Articles by Rich Whitworth - Pharmaceutical Technology

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Articles by Rich Whitworth

EMA Hosts Subgroup Analysis Workshop; Invites Esubmission Gateway Registrations

Dec 2, 2012

The EMA brought together European and US expert representatives from regulatory authorities, academia, industry and a health-technology-assessment agency on Nov. 18, 2011 to discuss the use and importance of subgroup analysis in the assessment of clinical trials.

Pfizer Contraceptive Pill Packaging Error Leads to Recall

Feb 9, 2012

Following a packaging error affecting birth-control pills, Pfizer has issued a one-million pack recall and warned women in the US who have been taking the medication during the last several months to consult with their physicians.

Cliffhanger

Feb 1, 2012

"The patent expiry of several major blockbuster drugs worth $150 billion between 2010 and 2017 will fuel the growth of the global generic pharmaceuticals market," so says a press release announcing new analysis from Frost & Sullivan.

EMA Releases Pharmacogenomics Concept Paper

Jan 26, 2012

The EMA has released a concept paper for a guideline on pharmacogenomic methodologies in the evaluation of authorized medicines to address the fact that genetic differences can cause variability in drug therapy efficacy and safety.

MS drug personalised with risk diagnostic

Jan 25, 2012

The FDA has approved a safety label change for Biogen and Elan?s multiple sclerosis drug Tysabri identified a diagnostic test that can help identify patients at risk of developing a serious brain infection, which has been associated with the drug.

Genentech Backs Epigenetics

Jan 20, 2012

Constellation Pharmaceuticals announced that it has entered into a broad collaboration with Genentech, a member of the Roche group, to discover and develop innovative treatments based on epigenetics, which focuses on the identification of small molecule inhibitors of protein activity.

Novartis Issues Recall and Suspends Operations at US Facility

Jan 12, 2012

Novartis Consumer Health has announced a voluntary recall of all lots of select, bottle-packaged configurations of Excedrin, NoDoz, Bufferin and Gas-X Prevention. The recall follows consumer complaints of chipped or broken pills and inconsistent bottle packaging line clearance practices that could lead to stray tablets, capsules or caplets from other Novartis products.

Multilayer-Tablet Technology

Industry experts discuss formulation and technical challenges in multilayer tablet manufacture.
Jan 2, 2012

Industry experts discuss formulation and technical challenges in multilayer tablet manufacture.

Go UK Bio

Jan 1, 2012

Firstly, Happy New Year! Please help yourself to a slice of cake.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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