EuropaBio has developed recommendations for changes to the Summary of Product Characteristics (SmPC) of biosimilars that would result in an enhanced level of transparency for the label.
We are living in a world of cutting-edge science, which holds the potential to transform the landscape for patients living with common and rare diseases within the next five years. This is of particular importance as we face a demographic evolution that will see an already-aging population expand significantly and rapidly across the globe.
Spanish Capital Cell was one of the first equity crowdfunding platforms that specialised in life sciences and biotech projects in Europe. In March, the group raised more than €1m through funding through the Spanish biotech campaign Bionure a new record. EuroBiotech talked to Capital Cell founder Daniel Oliver about their recent expansion into the UK and the development of the European life sciences crowdfunding scene.
Bayer has always been extremely supportive of the new Unitary Patent System (UPS) and has been one of the driving forces behind it within the German industry. However, the company will not be putting its full portfolio through the UPS and the Unified Patent Court (UPC).
Established in 2013, Polpharma Biologics is the biotechnology unit of the rapidly growing Polpharma Group one of the largest pharmaceutical players in the CEE region. Currently, with over 140 people, four sites, and full expertise for biopharmaceutical development and production, Polpharma Biologics is running five projects dedicated to monoclonal antibodies, and is just stepping into the contract development and manufacturing business.
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.
In December 2016, US biotech company Ionis Pharmaceuticals’ drug Spinraza received regulatory approval in the US. No doubt: the antisense technology behind Spinraza could be the next big thing
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 Australia’s largest patent attorneys’ firms.
There’s no way around it: renewables are the future, Matti Heikkilä believes. European Biotechnology talked to the CTO of Finnish bioeconomy company MetGen about what bio-based products need to bring to the table to usurp their fossil-based counterparts.
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.