Global report - September 3, 2017
First excessive pricing investigation on the pharma sector
The European Commission (EC) opens formal investigation into Aspen Pharma’s pricing practices for cancer medicines. The formal investigation address concerns that Aspen Pharma has engaged in excessive pricing concerning five life-saving cancer medicines. The Commission will investigate whether Aspen has abused a dominant market position in breach of EU antitrust rules. “When we get sick, […]
Drug Development Pharma - July 1, 2015
EC Approves Sobi Drug for HT-1
The European Commission has approved an oral suspension formulation of Swedish Orphan Biovitrum’s (Sobi) Orfadin (nitisinone). The orphan drug treats Hereditary Tyrosinaemia type-1 (HT-1), a rare genetic and potentially fatal condition that affects infants and children and can result in liver and kidney failure if untreated, according to PMLiVE. “The European Medicines Agency has called […]
Clinical Trials - June 27, 2015
Biovica Project Earns EC Funding
Biovica has been selected by the European Commission to receive support for a project as part of the Horizon 2020 phase 2 program. Biovica’s project “Clinical validation of the DiviTum assay in two high profile clinical studies in Europe” is receiving € 682,000 and being undertaken with a European cancer study group and Karolinska Institutet, […]
Companies - June 4, 2015
Lundbeck Urges Alcohol Curbs
Danish drugmaker Lundbeck, which markets the alcoholism drug Selincro, last month mobilized members of the European Parliament, anti-alcohol NGOs and academics to convince the European Parliament to vote to urge the European Commission to take a harder position against the detrimental affects of alcohol. Lundbeck employees also quietly ran anti-alcohol campaigns behind the scenes, Politico […]
Pharma Business - January 22, 2015
EC Grants Extension to Victoza
The license extension for Novo Nordisk’s Victoza® means the drug is now available to almost one million people in the UK who are affected by type 2 diabetes and moderate renal impairment. The decision by the European Commission (EC) means clinicians can treat patients with one daily injection. providing an effective treatment in an area where few treatments are available […]
Regulatory compliance - September 2, 2013
Lundbeck appeals EU decision
The Danish pharmaceutical group Lundbeck is appealing against the 93.8 million euros fine by the European Commission announced in June. Lundbeck was fined for deals with rivals to block the supply of generic versions of its citalopra anti-depressant to the market, a decision that was announced earlier this summer. In a press release, Lundbeck states that […]
