off label
COMMENT: What does Amarin’s off-patent victory over the FDA mean for the industry?
March 14, 2016Medical Communications, Sales and Marketing Amarin, FDA, off label, off-label, vascepa
Last week, Pharmafile.com reported that small biopharma Amarin had settled litigation with US drugs regulator the FDA that will allow …
Amarin wins case against FDA to promote Vascepa for off-label uses
March 10, 2016Medical Communications, Research and Development, Sales and Marketing Amarin, FDA, first amendment, off label, vascepa
Amarin has announced a settlement with the US Food and Drug Administration (FDA) that resolves the dispute over the Irish-based …
Regulation of drug promotion ‘should be toughened up’, study finds
January 29, 2016Medical Communications ABPI Code, Department of Justice, PMCPA, Prescription Medicines Code of Practice Authority, Sunshine Act, marketing, off label, off-label, promotion
The voluntary code of conduct system that regulates the pharma industry’s promotion of off-label prescribing has a ‘limited capacity’ to …
Italy eyes €1.2 billion pharma fine
May 30, 2014Sales and Marketing Novartis, Roche, avastin, off label, wet and
Italy’s health ministry says it is looking for €1.2 billion in damages from Roche and Novartis over claims that the …
$700m fines for Amgen
December 20, 2012Manufacturing and Production, Sales and Marketing Amgen, FDA, off label, off-label
Amgen has pleaded guilty to misbranding its anaemia drug Aranesp following a string of US lawsuits against the biotech company. The …
New Avastin data could be bad news for Lucentis
August 14, 2012Research and Development, Sales and Marketing DMO, Lucentis, Novartis, Roche, avastin, off label, off-label, wet AMD
The day after Novartis gained a new US licence for Lucentis to treat diabetic macular oedema, new data was published …
GMC won’t relax off-label prescribing guidelines
April 25, 2012Sales and Marketing GMC, Lucentis, Novartis, Roche, avastin, off label, off-label
The GMC has decided not to relax guidelines on off-label prescribing when a licensed alternative exists. The GMC’s current rules …
Charity challenges government on Avastin for wet AMD
April 24, 2012Sales and Marketing Lucentis, Novartis, Roche, avastin, off label, off-label, wet AMD
A leading patient group has called on the government to get to grips with the issue of off-label prescribing, as …
NICE looking into unlicensed and off-label drug use
March 26, 2012Sales and Marketing DoH, NICE, off label, off-label, postcode, unlicensed
NICE is reviewing the use of off-label and unlicensed medicines across the NHS in England. This follows a pilot project …
GMC guidance on off-label drug use delayed
March 19, 2012Sales and Marketing GMC, Lucentis, avastin, off label, off-label, prescribing
The General Medical Council has delayed the release of new guidance for off-label prescribing. The doctors’ regulator was expected to …
FDA: don’t broadcast discussion on off-label uses
January 6, 2012Medical Communications FDA, Facebook, Twitter, off label, social media
The FDA has released long-awaited guidance for pharma firms about social media use. The FDA held a two-day public hearing …
NICE to review wider use of off-label prescribing
October 5, 2011Sales and Marketing off label, off label prescribing
The government has asked NICE to review its plans to give doctors greater freedom for ‘off-label’ prescribing. It wants NICE, …
UK pharma opposes off-label rule change
June 6, 2011Sales and Marketing off label
Prescribing a drug off-label when a licenced alternative exists increases patient safety risks and threatens the development of new medicines, …
Avastin as effective as Lucentis in eye disease
May 4, 2011Research and Development Lucentis, avastin, off label, wet AMD
Roche’s cancer drug Avastin is as effective at treating wet AMD as Novartis’ Lucentis, which is licensed for the eye …
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