To enhance the safety and security of the US bioeconomy, a new public–private partnership should be established to facilitate information sharing and threat analysis among industry, government and academia, and to develop and deploy safeguards.

After two decades of experience with biosimilars, physicochemical and in vitro biological comparison with their reference products appear sufficient to guarantee clinical safety and efficacy. Hence, the regulation of biosimilars has become redundant, and biopharmaceuticals should now be regulated through the generic pathway available for small molecules.

Sparxell has made cellulose nanocrystals and could replace the shine in synthetic dyes, microplastics and unsustainable mined glitters such as titania or mica with natural, biodegradable components. Its cellulose nanocrystals reflect light to produce vibrant colors, just as in butterfly wings and peacock tails but using wood pulp or other plant waste instead. The colors are durable and fade resistant

Generative artificial intelligence models of molecular biology are often restricted to individual molecules or DNA segments and are built in a way that makes them computationally demanding when applied to long sequences. The ability to capture broader genomic interactions will be crucial for both the understanding and engineering of complex biological processes. Writing in Science, Nguyen et al. introduce

Beam Therapeutics’ early clinical data on its base-editing therapy BEAM-101 shows for the first time that the technology restores functional hemoglobin in people with sickle cell disease. In four patients treated with BEAM-101, functional fetal hemoglobin levels increased to over 60% at 1–6 months follow-up, and patients’ red blood cells had less sickling, reduced cell adhesion and improved flow properties

Recent patents relating to compositions, methods of preparation and use of stem cells.

The domestication of tomato (Solanum lycopersicum) has led to a massive increase in fruit size but at the cost of decreased sugar levels, a negative correlation that is probably the consequence of a loss of high-sugar alleles. In a study published in Nature, Zhang et al. engineer a sweet tomato that maintains its high yield and weight by mutating a gene that encodes a protein that regulates sugar accumulation

One year after partnering with clinical-stage Biotheus on a bispecific antibody targeting PD-L1 and VEGF-A, BioNTech announced the acquisition of the Zhuhai, China–based company for $800 million, with up to $150 million in potential milestone payments. The purchase gives BioNTech full global rights to Biotheus’s lead candidate PM8002, also known as BNT327; a pipeline of ten programs in various stages

The human genome contains thousands of long noncoding RNAs (lncRNAs), of which very few have been linked to a functional role. Although DNA-targeting CRISPR screens have identified functional lncRNAs, these screens suffer from limited specificity as DNA-based perturbation of lncRNA loci might also suppress nearby protein-coding genes and other regulatory elements. Writing in Cell, Liang et al. overcome

Cuba provides a rare example of a publicly owned biotech sector in a low-income country. Since its founding in 1986, Cuba’s Center for Genetic Engineering and Biotechnology (CIGB) has overseen the development of the country’s biopharmaceutical sector, from the initial conception of a drug through preclinical studies, clinical trials, licensing, manufacturing and export. We outlined the achievements

Implementation of intellectual property education in academic institutions can result in increased opportunities for protecting intellectual property and limit costs, but to be successful technology transfer offices must also adapt.

Recent moves of note in and around the biotech and pharma industries.

From mRNA drugs and the Achilles heel of obesity drugs, to single-cell biology and foundation models for drug discovery, these are some of the big stories most viewed by our readers.

Nature Biotechnology editors pick their favorite research articles from 2024.

In their April article, Mark Kessel and Chris Vickrey raise several valid concerns about the Japanese life sciences industry and why it is not reaching its full potential1. They acknowledge that a negative pricing environment for innovative medicines is part of the problem, as is a history of government underinvestment. Missing from their argument, however, are some recent initiatives from Japanese

Meet the biotech startups brewing milk in bioreactors to improve on baby formula.

Each year, Nature Biotechnology highlights companies that have received sizeable early-stage funding in the previous year. Gate Bioscience wants to tailor gates that stop problematic proteins at the source.

Correction to: Nature Biotechnology https://doi.org/10.1038/s41587-022-01637-z, published online 19 January 2023.

Wageningen-based agbiotech KeyGene, in collaboration with Chiquita and Wageningen University, develops a banana plant resistant to both Fusarium tropical race 4 (TR4), a fungus capable of devastating entire plantations, and black sigatoka, a widespread leaf disease. The new variety, named Yelloway One, was produced by combining traditional crossbreeding techniques and modern DNA analysis technology

Neoantigen cancer vaccines hold great promise for cancer treatment but are often limited by the immunosuppressive tumor environment. Now, as described in Nature, Redenti et al. have overcome this issue by harnessing the natural capacity of bacteria to colonize tumors and trigger immune responses. They have developed a microbial system that produces and delivers distinct sets of neoantigens to elicit

The first clinical results for an RNA-editing oligonucleotide designed to correct a disease-causing single-base mutation in mRNA have been released. The company, Wave Life Sciences, says the agent WVE-006 restored more than 60% of wild-type functional protein in two individuals with the genetic disorder alpha-1 antitrypsin (ATT; encoded by SERPINA1) deficiency. ATT deficiency affects the liver owing

The US Department of Energy (DOE) in October conditionally committed nearly $3 billion to two companies to scale up the production of sustainable jet fuel made from crops, vegetable oils and animal fats. Gevo in Englewood, Colorado, could receive a loan guarantee of nearly $1.5 billion to build a new jet fuel refinery in Lake Preston, South Dakota. And Montana Renewables could receive about the same

Over 10% of patients with a fatal neurodegenerative disease who received bluebird bio’s FDA-approved gene therapy Skysona (elivaldogene autotemcel) have developed hematological cancers, further highlighting the well-known risks of using lentiviral vectors. The patients were treated with Skysona to slow the progression of cerebral adrenoleukodystrophy (CALD), an X-linked rare inherited neurodegenerative

In this episode, Associate Editor Cláudia Vilhena sits down with Ali Shaib, the lead author of an exciting new study showcasing expansion microscopy and the visualization of individual protein shapes using standard laboratory microscopes. Tune in as Ali and Cláudia explore the “accidental” origins of the study, the importance of mentorship and collaboration, and the democratization of super-resolution

Beer lovers can now enjoy their wildest drink yet thanks to a yeast carried by wasps. AB Biotek from Peterborough in the UK has launched Pinnacle Crisp Sour — a brewer’s ingredient made from Lachancea thermotolerans, a yeast found in the bellies of wasps. Traditional beer uses just four ingredients: grain, hops, yeast and water. Hops add the distinctive bitter flavor, and yeast converts sugar from

Recent patents relating to retroviruses, transposons and other virus-like elements for use in gene transfer and gene therapy.

RNA viruses are omnipresent and can infect a wide range of hosts. Recent efforts to sequence ecological samples have identified tens of thousands of new species, yet uncovering the complete spectrum of RNA virus diversity remains challenging. In a new paper published in Cell, Hou et al. describe a deep learning algorithm, called LucaProt, to advance RNA virus discovery at global scale. LucaProt is

Using insulin to control diabetes can lead to dangerously low blood glucose levels (hypoglycemia). For many years, researchers have worked to engineer an insulin that avoids this risk by adjusting its activity in response to glucose, but so far without success. Writing in Nature, Hoeg-Jensen et al. describe an insulin with a glucose-sensitive switch that reversibly responds to ambient glucose levels

Recent moves of note in and around the biotech and pharma industries.

Amyloid deposits are present in the brains of cognitively impaired individuals, but also accumulate throughout the body. Some biotechs aim to keep these misfolded proteins in check to treat a range of diseases, including heart failure, ALS and Alzheimer’s disease.

Europe’s first field trial of gene-edited vines began in northern Italy on 30 September 2024. Developed by EdiVite, a spinoff from the University of Verona, these Chardonnay vines have undergone gene inactivation to enable them to better defend themselves against downy mildew, a major fungal disease. The trial is being conducted on university land, with plans to expand to another site in the Veneto

A strategic move by lawyers acting for Doudna and Charpentier is the latest twist in the battleground for CRISPR–Cas9 technology.