Latest News in the pharma Industry

Policy & Regulation

Merck Announces Samsung Bioepis receives approval of Renfelxis (infliximab), a biosimilar of Remicade, in Korea

Merck Announces Samsung Bioepis receives approval of Renfelxis (infliximab), a biosimilar of Remicade, in Korea

7 Dec 2015

Samsung Bioepis’ second immunology biosimilar approved, to be commercialized under partnership with Merck

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Sun Pharma receives FDA approval for generic Gleevec

Sun Pharma receives FDA approval for generic Gleevec

6 Dec 2015

Company eligible for 180-days marketing exclusivity on a first-to-file Para-IV ANDA.

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Amgen's first biosimilar marketing authorization application submitted to EMA for ABP 501

Amgen's first biosimilar marketing authorization application submitted to EMA for ABP 501

4 Dec 2015

Supported by Phase III studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.

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Baxalta receives CHMP positive opinion for Sanquin to begin production, enhancing global supply of plasma-based therapies

Baxalta receives CHMP positive opinion for Sanquin to begin production, enhancing global supply of plasma-based therapies

4 Dec 2015

Sanquin is now licensed to produce bulk material for HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] and GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] (marketed as KIOVIG in the EU) for the European Union, I...

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Health Canada approves Jardiance tablets for adults with type 2 diabetes

Health Canada approves Jardiance tablets for adults with type 2 diabetes

30 Nov 2015

Jardiance lowers the renal threshold for glucose, which leads to reduced renal reabsorption of filtered glucose and increased urinary glucose excretion.

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FDA approves Portrazza for specific type of lung cancer

FDA approves Portrazza for specific type of lung cancer

29 Nov 2015

Portrazza, in combination with gemcitabine and cisplatin, is the first biologic approved for first-line treatment of people with metastatic squamous non-small cell lung cancer.

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Epigenomics appeals recent FDA request for additional information

Epigenomics appeals recent FDA request for additional information

27 Nov 2015

Company believes that an approval for the intended use of Epi proColon is warranted based on the data that has been submitted to date.

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BMS announces regulatory update for Opdivo in advanced melanoma

BMS announces regulatory update for Opdivo in advanced melanoma

27 Nov 2015

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Ready for the change? — PTI provides guidance on new EU Clinical Trial Regulation

Ready for the change? — PTI provides guidance on new EU Clinical Trial Regulation

26 Nov 2015

The EU-CTR replaces the EU Clinical Trials Directive and is designed to improve harmonisation on conducting clinical trials of medicinal products for human use throughout the EU.

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Amgen's first biosimilar Biologics License Application for ABP 501 submitted To FDA

Amgen's first biosimilar Biologics License Application for ABP 501 submitted To FDA

26 Nov 2015

Supported by Phase III studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.

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Impax receives European Commission marketing authorization for Numient modified-release capsules for the symptomatic treatment of adults with Parkinson's disease

Impax receives European Commission marketing authorization for Numient modified-release capsules for the symptomatic treatment of adults with Parkinson's disease

25 Nov 2015

The company’s first branded drug approval outside of the US.

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Merck and Pfizer receive positive opinion for ODD for avelumab in Merkel cell carcinoma from EMA COMP

Merck and Pfizer receive positive opinion for ODD for avelumab in Merkel cell carcinoma from EMA COMP

25 Nov 2015

EMA ODD is an important regulatory milestone for avelumab in metastatic Merkel cell carcinoma (MCC).

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