Author Archive

MHRA’s New Corporate Plan To Prioritise Science And Research

“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 »

A World Without Polio by 2018

More than 400 eminent scientists and public health experts from around the world have come together to endorse a new initiative to eradicate polio by 2018. The Scientific Declaration on Polio Eradication, published on 11 April, stated that an end to polio is scientifically feasible and achievable. Read more »

UK Doctors Paid £40 Million in One Year by Pharma

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 »

EC Releases Revisions of GMP Guidelines

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 »

NICE Responsible for UK’s Value-Based Pricing of Medicines

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 »

Janssen and NHS Collaborate on Dementia Challenge

Janssen is partnering with the UK National Health Service (NHS) on a new programme that seeks to inspire innovative ideas that will help reshape and improve the way dementia care is delivered. The company recently launched the inaugural NHS innovation challenge prize for dementia, which is designed to harness the expertise of those working at the frontline of dementia care in the UK. Janssen is offering a prize of up to £150 000 for solutions that can make a real and sustained difference to the lives of those affected by dementia, both directly and indirectly. Read more »

Combined Oral Contraceptives Sparks Safety Review

There are growing concerns regarding the safety of third- and fourth-generation combined oral contraceptives following media reports on blood clots (venous thromboembolism) associated with the use of more recently-introduced contraceptive products containing newer progestins such as drospirenone, gestodene and desogestrel. France has requested that the European Medicines Agency (EMA) review this class of drugs to determine if their use should be restricted. This is the first time that a member state has requested the EMA to give an EU-wide recommendation for these medicines under the framework of the new pharmacovigilance legislation. Read more »

New Global Alliance Aims To Speed Up Academic Drug Discovery

Six of the world’s leading health research centres have joined forces to form a global alliance that seeks to strengthen international academic and not-for-profit drug development. The aim of the Global Alliance of Leading Drug Discovery and Development Centres, which consists of organisations from Europe and North America, is to accelerate the translation of academic research into usable medicines and therapies. Read more »

Big Pharma’s Shrinking Firepower for M&A Deals

VLUU L110  / Samsung L110Over the last two years, the gap between analysts’ estimates of big pharma sales and the global drug market forecast by IMS Health has widened significantly. In 2011, the overall drug market saw growth that overtook big pharma by approximately $20 billion; it is anticipated that this gap will further widen to $50 billion in 2012 because of major brands falling off the patent cliff.

A recent report by Ernst & Young, Closing the gap? Big pharma’s growth challenge and implications for deals, projects that the growth gap will reach $100 billion by 2015. As a result, big pharma is under increased pressure to drive growth through mergers and acquisitions (M&A). There is, however, another obstacle standing in the way—the firepower gap. Ernst & Young defines firepower as a company’s capacity for conducting M&A deals. Read more »

Roche on Continuous Manufacturing at the PDA/EMA Joint Conference

VLUU L110  / Samsung L110Continuous manufacturing is now becoming a trend as its advantages are being increasingly recognized. At the PDA/EMA joint conference, which took place earlier this month, Martin Wunderlich from F. Hoffmann-La Roche presented an industry case study on solid drug product manufacturing based on this concept. He explained how a continuous wet granulation process for one of the company’s product (referred to as ‘product X’ hereafter) was developed using a quality-by-design (QbD) approach and a control strategy based on process analytical technology (PAT), as well as the technical challenges involved in the development of the process. Read more »

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