ISPE says quality programme starts to bear fruit

02-Jun-2008 - The International Society of Pharmaceutical Engineers has reported the first findings of a five-year new programme aimed at working tackling one of the toughest problems in pharma manufacturing at present - how to implement the new quality systems model laid out by the International Conference on Harmonization.

Generic Plavix opens door for API manufacturers

13-May-2008 - Switzerland-based Schweizerhall appears to have circumnavigated patent law, with approval of its generic version of Bristol-Myers Squibb's (BSM) and Sanofi-Aventis' Plavix (clopidogrel bisulfate) in Germany "expected shortly".

US District finds for GSK in patent amendments case

07-Apr-2008 - GlaxoSmithKline (GSK) has scored a decisive victory in its efforts to head off new US patent rules that would strike at the heart of the way the drug industry goes about protecting its inventions.

Health Canada issues draft rules for subsequent entry biologics

26-Mar-2008 - Drug regulator Health Canada has published its draft guidelines for pharmaceutical firms seeking to gain approval for biosimilars or "subsequent entry biologics."

New US biosimilars bill a disappointing distraction, says GPhA

26-Mar-2008 - The generic pharmaceutical industry has given short shrift to the latest congressional attempt to construct a viable approval pathway for biosimilars in the US.

Weekly Comment

Warding off the generic attack

07-Jan-2008 - A recent report has detailed the challenges facing the pharma industry as the generic flood gates open, with the constant advice to start planning early still apparently not heeded by a bewildering number of firms.

Weekly Comment

Pharma must 'reinvent' itself to survive

02-Nov-2007 - With IMS Health's annual forecast for the pharma industry predicting slower approvals, more black box warnings and the continuation of the 'wave of genericization,' the shift by pharma firms to refocus and reinvent themselves will need to move on apace in order to secure their position in a changing market.

US dragging its heels on biosimilars, says report

16-Oct-2007 - The US is woefully lagging behind the EU when it comes to approving biosimilars, a new report says.

Risk management strategy progressing nicely

31-Jul-2007 - European pharmaceutical and medical authorities have announced their satisfaction on the progress being made with the European Risk Management Strategy (ERMS) following a meeting earlier this month.

EU biosimilars regulations still need 'clarifications'

16-May-2007 - There are some areas of the European approval system for biosimilars that still need to be clarified, a panel of industry experts said during BIO 2007.

Pharmas to lose $100bn to generics

22-Feb-2007 - A report to be published next week predicts that US and EU pharmas will lose up to $100bn in revenues over the next five years as generic products take advantage of major branded products losing patent protection.