A new variety of biotech fast-growing broccoli, which can grow from seed to harvest in eight to 10 weeks, is being developed by researchers at the John Innes Center in UK. Lead researcher Dr. Judith Irwin said that by using the technology, "growers could turn around two field-based crops in one season, or if the broccoli is grown in protected conditions, four to five crops in a year."
Scientists from the University of Maryland School of Medicine and Rockville biotech firm Sanaria are working on a unique and promising malaria vaccine approach that injects trial patients with the parasite that causes the disease. "It's not the most conventional approach of immunization, but given the magnitude of the malaria problem, it's well worth pursuing," said Pedro Alonso of the World Health Organization.
Valeant Pharmaceuticals Ireland has granted Swedish Orphan Biovitrum AB exclusive rights and license for distribution and sales of Ammonul injection in the Middle East, North Africa and Europe in a three-year agreement that will last until Dec. 31, 2019. Ammonul, or sodium phenyl acetate and sodium benzoate, is indicated for the treatment of acute urea cycle disorders.
The Department of Defense's Defense Advanced Research Projects Agency awarded Ceres Nanoscience a $750,000 grant to support development of its Nanotrap technology to detect Zika and other pathogens. Ceres will collaborate with George Mason University to develop the platform, which will allow for more sensitive detection and more accurate diagnosis.
Trevena's oliceridine has met the primary endpoint of two Phase III studies in which the drug showed analgesic efficacy compared with placebo in the treatment of moderate to severe acute pain after bunionectomy and abdominoplasty. The FDA has conditionally accepted Olinvo as the drug's proprietary brand name.
Celgene's Revlimid, or lenalidomide, has been approved by the FDA as a maintenance drug for patients with multiple myeloma after autologous hematopoietic stem cell transplantation. Two late-stage trials showed a significant increase in progression-free survival of patients compared with no maintenance treatment.
In response to Lannett's request for more time, the FDA has indefinitely suspended the deadline for the company to provide documentation for a hearing to consider the agency's request that the abbreviated new drug application for Lannett's generic attention-deficit/hyperactivity disorder medicine be withdrawn. The FDA will set a new application hearing date for the generic version of Janssen Pharmaceuticals' Concerta after it reviews the submitted materials.
Amicus' Galafold, or migalastat, has been endorsed by the National Institute for Health and Care Excellence for National Health Service use as an alternative treatment to injectable enzyme replacement therapies for Fabry disease. The regulator noted in its final appraisal document that the drug has a lower total cost and potentially greater benefits than ERT, but further studies are needed, especially on long-term use, to fill in gaps in the evidence.
All lots of XtraHRD Natural Male Enhancement capsules have been voluntarily recalled by Organic Herbal Supply after the FDA found the presence of tadalafil, an FDA-approved erectile dysfunction drug, not declared on the label. The product was sold nationwide in 2-, 4- and 10-count packages.
Louisiana-based Pick and Pay/Cili Minerals has been shut down after the US District Court for the Western District of Louisiana approved a consent decree of permanent injunction against the company and the owner for continued violations of the FDA's good manufacturing practice regulations that have gone unaddressed since 2012. The company was found to be selling unapproved and misbranded drugs, and misbranded and adulterated dietary supplements online and in retail locations in Lafayette, La.
- Page 1