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FDA Approves First And Only Single Monthly Injection For A PCSK9 Inhibitor

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Amgen announced that the U.S. FDA has approved the Repatha® (evolocumab) Pushtronex™ system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option.1

EMA accepts Merck's MAA for cladribine tablets in multiple sclerosis

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Merck, a leading science and technology company announced that the EMA to request the company for marketing approval for its investigational Cladribine Tablets for the treatment of relapsing multiple sclerosis (MS) to adopted examination.

Biogen SB5 accepted for review by European Medicines Agency

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The Marketing Authorization Application (MAA) for SB5, an adalimumab biosimilar candidate referencing Humira®1, has been accepted for review by the EMA. The MAA for SB5 is the third anti-TNF biosimilar candidate to be submitted to the EMA by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen .

Regeneron and Sanofi announce approval of praluent (alirocumab) in Japan

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Sanofi and Regeneron Pharmaceuticals, Inc. announced that the Ministry of Health, Labor and Welfare in Japan has granted marketing and manufacturing authorization for Praluent® (alirocumab) for the treatment of uncontrolled low-density lipoprotein (LDL) cholesterol, in certain adult patients with hypercholesterolemia at high cardiovascular risk.

Abbott laboratories says U.S. FDA approves tecnis symfony intraocular lenses

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  • Approval includes toric version of symfony iol for people with astigmatism
  • lenses provide high-quality continuous vision so patients can see clearly at near, intermediate and far-away distances, and points in between, while wearing glasses less

Dailies Total1 Multifocal contact lenses launched for presbyopia- Alcon

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Alcon, the global leader in eye care and a division of Novartis, introduces Dailies Total1 Multifocal contact lenses for people with presbyopia. This innovative multifocal lens provides both seamless distant, intermediate and near vision, and the outstanding comfort of the Dailies Total1 water gradient lens technology.

Boehringer Ingelheim and University of Dundee collaborate to develop new class of medicines

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  • Collaboration aims to develop PROteolysis TArgeting Chimeric molecules (PROTACs) – a new therapeutic modality that is able to degrade proteins playing a central role in disease processes
  • PROTACs and their new mechanism of action are expected to open new horizons for drug development allowing new drug targets to be accessible
  • Research bears potential to develop innovative new treatment options for patients with high medical need

Health Canada approves Abbott's Absorb Bioresorbable Stent

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  • Revolutionary Device Made Of Naturally Dissolving Material, Similar To Dissolving Sutures
  • Treats Coronary Artery Disease Like A Metallic Stent, But Then Disappears After The Artery Is Healed, Leaving No Metal Behind To Restrict Natural Vessel Motion
  • More Than 150,000 People In More Than 100 Countries Have Already Been Treated With This Novel Technology
  • Abbott announced that Health Canada has approved the company's Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people in Canada with coronary artery disease.

Sandoz Biosimilar Etanercept Recommended By US FDA For Approval To Treat Multiple Inflammatory Diseases

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Sandoz, a Novartis division and leader in biosimilars, announced that the US FDA Advisory Committee recommended approval of its proposed biosimilar etanercept. The committee voted unanimously (20-0), in support of biosimilar etanercept for all five indications of the reference product, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic psoriasis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA).

U.S. FDA Grants Priority Review to Janssen’s New Drug Application for Chewable Mebendazole Tablets

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Janssen Pharmaceuticals, Inc announced that the U.S. FDA has granted Priority Review designation for the NDA for a 500mg chewable tablet formulation of mebendazole.  If approved, the chewable mebendazole tablet will provide a treatment and prevention alternative for adults and children aged one year or older with soil-transmitted helminthiasis (STH), also known as intestinal worm infestations.

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