The company, which was founded in 2015, also announced that it has raised $3.4 million in seed funding, from DCM, Khosla Ventures, and Founders Fund.
The FDA's Center for Devices and Radiological Health plans to expand its digital health pre-certification pilot program by the end of 2018, the center's associate director for digital health Bakul Patel said March 22, according to Regulatory Focus.
Six big contract research companies, alongside Veeva Systems, are for the first time coming together to develop open technology standards aimed at “transforming clinical trial ops” to speed up development.
Global pharmaceutical company Mylan N.V. (MYL) today announced that it will introduce in the U.S. a third cost-saving HIV combination. The U.S. Food and Drug Administration (FDA) approved Symfi™ (efavirenz, lamivudine and tenofovir disoproxil fumarate) 600 mg/300 mg/300 mg tablets, a once-daily, single-tablet regimen (STR), indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.
Patients can access their record through a code for their iPhone. The idea is to help patients better understand their medical history, improve the quality of interactions with their physicians and family members, and make more informed decisions about their care.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced that the Company presented new results from the APOLLO Phase 3 study of patisiran, an investigational, RNAi therapeutic for the treatment of hereditary ATTR (hATTR) amyloidosis at the 16th International Symposium on Amyloidosis (ISA), being held March 26-29, 2018 in Kumamoto, Japan. In addition, the Company presented new data from the Phase 1 study of ALN-TTRsc02, an investigational, subcutaneously administered RNAi therapeutic in development for the treatment of ATTR amyloidosis.
This week, Bigfoot Biomedical announced a $55 million Series B to advance their push to integrate glucose monitoring, insulin delivery and smart software. The financing will support a pivotal trial and other efforts to gain premarket approval(PMA) from the FDA.
Medtronic has finally received FDA clearance for Guardian Connect, its smartphone-connected standalone CGM for patients who use multiple daily injections (MDI) for their insulin. Medtronic's closed-loop system for pump users was cleared in 2016.
Sequoia China has powered Adagene to a $50 million series C round. The investment positions the Chinese antibody discovery shop to move the most advanced assets in its oncology pipeline into human testing.
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