X-Chem and Ono Pharmaceutical have entered into a collaboration to develop cancer drugs using X-Chem's DNA-encoded DEX libraries. X-Chem will receive an upfront payment and research and licensing fees, and is entitled to development and regulatory milestone payments, while Ono gets the option to license certain compounds and develop and market programs arising from the collaboration.
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The FDA has approved Newron Pharmaceuticals' Xadago, or safinamide, as an add-on drug for patients with Parkinson's disease. Xadago is indicated for patients who already take levodopa/carbidopa but experience "off" episodes in which the treatment is not effective.
A regenerative medicine advanced therapy designation has been granted by the FDA to Humacyte's Humacyl, which was developed as a treatment for patients with kidney failure who can't receive fistula placement. Humacyte anticipates data from a late-stage trial of Humacyl by next year.
The FDA has granted tentative approval to Mylan's efavirenz, lamivudine and tenofovir disproxil fumarate tablets, 400 mg/300 mg/300 mg, or TLE400, under the President's Emergency Plan for AIDS Relief. TLE400 will be available as a first-line treatment in patients with HIV-1/AIDS infection.
Eli Lilly and Co.'s LY2835219, or abemaciclib, met the primary endpoint of a late-stage study in which the drug showed significant improvement in progression-free survival when combined with Faslodex, or fulvestrant, in postmenopausal women with hormone receptor-positive, HER2-negative breast cancer, compared with Faslodex as monotherapy. The company intends to file a new-drug application to the FDA this year.
Switzerland-based Debiopharm International will market its Decapeptyl and Pamorelin 22.5 mg, a triptorelin 6-month formulation, to 22 European countries after the drug received approval for use in treating central precocious puberty. The formulation was already registered as a prostate cancer treatment to the same countries.
Lin BioScience has been granted exclusive worldwide rights to develop and market the University of Sydney's blood-brain barrier permeable, small-molecule drug LBS-002 for brain cancer treatment. Financial details of the deal were not disclosed.
A Series B financing round has pulled in $64 million for Sutro Biopharma spinout SutroVax. The funding will be used to support a midstage trial of the company's lead pneumococcal conjugate vaccine candidate.
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Princess Anne of Britain said biotech crops and livestock provide important benefits in food production and that she would grow them on her farmland. "Surely if we are going to be better at producing food of the right value, then we have to accept that genetic technology ... is going to be part of that," Princess Anne said.
A team of researchers from Minnesota discovered that the endoplasmic reticulum, an organelle in fungal cells, synthesizes some sesquiterpenes that are a potential precursor to biofuels. Researchers suggest the sesquiterpene bisabolene may be a precursor to biodiesel, and biofuel and other valuable products could be generated by engineering the biochemical pathway in which the molecules are produced in fungal cells.
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