Newscast – Page 137 – media

Streamlined CFDA Review Process — New Opportunities in China

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.
- Source: brandwoodbiomedical
- 645
- December 8, 2017
CFDA China medical device
electroCore completes $70 million series B funding round

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.
- Source: globalbiotechinsights
- 525
- December 8, 2017
headache Market Views neuromodulation Series
Tudorza reduces exacerbations and demonstrates cardiovascular safety in COPD patients

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.
- Source: Astrazeneca
- 627
- December 8, 2017
AstraZeneca cardiovascular Clinical Trials COPD
FDA Grants Genentech’s Avastin Full Approval for Most Aggressive Form of Brain Cancer

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.
- Source: Gene
- 559
- December 8, 2017
FDA Genentech New Approvals Roche
Obsidian Therapeutics Announces $49.5 Million Series A Financing to Develop Controllable Cell and Gene Therapy Products

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.
- Source: Businesswire
- 557
- December 8, 2017
CAR–T Market Views Series
Winter could ‘break the backbone’ of the NHS

Health service experts are warning that the NHS could be “sorely tested” in the coming months as it is already running at near maximum capacity with “severe pressure” on the horizon.
- Source: pharmatimes
- 509
- December 8, 2017
NHS Policy
Personalised epilepsy seizure prediction a possibility with AI

The idea of personalised seizure prediction for epilepsy is closer to becoming a reality thanks to new research published today by the University of Melbourne and IBM Research-Australia.
- Source: medicalxpress
- 655
- December 7, 2017
AI epilepsy Researches
3-D mini brains accelerate research for repairing brain function

Three-dimensional neural circuit "asteroid" composed of neurons (blue) and astrocytes (red and green) generated from human pluripotent stem cells.
- Source: sciencedaily
- 429
- December 7, 2017
human stem cells mini brains
Diphtheria is spreading fast in Cox’s Bazar, Bangladesh

Diphtheria is rapidly spreading among Rohingya refugees in Cox’s Bazar, Bangladesh, WHO warned today.
- Source: reliefweb.int
- 915
- December 7, 2017
Diphtheria WHO
Down’s syndrome research breaks new ground

Down's syndrome, also known as trisomy 21, is one of the most common genetic diseases. Researchers from the University of Geneva (UNIGE) and ETH Zurich (ETHZ), Switzerland, have recently analysed the proteins of individuals with trisomy 21 for the first time: the goal was to improve our understanding of how a supernumerary copy of chromosome 21 could affect human development. Published in the journal Nature Communications, the research shows that trisomy 21, far from only affecting the proteins encoded by the chromosome 21 genes, also impacts on the proteins encoded by the genes located on the other chromosomes.
- Source: Medicalxpress
- 609
- December 7, 2017
Down's syndrome Researches

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