Legal and Regulatory - Page 2

Health Canada to speed up review process to ease drug shortage
Tuesday, March 20, 2012 Health Canada is speeding up its drug review process in order to approve replacement medications quickly in an attempt to ease the drug shortage affecting the...

Novartis eye division gains rights to sell ocriplasmin in Europe
Monday, March 19, 2012 Novartis’ eye care division Alcon has gained exclusive rights to commercialise ocriplasmin (microplasmin) outside the US for the treatment of symptomatic vitreomacular...

Denmark’s CareMed linked to fake Avastin exports
Friday, March 16, 2012 A Danish wholesaler has been linked to the illegal shipping of counterfeit versions of Roche and Genentech’s Avastin to the...

Teva gets first approval for generic Lexapro
Thursday, March 15, 2012 The US Food and Drug Administration (FDA) has approved the first generic copy of Forest Laboratories’ Lexapro to treat depression and generalised anxiety disorder in...

Indian Patent Office issues first compulsory license
Tuesday, March 13, 2012 The Indian Patent Office has issued Natco Pharma with a compulsory license, the first time an Indian pharmaceutical company has been granted...

AstraZeneca sues FDA over generic copies of Seroquel
Tuesday, March 13, 2012 AstraZeneca has filed a lawsuit against the US Food and Drug Administration for refusing to delay the market entry of generic versions of its antipsychotic drug...

Prostate cancer patients await Scottish decision over Zytiga
Monday, March 12, 2012 Patients with advanced prostate cancer in Scotland are waiting to find out if the National Health Service will pay for Johnson and Johnson’s new drug Zytiga which could extend their lives by...

J&J Risperdal settlement rejected
Monday, March 12, 2012 US-based pharmaceutical company Johnson & Johnson have had a proposed settlement relating to the promotion of its antipsychotic Risperdal rejected by federal prosecutors in Washington, D.C.,...

Eight pharmaceutical companies sued over drug coupon use
Friday, March 09, 2012 Four trade union health insurance plans and a consumer group have launched legal action against eight pharmaceutical companies over the use of coupons for drug co-payments, claiming them to...

Arena seeks European approval for lorcaserin
Monday, March 05, 2012 US-based biopharmaceutical firm Arena Pharmaceuticals is seeking European marketing approval for its weight loss and weight control medication...

US pharmaceutical companies settle Medicaid fraud charges
Friday, March 02, 2012 Two US-based pharmaceutical companies have settled charges after being found to have defrauded US federal healthcare programmes such as Medicaid, paying a total of $28m in...

EU Commission ends antitrust violation by AstraZeneca, Nycomed
Friday, March 02, 2012 The European Commission has ended its investigation into an alleged violation of EU antitrust rules by pharmaceutical firms AstraZeneca and...

FDA recommends label changes to statin drugs
Wednesday, February 29, 2012 The US Food and Drug Administration (FDA) will urge major pharmaceutical companies, including Pfizer and AstraZeneca, to add diabetes-risk language to the 'warnings and precautions' section...

Fake cancer drug contained salt, starch and solvents
Tuesday, February 28, 2012 Counterfeit versions of Roche and Genentech’s Avastin distributed in the US earlier this month have been found to contain salt, starch and chemicals used in animal feed, plastics and...

NHS to prescribe Roche’s RoActemra drug
Monday, February 27, 2012 A UK health watchdog has recommended that Roche's RoActemra (tocilizumab) drug should be made available on the National Health Service (NHS) for the treatment of rheumatoid arthritis...

FDA approves two suppliers to address cancer drug shortages
Wednesday, February 22, 2012 Two new suppliers of cancer treatments have been called upon by the US Food and Drug Administration to help the country cope with ongoing drug...

Proposed US healthcare budget criticised
Wednesday, February 15, 2012 US President Barack Obama's proposed budget for healthcare, which aims to reduce the nation's spend on healthcare programmes, has been heavily criticised by the country's pharmaceutical...

NICE rejects GSK/Roche breast cancer drugs
Wednesday, February 15, 2012 A UK health watchdog has published draft guidance that proposes to advise the National Health Service that GlaskoSmithKline's Tyverb and Roche's Herceptin should not be prescribed to...

Obama requests FDA budget increase
Tuesday, February 14, 2012 Industry fees could pay for almost half of the Food and Drug Administration’s $4.5bn budget, it has been...

Eisai leukaemia treatment Dacogen suffers approval setback
Monday, February 13, 2012 Potential leukaemia drug Dacogen, co-developed by Eisai and Astex Pharmaceuticals, has suffered a setback after the US Food and Drug Administration’s Oncologic Drugs Advisory Committee...