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Policies & Legislation

Pay for Delay DrugsMoneyGeneric V13F21

Endo accused of Opana pay-for-delay

Home/Policies & Legislation | Posted 31/10/2014

Specialty drugmaker Endo Health Solutions (Endo) has been accused of paying Impax Laboratories (Impax) more than US$112 million to keep their generic version of its powerful painkiller, Opana ER (oxymorphone), off the market from June 2010 to January 2013.

Pay for Delay DrugsMoneyGeneric V13F21

India drops planned price caps on non-essential drugs

Home/Policies & Legislation | Posted 24/10/2014

The Indian Government has scrapped plans to extend price cuts on both generic and brand-name drugs to include ‘non-essential’ drugs.

Canada EU V13J31

Implications of Canadian–European Trade Agreement for generics

Home/Policies & Legislation | Posted 17/10/2014

On 26 September 2014, Canada and the European Union (EU) successfully concluded negotiations on a trade deal, which will free the movement of goods, services, investment and labour between the two regions. However, some of the provisions in the agreement have been criticized by generics makers for delaying access to medicines by having a negative effect on the generics industry in Canada.

Substitution V13F14

Idaho proposes legislation on biosimilars substitution

Home/Policies & Legislation | Posted 29/08/2014

The Idaho Board of Pharmacy held a hearing on 5 and 6 August 2014 regarding proposed regulations for the treatment of biosimilars in their state.

Pay for Delay DrugsMoneyGeneric V13F21

Servier and generics makers fined for pay-for-delay

Home/Policies & Legislation | Posted 08/08/2014

French drugmaker Les Laboratoires Servier (Servier) and five generics companies have been fined a total of Euros 427 million by the European Commission due to practices delaying the entry of generic perindopril, a medicine to treat high blood pressure.

Pay for Delay V13C29

EC expected to dish out more pay-for-delay fines

Home/Policies & Legislation | Posted 01/08/2014

The European Commission (EC) is planning to fine French drugmaker Les Laboratoires Servier (Servier) and generics giant Teva Pharmaceutical Industries (Teva) in its latest round of investigations over so-called ‘pay-for-delay’ deals.

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Companies required to update information on drugs

Home/Policies & Legislation | Posted 04/07/2014

The European Medicines Agency (EMA) announced that as of 16 June 2014 marketing authorization holders would be required to update the information on medicines authorized in the European Union.

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EMA changes transparency plans to increase access to data

Home/Policies & Legislation | Posted 27/06/2014

The European Medicines Agency (EMA) has done an about-turn on its data transparency plans after the agency’s draft on the conditions of use for the EMA interface were criticized for limiting access to clinical trials data.

Law V13C29

Massachusetts governor signs biosimilars substitution bill

Home/Policies & Legislation | Posted 27/06/2014

Massachusetts has become the latest US state to pass a law allowing substitution of a biosimilar for an originator biological, but with certain restrictions.

Law V13C29

Court rules Canadian drug regulators cannot control generics' prices

Home/Policies & Legislation | Posted 27/06/2014

Canada’s Patented Medicine Prices Review Board (PMPRB) has been told that it has no jurisdiction over the pricing of generics.