Alternatives to animal testing can replace lengthy, resource-intensive studies for drug developers, helping to lower costs for companies, but a lack of regulatory global alignment can be a barrier to reducing animal testing, an expert says.
Achieving the EU Biotech Act’s clinical trial efficiency goals hinges on deeper collaboration and stronger integration across Europe’s regulatory authorities.
The version of the Critical Medicines Act adopted by a key committee of the European Parliament could mean uncertainty for the manufacturers of orphan drugs, warns industry.
The UK’s roadmap for reducing animal testing is a positive starting point, but greater transparency from the drug regulator and a more detailed workplan from government will be required to make the plans a reality, an expert from Cruelty Free International says.
The EU’s draft Biotech Act promises faster clinical trial approvals and innovation incentives, but the industry warns that intellectual property provisions have limited appeal.
Deputy chief Jonathan Benger moves up to become NICE’s fourth-ever CEO. While the face may be familiar, the challenges are anything but as the HTA body has launched a new joint scientific advice process with the MHRA and will implement new cost-effectiveness thresholds driven by a US trade deal.
The European Medicines Agency has said that Anavex’s Alzheimer’s candidate should not be authorized for use in the EU due to safety and efficacy concerns. Seven other products, including two new cancer drugs, received positive opinions.
Scientific advances in pharmacogenomics have prompted the European Medicines Agency to propose revisions to its existing guideline to ensure its continued relevance and applicability.
Flagship Pioneering is first partner in initiative aimed at giving drug developers early, informal, joint advice to fast-track the ‘most promising’ health care innovations. Pathway builds on an artificial intelligence collaboration between the UK MHRA and Singapore’s Health Sciences Authority.
A slash in rebate rates is only a first step towards restoring the competitiveness of the UK’s pharmaceutical industry, according to the ABPI.
The standard baseline of regulatory data protection will remain at eight years under the new pharma package, while market protection will drop to a year as standard. However, innovative products that fulfil certain criteria could get up to 11 years of market exclusivity.
The European Medicines Agency scheduled oral explanation meetings for Sanofi’s MS drug and two other products nearing the end of their EU regulatory review cycle. These meetings typically give companies a final chance to convince the agency their drugs merit approval.
The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab.
Seven new products, including Anavex’s Alzheimer’s candidate and GSK’s add-on asthma therapy, are up for an opinion from the European Medicines Agency on whether they should be authorized for use in the EU.
The UK’s medicines regulator reports promising outcomes from a pilot scheme testing streamlined processes for reviewing low-risk substantial modifications to ongoing clinical trials.
A new value set to be used by UK health technology appraisal body NICE is expected to impact the cost-effectiveness of some medicines and make room for higher drug prices.
The EU is finetuning a new coordinated procedure to streamline the evaluation of multinational clinical trials and address persistent delays and inconsistencies in approval timelines under the Clinical Trials Regulation.
New UK Cost-Effectiveness Thresholds Will Not Mean A Reprieve For Drugs Already Denied Reimbursement
Some companies in the UK undergoing a health technology appraisal by the HTA body, NICE, will see reimbursement recommendations for their products paused in the run up to the implementation of higher cost-effectiveness thresholds.
The growing use of non-clinical biomarkers in clinical trials of drugs for Parkinson’s disease has led the European Medicines Agency to propose changes to its guideline to clarify their role in patient enrollment for both targeted and non-targeted treatments.
Changes to the procurement of critical medicines and their active ingredients are among the amendments the Council of the EU has made to the draft Critical Medicines Act.