Latest News in the pharma Industry

Policy & Regulation

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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Watson Laboratories Files ANDA for Generic Version of BYSTOLIC

Watson Laboratories Files ANDA for Generic Version of BYSTOLIC

15 Mar 2012

Watson Laboratories has submitted an Abbreviated New Drug Application with the FDA to market Nebivolol Hydrochloride Tablets, a generic version of Forest Laboratories' BYSTOLIC.

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FDA Approves New Indication for Natazia Tablets

FDA Approves New Indication for Natazia Tablets

15 Mar 2012

With the approval for new indication, Natazia becomes the first and only oral contraceptive indicated for the treatment of HMB.

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Indian Patent Office Grants First Compulsory License to Generic Company

Indian Patent Office Grants First Compulsory License to Generic Company

14 Mar 2012

India's Natco Pharma has been granted a compulsory license to sell a generic version of Bayer's patented cancer drug Nexavar.

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EMA Launches Electronic Application Form Pilot

EMA Launches Electronic Application Form Pilot

13 Mar 2012

The pilot allows pharmaceutical companies to apply for initial marketing authorisation applications for human medicines, and variation and renewal applications for human and veterinary medicines, using an interactive PDF form.

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