Prevenar 13 licensed in UK

by Emma 8. November 2011 16:11

 

Pfizer’s Prevenar 13 (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent, Adsorbed]) has been launched in the UK for active immunisation of invasive disease caused by Streptococcus pneumoniae in adults aged 50 and over.

It becomes the first and only pneumococcal conjugate vaccine to be licensed for adults aged 50 and over after gaining a new indication from the EMA.

Dr George Kassianos, GP and immunisation lead for the Royal College of GPs and the British Travel Health Association, says its introduction is an “important achievement and step forward” for adult patients.

The vaccine was first licensed for infants and young children in December 2009 in Europe and used during the UK’s Childhood Immunisation Schedule in April last year.

The new indication provides a new treatment option for the prevention of adult invasive pneumococcal disease (IPD), which includes the potentially fatal bacteraemic pneumonia, meningitis and septicaemia.

Chris Head, CEO of the Meningitis Research Foundation, welcomed the vaccine’s launch in the UK. “The new license for Prevenar 13 provides an opportunity to protect adults over 50, who are more at risk of serious pneumococcal disease than younger adults,” he said.

Until Prevenar 13’s new indication, adults over 65 and those in clinical risk groups were treated with the pneumococcal polysaccharide vaccine. But in clinical trials, patients given Prevenar 13 had significantly higher antibody responses with the vaccine expected to protect against seven out of the most ten most comment serotypes which causes IPD.

New law to help protect small businesses’ patent rights

by emma 4. October 2011 10:47

MB medtech news

A new law has come into force that will give smaller businesses easier access to justice to protect their copyright and trademarks.

The Patents County Court Order No. 2 2011 now clearly defines which copyright and trademark disputes should be heard in the Patents County Court (PCC) and which should be sent to High Court.

A damages cap of £500,000 for all patent claims in the PCC means that small and medium sized companies are less likely to face expensive fees at High Court and will have lower value, less complex cases settled at the PCC.

Baroness Wilcox, Minister for Intellectual Property, said: “These changes provide clarity on the legal processes, certainty over the risks and give small enterprises the confidence to stand on an equal footing with financially stronger companies.”

Current evidence presented to the recent Hargreaves Review of Intellectual Property and Growth indicated that one in five (17%) of small and medium sized firms felt dissuaded from enforcing their IP rights due to potentially high court costs.

Baroness Wilcox commented: “A more accessible justice system will give companies greater incentive to protect and enforce their intellectual property rights. Making it easier for small firms and entrepreneurs to use the legal processes will give them more time to concentrate on business activities, innovate and support economic growth.”

The effectiveness of the damages cap will be monitored with a formal review in 2014.

NHS cervical cancer vaccine could be cheaper

by emma 28. September 2011 12:39

Pf NHS News

The Government’s choice of using GSK’s Cervarix to vaccinate against cervical cancer is less cost-effective than Merck’s Gardasil, a new study has found.

Authors of the Health Protection Agency (HPA) study stated that, if equally priced, Merck’s Gardasil was more cost-effective, despite the fact that Cervarix may provide better protection against cervical cancer, but said that “considerable uncertainty” remains about the differential benefits of the two vaccines.

In 2008, the UK Government chose Cervarix for its Human papillomavirus (HPV) vaccination programme, believed to be the cheapest option.

But since then, new evidence has emerged to differentiate the two vaccines.

The HPA has now found that Cervarix would need to be between £19 to £35 cheaper to match Gardasil’s price.

Also, Cervarix has proved to give better protection against cervical cancer caused by HPV types other than 16 and 18. Gardasil has also shown protection against vulvar, vaginal and anal cancer.

A spokesman for the HPA said: “The Department of Health will use the results of this study as part of its decision-making process when reviewing its current vaccine choice.”

The selection of the vaccine will be re-evaluated when the current tender for the vaccination programme expires before the end of 2011.

“Deciding which vaccine to use for national immunisation programmes is a complex task. Many factors, including the cost of the vaccine, must be taken in to account,” added the HPA spokesman.

Both vaccines protect against HPV types 16 and 18, which are responsible for over 70% of cervical cancer cases, as well as other types of cancer. Gardasil also vaccinates against types 6 and 11, which cause the majority of genital warts as well as a rare disease called respiratory papillomatosis.

Human papillomavirus is a common sexually transmitted infection seen most often in young women. There are more than 100 types of HPVs; some cause genital warts, but others cause cancers including cervical cancer.

HPV testing is currently being integrated into England's cervical cancer screening programme, and will be fully incorporated within the year.

Cervarix was found to protect against five of the most common cancer-causing viruses in July 2009.

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