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Advancing development of medicines by academia and non-profit research organizations in the European Union Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-23 Rosa Gonzalez-Quevedo; Constantinos Ziogas; Ivana Silva; Rosan Vegter; Anthony Humphreys
Providing support for medicine development by academics and clinical researchers is a priority for the European Medicines Agency. The recent launch of free scientific advice to academia and non-profit research organizations developing orphan medicines can help align research with regulatory requirements early during medicine development and enhance the chances of success.
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Publisher Correction: Targeting co-stimulatory molecules in autoimmune disease Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-18 Natalie M. Edner; Gianluca Carlesso; James S. Rush; Lucy S. K. Walker
An amendment to this paper has been published and can be accessed via a link at the top of the paper.
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Improving target assessment in biomedical research: the GOT-IT recommendations Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-16 Christoph H. Emmerich; Lorena Martinez Gamboa; Martine C. J. Hofmann; Marc Bonin-Andresen; Olga Arbach; Pascal Schendel; Björn Gerlach; Katja Hempel; Anton Bespalov; Ulrich Dirnagl; Michael J. Parnham
Academic research plays a key role in identifying new drug targets, including understanding target biology and links between targets and disease states. To lead to new drugs, however, research must progress from purely academic exploration to the initiation of efforts to identify and test a drug candidate in clinical trials, which are typically conducted by the biopharma industry. This transition can
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Combinations take centre stage in PD1/PDL1 inhibitor clinical trials Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-11 Samik Upadhaya; Svetoslav T. Neftelino; Jeffrey P. Hodge; Cristina Oliva; Jay R. Campbell; Jia Xin Yu
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Targeting receptor complexes: a new dimension in drug discovery Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-11 Mette Ishøy Rosenbaum; Louise S. Clemmensen; David S. Bredt; Bernhard Bettler; Kristian Strømgaard
Targeting receptor proteins, such as ligand-gated ion channels and G protein-coupled receptors, has directly enabled the discovery of most drugs developed to modulate receptor signalling. However, as the search for novel and improved drugs continues, an innovative approach — targeting receptor complexes — is emerging. Receptor complexes are composed of core receptor proteins and receptor-associated
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Small molecule targets toxic RNA repeats Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-10 Sarah Crunkhorn
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Impact of COVID-19 on pharmaceutical external innovation sourcing Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-10 Lucas Robke; Lotte Berghauser Pont; Jens Bongard; Stephan Wurzer; Katarzyna Smietana; Rachel Moss
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Addressing cancer’s grand challenges Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-10 Asher Mullard
The National Cancer Institute and Cancer Research UK’s US$380 million “Cancer Grand Challenges” programme highlights understudied knowledge gaps that could yet make big differences to patients.
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Therapeutic strategies targeting FOXO transcription factors Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-10 Giampaolo Calissi; Eric W.-F. Lam; Wolfgang Link
FOXO proteins are transcription factors that are involved in numerous physiological processes and in various pathological conditions, including cardiovascular disease, cancer, diabetes and chronic neurological diseases. For example, FOXO proteins are context-dependent tumour suppressors that are frequently inactivated in human cancers, and FOXO3 is the second most replicated gene associated with extreme
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Excipient developers call for regulatory facelift Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-09 Katie Kingwell
A lack of novel excipients is threatening the ability of drug developers to translate progress with small molecules and biologics into therapeutic success. The FDA could soon test a new model of excipient review to foster formulation innovation.
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WNK kinases: an untapped opportunity to modulate ion transport Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-06 Michael P. East; Tuomo Laitinen; Christopher R. M. Asquith
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Carolyn Bertozzi Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-06 Asher Mullard
The sugars that coat the surface of the cell have long fascinated Carolyn Bertozzi, a Professor of Chemistry at Stanford University. But her study of these complex carbohydrates has had much further reaching implications. Her pioneering work on bioorthogonal chemistry — reactions that can be run in living systems, without damaging them — has opened up basic drug discovery and therapeutic applications
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Trends in oncology drug innovation in China Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-05 Guanqiao Li; Yunhe Qin; Cuicui Xie; Yi-Long Wu; Xiaoyuan Chen
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Myosin inhibitor flexes, myosin activator flops Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-03 Asher Mullard
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FDA approves antibody cocktail for Ebola virus Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-03 Asher Mullard
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CRISPR pioneers win Nobel prize Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-03 Asher Mullard
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Neoantigen vaccine proven safe and immunogenic Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-02 Sarah Crunkhorn
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First-in-human trial of bispecific CAR-T cells Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-02 Sarah Crunkhorn
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Bicyclic azetidines treat cryptosporidiosis Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-02 Sarah Crunkhorn
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Targeting TGFβ signalling in T helper cells Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-11-02 Sarah Crunkhorn
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Antibiotic-induced disease tolerance Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-29 Kirsty Minton
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Targeted PI3K inhibitors reduce lung fibrosis in mice Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-29 Megan Cully
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Immunocytokines turn up the heat in glioblastoma Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-27 M. Teresa Villanueva
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Restoring vision loss with base editing Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-26 Sarah Crunkhorn
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Improving data sharing to increase the efficiency of antibiotic R&D Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-23 Wes Kim; Kevin Krause; Zak Zimmerman; Kevin Outterson
Greater investment is needed in antibiotic R&D, and more must be done to maximize the impact of such investments. More widespread data sharing, such as the recent joint data contribution from Merck and Kyorin to the Pew Charitable Trusts’ SPARK platform, has a key role.
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Author Correction: RAS-targeted therapies: is the undruggable drugged? Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-20 Amanda R. Moore; Scott C. Rosenberg; Frank McCormick; Shiva Malek
An amendment to this paper has been published and can be accessed via a link at the top of the paper.
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Base editing: advances and therapeutic opportunities Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-19 Elizabeth M. Porto; Alexis C. Komor; Ian M. Slaymaker; Gene W. Yeo
Base editing — the introduction of single-nucleotide variants (SNVs) into DNA or RNA in living cells — is one of the most recent advances in the field of genome editing. As around half of known pathogenic genetic variants are due to SNVs, base editing holds great potential for the treatment of numerous genetic diseases, through either temporary RNA or permanent DNA base alterations. Recent advances
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Kinase inhibition in autoimmunity and inflammation Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-19 Ali A. Zarrin; Katherine Bao; Patrick Lupardus; Domagoj Vucic
Despite recent advances in the treatment of autoimmune and inflammatory diseases, unmet medical needs in some areas still exist. One of the main therapeutic approaches to alleviate dysregulated inflammation has been to target the activity of kinases that regulate production of inflammatory mediators. Small-molecule kinase inhibitors have the potential for broad efficacy, convenience and tissue penetrance
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FDA new drug approvals in Q3 2020 Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-12 Lisa Urquhart
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Fragment-based screening sees the light Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-12 Asher Mullard
Fragment-based screening methodologies are proliferating, fuelled by interest in novel target space and targeted degraders.
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Integrin-targeted therapies branch out Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-09 Megan Cully
Small-molecule integrin inhibitors are catching the attention of pharmaceutical firms, with fibrosis joining gut dysfunction as a key indication for integrin-based interventions.
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Amgen cues up pivotal KRAS data Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-05 Asher Mullard
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Building antibiotics block by block Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-05 M. Teresa Villanueva
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Roche snaps up another NLRP3 contender Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-05 Asher Mullard
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ADCs inspire large pharma investments Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-05 Asher Mullard
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Mikael Dolsten Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-05 Asher Mullard
Between 2000 and 2010, Pfizer racked up three of the ten largest biopharmaceutical deals of all time, with a US$90 billion acquisition of Warner-Lambert, a $60 billion merger with Pharmacia and a $68 billion acquisition of Wyeth. The last deal, especially, was aimed at bolstering Pfizer’s flagging pipeline and protecting its revenue base from an upcoming patent cliff. More than a decade on — having
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Modulating gene regulation to treat genetic disorders Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-05 Navneet Matharu; Nadav Ahituv
Over a thousand diseases are caused by mutations that alter gene expression levels. The potential of nuclease-deficient zinc fingers, TALEs or CRISPR fusion systems to treat these diseases by modulating gene expression has recently emerged. These systems can be applied to modify the activity of gene-regulatory elements — promoters, enhancers, silencers and insulators, subsequently changing their target
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Doubling down on osteoarthritis Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-02 Katie Kingwell
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HCAR3: an underexplored metabolite sensor Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-10-02 Nicholas J. Kapolka; Daniel G. Isom
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Delivering CARs with oncolytic viruses Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-29 Sarah Crunkhorn
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Mitochondrial circular RNA mitigates NASH Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-29 Sarah Crunkhorn
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Hepatokine improves glucose control Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-29 Sarah Crunkhorn
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ACC inhibitors block platelet production Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-29 Sarah Crunkhorn
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Digital health technologies in clinical trials for central nervous system drugs: an EU regulatory perspective Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-29 Valentina Mantua; Celso Arango; Pavel Balabanov; Florence Butlen-Ducuing
Digital health technologies have the potential to help address some of the challenges in the clinical development of drugs for central nervous system disorders. This article discusses strategies for the development of such tools in the context of the European regulatory environment.
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The failure to fail smartly. Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-23 Steven Galson,Christopher P Austin,Eeshan Khandekar,Lynn D Hudson,Joseph A DiMasi,Robert Califf,John A Wagner
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Immuno-oncology drug development forges on despite COVID-19. Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-18 Samik Upadhaya,Vanessa M Hubbard-Lucey,Jia Xin Yu
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Selectively triggering mitotic failure. Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-17 Sarah Crunkhorn
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Targeting co-stimulatory molecules in autoimmune disease. Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-16 Natalie M Edner,Gianluca Carlesso,James S Rush,Lucy S K Walker
Therapeutic targeting of immune checkpoints has garnered significant attention in the area of cancer immunotherapy, in which efforts have focused in particular on cytotoxic T lymphocyte antigen 4 (CTLA4) and PD1, both of which are members of the CD28 family. In autoimmunity, these same pathways can be targeted to opposite effect: to curb the over-exuberant immune response. The CTLA4 checkpoint serves
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Targeting the epigenetic regulation of antitumour immunity. Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-14 Simon J Hogg,Paul A Beavis,Mark A Dawson,Ricky W Johnstone
Dysregulation of the epigenome drives aberrant transcriptional programmes that promote cancer onset and progression. Although defective gene regulation often affects oncogenic and tumour-suppressor networks, tumour immunogenicity and immune cells involved in antitumour responses may also be affected by epigenomic alterations. This could have important implications for the development and application
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First microbiome-based drug clears phase III, in clinical trial turnaround. Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-11 Ken Garber
Seres Therapeutics’ stool-derived treatment for recurrent Clostridium difficile infection could become the first FDA-approved microbiome therapy. Several other live biotherapeutic microbial products are close behind.
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Trispecific antibodies take to the clinic. Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-11 Asher Mullard
Sanofi and others are testing whether trispecific antibodies might have applications in cancer and infectious disease indications.
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Karen Akinsanya. Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-11 Asher Mullard
Computational chemistry is already embedded in the drug discovery process. Schrödinger — a company that was founded more than 30 years ago to develop chemical simulation software for biopharmaceutical partners — believes that it should be more foundational still. Having co-founded several biotechs in the past decade, including Nimbus Therapeutics and Morphic Therapeutics, Schrödinger launched its own
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Novel chemistry for covalent inhibitors. Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-10 Megan Cully
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Clinical trial recovery from COVID-19 disruption. Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-10 John Z Xue,Katarzyna Smietana,Pawel Poda,Kevin Webster,Guang Yang,Gaurav Agrawal
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Organs-on-chips: into the next decade. Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-10 Lucie A Low,Christine Mummery,Brian R Berridge,Christopher P Austin,Danilo A Tagle
Organs-on-chips (OoCs), also known as microphysiological systems or ‘tissue chips’ (the terms are synonymous), have attracted substantial interest in recent years owing to their potential to be informative at multiple stages of the drug discovery and development process. These innovative devices could provide insights into normal human organ function and disease pathophysiology, as well as more accurately
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Upcoming market catalysts in Q4 2020. Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-08 Luis Pablos
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Phase 0/microdosing approaches: time for mainstream application in drug development? Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-08 Tal Burt,Graeme Young,Wooin Lee,Hiroyuki Kusuhara,Oliver Langer,Malcolm Rowland,Yuichi Sugiyama
Phase 0 approaches — which include microdosing — evaluate subtherapeutic exposures of new drugs in first-in-human studies known as exploratory clinical trials. Recent progress extends phase 0 benefits beyond assessment of pharmacokinetics to include understanding of mechanism of action and pharmacodynamics. Phase 0 approaches have the potential to improve preclinical candidate selection and enable
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Author Correction: Radiopharmaceutical therapy in cancer: clinical advances and challenges. Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-07 George Sgouros,Lisa Bodei,Michael R McDevitt,Jessie R Nedrow
An amendment to this paper has been published and can be accessed via a link at the top of the paper.
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Evolution of the COVID-19 vaccine development landscape. Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-04 Tung Thanh Le,Jakob P Cramer,Robert Chen,Stephen Mayhew
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FDA approves first GPCR biased agonist. Nat. Rev. Drug. Disc. (IF 64.797) Pub Date : 2020-09-03 Asher Mullard
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