In what has surely been the most cost-effective clinical study ever to deliver FDA approval, a new paediatric product has received licensing authorisation following a trial involving just 15 participants. And that includes the placebo arm. In fairness, Anascorp is a highly specialised offering. It has been produced – as its name hints – for use as an anti-venom treatment for the 17,000 or so reported scorpion stings suffered by children in the US every year.
The EMEA has revealed that a review of restrictions on rules governing communications between pharmaceutical companies and patients has been ordered by the EU’s Council of Ministers. The Bloomberg news service, which reported the development, predicted the exercise was unlikely to deliver US-style direct to consumer advertising of Rx products. It added that a desire for increased uniformity in the regulations being implemented across the EU’s 27 member nations was likely to have motivated the announcement.
The condemned prisoner’s agonising and long drawn out court battle against execution ha s featured in countless movie plots but rarely has the appeals process concerned the off-label use of the drug that constitutes the lethal injection. That’s what’s been happening this week in Florida where the state’s Supreme Court is to consider whether Lundbeck’s pentobarbital product is untested and unsafe for use in lethal injections. Manuel Valle (pictured), who was convicted of the murder of a policeman in 1978, is the man whose life hangs in the balance as the judiciary considers this bizarre turn of events.
Although Take Two has heard rumours that off-license biosimilar prescribing may have already begun in some financially hard-pressed Irish hospitals, the FDA is still a very long way from creating an approval process for these products. The scale of this challenge is substantial because the process for making follow-on biologic agents differs massively from the generic replication of conventional small molecule branded medicines. This week, one of the US’s leading experts created big waves by claiming the regulatory bar might eventually be set so high that biologic products simply wouldn’t be competitive against the original of the species.
It’s a new health-related offering from a remarkable consumer technology company called Jawbone and its applicability is likely to have that part of your anatomy fall as far as the floor. The cynics amongst you may have suspected the colour-coded rubber wristband was nearing the end of its lifecycle. But the Up suggests this isn’t likely anytime soon. This fashionable-looking lifestyle gadget is designed to be worn every day and comes loaded with sensors that, link to apps on the smart phone in your pocket, will monitor your sleep, tracks your movement, monitor your nutritional intake and are said to be able to fend off heart disease, diabetes and other lifestyle-related health problems.
The Irish media’s coverage of a US federal court’s decision to back a Pfizer patent and block a generic Viagra says a lot about the lack of focus on monitoring breaking news in the all-important life sciences sector. Breathless reports suggesting that jobs in Cork (where Viagra is famously made) would be protected by the decision are undoubtedly true. Analysts told the Wall Street Journal two months ago that protecting exclusivity on the erectile dysfunction medicine could raise the company's earnings by 3% annually between 2013 and 2018. However, what’s significant is that we’ve yet to see many (or is that any?) articles in the Irish media about an event that will have a much more momentous impact on Pfizer’s manufacturing operations worldwide…Lipitor’s patent expiration.
Greece has led the way and now another under-pressure European economy has turned to radical drug budgeting in order to bail out struggling national finances. Madrid's approach has been to introduce new rules requiring doctors to only write scripts using a drug's generic name.