As a part of EU's new health authority, the Commission has set aside millions of euros to reserve the capacities of European manufacturers in times of need. The investment will create an "ever-warm" network of medical countermeasures.
A long-awaited proposal for the EU pharmaceutical strategy from the European Parliament doesn't directly reject the notion of changing the length of EU drug patents.
The European Medicines Agency's committee has at its October meeting recommended six drugs for market approval in Europe. In addition, the authority recommends new uses for ten other drugs.
The US President is ready to announce his candidate for the head of the US Food and Drug Administration, the FDA, Politico reports. The agency has not had a permanent leader since January, and Biden's likely candidate has previously held the post.
On Tuesday, Ministers for health from EU member countries met for the first time since the EU Commission presented a new European health preparedness agency, called HERA, in September.
The EU Committee ENVI recommends that the EU Commission expands its collaboration with the EMA for the faster approval of medicines, concerning the EU's pharmaceutical strategy.
The European Medicines Agency recommends that immunocompromised people receive a third dose of one of the coronavirus vaccines, and states that a third Pfizer jab should be considered for all adults.
Going forward, a task force under the European Medicines Agency (EMA) will advise developers on how to minimize animal testing during drug development.
Slow regulatory processes and an unwillingness to pay the price for new medicines are contributing factors to Europe losing its significance as the home of drug development, criticizes Roche CEO.
The Danish pharmaceutical company, among others, is in non-compliance with US law and thus risks penalty, say US health authorities.
The new EU regulation (IVDR) strikes fear into the industry, as a lack of notified bodies could cause bottlenecks in the certification process of in vitro diagnostics tests (IVDs). The EU Commission is working on a solution, reports Danish Minister of Health Magnus Heunicke.
Pharmacosmos is now withdrawing the press release that the Danish Medicines Agency has ruled was in breach of the Danish Medicines Act. The ruling was the root of the subsequent case which competitor Vifor brought against the company in the Maritime and Commercial High Court of Denmark.
Although the price of Biogen's treatment Spinraza has been dropped yet again, the Danish Medicines Council will not expand the drug's approved patient group. It is the sixth time that the council has declined this application – and Roche's muscle wasting disease treatment is also expected to be rejected.
Roche and Biogen are among the companies that have received recommendation for approval from the European Medicines Agency's committee (CHMP) at its September meeting. One Pfizer drug was the sole candidate to be rejected.
With a budget potentially exceeding EUR 47.1bn (DKK 350bn), the EU Commission wants to establish a new agency to ward against future health crises. While the financial makeup is uncertain, good news for future clinical trials might be on the way.
HERA, the new EU health authority inspired by the US counterpart BARDA, is tasked with anticipating and preparing for future health emergencies.
According to the media network Euractiv, the European Commission will be discussing a proposed future body to organise the union's health emergency preparedness, known as HERA.
The Danish state's plan to award EUR 108m to support phase III studies of Bavarian Nordic's covid-19 vaccine has been approved by the EU Commission.
This week, a special committee at Genmab will discuss whether to henceforth require personnel to be vaccinated against Covid-19 to access the company's offices and laboratories.
On Sunday, the Danish State Serum Institute send out the first invitations for a large-scale survey among residents in Denmark.
Patients taking Sanofi's long-acting insulin Lantus can now access Mylan's copy drug Semglee.
The pharmaceutical industry is fighting against a threat to companies' bottom lines: a global agreement which will harmonize corporation tax.
Japanese firm Kyowa Kirin's Parkinson's disease treatment was given a negative opinion at the council's meeting in July. Two other drugs were recommended for approval.
Two claims against the companies have been dropped, but one has been upheld.
The US Food and Drug Administration has approved yet another combination treatment for bone marrow cancer involving Darzalex – this time, in combination with two other drugs.
Data Analytics & Visualization Manager 
Director of Biostatistics 
GxP QA Compliance Manager for Quality Assurance 
Senior Manager/Associate Director Regulatory Affairs 
Nordic Field Sales Manager 
Training manager 
Key Account Manager – Lab & Diagnostic Senior Training and Learning Expert – Help us build a best-in-class global learning and quality culture 
Application Manager (GxP Systems) - Zealand Pharma Clinical Business Process Manager Chemist for Late Stage Analytical Development (1-year temporary position) Cleaning chemist 
CMC Product Support Manager CMC Project Manager Principal Statistician / Statistical Project Director 
Global Product Manager 
QA Specialist wanted 
Senior Validation Analyst, Zealand Pharma 
Clinical Trial Manager 
Jr. Software Developer, Cardiac Applications – Medical Devices, DK Medical Director Senior Clinical Project Manager Senior Programmer at Genmab Senior Legal Advisor Laboratory assistant for research department 
