Amgen and Allergan announced that the first anticancer biosimilars will now be available in the US, consisting of Mvasi, or bevacizumab-awwb, a biosimilar to Avastin, or bevacizumab, which is approved by the FDA for five cancer-related indications, and Kanjinti, or trastuzumab-anns, a biosimilar to Herceptin, or trastuzumab, indicated for HER2-overexpressing oncologic diseases such as breast cancer and for metastatic gastroesophageal junction or gastric adenocarcinoma. Both biosimilars will cost 12% to 15% less than their branded counterparts.
The CMS said it has updated the Medicaid and Children's Health Insurance Program Scorecard data to reflect information on postpartum care, well-child appointments, adult hospitalizations involving diabetes and more. "More states are voluntarily reporting their health outcomes in the scorecard, and the new data is leading us into an era of increased transparency and accountability," CMS Administrator Seema Verma said.
Novartis' Gilenya, or fingolimod, a drug indicated for use as a treatment for patients with multiple sclerosis, has gained the approval of Chinese regulators.
Janssen-Cilag International, a unit of Johnson & Johnson, has filed an extension application with the European Medicines Agency for the approval of its subcutaneous formulation of Darzalex, or daratumumab, indicated for multiple myeloma. An application was also filed by the company with the FDA last week for the same formulation.
Gilead Sciences announced it will acquire three of Novartis' preclinical antiviral programs. Novartis will receive an upfront payment of an undisclosed amount plus $291 million in royalties from annual net sales.
Celltrion of South Korea has entered a joint venture with Hong Kong's Nan Fung Group to create Vcell Healthcare for the production and commercialization of biosimilars in China. Vcell has rights for the development, manufacture and marketing of three of Celltrion's biosimilars -- Remsima, Herzuma and Truxima -- in China.
Inflection Biosciences, an Irish drug developer, has signed an international deal with AUM Biosciences of Singapore for the development of its leading cancer candidate IBL-302, to be renamed AUM302, which has shown potential as a treatment for oncologic diseases such as breast and lung cancer, leukemia and neuroblastoma.
Dova Pharmaceuticals announced that Doptelet, or avatrombopag, will now be commercially available in the US for patients with chronic immune thrombocytopenia who have not responded to prior therapies after the FDA gave its approval for the new indication.
Thailand's Biodiversity-based Economy Development Office, or Bedo, is adopting the use of a DNA barcoding system in order to protect ecological biodiversity by establishing the location of origin for fruit trees, herbs and related plants. Bedo is also collaborating with the country's National Centre for Genetic Engineering and Biotechnology in a study focused on DNA sequencing of plants included in its community biobank in order to settle patent and intellectual property issues faced by manufacturers of Thai supplements and herbal medicines.
The government of Japan has recently revised a policy recognizing ethyl tert-butyl ether's greenhouse gas benefits, and will now allow up to 44% of Japan's total estimated annual demand to be met by US corn-based ethanol. As a result of this policy change, the first shipment of ETBE has been delivered to Japan.
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