Newscast – Page 162 – media

NICE flip-flops to back Bristol’s Opdivo in head and neck cancer despite data ‘uncertainties’

Back in April, England’s cost watchdogs said they wouldn’t cover Bristol-Myers Squibb’s Opdivo in head and neck cancer due to “uncertain” clinical evidence. Now, though, they’re singing a different tune.
- Source: Fiercepharm
- 552
- October 16, 2017
New Approvals NHS Opdivo
Ebola vaccines from GSK, Merck elicit yearlong response, study finds

After initially setting out to test two vaccines on 28,000 volunteers during West Africa's deadly Ebola epidemic, a U.S.-Liberia research team had to dramatically reduce its aspirations when the outbreak started coming to an end. But the investigators have now published results showing the shots from GlaxoSmithKline and Merck elicited antibody responses that lasted one year after vaccination.
- Source: Fiercepharma
- 802
- October 16, 2017
aspirations Clinical Trials Ebola
University of Texas to develop cheap at-home test for heart failure

A research team at the University of Texas, US, is set to develop an affordable at-home diagnostic test for patients with heart failure.
- Source: medicaldevice-network
- 795
- October 16, 2017
diagnostic heart Researches
Ardelyx’s Pivotal Phase 3 Study of Tenapanor for IBS-C Hits Primary and All Secondary Endpoints to Support NDA Submission in 2018

Ardelyx, Inc. (ARDX) reported positive results from T3MPO-2, its second Phase 3 study of tenapanor for irritable bowel syndrome with constipation (IBS-C). The study hit statistical significance for the primary endpoint and all secondary endpoints evaluated for the topline results and demonstrated the ability to normalize bowel movements.
- Source: finance.yahoo
- 557
- October 16, 2017
bowel syndrome Clinical Trials constipation
NIH accelerates the development of new cancer immunotherapy strategies for more patients

The National Institutes of Health(NIH) and 11 leading biopharmaceutical companies have launched the Partnership for Accelerating Cancer Therapies (PACT), a five-year public-private research collaboration totaling $215 million as part of the Cancer Moonshot.
- Source: nih.gov
- 550
- October 16, 2017
Market Views NIH PACT
Durable end to the HIV/AIDS pandemic likely will require an HIV vaccine

Despite remarkable gains in the treatment and prevention of HIV infection, development of an effective HIV vaccine likely will be necessary to achieve a durable end to the HIV/AIDS pandemic, according to a new commentary from Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
- Source: Sciencedaily
- 563
- October 13, 2017
AIDS HIV Researches vaccine
Cholesterol byproduct hijacks immune cells, lets breast cancer spread

High cholesterol levels have been associated with breast cancer spreading to other sites in the body, but doctors and researchers don't know the cause for the link. A new study by University of Illinois researchers found that the culprit is a byproduct of cholesterol metabolism that acts on specific immune cells so that they facilitate the cancer's spread instead of stopping it.
- Source: Medicalxpres
- 721
- October 13, 2017
breast cancer cholesterol metabolism Researches
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
- 523
- 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
- 527
- 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
- 547
- October 13, 2017
EGFR New Approvals NSCLC sNDA

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