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Regulatory & Safety: Top Headlines

UK Gov should seek licenses for off-patent drugs in new indications says MP

24-Jul-2014 - The UK Government should seek licenses to use off-patent drugs in new indications according to MPs who say there is no incentive for pharma firms to apply for such approvals after a product goes generic.

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Is your drug name ok? Run a role-play, says FDA

24-Jul-2014 - Industry insiders have criticised new draft US Food and Drug Administration (FDA) guidance on choosing proprietary drug names, saying simulation studies involving doctors, nurses and pharmacists are time-consuming and unhelpful.

Italy to look at drug pricing during EU presidency

24-Jul-2014 - Italian health Minister Beatrice Lorenzin will focus on making drug National price regulations and decisions more trasnparent during the country's presidency of the EU.

Generics: change in pill shape makes patients 66% more likely to quit

23-Jul-2014 - Switching patients to generic pills of a different shape and colour increases the chances they will end their course of medicine early, according to research.


Jay-Z and Scarface: pharma staff’s anonymous Wikipedia interests

22-Jul-2014 - Big pharma employees are among the brightest minds in the world, and data released yesterday on their Wikipedia use shows their interests spread beyond drug development into lighter fare.

PhRMA supports Customs drug destruction, responds to critics of law

21-Jul-2014 - PhRMA (Pharmaceutical Research and Manufacturers of America) has warned that illegal medicines rejected at the US border will continue to be resubmitted for importation unless a proposed law allows their destruction.

People on the Move

Role changes for AbbVie and Shire CEOs after merger

21-Jul-2014 - It has been a hectic few days for the chief executives of AbbVie and Shire since their companies agreed a £32bn ($53bn) merger on Friday.

US FDA looks to increase cooperation with Latin American counterparts

21-Jul-2014 - The US FDA is looking to up its cooperative agreements with PAHO (Pan American Health Organization) as part of an effort that could bring as much as $10m over five years to the Latin American version of the WHO (World Health Organization).

Regulatory & Safety: Featured news


G-CON: Pfizer investment an endorsement of 'podular' manufacturing

Pfizer investment an endorsement of 'podular' manufacturing, says G-CON

G-CON says a multi-million dollar investment by Pfizer could hasten the “paradigm shift” in pharma manufacturing towards...

US FDA enforcement evolving in India will drive compliance costs

Indian firms must invest in compliance as USFDA ups enforcement, says S&P

Indian drugmakers must invest heavily in compliance processes in response to the US FDA’s “aggressive surveillance” and...

Ease regulations to cure drug industry antibiotic resistance, says RPS

Ease regulations to cure drug industry antibiotic resistance, says RPS

The current model of antibiotic development “is broken,” says the Professor of Pharmaceutical Innovation at Kings College,...

Zogenix adds abuse deterrents to Zohydro painkiller

Zogenix adds abuse deterrents to Zohydro painkiller

Zogenix has modified its much-debated painkiller Zohydro with abuse-deterrent formulations.

Afrezza approval: Validation for Mannkind's drug and delivery tech

Afrezza approval: US FDA validation for Mannkind's drug and delivery tech

The US FDA approved Afrezza last weekend after deeming that the inhaled insulin drug and the dry...

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