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Amgen enters biosimilars deal with PRA

Clinical Research Organisation (CRO) PRA announced on 26 April 2012 that it had entered into an agreement with US biotechnology giant Amgen as the sole provider of CRO services for ‘a series of phase III studies to develop several biosimilar drugs on a worldwide basis’.

CMS rules add to US drug shortages

Results of a survey carried out by the Institute for Safe Medication Practices (ISMP) and published on 22 March 2012 point to the fact that ‘too strict’ rules from the US Centers for Medicare & Medicaid Services (CMS) have led to waste of medications already in short supply.

Also noted on pharma: 13 April 2012

Drug shortages increase again in 2011
Despite efforts by FDA the number of drugs in short supply has increased again in 2011, according to data from the University of Utah, USA. Levels are more than 4.5 times higher than in 2004, when 58 drugs were reported to be in short supply, and have reached a new record high of 267 drugs experiencing shortages.

Related article

Record high drug shortages in the US

Source: The Washington Post

Also noted on pharma: 6 April 2012

MPs concerned over medicines shortages in UK
Nineteen UK Ministers of Parliament (MP) have now signed a Parliamentary motion demanding that the government holds ‘urgent discussions’ on the selling of UK medicines abroad, which according to many is only serving to exacerbate the current drug shortage situation in the UK.

Source: Chemist & Druggist

Canada drug shortages

Sandoz, the generics unit of pharma giant Novartis, is at the centre of Canadian drug shortages, however, the company is assuring Canadians that it will not raise prices of drugs sourced from overseas.

Top 10 most read GaBI Online articles in 2011

2011 was a busy year and biosimilars was the hot topic of the year for GaBI Online.

GaBI launches GaBI Journal

- A new information source for generics and biosimilars -

Canada’s generics and brand-name pharma come together to tackle drug shortages

Canada’s Research-Based Pharmaceutical Companies (Rx&D) and the Canadian Generic Pharmaceutical Association (CGPA) announced on 12 March 2012 their commitment and financial support in responding urgently to prescription drug shortages.

Greece drug shortages

A severe drug shortage is threatening to undermine the health and welfare of Greek citizens as prescription drugs and even basic over-the-counter medicines are in increasingly short supply. Even finding common drugs such as Aspirin has become a major problem in Greece.

Score lines won’t delay generics

In an attempt to delay generics competition, Irish pharma company Warner Chilcott had added a second line or score to its Doryx (doxycycline hyclate) tablet. On 8 February 2012, FDA however denied the company’s citizen petition demanding that generic versions should also have the two score lines.

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