Regulatory - Drug Discovery Today

Latest News

15 years of Op Pangea: over 25 million illegally traded medicines and devices seized in the UK valued at more than £84m
Over two million doses of illegally traded medicines valued at almost £5m seized so far this year.
Data shows Netherlands best base for international pharmaceutical companies
The ranking was calculated on cost and time efficiencies and United States was shown to be the most efficient jurisdiction on speed of business whereas Brazil, South Korea and China scored less favorably
Shionogi’s Novel Antibiotic, Fetcroja® (Cefiderocol), Has Been Selected By UK’s NICE / NHS&I as Part of an Antimicrobial Subscription Style Reimbursement Model
OSAKA, Japan, AMSTERDAM, NL – December 21, 2020 - Shionogi & Co., Ltd. and its European subsidiary, Shionogi B.V. (hereafter "Shionogi"), today announce that NICE and NHSE&I have selected its innovative antibiotic, cefiderocol, for inclusion in a pilot subscription reimbursement model in the UK which ‘de-links’ payment from volume of use, thereby recognising its potential in treating multidrug resistant Gram-negative bacterial infections and its benefits to society and healthcare systems. This scheme is called the UK Project for developing and testing an innovative model for the evaluation and purchase of antimicrobials. Pull incentives such as this are an important step to help bring urgently needed new antibiotics to market.
New framework to drive widespread adoption of Value-Based Health Care in Europe published
EIT Health launches an in-depth framework for adopting and accelerating Value-Based Health Care (VBHC) across Europe. The framework advises how healthcare services can improve patient outcomes and reduce wasted resources. It is published within a new handbook that draws on the experiences of over 240 European VBHC pioneers across 22 countries in Europe, including 32 site visits in leading medical centres.
UK withdrawal from the EU on 31 January 2020
The United Kingdom will formally leave the European Union on 31 January 2020 and will become a third country to the EU. On 1 February 2020 a transition period will start which is due to end on 31 December 2020.

Podcasts

Evotec strengthens and expands its Alliance Business
Dr Mark Ashton is Executive Vice President, Business Development of Evotec and is responsible for Evotec's commercial and partnering activities. Mark Whittaker is Senior Vice President Drug Discovery at Evotec where he manages a large drug discovery collaboration and the groups of computational chemistry and structural biology.
The Ubiquitin Story
In this podcast interview with Drug Discovery Today, Nobel Prize winner Professor Aaron Ciechanover will talk about his career, his Nobel Prize-winning discovery of the UPS, and the extraordinary opportunities and challenges for drug discovery in this area.
Califf, Behrman and Kramer discuss the Clinical Trials Transformation Initiative.
Download the Califf, Behrman and Kramer podcast as an mp3 file
Dr Brent Vose outlines AstraZeneca's oncology pipeline.
Download the Dr. Brent Vose podcast as an mp3 file

Webinars

The Promise of Epigenetics in Early Stage Drug Discovery
Epigenetic targets are exciting to drug discovery scientists because they hold great potential across a wide spectrum of therapeutic areas. The field of epigenetics focuses on the investigation of enzymes that alter gene expression through modification of their target substrates, usually through the addition or removal of methyl or acetyl groups. High-throughput assays to identify agents capable of modifying the action of such enzyme targets has, in the past, proven to be challenging due to the relatively small molecular alterations in addition to the possibility of sequential modifications, leading to multiple end products. As such, high-throughput bioassays that allow the direct, concurrent quantification of multiple modification states are attractive. The RapidFire platform enables high-throughput mass spectrometric analysis of native molecules from in vitro reactions by performing on-line desalting in seconds, as opposed to HPLC, which requires minutes. Moreover, the RapidFire system can be connected to any mass spectrometer providing unparalleled versatility in reaction detection.
Integrated Quant / Qual for In-vivo Discovery Bioanalysis using Hybrid Quadrupole-Time-of-Flight Mass Spectrometry
Ultra high performance liquid chromatography (UHPLC) coupled with orthogonal acceleration hybrid quadrupole-time-of-flight (QqTOF) mass spectrometry is an emerging technique offering new strategies for the efficient screening of new chemical entities (NCE) and related molecules at the early discovery stage within the pharmaceutical industry.
Drug Delivery: enabling technology for discovery and development
The integration of pharmacodynamic and pharmacokinetic parameters in non clinical pharmacology studies is a key aspect in drug discovery for efficacy and safety assessment, in the particular for the translation from the non clinical to the clinical field. Modeling the profile of plasma exposure achieved with the intended therapeutic route often requires the use of intravenous infusion. In addition, in most cases infusion parameters (infusion rate, volume, duration and sequences) need to be customized to achieve the appropriate pattern of plasma drug exposure. When pharmacodynamic parameters are recorded by telemetry, the use of implantable pumps rather than external pumps is necessary to preserve the improvement in physiological data recording offered by telemetry.
Part 2: How has HR-MS technology fundamentally changed the way we study drug biotransformation and disposition?
AB SCIEX is proud to present the 2nd installment of a Global 4-Part Live Webinar Series exploring novel and dynamic workflows for Metabolite Identification & Drug Metabolism solutions as it pertains to the 4 main stages of the drug discovery and development paradigm, Lead Discovery, Late Stage Discovery, Early Development and Late Stage Development. Part 2 of this webinar series will focus on how HRMS technology has fundamentally changed the way metabolite biotransformations are investigated in Lead Discovery.

Features

Getting the most out of your IP – patent management along its life cycle
We discover that successful patent portfolio management is rooted in managing the patents along their life cycles.

Downloads

Streamlining nonclinical drug development using the US FDA 505(b)(2) New Drug Application regulatory pathway
New drug applications (NDAs) using the FDA 505(b)(2) regulatory pathway can streamline and reduce nonclinical drug development requirements while potentially maintaining marketing exclusivity
“Bioexit”: Navigating the Policy and Regulatory Pathways for the Biotechnology Industry in a Post-Brexit Landscape
here we examine four post-Brexit political options and highlight the need to explore alternative approaches, with a focus on ensuring continued investment in biomedical research and development, while also safeguarding patients’ access to medicines
Marketing authorisation applications submitted to the European Medicines Agency by Small and Medium sized enterprises: an analysis of major objections and their impact on outcome
This report analyses the profile of major objections in applications for medicines for human use submitted by SMEs to the EMA with a positive or negative outcome (negative opinion or withdrawal) between 2011 and 2015, and their impact on the outcome.
Transparency in drug regulation public assessment reports in Europe and Australia
The authors describe the experiences of two established medicines regulators in publishing public assessment reports, and reflect on their future role in communicating medicines information.
Is the European regulatory framework sufficient to assure the safety of citizens using health products containing nanomaterials
The review examines the stratified regulatory framework concerning the use of nanomaterials in healthcare products intended to be marketed in the European Economic Area, and highlights the current criticisms associated with the framework.

25 Hottest Articles

Peptide therapeutics: current status and future directions • Review article
Drug Discovery Today, Volume 20, Issue 1, Pages 122-128 | Fosgerau, K.; Hoffmann, T.
Bispecific antibodies • Review article
Drug Discovery Today, Volume 20, Issue 7, Pages 838-847 | Kontermann, R.E.; Brinkmann, U.
Designing novel building blocks is an overlooked strategy to improve compound quality • Review article
Drug Discovery Today, Volume 20, Issue 1, January 2015, Pages 11-17 | Goldberg, F.W.; Kettle, J.G.; Kogej, T.; Perry, M.W.D.; Tomkinson, N.P.
The road ahead for large pharma: long-term science and innovation • Editorial
Drug Discovery Today, Volume 14, Issue 9-10, May 2009, Pages 439-441 | Lundberg, J.M.; Reilly, C.
The impact of aromatic ring count on compound developability - are too many aromatic rings a liability in drug design? • Review article
Drug Discovery Today, Volume 14, Issue 21-22, November 2009, Pages 1011-1020 | Ritchie, T.J.; Macdonald, S.J.F.

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