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Showing 15 posts of 18 posts found.

vascepa

COMMENT: What does Amarin’s off-patent victory over the FDA mean for the industry?

March 14, 2016
Medical 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 …

Feature
amarin_logo

Amarin wins case against FDA to promote Vascepa for off-label uses

March 10, 2016
Medical 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 …

News
ABPI code

Regulation of drug promotion ‘should be toughened up’, study finds

January 29, 2016
Medical 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 …

News

France ‘to approve’ Avastin use

July 3, 2014
Sales and Marketing AMD, France, Lucentis, Novartis, Roche, avastin, off label, off-label, wet AMD

The French government is planning to allow Roche’s cancer drug Avastin to be prescribed off-label to treat wet age-related macular …

News

Italy eyes €1.2 billion pharma fine

May 30, 2014
Sales 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 …

News
amgen image

$700m fines for Amgen

December 20, 2012
Manufacturing 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 …

News
novartis_window

New Avastin data could be bad news for Lucentis

August 14, 2012
Research 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 …

News

GMC won’t relax off-label prescribing guidelines

April 25, 2012
Sales 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 …

News
Lucentis image

Charity challenges government on Avastin for wet AMD

April 24, 2012
Sales 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 …

News
NICE hq pic

NICE looking into unlicensed and off-label drug use

March 26, 2012
Sales 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 …

News

GMC guidance on off-label drug use delayed

March 19, 2012
Sales 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 …

News

FDA: don’t broadcast discussion on off-label uses

January 6, 2012
Medical 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 …

News
NICE headquarters

NICE to review wider use of off-label prescribing

October 5, 2011
Sales 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, …

News

UK pharma opposes off-label rule change

June 6, 2011
Sales 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, …

News
Roche's Avastin (bevacizumab)

Avastin as effective as Lucentis in eye disease

May 4, 2011
Research 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 …

News
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