safety

Showing 15 posts of 20 posts found.

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Eisai’s weight loss drug lorcaserin found safe in major study

August 28, 2018
Manufacturing and Production, Research and Development, Sales and Marketing Eisai, lorcaserin, safety, study, weight loss

Eisai’s weight loss drug lorcaserin does not increase people’s risk of major cardiovascular events according to a study of 12,000 …

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FDA announces strongest warnings for opioid pain medications

March 23, 2016
Medical Communications, Research and Development FDA, abuse, addiction, boxed, label, misuse, opioids, public health, restrictions, safety, warnings

The US Food and Drug Administration has announced class-wide safety labelling changes for immediate release (IR) opioid pain medications. The …

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FDA criticised for safety data flaws

January 18, 2016
Sales and Marketing FDA, US Government Accountability Office, pharmacovigilance, post-marketing data, safety

The US FDA is failing to meet its ‘statutorily required’ obligations to track safety data for drugs post-marketing and publish …

FDA

FDA bans drug imports from Indian plant

July 21, 2015
Manufacturing and Production Emcure, FDA, GMP, Good Manufacturing Practices, India, compliance, manufacturing, production, safety

The FDA has blocked US imports from the manufacturing plants of a major Indian pharmaceutical firm over safety fears. The …

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UK government launches ‘Sign up to Safety’ initiative

March 26, 2014
Sales and Marketing Francis, Hunt, Mid Staffs, NHS, safety, sign up

A new ambition to reduce avoidable harm in the NHS by half over the next three years, cut costs and …

No cancer link with Lantus, says Sanofi

December 7, 2011
Sales and Marketing Cancer, Lantus, Sanofi, diabetes, insulin, safety

Sanofi has presented a new meta-analysis which suggests its insulin blockbuster Lantus does not raise the risk of cancer. A …

Avandia withdrawn in Europe, but remains in US

September 24, 2010
Sales and Marketing Avandia, FDA, pharmacovigilance, safety

GSK’s diabetes drug Avandia is to be withdrawn from the market in Europe because of high levels of heart attack, …

Safety First

September 22, 2009
Research and Development, Sales and Marketing EU, US, reg, safety

A series of high-profile drug withdrawals in recent years has brought safety concerns to the fore, prompting more rigorous monitoring …

Avandia hit by further restrictions

January 25, 2008
Sales and Marketing reg, safety

GlaxoSmithKline has strengthened the safety warnings on its diabetes drug Avandia following recommendations from European regulators. The drug was hit …

Europe unites with Canada on safety regulation

January 15, 2008
Sales and Marketing reg, safety

European and Canadian regulators have forged a transatlantic agreement to exchange confidential information about the authorisation and safety of medicines. …

Champix linked to depression and suicidal thoughts

November 22, 2007
Sales and Marketing reg, safety

Pfizer has alerted US regulator the FDA to cases of depression and suicidal thoughts in patients taking its smoking cessation …

Merck to pay $4.9 billion to end Vioxx claims

November 15, 2007
Sales and Marketing Vioxx, safety

Merck looks set to pay $4.9 billion in a settlement for the thousands of people claiming injury after taking its …

Liver problems delay Galvus launch

November 9, 2007
Sales and Marketing reg, safety

The European launch of new diabetes drug Galvus could be delayed by up to six months after small but significant …

FDA rejects painkiller Prexige

October 3, 2007
Sales and Marketing reg, safety

Novartis has received a "not approvable" letter from the FDA for its painkiller Prexige because of concerns about potential liver …

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