyx Pharmaceutical's UX007, being developed to treat patients with long-chain fatty acid oxidation disorders, has received fast-track and rare pediatric disease designations from the FDA.
The FDA has ordered the removal of Boston Scientific's and Coloplast's transvaginal surgical mesh products for the repair of pelvic organ prolapse from the US market because neither company demonstrated that the products are safe and effective.
The FDA is taking steps to implement additional regulatory actions, including consulting with federal health experts for guidance, to reduce the risks of contamination and infections associated with duodenoscopes, said Center for Devices and Radiological Health Director Jeffrey Shuren. The FDA is collaborating with device makers on disposable duodenoscopes that would make reprocessing unnecessary and on new device designs that may decrease contamination risks.
The FDA and CDC are investigating a Salmonella Newport outbreak linked to raw ground tuna that has sickened 13 people in seven states. States with reported cases are Connecticut, Iowa, Illinois, Minnesota, North Dakota, New York and Washington, according to the CDC.