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Ionis’ Inotersen NDA Accepted for Priority Review by the FDA

Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced that its New Drug Application (NDA) for inotersen has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA). Inotersen is an investigational drug for the treatment of patients with hereditary TTR amyloidosis (hATTR). Priority Review is granted by the FDA to drugs with the potential to address a serious condition and, if approved, would provide a significant improvement in safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of July 6, 2018. “TTR amyloidosis is a progressive, fatal disease with very limited treatment options. Receiving Priority Review in the U.S. and Accelerated Assessment in the EU for inotersen shows that the regulatory agencies recognize the high unmet need and the urgency to identify effective therapies to treat patients with this devastating disease,” said Sarah ...
- Source: Prnewswire;
- 477
- January 10, 2018
FDA hATTR New Approvals TTR amyloidosis
How doctors and bots can work together

The fear that machines will replace humans in the workplace is not a new one. In 1930, economist John Maynard Keynes conjectured that in the years to come, modern economies would face a new kind of affliction: what Keynes called “technological unemployment.”
- Source: Venturebeat
- 540
- January 10, 2018
AI digital health Market Views
Med-tech startup Metavention raises $65M, names new CEO

Metavention Inc., a startup developing a medical device to treat Type 2 diabetes, has closed on $65 million in venture capital and named former Torax Medical Inc. CEO Todd Berg its top executive
- Source: Business Journal
- 641
- January 10, 2018
Company Insight diabetes medical device
Latest Chinese Medical Device Regulatory Changes Affect Clinical Trials, Testing, Telehealth

The China Food and Drug Administration (CFDA) has announced new and updated regulations for medical device registration, testing and clinical trial requirements in the early days of 2018.
- Source: Emergo
- 804
- January 10, 2018
CFDA Clinical Trials medical device polices
Pfizer lines up an $830M alliance with Arvinas on protein degradation

Pfizer has signed on to fund the launch of a hunt for a slate of small molecules that can degrade proteins, a key therapeutic pathway that’s been playing a role in prostate cancer and other areas.
- Source: Endpts
- 489
- January 10, 2018
C4 Therapeutics Market Views Pfizer protein degradation
Increasing Rates of Surgery for Patients With Non-Malignant Colorectal Polyps in the United States

Despite the availability of endoscopic therapy, many patients in the United States undergo surgical resection for non-malignant colorectal polyps. We aimed to quantify and examine trends in the use of surgery for non-malignant colorectal polyps in a nationally representative sample.
- Source: gastrojournal.org
- 368
- January 10, 2018
endoscopic therapy non-malignant colorectal polyps Researches
Busy Takeda Takes Out Tigenix in $630M Deal

Shares of Belgium-based TiGenix NV shot up more than 72 percent in pre-market trading after Japan’s Takeda Pharmaceuticals opted to acquire the company with which it has a developmental partnership for $630 million.
- Source: Biospace
- 513
- January 9, 2018
Market Views pharmaceutical company stem cells
Sangamo and Pfizer announce collaboration for development of zinc finger protein gene therapy for ALS

Sangamo Therapeutics, Inc. and Pfizer Inc. announced a collaboration for the development of a potential gene therapy using zinc finger protein transcription factors to treat amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration (FTLD) linked to mutations of the C9ORF72 gene.
- Source: Prnewswire
- 448
- January 9, 2018
ALS FTLD Market Views neurodegenerative disease
Cancer deaths decline again in US

The cancer death rate in 2015 was 14 percent higher in blacks than in whites, down from a peak of 33 percent in 1993.
- Source: msn
- 545
- January 9, 2018
cancer Death rates smoking
California researchers highlight the benefits of total body scanner

The new total-body PET/CT scanner could revolutionize the understanding and treatment of disease through analysis of better imaging data from the whole body.
- Source: biospectrumasia
- 559
- January 9, 2018
PET PET sensitivity total-body PET/CT scanner

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