Latest News in the pharma Industry

Policy & Regulation

Indian FDA approves Innovus Pharma's Zestra, Zestra Glide, EjectDelay and Sensum+

Indian FDA approves Innovus Pharma's Zestra, Zestra Glide, EjectDelay and Sensum+

21 Aug 2016

Products now approved in seven countries.

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Portola Pharmaceuticals announces validation of MAA by EMA for IndexXa a Factor Xa inhibitoraAntidote

Portola Pharmaceuticals announces validation of MAA by EMA for IndexXa a Factor Xa inhibitoraAntidote

21 Aug 2016

EMA's CHMP to begin centralized review procedure.

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Portola Pharmaceuticals receives CRL for BLA for AndexXa

Portola Pharmaceuticals receives CRL for BLA for AndexXa

18 Aug 2016

Agency request additional information primarily related to manufacturing.

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FDA issues import alert for all drugs produced by Laxachem Organics in India

FDA issues import alert for all drugs produced by Laxachem Organics in India

17 Aug 2016

Decision taken after company refuses to allow FDA facility inspection.

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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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