Dec 28, 2021
Biogen-Eisai's potential Aduhelm sequel drug secured speedy review by FDA Biogen and Eisai’s Alzheimer’s disease treatment-in-waiting, lecanemab, has been secured a fast-track tag by the FDA, setting up a potentially swift path through the regulatory process. The drug is the next in line behind the pair’s app...
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Dec 23, 2021
Sky receives FDA clearance to market the geko™ device for venous insufficiency and ischemia On December 16, 2021, Sky Medical Technology Ltd, a medical device company, got approval from the US Food and Drug Administration (FDA) 510(k) to market the geko™ device for growing microcirculatory bl...
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Dec 14, 2021
Pfizer acquires drugmaker Arena for USD 6.7 billion to address unmet needs Pfizer declared that it is acquiring Arena Pharmaceuticals, a drug company specializing in inflammation and immunology, for almost USD 7 billion. The pharma giant said it would finance the agreement, worth USD 6.7 billion, with cash on ha...
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Dec 07, 2021
Aslan Pharmaceuticals enters into a strategic collaboration with IQVIA ASLAN Pharmaceuticals announced the appointment of IQVIA Biotech, a provider of analytics, technology solutions, and clinical research services to the life sciences industry, as its preferred clinical research organisation for log...
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Nov 30, 2021
GE Healthcare, Optellum collaborate for AI-based lung cancer diagnosis GE Healthcare has collaborated with Optellum to progress precision diagnosis and lung cancer treatment with artificial intelligence. The partnership is zeroed in on helping healthcare providers to evaluate the malignancy of a lung nodule a...
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Nov 23, 2021
Bluebird bio may finally get a gene therapy approved in the US Bluebird bio may get gene therapy approved in the US. The Cambridge, MA biotech declared that the FDA had accepted and given priority review for Zynteglo, its gene therapy for the rare blood disorder beta-thalassemia. The announcement sets up an expe...
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Nov 16, 2021
AstraZeneca, Moderna announces positive data of mRNA potential in heart failure patients Moderna, Inc., a biotechnology company is pioneering messenger RNA (mRNA) therapeutics and vaccines, declared positive data from the AstraZeneca-led Phase 2 (EPICCURE) study assessing the use of an mRNA therapeutic, wh...
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Nov 09, 2021
Alcon to acquire Ivantis for USD 475 Million Alcon announced that it intends to buy glaucoma surgery device maker Ivantis for USD 475 million upfront. Geneva, Switzerland-based Alcon aims to support its portfolio across cataract, refractive, retina and glaucoma offerings by taking over Ivantis and its n...
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Nov 02, 2021
Magnus Medical’s neurostimulation technology gets FDA breakthrough status to treat MDD Magnus Medical has secured a breakthrough device designation from the US Food and Drug Administration (FDA) for its neurostimulation technology for major depressive disorder (MDD) treatment. The individualised, rapid-acting...
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Oct 26, 2021
Ocular Therapeutix’s dry eye disease insert fails in phase 2 trial Ocular Therapeutix declared that its OTX-CSI (cyclosporine intracanalicular insert) for dry eye disease (DED) has flunked to reach the primary endpoint in the phase 2 clinical trial. The company has conducted the US-based, randomised, double-m...
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