Latest News in the pharma Industry

Policy & Regulation

NICE ‘no’ for Opdivo, could deny some lung cancer patients one of the most significant advances in almost 20 years

NICE ‘no’ for Opdivo, could deny some lung cancer patients one of the most significant advances in almost 20 years

15 Dec 2015

The draft decision specifically affects adult patients with locally advanced or metastatic squamous non-small cell lung whose disease has progressed after prior chemotherapy.

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Rx-360 summary of PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE-009-12)

Rx-360 summary of PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE-009-12)

10 Dec 2015

The Guide covers GMP principles and active substances used as starting materials.

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FDA approves Kanuma for the treatment of patients with lysosomal acid lipase deficiency

FDA approves Kanuma for the treatment of patients with lysosomal acid lipase deficiency

9 Dec 2015

Kanuma is the first approved treatment in the US for patients suffering from LAL-D, a life-threatening and ultra-rare metabolic disorder.

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Novo Nordisk files for regulatory approval of faster-acting insulin aspart in the EU for the treatment of type 1 and 2 diabetes

Novo Nordisk files for regulatory approval of faster-acting insulin aspart in the EU for the treatment of type 1 and 2 diabetes

8 Dec 2015

The company intends to make faster-acting insulin aspart available in the prefilled delivery device FlexTouch.

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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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