Gilead Sciences, Inc. GILD and its newly acquired cell therapy subsidiary -Kite Pharma- announced that they have inked an agreement to acquire Cell Design Labs, Inc. for $567 million. Gilead will also acquire 12.2% of Cell Design shares which are owned by Kite Pharma.
Medical researchers are increasingly turning to mobile devices such as smartphones and watches as a way to monitor patients in trials, an approach they hope improves participation and accuracy but that also has limitations.
The Draft Amendment to Order 650 published by CFDA last month brings some good news around the streamlined reviews of medical device submissions in China and especially for manufacturers of Innovative Devices. Not only will manufacturers of innovative medical devices be exempted from providing proof of sales abroad to CFDA, the mandatory local type testing requirements are also abolished. Nevertheless, there still exist some challenges for the unwary.
electroCore, a U.S.-based bioelectronic medicine healthcare company advancing better patient therapies through superior approaches to neuromodulation, has announced it completed its Series B financing that has brought in just over $70 million of capital to the company.
AstraZeneca today announced positive top-line results of the Phase IV ASCENT trial for Tudorza Pressair (aclidinium bromide 400 μg, twice-daily), a long-acting muscarinic antagonist (LAMA), in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), with a history of cardiovascular disease and/or significant cardiovascular risk factors.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has granted full approval for Avastin® (bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy (referred to as recurrent disease). Avastin was previously granted provisional approval in this setting under the FDA's accelerated approval program.
Obsidian Therapeutics, Inc., a biotechnology company dedicated to the development of next-generation cell and gene therapies with pharmacologic operating systems, announced the completion of a $49.5 million Series A financing to further build its technology platform and advance its lead programs toward clinical development.
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