Updates on key governmental and regulatory issues.
- Orphan drugs: rarity no guarantee of access
More orphan drugs for niche conditions are reaching the market, but this may actually hamper their availability, especially in Europe.
Aug 3, 2007
- French law recognises biosimilars
As debate in the US about follow-on biologicals/biogenerics continues, France has legally recognised that biosimilars are different from generic chemical entities. IMS looks at the varying opinions on the ramifications of this move.
Apr 10, 2007
- Biogenerics: Waiting for the Green Light
Speaking at the FT Global Biotech Conference held in London on October 20 2004 both Sandoz and Teva said they were ready to launch biogenerics - but regulators need to finalise their approval processes.
Oct 28, 2004
- Could Indian Drugmakers TRIP on Patent Reform?
Prior to the introduction of product patents in India from January 2005 the first Exclusive Marketing Rights have been granted - IMS looks at why both multinationals and domestic manufacturers are dissatisfied.
Oct 27, 2004
- Statin Self-Medication Arrives in the UK
In a widely heralded move the UK Health Secretary has granted over-the-counter status for Merck & Co's cholesterol reducer Zocor the first statin to be sold without a prescription.
May 26, 2004
- Shake-Up for US Antihistamine Market
Schering-Plough's blockbuster antihistamine Claritin went over-the-counter in the US in December 2002 shortly before its exclusivity expired... how will this impact the market?
Dec 18, 2002
