India has a name when it comes to generic drug development. According to a recent research on patent applications carried out by Withers & Rogers, innovation by Indian pharmaceutical companies has increased over the past few years; however, the quality did not match the standard seen in Europe. Read more »
Archive for the 'Europe News' Category
While the Affordable Care Act, Pope Francis, and the government shutdown were top general news stories in 2013, the bio/pharmaceutical industry had its own headlines. Pharmaceutical Technology analyzed the hundreds of news stories published in 2013, and found the top 10 most-read articles, based on reader clicks. To no surprise, the most-read articles reflect major bio/pharmaceutical business announcements and regulatory activity.
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The bacterial meningitis outbreak at Princeton University in recent weeks has raised questions about why there is no vaccine in the United States to prevent this deadly disease, when such a therapy is approved in Europe and Australia. The current Princeton health danger prompted the Centers for Disease Control and Prevention (CDC) to request emergency import of the vaccine, and the Food and Drug Administration approved that move, authorizing an investigational new drug application (IND) for Novartis’ Bexsero vaccine. New reports of additional meningitis B cases in California may spark further discussion about ensuring US access to protection against this dangerous infection.
The situation illustrates the complexities of vaccine development, approval and reimbursement at home and abroad. Studies to document vaccine safety usually require testing in thousands of healthy individuals, plus certain high-risk populations. There are four meningitis vaccines licensed in the US, but they protect against four other meningococcal disease strains, and not B, which has proven more difficult to attack.
Moreover, meningitis B is not that prevalent in the US, so Novartis and other vaccine makers have concentrated clinical trials for B preventives in Europe, Australia, and other regions. The resulting study data supported market approval for Bexsero in the European Union in January 2013 and more recently in Australia. More trials have been launched in Latin America and even Canada, but not in the US where Novartis did run a small, early trial on adolescents several years ago. Meningitis is most deadly in infants and very young children, and testing in those populations raises difficult risk-benefit calculations for a relatively uncommon condition.
In April 2011, the FDA advisory committee on vaccines and related biological products discussed the effectiveness of meningococcal vaccines in young children and approaches for demonstrating effectiveness in serogroup B vaccines. Representatives from Novartis and Pfizer made presentations on new but differing approaches for developing effective therapies and new surrogates for demonstrating protection.
Novartis says it is discussing a “pathway to licensure” with FDA and “evaluating its phase 3 plans” for the US and other regions. But market approval of a meningitis B vaccine in the US may take much longer because Novartis and other vaccine makers now appear more interested in developing a combination vaccine that will cover all five meningitis strains.
To some extent, that decision reflects problems with reimbursement for new vaccines, which largely comes from public health agencies. Novartis received a blow in July when the UK’s Joint Committee on Vaccination and Immunisation advised against adding Bexsero to its routine vaccination program. The Committee is reconsidering that recommendation, which was based largely on cost-benefit considerations: whether it is worth the money to vaccinate some 800,000 infants a year when only 1800 cases of the disease are found in children in the UK each year, and there are concerns that the vaccine may be only 73% effective.
These developments have spurred more talk about Novartis selling its vaccine business, which has struggled to be profitable, according to market analysts. Novartis recently announced the sale of its blood transfusion diagnostics unit, which is housed with its vaccines unit.
Researchers and patient advocates for a more effective meningitis vaccine point out that cost-effectiveness studies often fail to assess prevention appropriately. They also fear that a final UK non-coverage decision for Bexsero could discourage vaccine research in general. Coverage certainly would be easier to justify for an all-strain meningitis vaccine, but that may involve years of more testing.
Craig Stobie from Domino Printing Sciences shares on how to prepare for FMD and other emerging legislation.
The Falsified Medicines Directive (FMD) has finally been transposed into UK legislation. The FMD came into force on 20 August 2013. “It is now time for pharmaceutical manufacturers to walk the talk,” said Craig Stobie, global life sciences sector manager at Domino Printing Sciences. Read more »
The issue of patients not receiving essential medicines because they cannot afford them is becoming a serious problem in the EU as the region battles through its economic crisis. In a briefing by the European Public Health Alliance (EPHA) on Access to Medicines in Europe in Times of Austerity, it was highlighted that the three factors that will determine whether or not a patient gets his/her medicine are “affordability and availability, in terms of access to medicines, and innovation in terms of developing new methods of assuring best possible health outcomes.” Read more »
Steven Eaton, a scientist working for Aptuit, a US pharmaceutical company, has been jailed three months for falsifying preclinical safety data on experimental anticancer drugs due for clinical evaluation. Eaton, 47, who worked at the company’s drug discovery and development site in Riccarton, near Edinburgh, Scotland, is the first person in the UK to be jailed under the country’s scientific safety laws. Read more »
“Our vision of success is to enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research,” stated the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom as it unveiled its 2013–2018 corporate plan on 11 April. The agency announced its aims to be a leading regulator on the world stage in supporting science and research as part of its five-year corporate plan, which was developed using responses from a public consultation launched last December. Read more »
New figures show that last year, doctors in the UK received approximately £40 million from big pharmaceutical companies. According to the Association of the British Pharmaceutical Industry (ABPI), a trade body representing pharmaceutical companies, both National Health Service (NHS) and private staff were paid the sum for consultancies and sponsorships and other interactions with drug businesses in 2012. Read more »
The European Commission (EC) has released the draft revision for four chapters of its good manufacturing practice (GMP) guidelines—chapters 3, 5, 6 and 8. A public consultation was launched earlier this year with comments due on 18 July 2013. The EC stated that these revisions were needed to reflect the latest thinking relating to best practices. Read more »
The UK government has confirmed that from 2014 onwards, the National Institute for Health and Clinical Excellence (NICE), which is the country’s cost-effectiveness watchdog, will play a central role in the new value-based pricing system for assessing the costs and benefits of medicines. Read more »