Company Insight – Page 26 – media

FDA panel votes in favor of Spark’s blindness gene therapy

Spark Therapeutics Inc's experimental gene therapy for a rare form of blindness improves vision and should be approved, advisers to the Food and Drug Administration concluded on Thursday, paving the way for the first U.S. gene therapy for an inherited disease.
- Source: cnbc
- 1,036
- October 17, 2017
Company Insight gene inherited therapy
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
- 530
- October 13, 2017
Company Insight Consumer Healthcare strategic
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
- 506
- 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
- 825
- October 12, 2017
Company Insight epilepsy New Approvals VNS
Synaptive Medical introduces new surgical robotic device

Canadian firm Synaptive Medical has introduced its second-generation, high-powered Modus V digital microscope that has a robotic arm to aid neurosurgery.
- Source: medicaldevice-network
- 587
- October 11, 2017
Company Insight microscope Modus V neurosurgery
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
- 540
- October 10, 2017
cataract Company Insight IOL New Approvals
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
- 511
- October 9, 2017
Company Insight Implantable hearing solutions iPhone
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
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
- 559
- September 28, 2017
cardiovascular Company Insight diabetes kidney

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