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Biotechs Ramp up Clinical Trial Programs as FDA Looks at More Efficient Drug Development Programs

The hope of new measures for the FDA to advance the regulatory path for drug development is forging ahead incorporating relatively swift pivotal data in seeking accelerated approvals.

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Mylan says Allergan misusing tribal sovereignty in patent dispute

Generic drugmaker Mylan NV alleged in a court filing that rival Allergan Plc is trying to take advantage of Native American sovereignty to shield its patent for the blockbuster dry-eye treatment Restasis.

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U.S. tribal patent deal could have big impact on generic drug market

A groundbreaking deal between Allergan Plc and a Native American tribe to shield the company’s patents in administrative proceedings could also be used be to protect them from challenges in federal court, legal experts said, potentially dealing a blow to generic competition.

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Kala Pharmaceuticals Announces Positive Results from Confirmatory Phase 3 Trial of KPI-121 1% Following Cataract Surgery

Kala Pharmaceuticals Inc. today announced positive top-line results from its confirmatory Phase 3 trial of KPI-121 1% for the treatment of inflammation and pain in patients who have undergone cataract surgery.

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Tiny Parion Sciences Seals Dry Eye Drug Deal Worth $535 Million With Biotech Giant Shire

North Carolina-based Parion Sciences snagged a deal worth up to $535 million from Shire for its experimental dry eye disease treatment, P-321.

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Allergan, Argentum settle patent dispute over eye drug Restasis

U.S. generic drug company Argentum Pharmaceuticals LLC said it reached an agreement with Allergan Plc that settles a patent dispute over the generic version of Allergan’s eye drug Restasis.

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Allergan’s New Eyepowerment Campaign Urges The Up To 33 Million Americans Suffering from Symptoms of Chronic Dry Eye to Take Action

“Before we had our voice, we had our eyes,” is the powerful opening message from Allergan’s new campaign to raise awareness for chronic dry eye. The campaign, titled “Eyepowerment,” aims to empower individuals who may be struggling with symptoms of chronic dry eye to talk to their doctor.

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J&J Pays $4.325 Billion for Abbott’s Eye Surgery Biz

Johnson & Johnson announced it will acquire Abbott Medical Optics for more than $4 billion. The deal is expected to close in the first quarter of 2017.

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In the branding of Xiidra, the ii’s have it

Shire Inc. recently launched Xiidra, the first medicine indicated for the signs and symptoms of dry eye disease and the company’s first ophthalmic drug.

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U.S. approves Shire’s keenly awaited eye drug

Shire won U.S. approval for its most important new medicine, a treatment for dry eyes, in a fresh boost for the company which completed its $32 billion acquisition of U.S. rare diseases specialist Baxalta in June.

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