Small companies and academic institutions develop their assets, in most cases, under budget constraints. Still, they have to meet the expectations of future strategic partners or investors in order to be an attractive option for them and to have a chance to get the product onto the market.
The decision of the European Patent Office to examine all patent applications within 12 months can unintentionally block companies from filing for life sciences patents in Europe, says Gavin Recchia, Principal of one of Australias largest patent attorneys firms.
The pharmaceutical industry of the European Union is currently toiling at a veritably Herculean task. They jointly took up the fight against falsified pharmaceuticals in the legal supply chain. Forgers have discovered that falsified drugs are a lucrative business. However, the EU legislature has recognised this risk, and responded by passing the Falsified Medicines Directive in 2011. In 2016, it was put in more concrete terms with the delegated regulation, which stipulates the implementation of the directive for prescription drugs.
Like every sector of the UK economy, life sciences has been beset with uncertainty since the country voted to leave the European Union. Last week prime minister Theresa May finally gave us some clarity on her plans for Brexit, which will allow us to prepare for the future.
The surprising election of Donald Trump as the next US President led to a spectacular comeback of biotech shares. The long-term prospects depend on Trumps healthcare strategy and the (much-desired) return of generalist funds.
The randomised clinical trial (RCT) is the gold standard for drug evaluation. RCTs provide the core for drug development and subsequent drug approval often in the form of rigorously designed efficacy trials in carefully selected subjects. In fact, in- and exclusion criteria are often so restrictive that only 17% of patients from outpatient clinics would be eligible for trials in asthma and chronic obstructive pulmonary disease (COPD).
Well, that was a weight off my chest, better out than in, as they say. After Brexit, at least the world will be pulled back into its axis with the election of Americas first woman president and wait a minute, what are you saying? No, that cant be right he won? Really? REALLY?