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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.

Ipca halts API shipments to US following 483 at Indian plant

24-Jul-2014 - Ipca Laboratories has halted shipments to the US of active pharmaceutical ingredients (APIs) made from a facility in India following a US FDA inspection.

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.

European Pharmacopoeia plans revisions of elemental impurities guideline

23-Jul-2014 - As the International Conference on Harmonisation (ICH) signs off on a new tripartite guideline related to elemental impurities, the European Pharmacopoeia Commission will revise its texts to ensure consistency. 

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).

India's CDSCO to pay people who report fake drugs

17-Jul-2014 - The CDSCO has accused international “vested interests” of labelling counterfeit drugs as “made in India” to damage the reputation of the country’s pharmaceutical industry and launched a scheme to reward people who report fakes.

Dispute over FDA bid to destroy personally imported drugs

17-Jul-2014 - Pharma groups and patients have objected to US Food and Drug Administration (FDA) plans to destroy prescription medicines personally imported into the US by patients.

Janssen's tramadol supply chain ready for DEA's rescheduling deadline

16-Jul-2014 - Janssen Pharmaceuticals is prepared for Tramadol's reclassification by the US Drug Enforcement Administration (DEA) and says the supply of its versions of the opioid analgesic will not be interrupted.

Italian API manufacturer hit with FDA warning letter over data control

16-Jul-2014 - Cited with data quality issues, Italian API manufacturer Trifarma has until July 24 to respond to a litany of requests from the US FDA.

FDA proposed rule could delay import of excipients, PhRMA says

15-Jul-2014 - Although industry group PhRMA has called for the full implementation of a proposed rule that would allow the US FDA to destroy detained drugs deemed to be counterfeit or unapproved, the group also warns that such destruction could lead to manufacturing delays.

David and Goliath can coexist says group accusing US Pharma of anti-Indian tactics

10-Jul-2014 - The Indian industry group that accused US Big Pharma of anti-Indian tactics last week has said there is room for both generics firms and innovators. 

Waters to open laboratory with Chinese Pharmacopoeia

10-Jul-2014 - Pharma technology provider Waters as agreed with the Chinese Pharmacopoeia Commission (ChP) to establish a joint open laboratory to develop new pharmacopoeia standards.

GRAS always greener? FDA considers overhauling OTC monograph system

09-Jul-2014 - The US FDA has given stakeholders more time to comment on the 40-year old monograph system used to regulate OTC drugs and reiterated its concerns that the approach does not allow it to keep up with new drug safety testing advances. 

Apotex hit with warning letter on troubled API facility in India

09-Jul-2014 - Apotex is getting reprimanded once again for its API facility in Bangalore, India, after the company failed to adequately respond to an FDA Form 483 over data integrity issues, according to an FDA warning letter dated June 16 .

Ease regulations to cure drug industry antibiotic resistance, says RPS

08-Jul-2014 - The current model of antibiotic development “is broken,” says the Professor of Pharmaceutical Innovation at Kings College, London, who told the key to encouraging antibiotics manufacture is lightening companies’ regulatory burden.

European Commission outlines priorities for pharma sector in new report

07-Jul-2014 - In a sweeping report on the industry as a whole, the European Commission says that with an annual output of €220bn, and nearly 800,000 employees, the pharma industry is vital for the EU economy, though more needs to be done to meet its full potential.


Pfizer and Protalix’s Gaucher’s drug gets kosher status

03-Jul-2014 - Elelyso has been certified as kosher by a US Jewish group, which says the process used to make the lysosomal storage disease drug means it conforms to religious dietary laws.

US FDA issues draft strategic priorities document

02-Jul-2014 - The US FDA has set emphasising the benefits of QbD, traceability and risk based manufacturing facility inspections as strategic priorities for the next four years in document published for consultation this week.

Bill tying FDA review timelines to EU approvals questioned

01-Jul-2014 - A regulatory expert has warned of the “unintended consequences” of that would require the US Food and Drug Administration (FDA) to begin reviewing drug candidates within 90 days of their approval in the EU.

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