Latest News in the pharma Industry

Policy & Regulation

EMA validates application for BMS’s Sprycel in children with chronic myelogenous leukemia

EMA validates application for BMS’s Sprycel in children with chronic myelogenous leukemia

20 May 2017

Proposal extends application to the treatment of children and adolescents with chronic phase Philadelphia-chromosome positive chronic myelogenous leukemia and to the powder for oral suspension.

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Saneca Pharma receives confirmation of multi-dosage cGMP approval for Russia

Saneca Pharma receives confirmation of multi-dosage cGMP approval for Russia

17 May 2017

Certification covers the manufacture and packaging of hard and soft gel capsules, liquids for external use, semi-solids such as ointments and film coated tablets.

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Aptar Pharma’s electronic Lockout device approved by EMA

Aptar Pharma’s electronic Lockout device approved by EMA

16 May 2017

The e-Lockout device being the first and only fully integrated electronic nasal drug delivery device to be approved by a US or European regulatory authority.

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Research reveals manufacturers and contract packagers may miss serialization deadlines

Research reveals manufacturers and contract packagers may miss serialization deadlines

15 May 2017

Many companies currently unprepared because they lack the internal resources to devote to serialization.

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Hikma receives CRL regarding its ANDA for generic Advair Diskus

Hikma receives CRL regarding its ANDA for generic Advair Diskus

11 May 2017

Company believes low likelihood of approval this year.

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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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