Latest News in the pharma Industry

Policy & Regulation

FDA approves Flonase Sensimist Allergy Relief

FDA approves Flonase Sensimist Allergy Relief

4 Aug 2016

Another Rx-to-OTC Switch from GSK Consumer Healthcare to help allergy sufferers find more complete relief.

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Novartis CDK4/6 inhibitor LEE011 receives FDA Breakthrough Therapy designation

Novartis CDK4/6 inhibitor LEE011 receives FDA Breakthrough Therapy designation

3 Aug 2016

LEE001 potential first-line treatment for HR+/HER2- advanced breast cancer.

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EMA accepts for review the Marketing Authorisation Application for sarilumab

EMA accepts for review the Marketing Authorisation Application for sarilumab

1 Aug 2016

Sarilumab is an investigational human monoclonal antibody directed against the IL-6 receptor that is intended for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

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Sunovion submits NDA for SUN-101/eFlow to FDA for the treatment of patients with COPD

Sunovion submits NDA for SUN-101/eFlow to FDA for the treatment of patients with COPD

31 Jul 2016

If approved, SUN-101/eFlow will be the first nebulized long-acting muscarinic antagonist (LAMA) for the long-term, maintenance treatment of airflow obstruction in patients with COPD.

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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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