The Medicines and Healthcare products Regulatory Agency (MHRA) has published its 2030 Strategy, setting out ambitious plans to translate scientific and technological innovation into better health outcomes. The regulator says that the commitments will enable it to keep pace with rapid advances in science, technology and personalised… Read More
Claus Zieler, Chief Commercial & Medical Affairs Officer, Astellas Pharma discusses the barriers preventing patients from accessing innovative medicines at the scale at which they’re being devleoped and approved. Strong innovation, uneven access Innovation in medicines is accelerating globally. In oncology, immunology, rare diseases, and other specialty areas, scientific advances are translating into more targeted… Read More
DDW Editor Reece Armstrong speaks to David Crean, Chief Business Officer of biopharmaceutical company MediciNova, about recent turmoil within the FDA and what the pharma sector should expect from the agency going forward. It’s been a volatile couple of years for the United States. President Trump’s second term… Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending a cream to treat atopic dermatitis (AD). Opzelura (ruxolitinib) cream, developed by Incyte International for the treatment of moderate atopic dermatitis (AD), has been recommended for adult patients for whom topical corticosteroids… Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a treatment for severe alopecia. The recommended approval of upadacitinib is for the treatment of adult and adolescent patients with severe alopecia areata (AA), an unpredictable autoimmune disease causing a… Read More
Bruno Quinney speaks to Adrian Kells, Senior Vice President and Integrated Product Team Lead PD at AskBio, about the company’s gene therapy programme and pioneering treatment for Parkinson’s. The drug discovery landscape for Parkinson’s disease is becoming one of the most exciting frontiers in the industry. It is unsurprising to… Read More
The latest episode of the DDW Highlights Podcast is now available to listen to below. DDW’s Bruno Quinney narrates five key stories of the previous week to keep DDW subscribers up-to-date on the latest industry news. Last week, new research showed anti-IL-1β drugs could prevent lung cancer. Elsewhere, the… Read More
News round-up for 8 – 12 June by Bruno Quinney, Content Team at DDW. This week, new research suggests anti-IL-1β drugs could prevent lung cancer. Elsewhere, the UK is set to benefit from specialised blood tests and funding for researchers. The top stories: … Read More
The UK Medicines & Healthcare Regulatory Agency (MHRA) is consulting on a new regulatory framework for bringing rare disease drugs more quickly to market. The new Rare Disease Therapies Regulatory Framework is intended to “support earlier, more frequent, and iterative engagement with developers, providing structured regulatory flexibility… Read More
Introduction In an age where novel biotechnology products are being developed on a much larger and more rapid scale at significantly higher costs and risks than ever before, it is important that this urgency is maintained through to patient access. Owing to the broad reach and the mass… Read More
Now that this industry is seriously looking to advanced automation to reinvent the work it does, the data transformation imperative has soared back up the strategic agenda, says Ian Crone, ArisGlobal’s VP Europe & APAC Regulatory Solutions. Here, he reports on an impassioned panel debate that took place as part of the Life Science AI Exchange Podcast last year. The panel included subject… Read More
On International Clinical Trials Day, industry experts speak to DDW about the current state of play within global clinical trials. DDW: How encouraged are you by regulatory reforms… Read More
The latest episode of the DDW Highlights Podcast is now available to listen to below. DDW’s Bruno Quinney narrates five key stories of the previous week to keep DDW subscribers up-to-date on the latest industry news. Last week, the FDA advanced an initiative to implement real-time clinical trials. Elsewhere, UCB made… Read More
News round-up for 4 – 8 May by Bruno Quinney, Content Team at DDW. This week, the FDA has advanced an initiative to implement real-time clinical trials. Elsewhere, UCB has made headlines for through an acquisition and its cancer research venture. The top stories: FDA moves… Read More
The recent report that pharmaceutical company uniQure’s data from its Phase I/II studies provide insufficient evidence for the approval of its investigational gene therapy drug for Huntington’s disease (HD) are a major blow for patients. Huntington’s disease is a rare genetic disorder that can affect around 5-10 people per… Read More
DDW Editor Reece Armstrong attended day one of BioTrinity. Here he offers an overview of the conference and the themes to come out of it. In an era of turbulence, BioTrinity stood out with an air of general positivity concerning the UK’s current standing within the life… Read More
