Regulatory

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of erdafitinib for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations, with disease progression during or […]

As the second quarter of 2023 draws to a close, DDW’s Megan Thomas reviews key updates and results from three top pharmaceutical companies. Business updates   Pfizer reported second quarter 2023 revenues totalling $12.7 billion, a decrease of $15.0 billion, or 54%, compared to the prior year quarter, reflecting an operational decline of $14.7 billion, or […]

This is the latest episode of the free DDW narrated podcast, “How is mass spectrometry advancing drug discovery?”, which covers two articles written for Volume 23, Issue 3 – Summer 2022 of DDW. They are called “Native mass spectrometry: Drug discovery’s new kid on the block”, and “Addressing the developability gap in pharma”. In the […]

Join DDW for this exclusive free event, Are in vitro metabolism and drug-drug interaction studies critical for an investigational new drug application? which is supported by BioIVT. Expert Dr Andrew G Taylor, PhD, ADME Technical Sales Specialist, BioIVT, will present this event which will take place on 5 September 2023, 4PM BST, 11AM EST, 5PM CEST, 8AM PDT. […]

Join DDW for this exclusive free event, Are in vitro metabolism and drug-drug interaction studies critical for an investigational new drug application? which is supported by BioIVT. Expert Dr Andrew G Taylor, PhD, ADME Technical Sales Specialist, BioIVT, will present this event which will take place on 5 September 2023, 4PM BST, 11AM EST, 5PM CEST, 8AM PDT. […]

Claire D’Abreau-Hayling, Chief Scientific Officer at Sandoz, examines how generic products can relieve industry pressure and improve access to essential medicines.   Off-patent medicines today account for about 80% of global prescriptions at an estimated 20% of the total cost. This will continue to be the case going forward, but the nature of the off-patent landscape will evolve […]

AstraZeneca’s Forxiga (dapagliflozin) has been approved in China to reduce the risk of cardiovascular death, hospitalisation for heart failure (HF), or urgent HF visits in adults with symptomatic chronic HF. The drug was previously approved in China but was limited to HF patients with reduced ejection fraction (HFrEF). The approval by China’s National Medical Products […]

Ipsen’s Sohonos (palovarotene) has become the first drug approved for patients with fibrodysplasia ossificans progressiva (FOP) in the US, following the granting of a marketing authorisation by the Food and Drug Administration (FDA). The capsules are approved for reduction in the volume of new heterotopic ossification (extra-skeletal bone formation) in adults and children aged eight […]

Join DDW for this exclusive free event, Are in vitro metabolism and drug-drug interaction studies critical for an investigational new drug application? which is supported by BioIVT. Expert Dr Andrew G Taylor, PhD, ADME Technical Sales Specialist, BioIVT, will present this event which will take place on 5 September 2023, 4PM BST, 11AM EST, 5PM CEST, 8AM PDT. […]

Lung-I Cheng, Vice President and Head of Cell & Gene Therapy Service Line at AmerisourceBergen, and Cori Gorman, Senior Director of CMC and Regulatory Affairs at Biopharma Excellence, offer advice on navigating the different and sometimes contradictory regulatory requirements in the US and EU. Over the past few decades, the incredible progress in personalised medicine […]

In this article, Amplexor asks some of the company’s closest industry partners and BE THE EXPERT event speakers for their views on the biggest developments in the Life Sciences Regulatory sphere over the last 12 months – and explore some of the most prominent themes and priorities seen throughout 2023.   Those asked to share their […]

Join DDW for this exclusive free event, Are in vitro metabolism and drug-drug interaction studies critical for an investigational new drug application? which is supported by BioIVT. Expert Dr Andrew G Taylor, PhD, ADME Technical Sales Specialist, BioIVT, will present this event which will take place on 5 September 2023, 4PM BST, 11AM EST, 5PM CEST, 8AM PDT. […]

In vitro ADME and drug-drug interaction (DDI) investigations are early activities in the drug development process that are critical for framing downstream decision making. Understanding the ADME properties and DDI risks of your compound helps you avoid unnecessary clinical studies, costs, delays and more. This webinar will provide insights at a high-level related to regulatory […]

GSK’s Jemperli (dostarlimab) has been approved in the US plus chemotherapy as the first new frontline treatment option in decades for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). The US Food and Drug Administration (FDA) approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single […]

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. What is the regulatory landscape of medical cannabis?  Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to […]

On 31 January 2020, the United Kingdom (UK) withdrew from the European Union (EU). Alongside a number of repercussions, the most impactful to the drug discovery sector arguably relates to regulatory affairs on account of adjusting from the European Medicines Agency (EMA) to the Medicines and Healthcare products Regulatory Agency (MHRA). DDW’s Megan Thomas evaluates […]