Latest News in the pharma Industry

Policy & Regulation

Merck's Keytruda scores another FDA approval

Merck's Keytruda scores another FDA approval

11 May 2017

FDA approves Keytruda as first-line combination therapy with pemetrexed and carboplatin for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) irrespective of PD-L1 expression.

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First approval for Keytruda in a hematologic malignancy in the EU

First approval for Keytruda in a hematologic malignancy in the EU

7 May 2017

European Commission approves Keytruda for patients with relapsed or refractory classical Hodgkin lymphoma who failed ASCT and BV or who are transplant-ineligible and have failed BV.

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AstraZeneca’s Imfinzi receives FDA accelerated approval for previously treated patients with advanced bladder cancer

AstraZeneca’s Imfinzi receives FDA accelerated approval for previously treated patients with advanced bladder cancer

2 May 2017

Imfinzi is the cornerstone in an extensive immuno-oncology program across multiple cancer types and stages of disease.

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Impax announces FDA approval and launch of a generic version of Vytorin

Impax announces FDA approval and launch of a generic version of Vytorin

1 May 2017

One of the first companies to offer a generic version of Vytorin.

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Takeda announces FDA Accelerated Approval of Alunbrig

Takeda announces FDA Accelerated Approval of Alunbrig

30 Apr 2017

Alunbrig approved for ALK+ metastatic non-small Cell lung cancer patients who have progressed on or are intolerant to crizotinib.

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China FDA approves country’s first all-oral regimen for chronic hepatitis C, Daklinza in combination with Sunvepra

China FDA approves country’s first all-oral regimen for chronic hepatitis C, Daklinza in combination with Sunvepra

28 Apr 2017

Daklinza and Sunvepra combination approved for genotype 1b, the most common chronic hepatitis C (HCV) genotype in China; combination has a 91-99% cure rate.

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Shire granted EU conditional marketing authorisation for Natpar for the treatment of chronic hypoparathyroidism

Shire granted EU conditional marketing authorisation for Natpar for the treatment of chronic hypoparathyroidism

26 Apr 2017

Natpar is the first and only licensed recombinant human parathyroid hormone therapy for chronic hypoparathyroidism.

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Regeneron and Sanofi receive FDA approval of a new once-monthly dosing option for Praluent Injection

Regeneron and Sanofi receive FDA approval of a new once-monthly dosing option for Praluent Injection

26 Apr 2017

Monthly dosing schedule now approved in both US and EU.

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Recipharm delivers first serialised batch to Saudi Arabia

Recipharm delivers first serialised batch to Saudi Arabia

23 Apr 2017

Company has invested €300,000 into the project, which is part of a wider €40 million investment into new serialisation technology and processes to comply with the European Falsified Medicines Directive.

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Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe

Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe

23 Apr 2017

Company receives positive CHMP opinions for biosimilars rituximab and etanercept to treat immunological diseases. Biosimilar rituximab also recommended to treat blood cancers.

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FDA approves Genentech’s Lucentis for diabetic retinopathy

FDA approves Genentech’s Lucentis for diabetic retinopathy

18 Apr 2017

First and only medicine FDA-approved to treat all forms of diabetic retinopathy.

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FDA issues complete response letter for baricitinib

FDA issues complete response letter for baricitinib

16 Apr 2017

Additional clinical data are needed to determine the most appropriate doses.

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