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India urged to drop cost-based drug policy

Indian industry trade group the Associated Chambers of Commerce and Industry of India (ASSOCHAM) has urged the Indian Government to drop its cost-based price controls on both brand-name and generic drugs and instead introduce a market-based pricing policy.

Momenta versus Amphastar and the safe harbour provision

On 3 August 2012, the US Federal Circuit issued a decision holding that the safe harbour* provision of the Hatch-Waxman Act 35 U.S.C. § 271(e)(1) covers post-approval testing as long as it is ‘reasonably related’ to the submission of information to FDA. The case involved was that of Momenta Pharmaceuticals (Momenta) versus Amphastar Pharmaceuticals (Amphastar) (Federal Circuit No. 2012-1062, 8/3/12).

FDA gives generics greater importance

The Office of Generic Drugs has been promoted to the highest position within FDA because of the great amount of work and income/expenditure now associated with generics.

Canada takes another step towards generics

For the first time, two of Canada’s biggest health insurance companies are going to require that generics be prescribed if one is available.

Poor quality pharma ingredients abound in China

Lack of regulatory enforcement in China is allowing poor quality pharmaceutical ingredients to be sold to drug manufacturers with potentially dangerous or even fatal consequences for patients.

Austria could save Euros 256 million by using more generics

A recent study by IMS Health Austria (IMS) revealed that in Austria healthcare payers could have saved more than a quarter billion Euros during 2011 if physicians would have prescribed more generics to their patients.

Coupons help Big Pharma to fend off generics

Pfizer’s success at using co-pay coupons to prevent patients switching from brand-name products to generics is encouraging other pharmaceutical giants to follow suit.

Canada grapples with drugs costs

Government report calls for the widening of the current scheme for brand-name medicines to include generics.

UK spending on brand-name drugs predicted to reduce

Spending by the UK’s National Health Service (NHS) is under control according to a new report, and in fact spending on brand-name medicines is expected to reduce in real terms and as a proportion of the UK healthcare budget over the next three years.

Generics have their feet under the table in Malaysia

Generics manufacturing, prescribing and sales are becoming firmly part of the scene in Malaysia.

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