ParaPRO granted RedHill Biopharma exclusive rights to market gastroesophageal reflux disease drug Esomeprazole Strontium Delayed-Release capsules to gastroenterologists in some US territories for at least three years. Under the terms of the deal, RedHill will not need to make upfront or milestone payments but will share revenues with ParaPRO.
AstraZeneca and Merck received approval from the FDA to expand the indication for Lynparza, or olaparib, to cover use as a maintenance therapy in patients with recurrent ovarian cancer that is responsive to platinum-based chemotherapy. The drug was previously approved as a treatment for women with advanced ovarian cancer who had at least three prior treatments with chemotherapy and were no longer responding to it.
Patients with chronic lymphocytic leukemia previously treated with ibrutinib had an overall response rate of 71% to CD19-specific chimeric antigen receptor T-cell therapy, according to a study in the Journal of Clinical Oncology. In 17 of 21 patients whose bone marrow was tested with high-resolution flow cytometry, no marrow disease was detected.
Makers of brand-name drugs "game the system and game the rules" of a patient safety program to prevent generic-drug makers from obtaining adequate samples for equivalence studies, says FDA Commissioner Scott Gottlieb, who has vowed action to curb the practice.
EpiPen maker Mylan agreed to pay $465 million as part of a final settlement deal with the Justice Department, resolving claims that the firm overcharged the US government by misclassifying the epinephrine auto-injector as a generic product under Medicaid's Drug Rebate Program while it was being marketed and priced as a branded treatment. The settlement, which requires Mylan to reclassify EpiPen and pay rebates applicable to its new classification effective April 1, was criticized by several lawmakers who believe the settlement is too low.
Johnson & Johnson and India's Institute of Microbial Technology, part of the Council of Scientific and Industrial Research, will collaborate on the research and development of new drug compounds for tuberculosis. The partnership will take advantage of J&J's research capabilities and CSIR-IMTECH's microbial technology competence.
Specialty drugmaker Arbor Pharmaceuticals attracted bids from Shanghai Pharmaceuticals and Fosun Pharmaceutical's Hong Kong unit. Arbor, based in Atlanta, develops treatments for the hospital, pediatric and cardiovascular markets.
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Monsanto secured intellectual property rights to ToolGen's CRISPR technology platform for the development of agricultural products. The agreement could help Monsanto further expand its portfolio of gene-editing tools to develop and improve sustainable crops.
The renewable fuel standard has helped the US economy through the reduction of both fuel prices and oil imports along with increases in tax revenues and GDP, writes Bob Dinneen, president and CEO of the Renewable Fuels Association, citing a study featured in an upcoming issue of the American Journal of Agricultural Economics. "The results that we have presented confirm that the current RFS program considerably benefits the agriculture sector," the authors of the study say.
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