Latest News in the pharma Industry

Policy & Regulation

Shire’s SHP626 (volixibat) receives FDA fast track designation

Shire’s SHP626 (volixibat) receives FDA fast track designation

29 Jul 2016

Designation is for an investigational treatment of adults who have nonalcoholic steatohepatitis (NASH) with liver fibrosis.

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Sanofi receives FDA approval of Adlyxin for treatment of adults with type 2 diabetes

Sanofi receives FDA approval of Adlyxin for treatment of adults with type 2 diabetes

28 Jul 2016

Adlyxin is approved as Lyxumia in more than 60 countries.

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Ocular Therapeutix receives CRL from FDA for its NDA for Dextenza

Ocular Therapeutix receives CRL from FDA for its NDA for Dextenza

26 Jul 2016

FDA reports deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility.

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Allergan receives Positive Opinion For Truberzi for treatment of IBS-D in adults

Allergan receives Positive Opinion For Truberzi for treatment of IBS-D in adults

25 Jul 2016

Significant step towards bringing the only licensed prescription medication for IBS-D to patients in 28 countries of the EU.

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FDA grants QIDP and Fast Track designations to MCB3837

FDA grants QIDP and Fast Track designations to MCB3837

25 Jul 2016

Morphochem’s novel intravenous antibacterial to treat C. difficile infections.

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Amgen and UCB submit BLA for romosozumab to the FDA

Amgen and UCB submit BLA for romosozumab to the FDA

22 Jul 2016

Based on Phase III FRAME Study in postmenopausal women with osteoporosis.

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Mylan and Biocon announce regulatory submission for proposed biosimilar Pegfilgrastim accepted for review by EMA

Mylan and Biocon announce regulatory submission for proposed biosimilar Pegfilgrastim accepted for review by EMA

21 Jul 2016

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FDA expands indication for type 2 diabetes treatment Synjardy

FDA expands indication for type 2 diabetes treatment Synjardy

19 Jul 2016

Expanded indication now includes treatment-naïve adults.

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SB5, an adalimumab biosimilar referencing Humira, accepted for review by EMA

SB5, an adalimumab biosimilar referencing Humira, accepted for review by EMA

18 Jul 2016

The approval of SB5 could make Biogen the first company to commercialize three anti-TNF biosimilar therapies in Europe.

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Allergan files application to FDA for approval of Oculeve Intranasal Tear Neurostimulator

Allergan files application to FDA for approval of Oculeve Intranasal Tear Neurostimulator

18 Jul 2016

A first of its kind approach to increasing tear production in patients suffering from dry eye disease.

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Sandoz biosimilar etanercept recommended by FDA advisory committee for approval to treat multiple inflammatory diseases

Sandoz biosimilar etanercept recommended by FDA advisory committee for approval to treat multiple inflammatory diseases

14 Jul 2016

Committee votes unanimously in favor of the Sandoz proposed biosimilar etanercept for all approved indications of the reference product.

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Pfizer receives FDA approval for Prevnar 13 in adults age 18 through 49

Pfizer receives FDA approval for Prevnar 13 in adults age 18 through 49

13 Jul 2016

Prevnar 13 is the only pneumococcal vaccine approved in the US for patients 6 weeks through adulthood.

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