Latest News in the pharma Industry

Policy & Regulation

Amgen's Repatha significantly reduced the risk of cardiovascular events in FOURIER outcomes study

Amgen's Repatha significantly reduced the risk of cardiovascular events in FOURIER outcomes study

6 Feb 2017

Landmark Repatha cardiovascular outcomes study meets primary and key secondary endpoint.

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FDA accepts two sBLAs for Merck's Keytruda for metastatic urothelial cancer

FDA accepts two sBLAs for Merck's Keytruda for metastatic urothelial cancer

5 Feb 2017

Keytruda also receives Breakthrough Therapy Designation for second-line treatment.

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FDA approves BMS's Opdivo for bladder cancer

FDA approves BMS's Opdivo for bladder cancer

5 Feb 2017

Opdivo has now been approved in six tumour types in just over 2 years.

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Merck gets the thumbs up in Europe for Keytruda to treat patients with metastatic NSCLC

Merck gets the thumbs up in Europe for Keytruda to treat patients with metastatic NSCLC

2 Feb 2017

First anti-PD-1 therapy approved in Europe for previously untreated patients with metastatic NSCLC.

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EPO upholds decision regarding Sprycel

EPO upholds decision regarding Sprycel

1 Feb 2017

Patent found to be invalid.

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Sanofi's Xyzal Allergy 24HR approved for OTC use in the US

Sanofi's Xyzal Allergy 24HR approved for OTC use in the US

1 Feb 2017

Xyzal is an oral antihistamine with a proven 24-hour effect.

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Novartis' Votubia receives EU approval to treat refractory partial-onset seizures in patients with TSC

Novartis' Votubia receives EU approval to treat refractory partial-onset seizures in patients with TSC

31 Jan 2017

Decision marks the third TSC-related indication for Votubia in the EU.

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Mylan wins US District Court ruling related to Copaxone 40 mg/mL patents

Mylan wins US District Court ruling related to Copaxone 40 mg/mL patents

31 Jan 2017

Patents in question invalidated based on obviousness.

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FDA approves Allergan's sNDA for Avycaz to include new Phase III data in patients with cUTI

FDA approves Allergan's sNDA for Avycaz to include new Phase III data in patients with cUTI

30 Jan 2017

New clinical data for Avycaz demonstrates efficacy in cUTI patients including those with infections due to resistant Gram-negative pathogens.

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Sunovion’s Latuda receives FDA approval to treat adolescents with schizophrenia

Sunovion’s Latuda receives FDA approval to treat adolescents with schizophrenia

30 Jan 2017

First treatment approved in 5 years for adolescents aged 13-17 years with schizophrenia.

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First adalimumab biosimilar candidate recommended for EMA approval

First adalimumab biosimilar candidate recommended for EMA approval

29 Jan 2017

Amgen receives positive CHMP opinion for biosimilar adalimumab.

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FDA approves 72 mcg dose of Linzess for adults with chronic idiopathic constipation

FDA approves 72 mcg dose of Linzess for adults with chronic idiopathic constipation

26 Jan 2017

New dosage strength expected to be available in first quarter of 2017.

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