H. Lundbeck A/S (Lundbeck) has filed its appeal against the European Commission's decision of 19 June 2013 with the General Court, with the aim of having the decision annulled and/or the fine of EUR 93.8 million (approximately DKK 700 million) reduced. Lundbeck strongly disagrees with the Commission's decision, and considers that it contains several serious legal and factual errors, and several violations of Lundbeck's right of defense. Through its appeal Lundbeck seeks a remedy to these serious problems.
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Pfizer statement on PhRMA-EFPIA principles for responsible clinical trial data sharing
The Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) have published new commitments for responsible data sharing practices by biopharmaceutical companies. The new commitments are designed to expand access to clinical trial data and advance science. They propose ways of sharing data that will protect patient privacy, respect the regulatory process, and preserve incentives to undertake novel medical research for the benefit of patients. We believe the solutions offered by PhRMA and EFPIA provide a responsible alternative to other approaches currently being discussed in Europe.
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UK children remain unnecessarily at risk for life-threatening and disabling meningitis B disease
Novartis is disappointed by the interim position of the UK Joint Committee on Vaccination and Immunisation (JCVI) to not recommend Bexsero® for inclusion in the National Immunisation Programme at this time, and does not believe that the decision is in the interest of the public. Key feedback included in the JCVI interim position states that Bexsero is unlikely to prove cost-effective based on the current method of evaluation in the UK[3]. Novartis was not asked for pricing information as part of the JCVI deliberation and intends to provide related input prior to the recommendation being finalized.
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"Roche Continents" at the Salzburg Festival explores the common ground of creativity in art and science
For the seventh time, Roche invites 100 students from all over Europe to the Salzburg Festival for the creativity workshop “Roche Continents”. During the course of one week, students from the major European academies will discover the common grounds of innovation in arts and science, aided by a varied program of workshops and discussions with scientists and artists. "Roche Continents" is part of Roche commitment to contemporary culture. By supporting the exchange between young minds in science and art, the program pays homage to confrontation as one of the drivers of creativity.
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Boehringer Ingelheim and EFSD announce first recipients of diabetes research funding
The Boehringer Ingelheim (BI) and European Foundation for the Study of Diabetes (EFSD) partnership today announced the recipients of their European-wide funding initiative targeted at diabetes research. Totalling €2.5 million, these are the first grants to be awarded as part of the EFSD/Boehringer Ingelheim European Diabetes Research Programmes, which aim to stimulate and accelerate European research in diabetes.
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Roche's Erivedge receives conditional EU approval for treatment of advanced basal cell carcinoma
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted conditional approval to Erivedge (vismodegib) for the treatment of adult patients with symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC inappropriate for surgery or radiotherapy. This approval makes Erivedge, a capsule taken once-a-day, the first licensed medicine for patients in the European Union with this disfiguring and potentially life-threatening form of skin cancer.
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Eli Lilly and Company and Boehringer Ingelheim announce regulatory submission for new insulin glargine biosimilar product
Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim announced that the companies' marketing authorisation application (MAA) for LY2963016, an investigational basal (long-acting) insulin for the treatment of type 1 and type 2 diabetes, has been accepted for review by the European Medicines Agency (EMA). LY2963016 is a new insulin glargine product and has been filed through the EMA's biosimilar pathway.
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