Newscast – Page 164 – media

AstraZeneca’s Tagrisso Gets Breakthrough Therapy Designation

AstraZeneca announced that the FDA has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
- Source: finance.yahoo
- 579
- October 10, 2017
Company Insight EGFR FDA New Approvals NSCLC
Alcon gets CE-Mark for new preloaded IOL delivery system

Novartis’ division Alcon has obtained CE-Mark for its AutonoMe preloaded intraocular lens (IOL) delivery system to accurately deliver the IOL into the capsular bag during cataract surgery. The AutonoMe system is preloaded with a new biomaterial called Clareon IOL that features an advanced design for sharp vision, low edge glare and enhanced optic clarity. With an automated CO2-powered delivery mechanism, the preloaded system is intended to enable accurate single-handed control of IOL placement. Alcon CEO Mike Ball said: “With the introduction of Clareon AutonoMe, we are proud to unveil our latest innovations to benefit doctors and their patients undergoing cataract surgery. “Clareon AutonoMe builds upon the comprehensive legacy of AcrySof by offering cataract surgeons easy, intuitive control of IOL delivery with the newest optic material.” “The intuitive and easy-to-use device is expected to simplify the procedure and minimise surgical time.” The intuitive and easy-to-use device is expected to simplify the procedure ...
- Source: medicaldevice-network
- 537
- October 10, 2017
cataract Company Insight IOL New Approvals
Cardiologs raises $6m in Series A to support ECG Analysis Platform

Cardiologs Technologies said this week it raised $6.4 million in a Series A round of financing to support accelerated commercialization of its Cardiologs ECG Analysis Platform in the US and Europe.
- Source: Massdevice
- 471
- October 10, 2017
Cardiologs Market Views Series
Big Pharma Gets Boost as China Speeds Up New Drug Approvals

For decades, Chinese patients have struggled to gain access to cutting-edge medicines thanks to bureaucratic delays that have hamstrung drug development. Now a sweeping government overhaul of drug approvals is poised to change that.
- Source: bloomberg
- 512
- October 10, 2017
Chinese drug approval Market Views
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
- 509
- 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
- 618
- 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
- 839
- 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
- 593
- 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
- 881
- 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
- 426
- September 29, 2017
Company Insight diabetes implanted

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