Author Archive

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

Over 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. Read more »

Roche on Continuous Manufacturing at the PDA/EMA Joint Conference

Continuous 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 »

PDA/EMA Joint Conference on Process & Validation

On the second day of the PDA/EMA joint conference, we had a choice of three different topics, all running simultaneously: GMP inspection practice, process and validation, and challenges for EU harmonisation. I somehow found myself listening to Lina Ertle from the French national agency for medicines and health products (ANSM), who gave an update on process validation guidelines. Read more »

Highlights from the PDA/EMA Joint Conference

Last week, I attended the PDA/EMA joint conference in Cascais, Portugal. The topic was on compliance, a prerequisite for availability of medicinal products. The conference kicked off with a plenary session on the impact of the new falsified medicines directive (FMD) on regulators and the pharmaceutical industry. Belen Escribano Romero from the AEMPS (Agencia Española de Medicamentos y Productos Sanitarios), a public body that belongs to the Spanish Ministry of Health, provided an overview of the main changes in the new legislation, which included, amongst others, the importation of APIs and excipients from third-world countries, inspection planning, revisions of the GMP guidelines, new GDP guidelines for the distribution of medicinal products by wholesalers and brokers, as well as pending regulations relating to safety features and purchasing medicines via the internet. It is hoped that these additional requirements will increase the quality of medicinal products, reinforce supply-chain security and prevent penetration of counterfeits, and better protect those buying medicines online. Read more »

In Favour of Needle-Free Injectables

No one likes needles, so imagine the benefits of needle-free delivery systems, especially for chronic conditions where lifetime therapy is required, for example rheumatoid arthritis (RA). Patients already have enough stress to deal with and can definitely do without the added fear and anxiety associated with needles. Other advantages of course include the lack of contamination risks and needle stick injuries, plus disposals are easier when you don’t need a bin for sharps. Read more »

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