StemImmune and Accurexa will collaborate on the development of a stem cell-mediated cancer immunotherapy using StemImmune's immunotherapy, which targets cancer using the patient's stem cells, and Accurexa's targeted therapy delivery methods. Financial terms of the deal were not disclosed.
A supplemental new drug application was approved for Shire's Vyvanse, or lisdexamfetamine dimesylate, updating the drug's label to include longer-term maintenance of efficacy data from a late-stage study of adults with moderate to severe binge-eating disorder. The drug is indicated as a treatment for attention-deficit/hyperactivity disorder and moderate to severe binge-eating disorder in adults.
Intercept Pharmaceuticals has received conditional approval from the European Medicines Agency for Ocaliva, or obeticholic acid, as a treatment for primary biliary cholangitis in combination with ursodeoxycholic acid for adults whose treatment with UDCA is inadequate or as a monotherapy for adults who can't tolerate UDCA.
Allergan's supplemental new drug application to update labeling for Avycaz, a combination of ceftazidime and avibactam, has been accepted for review by the FDA with a decision expected by the first quarter of next year. The firm seeks to expand the current product label with trial findings that show the safety and efficacy of the drug to treat patients with complicated urinary tract infections caused by designated susceptible pathogens.
The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of eight new drugs, including Ferring Pharmaceuticals' Rekovelle for controlled ovarian stimulation in assisted reproduction, Orphan Europe's Cystadrops for treating corneal cystine crystal deposits in cystinosis and three generic drugs to treat HIV infection in adults. The panel also endorsed the authorization of Advanced Accelerator Applications' SomaKit-TOC for use in diagnosing gastroenteropancreatic neuroendrocrine tumors.
A public offering of common stock and warrants has been priced by Biocept in hopes of obtaining about $10 million in gross proceeds. The company, which makes liquid biopsy assays for cancer, did not disclose how it intends to use the proceeds.
Indian drugmaker Cipla has signed an agreement to build a biosimilars manufacturing plant in South Africa, with construction beginning in 2017 and operations projected to begin in the third quarter of 2018.
Monsanto plans to build a 7-acre greenhouse research facility in Marana, Ariz., for biotech corn breeding and trait integration. The facility is for advanced germplasm development and will support the production of biotech and conventional corn inbreds, according to Monsanto.
JetBlue has signed a historic agreement making SG Preston its biofuel supplier for the next decade. "This marks the largest, long-term, commitment globally by any airline for a jet fuel based on fatty acids, a way to extract carbon to burn for energy," writes Sophia Mendelsohn, JetBlue's head of sustainability.
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