The World Health Organization has released an updated model list of essential medicines, which now includes 12 new treatments for diseases such as leukemia, melanoma, multiple myeloma, and prostate and lung cancers. The revised list, which is recommended internationally for public health systems, now contains 460 products due to the addition of 23 medicines for children and 28 for adults, and also includes new uses for 26 products already included in the list.
The marketing application for Sandoz's generic version of AstraZeneca's Farxiga, or dapagliflozin, a type 2 diabetes medication, has received tentative approval from the FDA.
Horizon Therapeutics' new drug application for its new dosage formulation for Procysbi, or cysteamine bitartrate, has been accepted by the FDA for review. Procysbi is indicated as a treatment of nephropathic cystinosis in patients age 12 months and older.
The FDA has accepted the marketing application filed by Allergan for its Bimatoprost Sustained-Release implant, used to reduce intraocular pressure for patients with ocular hypertension or open-angle glaucoma. The agency set the action date for the first half of 2020.
South Korean biotech Orum Therapeutics gained $30 million from a Series B funding round that it will use to expand its proprietary antibody platform technology Oromab, which targets undruggable proteins.
MacroGenics reports that their collaboration and licensing agreement with Laboratoires Servier will be terminated no later than the middle of January next year. Termination of the agreement will mean that MacroGenics will regain full global rights to flotetuzumab, which it is developing as a treatment for primary refractory acute myeloid leukemia.
The USDA Foreign Agricultural Services Global Agricultural Information Network has released a report suggesting that South Korea is considering revisions to its ethanol-blended fuel regulations. The South Korean government has conducted a feasibility study for the use of ethanol-blended fuels in the transportation sector.
Chembio Diagnostics and Shire Human Genetic Therapies, a unit of Takeda, have agreed to work together to develop a point-of-care diagnostic test for an undisclosed biomarker based on Chembio's DPP platform and hand-held optical analyzer. Financial terms of the deal were not disclosed.
The FDA granted Centinel Spine investigational device exemption approval to move forward with its evaluation of prodisc C Vivo and prodisc C SK anterior cervical total disc devices through a two-level clinical safety and efficacy study.
A series C funding round raised $17.5 million for Seer, a startup that is focused on several programs, including the development of liquid biopsies for early disease detection for use in cancer and neurological diseases.
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