Legal and Regulatory
A NICE by-pass?
UK science and health ministers Paul Drayson and Ara Darzi have proposed that some innovative new drugs could be used by the NHS while the National Institute for Health and Clinical Excellence (NICE) performs its review.
Biotech developers protected from generics
In the US, the senate, education, labour and pensions committee overwhelmingly approved an amendment that would protect biotech developers from generic competition for the next 12 years.
Cracking down on delayed generics
In an appellate court filing, the US department of justice has made it unlawful for branded drug-makers to pay generic firms to stand down from patent challenges.
IMB issues warning on Exenatide
The Irish Medicines Board recently issued a health warning on Exenatide (Byetta), first-in-class incretin mimetic for the treatment of type 2 diabetes mellitus in combination with metformin produced by Amylin Pharmaceuticals and Eli Lily, which is widely thought to be a potential blockbuster.
New biotech regulatory agency for India
India's department of biotechnology (DBT) is planning to set up a National Biotechnology Regulatory Board to regulate drugs and vaccines from natural sources such as humans, animals or micro-organisms.
New man heading NIH
President Obama has hired Dr. Francis Collins to run the National Institutes of Health, meaning he will be in charge of allocating some $29 billion worth of research funds.
