Newscast – Page 165 – media

Cochlear launches iPhone implant sound processor in UK

Implantable hearing solutions provider Cochlear has launched its Nucleus 7 Sound Processor for iPhone cochlear implant in the UK and Ireland markets.
- Source: medicaldevice-network
- 536
- October 9, 2017
Company Insight Implantable hearing solutions iPhone
FDA awards 15 grants for clinical trials to stimulate product development for rare diseases

The U.S. Food and Drug Administration(FDA) announced that it has awarded 15 new clinical trial research grants totaling more than $22 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry across the country.
- Source: fda.gov
- 665
- October 9, 2017
Clinical FDA rare diseases Researches
FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration

The U.S. Food and Drug Administration(FDA) approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip (often referred to as a “fingerstick”).
- Source: fda.gov
- 883
- September 30, 2017
FDA Glucose Monitoring System New Approvals
Merck Discontinues MK-3682B and MK-3682C Development Programs

Merck (NYSE:MRK), known as MSD outside of the United States and Canada, announced its strategic decision to discontinue the development of the investigational combination regimens MK-3682B (grazoprevir/ruzasvir/ uprifosbuvir) and MK-3682C (ruzasvir/uprifosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection.
- Source: Mrknewsroom
- 626
- September 30, 2017
chronic hepatitis C virus (HCV) infection Market Views Merck
FDA approves new treatment for certain advanced or metastatic breast cancers

The U.S. Food and Drug Administration(FDA) approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy).
- Source: fda.gov
- 981
- September 30, 2017
breast cancer FDA New Approvals therapy
FDA rejects Intarcia’s hotly promoted diabetes drug/device, citing manufacturing issues

Boston-based Intarcia Therapeutics became the latest casualty of the FDA’s manufacturing standards. The agency has rejected Intarcia’s implanted diabetes drug/device, which company execs have long insisted is on a straight path to blockbuster sales.
- Source: Endpts
- 465
- September 29, 2017
Company Insight diabetes implanted
Two Scientists Nab Another $20 Million for Their CRISPR Biotech Eligo Bioscience

Eligo Bioscience, the French microbiome company developing drugs to prevent and treat bacteria-associated diseases, has secured a $20 million Series A round of financing from Khosla Ventures and Seventure Partners, including a $2 million award from the Worldwide Innovation Challenge. This comes just months after Eligo was selected as one of the 30 Most Innovative Companies in 2017 by the World Economic Forum. This funding will enable Eligo to strengthen its biotherapeutic platform, begin clinical trials for its lead indication and extensively grow its international team of scientists, engineers, and executives.
- Source: Biospace
- 569
- September 29, 2017
Market Views microbiome Series
Novo Nordisk’s new-generation basal insulin Tresiba® approved in China

Novo Nordisk announced that the China Food and Drug Administration (CFDA) has approved Tresiba® (insulin degludec) for the treatment of diabetes in China. Tresiba® is a new-generation, once-daily basal insulin with an ultra-long duration of action which allows for flexibility in day-to-day dosing.
- Source: Novonordisk
- 585
- September 29, 2017
CFDA diabetes New Approvals Tresiba
Boehringer’s new risk-prediction model will tap patients who could be good Jardiance candidates

Boehringer Ingelheim has reason to believe its diabetes medication Jardiance can help fend off cardiovascular death, kidney failure and hospitalization for heart failure. And now, it’s developing a model to help predict which patients are best suited for treatment with the therapy.
- Source: company insights
- 597
- September 28, 2017
cardiovascular Company Insight diabetes kidney
Siemens gets CE-Mark for new diagnostic solution

Siemens Healthineers has received CE-Mark for its new Atellica Solution with immunoassay and chemistry analysers, which will allow commercial launch in Europe.
- Source: medicaldevice-network
- 583
- September 28, 2017
CE IVD New Approvals

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