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Nature Reviews Drug Discovery


Combination products: modernizing the regulatory paradigm


New opportunities to develop innovative — and often complex — products that combine drugs, devices and/or biological components are rapidly emerging, raising questions about how such products should be regulated. Here, we discuss the ongoing efforts of the FDA to develop a modern, transparent, flexible

Calls grow to tap the gold mine of human genetic knockouts


A Human Knockout Project would systematically search for loss-of-function genetic mutations in humans to help uncover new drug targets.

FDA approvals for the first 6 months of 2017


The US FDA approved 23 new drugs in the first 6 months of 2017 (Table 1). This is more than the agency approved in the entirety of 2016, a lacklustre year with only 22 approvals (Nat. Rev. Drug Discov.16, 73–76;

FDA approves first new sickle cell drug in 20 years


The US FDA approved Emmaus Medical's L-glutamine for sickle cell anaemia, providing the first new drug for these patients in 20 years.Emmaus's drug is an oral, pharmaceutical-grade amino acid. The mechanism of action of the drug is not understood, but it is thought

New cancer vaccines show clinical promise


Personalized cancer vaccines can help to stave off melanoma, suggested two phase I clinical trials published in Nature. The findings buoyed an emerging field that is using neoantigens — antigens that are unique to each patient's cancer — to prime the immune system to

Market watch: Strategies for biosimilars in emerging markets


Biologic drugs remain inaccessible to most patients in emerging markets. Biosimilars represent a compelling proposition for patient affordability and access, and attractive value for governments in many of these countries. However, quality concerns, technology hurdles, lack of robust regulatory frameworks, and development timelines and costs

Patent watch: Supreme Court decision favours biosimilars


On June 12, 2017, the US Supreme Court issued a unanimous decision in Sandoz Inc. v. Amgen Inc. (No. 15-1039), providing its first interpretation of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court essentially held that

Joshua Gordon


In September 2016, Joshua Gordon joined the NIH as Director of the National Institute of Mental Health (NIMH). For Gordon, who was previously a psychiatrist and neuroscientist at Columbia University Medical Center, this role presented a once-in-a-lifetime opportunity to oversee a US$1.5 billion budget and shape the future of mental health research. When he started, he said his first order of business would be to listen and learn. One year on, he has heard a lot about the institute's classification of mental illnesses for research purposes (known as RDoC), the appropriate balance between basic and clinical research, and the challenges of using genetics to understand psychiatric disease, he told Asher Mullard.

Colorectal cancer drugs market


The market for colorectal cancer therapies, which is currently dominated by drugs targeting vascular endothelial growth factor and epidermal growth factor receptor, is poised for change with the anticipated entry of immunotherapies and other targeted drugs.

Infectious diseases: Decrypting Cryptosporidium


Infections that cause diarrhoea — such as cryptosporidiosis, caused by the protozoan parasites Cryptosporidium hominis and Cryptosporidium parvum — are responsible for nearly a million deaths every year, mostly among children in low-income countries as well as immunodeficient patients. Unfortunately, drug development against

Muscle disorders: FGF19 reduces muscle wasting


Muscle wasting can result from numerous conditions, including obesity, sarcopenia and cachexia, as well as long-term glucocorticoid treatment for inflammatory diseases. Writing in Nature Medicine, Benoit and colleagues demonstrate that fibroblast growth factor 19 (FGF19) can reduce muscle wasting in mice, likely though effects

Anticancer therapy: Neutrophils deliver the goods


Glioblastoma is a notoriously difficult cancer to treat, partly because its invasive nature makes surgery challenging, and partly because the blood–brain barrier (BBB) impedes the delivery of chemotherapeutics. Delivery of therapeutic agents using endogenous carrier cells is a promising strategy for the treatment of brain

Cancer: RNA-based approaches target KRAS


Activating mutations in the KRAS oncogene commonly occur in human tumours and are associated with cancer initiation, metastasis and poor prognosis. Despite significant effort, direct and specific therapeutic targeting of KRAS has so far proved elusive. Two new papers now report the use

Infectious diseases: Soil-sifting snags new antibiotic


Multidrug-resistant bacteria pose a considerable public health threat, and new treatment options are urgently needed. Now, Maffioli et al. have identified a nucleoside-analogue inhibitor that targets bacterial RNA polymerase (RNAP) and shows antibacterial activity against drug-resistant pathogens.The authors began by screening a library

Cardiovascular disease: CRHR2 blockade prevents heart failure


Despite improvements in the treatment of cardiovascular diseases, the prognosis of heart failure remains poor. To identify potential novel therapeutic targets, Tsuda et al. analyzed G-protein-coupled receptor (GPCR) expression in mouse cardiomyocytes 2 weeks following transverse aortic constriction (TAC) and identified markedly increased expression

Type 2 diabetes: Broccoli extract lowers glucose levels


Targeting elevated hepatic glucose production in type 2 diabetes (T2D) represents an attractive therapeutic approach. To investigate this, Axelsson et al. first analyzed liver gene expression in a diabetic mouse model, in combination with other genetic data, to identify a 50-gene liver disease signature.

Neurodegenerative disorders: SRC-ABL inhibitors protect motor neurons


Currently approved therapies for amyotrophic lateral sclerosis (ALS) — a progressive neurodegenerative disease characterized by loss of motor neurons — exhibit limited effectiveness. By screening a panel of existing drugs in induced pluripotent stem cell (iPSC)-derived motor neurons from patients with familial ALS, Imamura et

Cancer: mRNA-encoded bispecific antibodies eliminate tumours


The development of therapeutic bispecific T cell-engaging antibodies, which recruit cytotoxic T cells to tumour cells, has been hampered by manufacturing challenges as well as their short serum half-life. To circumvent these issues, Stadler et al. generated 1-methylpseudouridine-containing mRNAs encoding bispecific antibodies directed against

Opportunities and challenges in phenotypic drug discovery: an industry perspective


Phenotypic drug discovery (PDD) approaches do not rely on knowledge of the identity of a specific drug target or a hypothesis about its role in disease, in contrast to the target-based strategies that have been widely used in the pharmaceutical industry in the past three

Breaking barriers to novel analgesic drug development


Acute and chronic pain complaints, although common, are generally poorly served by existing therapies. This unmet clinical need reflects a failure to develop novel classes of analgesics with superior efficacy, diminished adverse effects and a lower abuse liability than those currently available. Reasons for this

Broad-spectrum agents for flaviviral infections: dengue, Zika and beyond


Infections with flaviviruses, such as dengue, West Nile virus and the recently re-emerging Zika virus, are an increasing and probably lasting global risk. This Review summarizes and comments on the opportunities for broad-spectrum agents that are active against multiple flaviviruses. Broad-spectrum activity is particularly desirable

Upcoming market catalysts in Q3 2017


Nature Reviews Drug Discovery16, 449 (2017)There was an error in the description of the patient population for the PACIFIC trial of durvalumab. This has been corrected in the html and pdf versions.