Latest News in the pharma Industry

Policy & Regulation

Merck announces FDA filing acceptance of NDA for MK-1293, an investigational follow-on biologic insulin glargine

Merck announces FDA filing acceptance of NDA for MK-1293, an investigational follow-on biologic insulin glargine

8 Aug 2016

Marketing Authorization Application to the EMA currently under review.

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FDA approves Merck’s Keytruda for patients with recurrent or metastatic HNSCC

FDA approves Merck’s Keytruda for patients with recurrent or metastatic HNSCC

7 Aug 2016

New treatment option for patients with with disease progression on or after platinum-containing chemotherapy.

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FDA approves first generic version of influenza drug

FDA approves first generic version of influenza drug

7 Aug 2016

Natco receives approval for generic Tamiflu.

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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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