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FDA rolls out an early and historic OK for Spark’s pioneering gene therapy

Spark Therapeutics $ONCE has scored an historic FDA approval of Luxturna, the world’s first such AAV-delivered gene therapy designed to cure a rare eye disease triggered by a genetic mutation. The drug is OK’d for RPE65 mutation linked retinal dystrophy. The treatment uses a viral vector to insert the correct copy of a gene retinal cells need to create a protein that turns light into electric signals which can restore vision lost to the disease. As with the earlier pioneering approval of the world’s first CAR-T, FDA commissioner Scott Gottlieb did the honors in recognizing the importance of this approval. And he says the agency will make sure that the regulatory path is straight and clear for the rest of the field looking to following Spark’s footsteps. “We’re at a turning point when it comes to this novel form of therapy and at the FDA, we’re focused on establishing ...

Source: drugdu
752
December 20, 2017

Ultragenyx Sells Priority Review Voucher for $130 million

“The sale of the PRV provides us with an important source of non-dilutive capital to help advance our pipeline of rare and ultra-rare therapies, and accelerates the availability of these potential therapies to patients,” said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx.

Source: finance.yahoo
716
December 20, 2017

FDA Market Views Novartis PRV

Are You Doing A Good Job In Bed?

A lack of sleep has been linked to high blood pressure and other cardiovascular ailments, mental health conditions like depression and weight-related issues such as obesity and diabetes.

Source: msn
660
December 20, 2017

diabetes high blood pressure obesity Researches sleep

Blockchain Health Tech Company Launches with $3.5 Million Seed

Curisium, a new healthcare technology that builds blockchain-based contracting technology for payers, providers, and life sciences companies, officially launche with the announcement that it has secured $3.5 million in seed funding.

Source: hcanews
652
December 19, 2017

Market Views Sanofi seed funding Series

Artificial Intelligence Could Help in Breast Cancer Diagnosis

Researchers say AI procedure was successful in detecting the spread of breast cancer. It’s the latest artificial intelligence innovation in the medical world.

Source: healthline
650
December 19, 2017

Artificial Intelligence breast cancer Researches

Electric eel-inspired devices could power artificial human organs

A flexible and transparent power source inspired by the electric eel could be used to power electrical devices in the body, such as cardiac pacemakers, implantable sensors or even prosthetic organs. The prototype, described in Nature1 on 13 December, runs on a solution of salt and water, but researchers hope that future versions might get their energy from bodily fluids.

Source: nature
450
December 19, 2017

electrical devices Researches

US FDA Accepts Regulatory Submission for TAGRISSO (Osimertinib) in 1st-Line EGFR-Mutated Non-Small Cell Lung Cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of TAGRISSO® (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations). The FDA has granted TAGRISSO Priority Review status, and previously granted Breakthrough Therapy Designation for TAGRISSO in the 1st-line treatment of patients with metastatic EGFR mutation-positive (EGFRm) NSCLC.

Source: finance.yahoo
613
December 19, 2017

AstraZeneca CNS FDA New Approvals NSCLC TAGRISSO®

FDA Accepts Biologics License Application for Fremanezumab with Priority Review for Prevention of Migraine and Grants Fast Track Designation for Cluster Headache Development Program

Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraine. Additionally, the FDA has granted fast track designation for fremanezumab for the prevention of cluster headache.

Source: finance.yahoo
570
December 19, 2017

cluster headache FDA fremanezumab migraine New Approvals Teva

Novartis-backed resTORbio raises $40M for aging disease trials

Boston biotech resTORbio has pocketed another $40 million from a second-round financing that it hopes gives it enough cash to move its lead candidate for respiratory tract infections in elderly patients into phase 3.

Source: Fiercebiotech
619
December 19, 2017

financing immune system Market Views Novartis

No interventions proven to prevent late-life dementia

There is no proven intervention for preventing late-life dementia. Researchers from the Minnesota Evidence-based Practice Center (EPC) reviewed published research to determine if physical activity, prescription medications, over-the-counter vitamins and supplements, or cognitive training interventions could help to prevent dementia in patients who did not have it at the time of the studies. The vast majority of research showed that none of the interventions worked. Findings from four systematic evidence reviews are published in Annals of Internal Medicine.

Source: medicalxpress
414
December 19, 2017

late-life dementia Researches

FDA rolls out an early and historic OK for Spark’s pioneering gene therapy

Ultragenyx Sells Priority Review Voucher for $130 million

Are You Doing A Good Job In Bed?

Blockchain Health Tech Company Launches with $3.5 Million Seed

Artificial Intelligence Could Help in Breast Cancer Diagnosis

Electric eel-inspired devices could power artificial human organs

US FDA Accepts Regulatory Submission for TAGRISSO (Osimertinib) in 1st-Line EGFR-Mutated Non-Small Cell Lung Cancer

FDA Accepts Biologics License Application for Fremanezumab with Priority Review for Prevention of Migraine and Grants Fast Track Designation for Cluster Headache Development Program

Novartis-backed resTORbio raises $40M for aging disease trials

No interventions proven to prevent late-life dementia

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