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Regulation & Policy
Genmab to receive $16 million on Arzerra approval
Tuesday 20 April 2010
Genmab A/S is set to receive DKK 87 million ($16 million) from GlaxoSmithKline Plc following the conditional approval in Europe of Arzerra (ofatumumab), its treatment for refractory chronic lymphocytic leukaemia (CLL).
Location
Denmark
Novartis Europharm withdraws EMA application
Monday 19 April 2010
The European Medicines Agency said that Novartis Europharm Ltd has withdrawn its marketing authorisation application for a drug to treat chronic hepatitis C virus infection. The product is Joulferon (albinterferon alpha-2b).
Location
United Kingdom
See map: Google Maps
FDA approves new treatment option for Tarceva
Monday 19 April 2010
The US Food and Drug Administration has approved a new treatment option for Tarceva (erlotinib) for patients with locally advanced or metastatic non-small cell lung cancer. This follows a positive opinion for the same indication from the EMA.
Location
United States
See map: Google Maps
BioAlliance wins FDA approval for anti-fungal therapy
Sunday 18 April 2010
BioAlliance Pharma SA said that it has won approval from the US Food and Drug Administration to market its anti-fungal therapy, Loramyc, to treat patients whose immune systems have been compromised following chemotherapy or radiotherapy.
Location
France
FDA turns back new drug for mixed dyslipidemia
Tuesday 30 March 2010
The US Food and Drug Administration has said it can’t approve a new lipid-lowering drug from AstraZeneca Plc and Abbott Laboratories without further data. The two companies announced receiving the complete response letter on 30 March 2010.
Location
United States
See map: Google Maps
New indication in Europe for Roche colon cancer drug
Tuesday 30 March 2010
The Roche group said that its cancer drug, Xeloda (capecitabine) has been approved in Europe in combination with the chemotherapy drug, oxaliplatin, for the adjuvant treatment of patients with early colon cancer. The combination is called Xelox.
Location
Switzerland
See map: Google Maps
New treatment option for Tarceva in Europe
Monday 22 March 2010
The European Medicines Agency is recommending that the cancer drug, Tarceva (erlotinib), be approved for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer. This represents a new treatment option.
Location
United Kingdom
See map: Google Maps
Sutent fails in advanced breast cancer
Tuesday 16 March 2010
Pfizer Inc has announced that two Phase 3 studies of Sutent (sunitinib malate) in advanced breast cancer did not meet their primary endpoints. The drug is currently approved for gastrointestinal stromal tumour and advanced renal cell carcinoma. The company announced the trial results on 11 March 2010.
Location
United States
See map: Google Maps
Avastin fails to meet primary endpoint in prostate cancer trial
Friday 12 March 2010
A Phase 3 trial of Avastin (bevacizumab) in combination with docetaxel and prednisone in men with late-stage prostate cancer has failed to meet its primary endpoint of extending overall survival, the Roche Group announced.
Location
Switzerland
See map: Google Maps
Actelion receives FDA complete response letter for Zavesca
Tuesday 9 March 2010
Actelion Ltd said that it has received a complete response letter from the US Food and Drug Administration for its treatment for Niemann-Pick disease, Zavesca (miglustat). This means the agency cannot approve the application in its present form.
Location
Switzerland
See map: Google Maps
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Recent Appointments
Tim Edwards elected chairman of BIA
Tuesday September 7 2010
Index Ventures appoints antibody expert as partner
Friday September 3 2010
Colin Stewart appointed CEO at Amarin
Friday August 20 2010
Karl Keegan nominated as CFO of Pharming
Friday August 20 2010
Axel Müller becomes CEO at SkyePharma
Thursday August 19 2010