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ArmaGen’s AGT-181 Granted Fast Track Designation for the Treatment of Hurler Syndrome

ArmaGen Inc. today reported that the U.S. FDA granted Fast Track designation to AGT-181. The novel, investigational enzyme replacement therapy is being developed for the treatment of somatic and cognitive symptoms in patients with Hurler syndrome (also known as mucopolysaccharidosis type I, or MPS I).

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FDA Clears First Medical Device Accessory for Apple Watch

AliveCor today announced FDA clearance of KardiaBand in the U.S., allowing Apple Watch users to discreetly capture their EKG anytime and anywhere in order to quickly detect normal sinus heart rhythms and atrial fibrillation (AFib), the most common heart arrhythmia.

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The Medicines Co. Deals Infectious Disease Biz

The Medicines Company is selling its infectious disease business unit to Melinta Therapeutics. The deal is expected to close in the first quarter of 2018.

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Troubled Otonomy Cuts Jobs

Otonomy, which develops innovative therapeutics for diseases and disorders of the ear, is initiating more job cuts as well as planning to divest one of its assets.

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Kyowa Hakko Kirin Announces FDA Acceptance for Filing and Priority Review Designation of Mogamulizumab’s Biologics License Application

Kyowa Hakko Kirin Co. Ltd. announced that the U.S. Food and Drug Administration has accepted for review the Biologics License Application for mogamulizumab to treat cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy, and has granted Priority Review status.

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Cochlear obtains FDA approval for first remote programming option for cochlear implants

Cochlear Limited received U.S. Food and Drug Administration approval for the first remote feature to allow follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform.

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FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients

The U.S. Food and Drug Administration approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses.

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Pfizer and Genentech Duke it Out in Court over Herceptin Biosimilar Patents

Roche company Genentech is suing Pfizer in a federal court in Wilmington, Delaware, over Pfizer’s biosimilar for Genentech’s Herceptin. Genentech claims that Pfizer’s proposed biosimilar infringes 40 of its patents.

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AmerisourceBergen settles U.S. government probe

A unit of AmerisourceBergen Corp. – one of the largest U.S. drug wholesalers – agreed to pay $625 million to resolve a U.S. government probe involving pre-filled syringes.

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Ardelyx to Ditch Phase III Hyperkalemia Drug

Ardelyx decided to shutter development of RDX7675 – an experimental medicine for hyperkalemia – including the onset-of-action trial and Phase III studies.

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