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Breaking News on Global Pharmaceutical Technology & Manufacturing

Regulatory & Safety: Top Headlines

EMA tells us it looks forward to continuing close relationship with DG SANCO

Juncked: Plan to move EMA from DG Health to DG Enterprise is abandoned

European Parliament in Strasbourg, France

22-Oct-2014 - DG Health will keep responsibility for the EMA according to European Commission President-elect Jean-Claude Juncker, who confirmed plans to hand the agency to DG Enterprise have been abandoned.

News in brief

Global TB drug development efforts underfunded says WHO

22-Oct-2014 - Janssen-Cilag’s bedaquiline and Otsuka’s delamanid notwithstanding, the drug industry is not spending enough on the development of tuberculosis medicines according to the WHO.

NIH: without budget cuts, we’d have Ebola vaccine

22-Oct-2014 - The head of the US National Institutes of Health has said the organisation would have developed a finished Ebola vaccine by now if its funding had not been slashed over the last decade.

Correction

Biotherapeutics need general chapters not individual Ph. Eur. monographs says EGA

21-Oct-2014 - Generic drugmakers want biotherapeutic products to have general recommendations in the European Pharmacopoeia rather than individual monographs.

NEWS FROM CPHI

The key to market exclusivity? Forget molecules, patent your tests

21-Oct-2014 - Makers of branded drugs are finding ways to extend their marketing authorisation by patenting not only molecules, but patient screening methods and ways of proving bioequivalence.

FDA to combine all of its quality ops under a new ‘super’ office

21-Oct-2014 - By early next year the US FDA is set to launch a new “super” office known as OPQ (Office of Pharmaceutical Quality), which will better align the review, inspection, and research of drugs.

People on the Move

Job changes: Sanofi, AstraZeneca, Novo Nordisk

20-Oct-2014 - Comings and goings in the pharma world in this week's People on the Move column.

Canada issues licenses for critical drugs hit by Apotex/IPCA import alert

20-Oct-2014 - Over forty “necessary products” made at Apotex and IPCA facilities hit with an import alert can be sold in Canada after regulators took steps to prevent shortages.

Spotlight

Share API audits or see quality slump, says Hovione

Share API audits or see quality slump, says Hovione

The sharing of audit reports for active pharmaceutical ingredients (APIs) is essential in order to help avert...

Personalised meds to deliver bigger market for oral film technologies says expert
dispatches from technopharm

Personalised meds to deliver bigger market for oral film technologies says expert

Flexible inkjet printing and personalized medicine will grow the market for orodispersible delivery technologies according to experts...

Complex regs and unknown markets top API shippers' logistics headaches
Pre CPhI Special

Complex regs and unknown markets top API shippers' logistics headaches

The world is getting larger, at least it is in terms of the pharmaceutical industry, according to...

How green was my Valium? Not very, despite industry claims
Pre CPhI Special

How green was my Valium? Not very, despite industry claims

Making active pharmaceutical ingredients (API) is a dirty business and you’d have to be pretty green to...

WHO welcomes industry response to Ebola crisis but calls for new drugs

WHO welcomes industry response to Ebola crisis but calls for new drugs

The Pharma industry has responded to the Ebola crisis in West Africa with developmental vaccines and aid...

Say ‘cheese’: database collects pill photos

Say ‘cheese’: database collects pill photos

The US National Institutes of Health (NIH) is collecting photos of pills and tablet in a database...

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