Newscast – Page 163 – media

Respicardia gets FDA approval for remede system to treat sleep apnea

The US Food and Drug Administration (FDA) has approved Respicardia’s transvenous implantable neurostimulation system, remede, for moderate to severe central sleep apnea (CSA) in adults.
- Source: medicaldevice-network
- 530
- October 13, 2017
CSA FDA neurostimulation New Approvals
Pfizer reviewing strategic alternatives for consumer healthcare business

Pfizer Inc. announced that it is reviewing strategic alternatives for its Consumer Healthcare business. A range of options will be considered, including a full or partial separation of the Consumer Healthcare business from Pfizer through a spin-off, sale or other transaction, and Pfizer may ultimately determine to retain the business. Today’s announcement is part of Pfizer’s continuing efforts to allocate resources and capital to best serve patients and maximize value for its shareholders.
- Source: Pfizer
- 541
- October 13, 2017
Company Insight Consumer Healthcare strategic
FDA Grants Priority Review To Gilotrif For Uncommon EGFR Mutations In Advanced NSCLC

Boehringer Ingelheim announced that the supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). The application for Gilotrif is currently under review for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 21 (L861Q), G719X or S768I substitution mutations as detected by an FDA-approved test.
- Source: careers.biospace
- 554
- October 13, 2017
EGFR New Approvals NSCLC sNDA
ICR researchers demonstrate use of genetic test for prostate cancer therapy

Scientists from the Cancer Biomarkers laboratory team of the Institute of Cancer Research in the UK have carried out research to demonstrate the use of a quick genetic test for the targeted treatment of prostate cancer.
- Source: medicaldevice-network
- 650
- October 12, 2017
cancer genetic prostate Researches
Pfizer unloads Colorado plant as it continues to hive off unwanted Hospira operations

Pfizer has sold another Hospira plant, its second in eight weeks, as it continues to whittle down the unwanted operations it picked up in its $15 billion buyout of the sterile drug manufacturer.
- Source: Fiercepharm
- 515
- October 12, 2017
API Company Insight Hospira
FDA approves LivaNova’s VNS therapy system for epilepsy

UK-based firm LivaNova has obtained approval from the US Food and Drug Administration (FDA) for its new Vagus Nerve Stimulation (VNS) Therapy System designed to treat drug-resistant epilepsy.
- Source: medicaldevice-network
- 832
- October 12, 2017
Company Insight epilepsy New Approvals VNS
Merck buys into KalVista and its DME candidate

Shares in KalVista Pharmaceuticals have surged on news of a deal with Merck & Co potentially worth more than $750 million. Under the deal, Merck, which is known as MSD outside of the US and Canada, is paying KalVista $37 million upfront and taking a 9.9 percent stake in the firm in return for access to its experimental diabetic macular oedema drug KVD001.
- Source: Pharmatime
- 600
- October 12, 2017
diabetic macular Market Views oedema
FDA grants orphan drug status to UniQure’s Huntington’s Disease treatment

Dutch biotech UniQure has won orphan drug designation (ODD) for its investigational treatment for Huntington’s Disease, a rare, inherited neurodegenerative disorder that leads to loss of muscle coordination, behavioural abnormalities and cognitive decline.
- Source: 4-traders
- 762
- October 12, 2017
Huntington’s Disease neurodegenerative New Approvals ODD
Ebola vaccine tests hailed a success

The worst Ebola virus disease outbreak in history ended in 2016 after infecting 28,600 people and killing about 11,300 worldwide.
- Source: medicalxpress
- 1,181
- October 11, 2017
Ebola Market Views vaccine
Nanopatch polio vaccine delivers

Efforts to rid the world of polio have taken another significant step, thanks to research led by University of Queensland bioscience experts and funding from the World Health Organisation (WHO).
- Source: sciencedaily
- 638
- October 11, 2017
polio Researches WHO

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