News and Analysis

  • News and Analysis |

    A historic amount of capital flowed to newly public biotech companies in 2018.

    • Chris Morrison
  • News and Analysis |

    With clinical failures mounting and companies disinvesting, researchers are revising the cancer stem cell model.

    • Ken Garber
  • News and Analysis |

    With the FDA's approval of GlaxoSmithKline's tafenoquine, global health experts will at last have access to a long-awaited new treatment for Plasmodium vivax recurrence. Much-needed novel treatments for the more common Plasmodium falciparum are in phase II trials.

    • Asher Mullard
  • News and Analysis |

    Ongoing and upcoming clinical trials of metformin, mTOR inhibitors and senescent cell-killing drugs could prove that ageing and ageing-related diseases are viable drug discovery indications.

    • Asher Mullard
  • News and Analysis |

    Constrained peptides have long tantalized drug developers with their potential ability to combine the best attributes of antibodies and small molecules. Finally, a handful of constrained peptides are in late-stage clinical trials.

    • Chris Morrison
  • News and Analysis |

    Amgen's erenumab recently secured FDA approval as the first G protein-coupled receptor-targeted antibody. More of these biologics are on the way, despite remaining challenges.

    • Elie Dolgin
  • News and Analysis |

    Two immune-boosting strategies have independently indicated promise in sepsis clinical trials, after years of failures with anti-inflammatories in this same space. Will it be enough to take sepsis drug development out of 'critical condition'?

    • Asher Mullard
  • News and Analysis |

    Many drugs unexpectedly influence the human gut microbiome, showed a recent study, prompting questions about toxicity assays, clinical implications and repurposing opportunities.

    • Cassandra Willyard
  • News and Analysis |

    With Alnylam's rare disease drug candidate patisiran nearing the regulatory finish line, the RNA interference community is now turning its attention to next-generation delivery technology to solidify the future of the emerging modality.

    • Chris Morrison
  • News and Analysis |

    The FDA approved 46 new drugs last year, the highest total in more than two decades.

    • Asher Mullard
  • News and Analysis |

    Novartis, Merck, Pfizer and biotech entrepreneurs have started working on small-molecule drugs that act on an assortment of RNA targets, hoping to unlock once undruggable targets and new biology.

    • Asher Mullard
  • News and Analysis |

    CARB-X, a public–private partnership aimed at bolstering the antibiotic pipeline, funded a diverse set of 17 early-stage drug development projects in its first year.

    • Asher Mullard
  • News and Analysis |

    The FDA is weighing the fate of Spark Therapeutics' voretigene neparvovec, potentially the first among a wave of new gene therapies.

    • Chris Morrison
  • News and Analysis |

    The FDA could soon approve the first bispecific antibody for a non-oncology indication, but clinical applications that make full use of the biological opportunity afforded by the nascent modality remain rare.

    • Asher Mullard
  • News and Analysis |

    In vitro data can be used to accelerate the approval of drugs that target specific disease-causing mutations for additional subpopulations of patients with rare diseases such as cystic fibrosis.

    • Katie Kingwell
  • News and Analysis |

    In the search for the first disease-modifying therapy for Parkinson disease, drug developers are advancing α-synuclein-targeted agents into proof-of-concept clinical trials.

    • Katie Kingwell
  • News and Analysis |

    The FDA could soon approve the first chimeric antigen receptor (CAR) T therapies for blood cancers, but this young field is still working on how to address solid tumours, safety concerns and manufacturing issues.

    • Katie Kingwell
  • News and Analysis |

    A lipid-modulating protein that exemplifies the value of human genetics for target validation has provided a fertile testing ground for new drug modalities including long-acting RNA interference drugs, vaccines against self-antigens, CRISPR therapeutics and small molecules that control ribosomal activity.

    • Asher Mullard
  • News and Analysis |

    Libraries of functionalized small-molecule fragments that can be screened in whole cells could take phenotypic drug discovery to the next level, providing new opportunities against undertargeted proteins.

    • Monya Baker
  • News and Analysis |

    The European Medicines Agency's PRIME scheme to accelerate the development of promising drugs that address unmet medical needs has enrolled 19 products in its first year, showing considerable overlap with FDA breakthrough therapy designees but also key differences.

    • Asher Mullard
  • News and Analysis |

    An innovative alliance structure is the latest advance in pharma's externalization push.

    • Chris Morrison
  • News and Analysis |

    The regulatory uncertainty around biosimilars in the United States is finally lifting, just months after the first biosimilar monoclonal antibody hit the US market.

    • Asher Mullard
  • News and Analysis |

    FDA approval count fell last year, despite a steady regulatory filing rate.

    • Asher Mullard
  • News and Analysis |

    Despite the failure of Eli Lilly's anti-amyloid antibody solanezumab in its latest phase III trial for Alzheimer disease, a bulging pipeline of amyloid-modulating candidates and novel clinical trial strategies still hold promise.

    • Asher Mullard
  • News and Analysis |

    Pivotal trials of Alkermes's antidepressant ALKS 5461 show how a patented clinical trial design might be able to help control problematic placebo responses.

    • Asher Mullard
  • News and Analysis |

    Drug developers are still hunting for surrogate end points that can better capture the benefits of checkpoint inhibitors, oncolytic viruses and modified T cell therapies.

    • Elie Dolgin
  • News and Analysis |

    Clinical trial failures of two drugs for hearing loss and tinnitus underscore pitfalls for a nascent area of drug development, but lessons learned may help in navigating the uncharted path to approval.

    • Katie Kingwell
  • News and Analysis |

    Although Agios and Celgene are set to file for approval for their first-in-class cancer metabolism drug, the field has started looking in new directions for the next batch of metabolic targets.

    • Asher Mullard
  • News and Analysis |

    A wave of companies are developing personalized vaccines, built from tumour-specific neo-antigens, providing a timely boost for a failure-ridden area of cancer immunotherapy.

    • Asher Mullard