Latest News in the pharma Industry

Policy & Regulation

FDA Committee Votes in Favour of Quad Approval

FDA Committee Votes in Favour of Quad Approval

14 May 2012

Gilead Sciences has announced that a US FDA committee has voted to support the approval of the Quad regimen and Truvada.

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FDA & EMA Approve Genzyme  Filling & Finishing Suite

FDA & EMA Approve Genzyme Filling & Finishing Suite

7 May 2012

With this approval, Genzyme has nearly doubled its ability to fill and finish Myozyme and Lumizyme produced at the 4000 liter bioreactor scale.

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EMA Recommends Authorisation of Forxiga for Type 2 Diabetes

EMA Recommends Authorisation of Forxiga for Type 2 Diabetes

25 Apr 2012

The Agency’s Committee for Medicinal Products for Human Use has recommended the granting of a marketing authorisation for Forxiga, a novel treatment for type 2 diabetes mellitus.

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Merck Wins Fifth Fosamax State Court Trial

Merck Wins Fifth Fosamax State Court Trial

23 Apr 2012

Merck says it has won its latest lawsuit connected to osteoporosis drug Fosamax.

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Johnson & Johnson Fined $1.1B for Concealing Risperdal Risks

Johnson & Johnson Fined $1.1B for Concealing Risperdal Risks

18 Apr 2012

Johnson & Johnson has been ordered to pay $1.1 billion for failing to make clear the risks associated with its anti-psychotic drug Risperdal.

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EMA Publishes New Document on Regulatory Procedural Advice on similar Biological Medicines

EMA Publishes New Document on Regulatory Procedural Advice on similar Biological Medicines

18 Apr 2012

The Agency has published a new document on regulatory procedural advice on similar biological medicines.

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NICE Rejects Halaven for Breast Cancer Treatment

NICE Rejects Halaven for Breast Cancer Treatment

5 Apr 2012

UK's National Insitiute for Clinical Excellence has rejected Eisai's Halaven for the treatment of advanced or metastatic breast cancer in people whose disease has progressed after at least two chemotherapeutic regimens.

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Brazil Tightens Gelatin Production Controls

Brazil Tightens Gelatin Production Controls

30 Mar 2012

The Brazilian government is tightening its gelatin production controls after pressure from the EU about consumer health concerns.

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Byetta Approved for Use with Basal Insulin in Europe

Byetta Approved for Use with Basal Insulin in Europe

26 Mar 2012

Amylin and Eli Lilly announced the marketing authorization from the European Commission for the use of BYETTA with basal insulin.

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Perrigo Receives Australian Approval for Generic Temozolomide

Perrigo Receives Australian Approval for Generic Temozolomide

22 Mar 2012

Perrigo's product is the generic equivalent to Schering-Plough's Temodar, indicated for patients with malignant glioma, where the product is currently generating over $20 million in sales in Australia.

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FDA Approves First Boniva Generics for Osteoporosis

FDA Approves First Boniva Generics for Osteoporosis

21 Mar 2012

The FDA has approved the first generic versions of Boniva tablets to treat or prevent osteoporosis.

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CHMP Adopts Positive Opinion for Zoledronic Acid

CHMP Adopts Positive Opinion for Zoledronic Acid

19 Mar 2012

The CHMP has adopted a positive opinion, recommending the granting of a marketing authorisation for Teva Pharma's Zoledronic Acid.

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