Free trade, always a subject of concern for business, has been a topic of particular interest for the pharmaceutical and allied industries this past week as individual companies and trade associations weigh in on the debate on several free-trade measures. Read more »
Healthcare reform in Germany has had pharma companies grumbling for months. Among other things, the new system limits the amount that pharma companies can charge for prescription drugs; a law known as AMNOG demands that companies submit a cost–benefit dossier for new drugs, with the outcome being used to set the price, which is a bit of a thorn in pharma’s side. Read more »
Pharmaceutical companies’ interest in furthering their positions in emerging markets is no secret, and this past week, two companies, Novartis and AstraZeneca, offered updates of current projects in one country, Russia. Read more »
Children are not just small adults, which is part of the reason why developing paediatric drugs is not easy. Most medicines are designed for and tested in adults, and then prescribed to children off-label. In particular, there is a lack of medicines for infants aged 0–2 years. There are a variety of reasons for this shortage — mostly relating to the ethical, regulatory and practical issues associated with testing new drugs in infants. Most parents, for instance, would not want new drugs to be tested on their children! Read more »
Biosimilars can be considered a controversial subject because of safety concerns related to immunogenicity. Despite this, the biosimilars industry seems to be booming. Recent research from industry analysts Datamonitor estimated that the value of the global market for biosimilars would jump from $243 million in 2010 to $3.7 billion in 2015, and the biosimilars have now been used safely for 5 years, according to the European Generic Medicines Association (EGA). Read more »
The European Medicines Agency (EMA) has released recommendations concerning pack design and labelling for non-prescription medicines for a 3-month public consultation period, which will run until 30 June 2011. Such features are important for the safe use of all medicines, but are arguably more crucial for non-prescription medicines — especially when no intervention from a pharmacist is required. For this blog, I thought I’d take a an in-depth look at the recommendations and what pharma manufacturers will be required to provide, if the recommendations are enforced.
This week, the European Commission (EC) began a public consultation in relation to a review of the ‘Transparency Directive’ (89/105/EEC), which concerns the transparency of the pricing and reimbursement of medicines in different EU Member States. Considering the fact that the Directive hasn’t been amended for more than 20 years, it’s about time someone took a closer look at its implications on modern healthcare! Read more »
A possible link between cases of the chronic sleep disorder narcolepsy and GlaxoSmithKline’s H1N1 pandemic vaccine, Pandemrix, has led to a call from the World Health Organization (WHO) for further investigation. Narcolepsy is a rare condition with no currently available cure. Read more »
At a press conference in the waning days of 2010, Senator Amy Klobuchar (D-MN) raised an alarm about what she called an “unprecedented” drug shortage. Citing a scarcity of treatments for chemotherapy, she called for greater collaboration between industry and FDA to ensure that Americans have access to the medicines they need. But shortages also can affect drugs that are used for purposes other than healing. Read more »
There was no joy in Paris, at least at sanofi-aventis (Paris) headquarters, on Friday. When the company’s offer to acquire Genzyme (Cambridge, MA) at $69 per share expired that day, fewer than 1% of the biopharmaceutical company’s outstanding shares had been tendered. In response, sanofi extended its deadline to January 21, 2011 without modifying the terms of its offer. Why should the company expect a different result in six weeks’ time? Read more »
From PharmTech.com