MWV expands blister pack range with Shellpak-170

16-Apr-2009 -  US contractor MeadWestvaco (MWV) claims the latest addition to its Shellpack range, the Shellpak-170, offers drugmakers more options for adherence promotion blister packaging. 

Drugmakers still confused by CFR-21 parts 210 and 211, says West

30-Mar-2009 - Since coming into effect late last year, US Code of Federal Regulations-21 parts 210 and 211 testing rules have been the subject of much confusion in the pharmaceutical industry, according to West Pharmaceutical Services.

SAFC launches service to secure supply chain

30-Mar-2009 -  SAFC has launched its Vendor Audit Services that are designed to increase clients’ confidence in the supply chain by providing traceability and quality confirmation of raw materials.

Tabletting delay caused lethal allopurinol contamination, say HK chiefs

10-Mar-2009 -  Macao Health Bureau director Lam Ping-yan says tabletting delays at Euopharm Laboratories' plant in Hong Kong, China may have led to contamination of the hyperuricemia drug Purinol (allopurinol) linked to several deaths.

PPD doesn’t expect alogliptin milestone this year

09-Mar-2009 -  PPD says it is unlikely to receive a $25m (€20m) milestone for US approval of Takeda’s diabetes drug alogliptin this year after the FDA said that cardio vascular (CV) safety data filed as part of the NDA are insufficient. 

Nigerians can sue Pfizer in US courts, rule appeals judges

03-Feb-2009 -  A US federal appeal court has reinstated lawsuits by Nigerian families against Pfizer in a move that could have wide ranging implications for companies conducting clinical trials abroad.

Trial patients OD after clinic failed to weigh them

14-Jan-2009 -  A FDA warning letter has been sent to a clinical investigator who administered incorrect doses of investigational drugs having taken the patient’s weight and height from their driving license.

Pharmaceutical Profiles the effects of diabetes drug

18-Sep-2008 -  UK-based Pharmaceutical Profiles has used an imaging technique known as scintigraphy to quantify the effects of Amylin / Eli Lilly’s latest diabetes drug on the stomach.

Outsourcing drives growth in trial sector, Bilcare GCS

16-Sep-2008 -  Bilcare GCS, the clinical supplies arm of Indian packaging giant Bilcare, has considerably expanded its Phase III trial offering in an effort to provide drugmakers with a complete package.

Merck’s ADVANTAGE trial misled patients, claim researchers

02-Sep-2008 -  Merck & Co has been accused of carrying out clinical trials of its Vioxx (rofecoxib) painkiller that were designed primarily for marketing purposes rather than to answer a clinical hypothesis.

Indian congressmen says clinical trials must stop

21-Aug-2008 - The revelation that 49 infants died during clinical trials in India has sparked anger among the nation’s congress, with some calling for all studies to be stopped while investigations take place despite the trials having an infant mortality rate (IMR) below the national average.

FDA builds higher walls between advisors, industry

05-Aug-2008 -  Panellists serving on the FDA's advisory committees will have stricter limits on their financial ties to industry under a raft of reforms announced by the agency yesterday.

Brown steps up pharma outsourcing probe

31-Jul-2008 - US Senator Sherrod Brown has fired off another broadside in his probe into pharmaceutical outsourcing, this time sending a request to Merck & Co “for further information on its heavy reliance on global outsourcing for the manufacture of pharmaceutical ingredients and finished products.”

Tougher tests for diabetes drugs?

07-Jul-2008 - The US Food and Drug Administration (FDA) could raise the bar for clinical trials of diabetes drugs if it follows the advice of one of its advisory committees.

Binto eliminating the detective work from clinical trials

03-Jul-2008 - A service provider called Binto is filling a much needed vacuum in the clinical trial industry in terms of patient tracking, eliminating the need for big pharmaceutical firms to resort to methods such as hiring private investigators to track down "lost" patients.

Repackaging ban 'most powerful tool to prevent counterfeiting in Europe'

24-Jun-2008 - European pharmaceutical manufacturers stepped up calls for a blanket ban on repackaging of pharmaceuticals last week, suggesting that this would be the single most effective way to seal the supply chain for counterfeiting drugs.

EFPIA says traceability pilot will start next year

23-Jun-2008 - A pilot study looking at a national system for mass serialisation of medicine packs using 2D matrix coding is due to get underway next year in Germany.

FDA set for funding boost to grow foreign muscle

17-Jun-2008 - The US Food and Drug Administration (FDA) is likely to receive a $275m budget boost to aid it in its ability to conduct foreign inspections.

Weekly comment

US Senator seeks probe into pharma outsourcing

16-Jun-2008 - A US senator has asked the Food and Drug Administration (FDA) for a probe into outsourcing of production for pharmaceuticals, as well as ways to make drugmakers accountable for products which fail to meet quality standards.

Heparin declared "safe", China remains nonchalant

19-May-2008 - The US Food and Drug Administration has declared the country's previously-tainted heparin supply to be "safe" due to stronger testing and controls that are now in place. Meanwhile, China continues to distance itself from the matter.

Independant safety monitoring 'lacking' in child trials

26-Mar-2008 - International drug trials on children are monitoring safety at levels that are "unacceptable," according to a new analysis.