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).
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 ...
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.
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.
Roche has received European Commission(EC) approval for its anti-PD-L1 cancer immunotherapy Tecentriq (atezolizumab) to treat specific lung and bladder cancers. The green light means that it can be used as monotherapy for people in the EU with previously-treated locally advanced or metastatic non-small cell cancer (NSCLC), or those with metastatic urothelial carcinoma (mUC) who have received a platinum-based chemotherapy or who are ineligible to receive cisplatin chemotherapy.
Regardless of what it’s protecting you against, few people would likely say that getting a vaccine injection is an altogether enjoyable vaccine. Fortunately, engineers at the Massachusetts Institute of Technology are coming to the rescue with a new 3D fabrication technique that could allow for multiple doses of a drug or vaccine to be delivered to a patient over an extended period of time — with just one jab needed.
Medtronic has secured the US Food and Drug Administration (FDA) approval for its next generation spinal cord stimulator branded as Intellis platform for the management of certain forms of chronic intractable pain.
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