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What It’s like to Live with a Brain Chip, according to Neuralink’s First User

Thirty-year-old Noland Arbaugh says the Neuralink chip has let him “reconnect with the world”

Lauren Leffer

3d rendering of a human tooth on a gray background

This Start-Up Wants You to Put Custom Bacteria on Your Teeth

Lumina Probiotic has said a genetically modified microbe could prevent cavities. Experts, though, have safety concerns

Christina Szalinski

Illustration of the back of a person with piano keys for fingers, about to play the piano

‘Smart Gloves’ Teach Piano Playing through Touch

A high-tech pair of gloves can help make learning instruments and other hands-on activities easier

Riis Williams

An illustrated pink snail leaves a trail of shiny green slime beneath the title "magical mucus"

The Tale of the Snail Slime Wrangler

Mucus is a miracle of evolution, and some researchers are trying to re-create what nature makes naturally.

Christopher Intagliata

Shadow of the plane on an agricultural field.

Your Next Flight's Fuel Could Be Made By Microbes

The aviation industry is getting ready to embrace fuel produced by fermentation

Emily Waltz, Nature Biotechnology

Illustration of a hand clutching its heart, with a heart beat line above it.

A-fib—a Rapid, Irregular Heartbeat—Can Kill You, but New Tech Can Spot It

A fluttering heartbeat called A-fib can lead to stroke, but smartwatches can detect it, and there are good treatments

Lydia Denworth

Profile silhouette of Elon Musk

Elon Musk’s Neuralink Has Implanted Its First Chip in a Human Brain. What’s Next?

The wealthiest person on Earth has taken the next step toward a commercial brain interface

Ben Guarino

Artist's interpretation, visualization of sound waves, white wireframe illustration on black background

Ultrasound Enables Remote 3-D Printing—Even in the Human Body

For the first time, researchers have used sound waves to 3-D print an object from a distance—even with a wall in the way

Rachel Berkowitz

Resin casts of major human organs

Your Organs Might Be Aging at Different Rates

It turns out that your chronological age really is just a number. What’s more important for knowing disease risk is the biological age of each of your organs

Lori Youmshajekian

Close up photo of the electrode.

New Soft Electrode Unfolds inside the Skull

An electrode inspired by soft robotics could provide less invasive brain-machine interfaces

Simon Makin

Illustration of an elderly man and a young girl birdwatching.

Hearing Aids May Lower Risk of Cognitive Decline and Dementia

As few as 15 percent of people who would benefit from hearing aids use them

Close-up of a black soldier fly on a green leaf.

How Gene-Edited Insects Are Providing Food, Fuel and Waste Disposal

Companies are recruiting black soldier flies and mealworms as a protein source in animal feed, fertilizer, biofuels and even as ingredients for burgers and shakes

Karl Gruber, Lisa Melton, Nature magazine

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Microvesicles-delivering Smad7 have advantages over microvesicles in suppressing fibroblast differentiation in a model of Peyronie’s disease

This study compared the differences of microvesicles (MVs) and microvesicles-delivering Smad7 (Smad7-MVs) on macrophage M1 polarization and fibroblast differentiation in a model of Peyronie’s disease (PD).

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Improvement and prediction of the extraction parameters of lupeol and stigmasterol metabolites of Melia azedarach with response surface methodology

Melia azedarach is known as a medicinal plant that has wide biological activities such as analgesic, antibacterial, and antifungal effects and is used to treat a wide range of diseases such as diarrhea, malaria, ...

Dual release of daptomycin and BMP-2 from a composite of β-TCP ceramic and ADA gelatin

Antibiotic-containing carrier systems are one option that offers the advantage of releasing active ingredients over a longer period of time. In vitro sustained drug release from a carrier system consisting of ...

Minimizing IP issues associated with gene constructs encoding the Bt toxin - a case study

As part of a publicly funded initiative to develop genetically engineered Brassicas (cabbage, cauliflower, and canola) expressing Bacillus thuringiensis Crystal ( Cry )-encoded insecticidal (Bt) toxin for Indian an...

Activating the healing process: three-dimensional culture of stem cells in Matrigel for tissue repair

To establish a strategy for stem cell-related tissue regeneration therapy, human gingival mesenchymal stem cells (hGMSCs) were loaded with three-dimensional (3D) bioengineered Matrigel matrix scaffolds in high...

latest research articles in biotechnology

Co-overexpression of chitinase and β-1,3-glucanase significantly enhanced the resistance of Iranian wheat cultivars to Fusarium

Fusarium head blight (FHB) is a devastating fungal disease affecting different cereals, particularly wheat, and poses a serious threat to global wheat production. Chitinases and β-glucanases are two important ...

A new mRNA structure prediction based approach to identifying improved signal peptides for bone morphogenetic protein 2

Signal peptide (SP) engineering has proven able to improve production of many proteins yet is a laborious process that still relies on trial and error. mRNA structure around the translational start site is imp...

Correction: Transcriptomic and targeted metabolomic analyses provide insights into the flavonoids biosynthesis in the flowers of Lonicera macranthoides

The original article was published in BMC Biotechnology 2024 24 :19

A model approach to show that monocytes can enter microporous β-TCP ceramics

β-TCP ceramics are versatile bone substitute materials and show many interactions with cells of the monocyte-macrophage-lineage. The possibility of monocytes entering microporous β-TCP ceramics has however not...

Nutritional composition, lipid profile and stability, antioxidant activities and sensory evaluation of pasta enriched by linseed flour and linseed oil

Pasta assortments fortified with high quality foods are a modern nutritional trends. This study, explored the effects of fortification with linseed flour (LF) and linseed oil (LO) on durum wheat pasta characte...

In vitro assessment of the effect of magnetic fields on efficacy of biosynthesized selenium nanoparticles by Alborzia kermanshahica

Cyanobacteria represent a rich resource of a wide array of unique bioactive compounds that are proving to be potent sources of anticancer drugs. Selenium nanoparticles (SeNPs) have shown an increasing potentia...

ECM-mimetic, NSAIDs loaded thermo-responsive, immunomodulatory hydrogel for rheumatoid arthritis treatment

Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease, and it leads to irreversible inflammation in intra-articular joints. Current treatment approaches for RA include non-steroidal anti-infla...

latest research articles in biotechnology

Development of a chemiluminescence assay for tissue plasminogen activator inhibitor complex and its applicability to gastric cancer

Venous thromboembolism (VTE), is a noteworthy complication in individuals with gastric cancer, but the current diagnosis and treatment methods lack accuracy. In this study, we developed a t-PAIC chemiluminesce...

High-performance internal circulation anaerobic granular sludge reactor for cattle slaughterhouse wastewater treatment and simultaneous biogas production

This research investigates the efficacy of a high-performance pilot-scale Internal Circulation Anaerobic Reactor inoculated with Granular Sludge (ICAGSR) for treating cattle slaughterhouse wastewater while con...

Hindering the biofilm of microbial pathogens and cancer cell lines development using silver nanoparticles synthesized by epidermal mucus proteins from Clarias gariepinus

Scientists know very little about the mechanisms underlying fish skin mucus, despite the fact that it is a component of the immune system. Fish skin mucus is an important component of defence against invasive ...

3D printing of Ceffe-infused scaffolds for tailored nipple-like cartilage development

The reconstruction of a stable, nipple-shaped cartilage graft that precisely matches the natural nipple in shape and size on the contralateral side is a clinical challenge. While 3D printing technology can eff...

A cleavable peptide adapter augments the activity of targeted toxins in combination with the glycosidic endosomal escape enhancer SO1861

Treatment with tumor-targeted toxins attempts to overcome the disadvantages of conventional cancer therapies by directing a drug’s cytotoxic effect specifically towards cancer cells. However, success with targ...

Multiprotein collagen/keratin hydrogel promoted myogenesis and angiogenesis of injured skeletal muscles in a mouse model

Volumetric loss is one of the challenging issues in muscle tissue structure that causes functio laesa . Tissue engineering of muscle tissue using suitable hydrogels is an alternative to restoring the physiological...

Analysis of the impact of pluronic acid on the thermal stability and infectivity of AAV6.2FF

The advancement of AAV vectors into clinical testing has accelerated rapidly over the past two decades. While many of the AAV vectors being utilized in clinical trials are derived from natural serotypes, engin...

Rice yellow mottle virus is a suitable amplicon vector for an efficient production of an anti-leishmianiasis vaccine in Nicotiana benthamiana leaves

Since the 2000’s, plants have been used as bioreactors for the transient production of molecules of interest such as vaccines. To improve protein yield, “amplicon” vectors based on plant viruses are used. Thes...

Extraction and analysis of high-quality chloroplast DNA with reduced nuclear DNA for medicinal plants

Obtaining high-quality chloroplast genome sequences requires chloroplast DNA (cpDNA) samples that meet the sequencing requirements. The quality of extracted cpDNA directly impacts the efficiency and accuracy o...

Transcriptomic and targeted metabolomic analyses provide insights into the flavonoids biosynthesis in the flowers of Lonicera macranthoides

Flavonoids are one of the bioactive ingredients of Lonicera macranthoides ( L. macranthoides ), however, their biosynthesis in the flower is still unclear. In this study, combined transcriptomic and targeted metabo...

The Correction to this article has been published in BMC Biotechnology 2024 24 :33

Effects of solid lipid nanocarrier containing methyl urolithin A by coating folate-bound chitosan and evaluation of its anti-cancer activity

Nanotechnology-based drug delivery systems have received much attention over the past decade. In the present study, we synthesized Methyl Urolithin A-loaded solid lipid nanoparticles decorated with the folic a...

Neq2X7: a multi-purpose and open-source fusion DNA polymerase for advanced DNA engineering and diagnostics PCR

Thermostable DNA polymerases, such as Taq isolated from the thermophilic bacterium Thermus aquaticus , enable one-pot exponential DNA amplification known as polymerase chain reaction (PCR). However, properties oth...

A solution for highly efficient electroporation of primary cytotoxic T lymphocytes

Cytotoxic T lymphocytes (CTLs) are central players in the adaptive immune response. Their functional characterization and clinical research depend on efficient and reliable transfection. Although various metho...

Adsorption of Hg 2+ /Cr 6+ by metal-binding proteins heterologously expressed in Escherichia coli

Removal of heavy metals from water and soil is a pressing challenge in environmental engineering, and biosorption by microorganisms is considered as one of the most cost-effective methods. In this study, the m...

Derivation of a novel antimicrobial peptide from the Red Sea Brine Pools modified to enhance its anticancer activity against U2OS cells

Cancer associated drug resistance is a major cause for cancer aggravation, particularly as conventional therapies have presented limited efficiency, low specificity, resulting in long term deleterious side eff...

Polyphyllin B inhibited STAT3/NCOA4 pathway and restored gut microbiota to ameliorate lung tissue injury in cigarette smoke-induced mice

Smoking was a major risk factor for chronic obstructive pulmonary disease (COPD). This study plan to explore the mechanism of Polyphyllin B in lung injury induced by cigarette smoke (CSE) in COPD.

Quantifying carboxymethyl lysine and carboxyethyl lysine in human plasma: clinical insights into aging research using liquid chromatography-tandem mass spectrometry

The objective of this study was to establish a methodology for determining carboxymethyl lysine (CML) and carboxyethyl lysine (CEL) concentrations in human plasma using liquid chromatography-tandem mass spectr...

Iron/Copper/Phosphate nanocomposite as antimicrobial, antisnail, and wheat growth-promoting agent

One of the current challenges is to secure wheat crop production to meet the increasing global food demand and to face the increase in its purchasing power. Therefore, the current study aimed to exploit a new ...

Staphopain mediated virulence and antibiotic resistance alteration in co-infection of Staphylococcus aureus and Pseudomonas aeruginosa : an animal model

Polymicrobial communities lead to worsen the wound infections, due to mixed biofilms, increased antibiotic resistance, and altered virulence production. Promising approaches, including enzymes, may overcome th...

Strain-specific features of Pleurotus ostreatus growth in vitro and some of its biological activities

The production of Pleurotus ostreatus mycelium as a promising object for use in food and other industries is hampered by a lack of information about the strain-specificity of this fungus mycelium growth and its a...

Antibacterial, antibiofilm, and anticancer activity of silver-nanoparticles synthesized from the cell-filtrate of Streptomyces enissocaesilis

Silver nanoparticles (Ag-NPs) have a unique mode of action as antibacterial agents in addition to their anticancer and antioxidant properties. In this study, microbial nanotechnology is employed to synthesize ...

Deep orange gene editing triggers temperature-sensitive lethal phenotypes in Ceratitis capitata

The Mediterranean fruit fly, Ceratitis capitata , is a significant agricultural pest managed through area-wide integrated pest management (AW-IPM) including a sterile insect technique (SIT) component. Male-only re...

Characterization, modeling, and anticancer activity of L.arginase production from marine Bacillus licheniformis OF2

L-arginase, is a powerful anticancer that hydrolyzes L-arginine to L-ornithine and urea. This enzyme is widely distributed and expressed in organisms like plants, fungi, however very scarce from bacteria. Our ...

Green and environmentally friendly synthesis of silver nanoparticles with antibacterial properties from some medicinal plants

Recently there have been a variety of methods to synthesize silver nanoparticles, among which the biosynthesis method is more noticeable due to features like being eco-friendly, simple, and cost-efficient. The...

Reaping the benefits of liquid handlers for high-throughput gene expression profiling in a marine model invertebrate

Modern high-throughput technologies enable the processing of a large number of samples simultaneously, while also providing rapid and accurate procedures. In recent years, automated liquid handling workstation...

Induction of antimicrobial, antioxidant metabolites production by co-cultivation of two red-sea-sponge-associated Aspergillus sp. CO2 and Bacillus sp. COBZ21

The growing spread of infectious diseases has become a potential global health threat to human beings. According to WHO reports, in this study, we investigated the impact of co-cultivating the isolated endophy...

A novel starch-active lytic polysaccharide monooxygenase discovered with bioinformatics screening and its application in textile desizing

Lytic polysaccharide monooxygenases (LPMOs) catalyzing the oxidative cleavage of different types of polysaccharides have potential to be used in various industries. However, AA13 family LPMOs which specificall...

Tuning spacer length improves the functionality of the nanobody-based VEGFR2 CAR T cell

The chimeric antigen receptor-expressing T (CAR-T) cells for cancer immunotherapy have obtained considerable clinical importance. CAR T cells need an optimized intracellular signaling domain to get appropriate...

Fabrication and characterization of metformin-loaded PLGA/Collagen nanofibers for modulation of macrophage polarization for tissue engineering and regenerative medicine

In tissue engineering (TE) and regenerative medicine, the accessibility of engineered scaffolds that modulate inflammatory states is extremely necessary. The aim of the current work was to assess the efficacy ...

Production of a potential multistrain probiotic in co-culture conditions using agro-industrial by-products-based medium for fish nutrition

Probiotics are viable microorganisms that when administered in adequate amounts confer health benefits to the host. In fish, probiotic administration has improved growth, and immunological parameters. For this...

Research on the targeted improvement of the yield of a new VB 12 -producing strain, Ensifer adhaerens S305, based on genomic and transcriptomic analysis

Vitamin B 12 (VB 12 ) has a wide range of applications and high economic value. In this study, a new strain with high VB 12 production potential, Ensifer adhaerens S305, was identified in sewage. Because E. adhaerens

Validation and calibration of a novel GEM biosensor for specific detection of Cd 2+ , Zn 2+ , and Pb 2+

In this study, we designed a novel genetic circuit sensitive to Cd 2+ , Zn 2+ and Pb 2+ by mimicking the CadA/CadR operon system mediated heavy metal homeostasis mechanism of Pseudomonas aeruginosa . The regular DNA m...

Exploring the microbial diversity and characterization of cellulase and hemicellulase genes in goat rumen: a metagenomic approach

Goat rumen microbial communities are perceived as one of the most potential biochemical reservoirs of multi-functional enzymes, which are applicable to enhance wide array of bioprocesses such as the hydrolysis...

The transcriptional factor Clr-5 is involved in cellulose degradation through regulation of amino acid metabolism in Neurospora crassa

Filamentous fungi are efficient degraders of plant biomass and the primary producers of commercial cellulolytic enzymes. While the transcriptional regulation mechanisms of cellulases have been continuously exp...

An online soft sensor method for biochemical reaction process based on JS-ISSA-XGBoost

A method combining offline techniques and the just-in-time learning strategy (JITL) is proposed, because the biochemical reaction process often encounters changing features and parameters over time.

Preparation, purification, and biochemical of fat-degrading bacterial enzymes from pig carcass compost and its application

A lot of kitchen waste oil is produced every day worldwide, leading to serious environmental pollution. As one of the environmental protection methods, microorganisms are widely used treating of various wastes...

Coupling fermentation of glutamic acid and γ-polyglutamic acid and preparation of poly(amino acid) superabsorbent polymers

γ-polyglutamic acid (γ-PGA) is a biomarker that can be directly obtained by microbial fermentation. Poly(amino acid) superabsorbent polymers (SAPs) were prepared with purified γ-PGA as raw material and ethylen...

Serodiagnosis of human brucellosis by an indirect ELISA test using recombinant outer membrane protein 19 kDa (rOMP19) as an antigen

Brucellosis remains one of the global health concerns that reemerges in recent years. Delayed or inaccurate diagnosis end to a long treatment duration and financial burden; therefore, finding a good antigen fo...

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The first gene-editing treatment: 10 Breakthrough Technologies 2024

Sickle-cell disease is the first illness to be beaten by CRISPR, but the new treatment comes with an expected price tag of $2 to $3 million.

  • Antonio Regalado archive page

a scientist looks at a tall strand of DNA in a suspension of liquid. A hose sends the liquid back to an IV and into the arm of a patient seated comfortably in a domestic chair with two nice plants and a happy, observant cat.

CRISPR Therapeutics, Editas Medicine, Precision BioSciences, Vertex Pharmaceuticals

The first gene-editing cure has arrived. Grateful patients are calling it “life changing.”

It was only 11 years ago that scientists first developed the potent DNA-snipping technology called CRISPR. Now they’ve brought CRISPR out of the lab and into real medicine with a treatment that cures the symptoms of sickle-cell disease.

Sickle-cell is caused by inheriting two bad copies of one of the genes that make hemoglobin. Symptoms include bouts of intense pain, and life expectancy with the disease is just 53 years. It affects 1 in 4,000 people in the US, nearly all of them African-American. 

So how did this disease become CRISPR’s first success ? A fortuitous fact of biology is part of the answer. Our bodies harbor another way to make hemoglobin that turns off when we’re born. Researchers found that a simple DNA edit to cells from the bone marrow could turn it back on.

Many CRISPR treatments are in trials, but in 2022, Vertex Pharmaceuticals, based in Boston, was first to bring one to regulators for approval. That treatment was for sickle-cell. After their bone marrow was edited, nearly all the patients who volunteered in the trial were pain free. 

Good news. But the expected price tag of the gene-editing treatment is $2 to $3 million. And Vertex has no immediate plans to offer it in Africa—where sickle-cell disease is most common, and where it still kills children.

The company says this is because the treatment regimen is so complex. It involves a hospital stay; doctors remove the bone marrow, edit the cells, and then transplant them back. In countries that still struggle to cover basic health needs, the procedure remains too demanding. So simpler, cheaper ways to deliver CRISPR could come next. 

Biotechnology and health

What’s next for mdma.

The FDA is poised to approve the notorious party drug as a therapy. Here’s what it means, and where similar drugs stand in the US. 

  • Cassandra Willyard archive page

FDA advisors just said no to the use of MDMA as a therapy

The studies demonstrating MDMA’s efficacy against PTSD left experts with too many questions to greenlight the treatment.

Beyond Neuralink: Meet the other companies developing brain-computer interfaces

Companies like Synchron, Paradromics, and Precision Neuroscience are also racing to develop brain implants

My biotech plants are dead

Two ‘Firefly petunias’ perished in a shipping misadventure, but other customers have had better luck.

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latest research articles in biotechnology

Research team uses CRISPR/Cas9 to alter photosynthesis for the first time

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Scientists push single-molecule DNA sequencing to the next level

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Engineering cells to broadcast their behavior can help scientists study their inner workings

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Biotechnology is a field of science that harnesses cellular and biomolecular processes to develop technologies and products that help improve our lives and the health of our planet. This discipline combines biology, chemistry, physics, and engineering to manipulate living organisms and biological systems, often using genetic engineering and other forms of molecular biology. Biotechnology has a wide range of applications across various sectors including medicine, agriculture, industrial processes, and environmental management.

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The Long-Overlooked Molecule That Will Define a Generation of Science

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By Thomas Cech

Dr. Cech is a biochemist and the author of the forthcoming book “The Catalyst: RNA and the Quest to Unlock Life’s Deepest Secrets,” from which this essay is adapted.

From E=mc² to splitting the atom to the invention of the transistor, the first half of the 20th century was dominated by breakthroughs in physics.

Then, in the early 1950s, biology began to nudge physics out of the scientific spotlight — and when I say “biology,” what I really mean is DNA. The momentous discovery of the DNA double helix in 1953 more or less ushered in a new era in science that culminated in the Human Genome Project, completed in 2003, which decoded all of our DNA into a biological blueprint of humankind.

DNA has received an immense amount of attention. And while the double helix was certainly groundbreaking in its time, the current generation of scientific history will be defined by a different (and, until recently, lesser-known) molecule — one that I believe will play an even bigger role in furthering our understanding of human life: RNA.

You may remember learning about RNA (ribonucleic acid) back in your high school biology class as the messenger that carries information stored in DNA to instruct the formation of proteins. Such messenger RNA, mRNA for short, recently entered the mainstream conversation thanks to the role they played in the Covid-19 vaccines. But RNA is much more than a messenger, as critical as that function may be.

Other types of RNA, called “noncoding” RNAs, are a tiny biological powerhouse that can help to treat and cure deadly diseases, unlock the potential of the human genome and solve one of the most enduring mysteries of science: explaining the origins of all life on our planet.

Though it is a linchpin of every living thing on Earth, RNA was misunderstood and underappreciated for decades — often dismissed as nothing more than a biochemical backup singer, slaving away in obscurity in the shadows of the diva, DNA. I know that firsthand: I was slaving away in obscurity on its behalf.

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ASCO 2024 Round-Up: Some Of The Most Impactful Cancer News Out Of The Big Meeting

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  • AstraZeneca PLC showcased projects in two plenary lecture presentations at the Annual Meeting of the American Society of Clinical Oncology, or ASCO, including a trial that established osimertinib as the standard of care for EGFR-mutant NSCLC.
  • Bristol Myers Squibb presented the first efficacy results from the NADINA trial, showing that neoadjuvant immunotherapy with nivolumab plus ipilimumab reduced the risk of melanoma returning after surgery.
  • Novartis' asciminib significantly improved the rate of major molecular response in patients with chronic myeloid leukemia.

Waterfall Dropping into Fjord

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When I was preparing my article on the biotech companies to watch at this year's Annual Meeting of the American Society of Clinical Oncology, it was based on only the abstract titles and not much on the substance, just what we could glean from having different companies be present.

In following up on this, I wanted to prepare a post-mortem highlighting some of the presentations with a likely substantial impact on the coming year in cancer care. Certainly, many articles on Seeking Alpha are going to offer individual takes on relatively narrow bits of information focused on specific companies. In this article, I want to give a rundown of some of the most impactful or surprising findings to come out of the meeting, at least in my opinion.

This is not remotely a complete rundown of all the presentations of interest. I will be focusing mainly on the presentations I was looking forward to in the preview article, and giving some summary of how they shaped up.

AstraZeneca Steals the Show

AstraZeneca PLC ( AZN ) has been a dominating force of ASCO for years running, providing details of practice-changing findings, particularly within lung cancer. 2024 was no exception, as AZN showcased projects in 2 of the 5 plenary lecture presentations.

LAURA was a randomized, phase 3 trial taking patients with stage III unresectable, EGFR-mutant NSCLC and giving them standard of care chemoradiation therapy, followed by either placebo or osimertinib. Osimertinib treatment led to a decisive progression-free survival benefit over placebo (median 39.1 vs 5.6 months), with a most notable ability to apparently prevent the development of brain metastases in this high-risk group of patients.

This shifts the standard of care toward domination of osimertinib across nearly every disease stage for this EGFR-mutant population. The FLAURA and ADAURA trials have already established osimertinib as the standard of care in metastatic and operable cases, respectively. There are some questions about how long we truly need to be giving osimertinib (as highlighted by Dr. Sequist in the discussion, brain metastases appeared to be prevented only as long as osimertinib is continued, as evidenced by the ADAURA study). Also, osimertinib was associated with an increased risk of radiation pneumonitis, so there are considerations to balance, but overall this is a very positive result, continuing to support the use of osimertinib as a standard for EGFR-mutant NSCLC, now almost regardless of disease setting.

ADRIATIC was the second AZN trial to be featured in the plenary session. Here, patients with limited stage small cell lung cancer received standard chemoradiation therapy, followed by either consolidation durvalumab, durvalumab plus tremelimumab, or placebo. This presentation only included finding for durvalumab vs placebo, showing that immune checkpoint blockade in this setting could improve median OS by 22 months (55.9 vs 33.4 months). This came at only a modestly increased risk of radiation pneumonitis.

This puts durvalumab square in the sights as a standard of care for patients with limited stage SCLC, helping AZN continue to carve out this niche and distance itself from Roche's atezolizumab, which is approved (as is durvalumab) in combination with chemotherapy for extensive-stage (i.e., metastatic) small cell lung cancer.

Bristol Myers Squibb Might Become More Dominant in Resectable Melanoma

From an investor's standpoint, Bristol Myers Squibb Company ( BMY ) also had a critical presentation at the plenary lecture. Dr. Blank presented the first efficacy results from the NADINA trial, which is the first large, randomized study to assess whether it's better to give immunotherapy before surgery (neoadjuvant) compared with the standard of care, which is to reserve checkpoint inhibitors for after surgery (adjuvant).

NADINA enrolled patients with stage III disease, and the long story made short was that giving nivolumab plus ipilimumab for 6 weeks before surgery led to a substantial reduction in the risk of melanoma returning after surgery. There are questions remaining about the censoring for the trial, but I think this is a clear path forward to get a first official approval for this strategy in this high-risk melanoma population. Moving some anti-PD-1 therapy to the neoadjuvant setting has already shown benefit for patients in this setting, so it seemed like a matter of time. However, this confirmation was extremely exciting, and I've seen various researchers on Twitter showing enthusiasm for neoadjuvant immunotherapy in other tumor settings.

And realistically, it could allow BMY to stake a claim as the immunotherapy to use for resectable melanoma, building on other neoadjuvant experience they've seen with different combinations like nivolumab and relatlimab.

From here, I want to turn our attention back to more disease-area focused studies. The plenary session seems to dominate the conversation year over year, but there are a lot of other things worth focusing on as well. Here's what caught my attention from ASCO 2024.

Lung Cancer

There were several significant threads in the lung cancer session, setting aside the general disappointment with Trop2-directed ADCs. First, a 5-year update of the CROWN study continues to suggest best-in-class activity for Pfizer's ( PFE ) ALK inhibitor lorlatinib, as overall survival continues to far outperform crizotinib, and the activity again tumors in the CNS continues to impress. There is controversy surrounding the use of crizotinib as a control, since second-generation ALK inhibitors have been standard treatment options for years, but this study continues to make a strong case for considering lorlatinib in the upfront setting for ALK-positive NSCLC.

Another exciting study was PALOMA-3, which compared Amgen Inc.'s ( AMGN ) lazertinib plus either subcutaneous amivantamab or the approved intravenous formulation for patients with EGFR-positive NSCLC. The study established that the pharmacokinetics of amivantamab were similar between the 2 formulations. Meanwhile, there was a numeric advantage for subcutaneous amivantamab in terms of PFS (6.1 vs 4.3 months for subcu and IV, respectively). Surprisingly, there was a rather strong signal of overall survival benefit with subcu amivantamab, with 12-month overall survival rates of 65% and 51%, respectively. Meanwhile, infusion reaction risk was dramatically reduced with subcu amivantamab (13% vs 66%), while other rates of adverse events were similar between the two arms. Venous thrombotic events were also reduced with subcu amivantamab.

These findings paint a clearly favorable picture for a future approval of subcutaneous amivantamab, and the combination looks like a strong candidate in the post-osimertinib disease relapse setting.

Finally, the ivonescimab trial HARMONi-A has made a fairly significant, though controversial, splash for EGFR-mutated NSCLC. I actually covered this study (and Summit Therapeutics ( SMMT )) in more detail in a recent article that I encourage you to check out if you are keen to learn more.

A final abstract of note was out of NovoCure Limited's ( NVCR ) stable. They presented findings from the METIS study , showing that their tumor-treating fields could significantly prolong time to intracranial progression in patients who have NSCLC and brain metastases. This continues to affirm the increasingly clear benefit that tumor-treating fields can have in patients with cancers affecting the brain.

Melanoma/Skin Cancers

RELATIVITY-048 provided a look at the use of BMY's nivolumab plus ipilimumab plus relatlimab in patients with advanced melanoma, showing a confirmed response rate of 59%, and 4-year survival rate of 72%. These findings compare reasonably well with historical data on nivo-ipi and nivo-rela on their own, but we need larger studies to validate this benefit, considering the high rate of immune-related adverse events.

The Iovance Biotherapeutics, Inc. ( IOVA ) cell therapy lifileucel was also highlighted here, combining the treatment with pembrolizumab in checkpoint inhibitor-naive melanoma. The response rate to this combination was 65.2%, with 30.4% of patients achieving a complete response. The median duration of response was not reached after median follow-up of 21.7 months. This compares favorably with a benchmark ~33% response rate for pembrolizumab alone in this setting. IOVA is conducting a phase 3 trial, TILVANCE-301, to confirm these findings and possibly establish a new standard of care for metastatic melanoma.

Building on my article about Moderna, Inc.'s ( MRNA ) neoantigen vaccine, the company had updated findings from their phase 2b study , with mRNA-4157 plus pembrolizumab showing a 49% reduction in recurrence-free survival and 62% reduction in distant metastasis compared with pembrolizumab alone. In all, 96% of patients remain alive in the study, giving a signal that mRNA-4157 could have a survival advantage over pembrolizumab, which would be a first. Per commentary on a company investor event to discuss these findings.

one of the things that I've said about this technology overall for [individualized neoantigen therapy, INT] is that it really sits at this precipice and interface of technological advancement with next-generation sequencing and our understanding of cancer biology. And not only is that showcased in what we're achieving for INT, but it's also showcased with how we're designing our studies to learn about what INT can do and how we're sitting sort of at that peak of technological advancement.

Hematologic Malignancies

The biggest study coming out of ASCO for blood cancer was arguably presentation of ASC4FIRST, a phase 3 trial of Novartis AG's ( NVS ) next-generation Abl inhibitor asciminib versus other frontline TKIs in patients with CML. Asciminib significantly improved the rate of major molecular response at week 48, one of the co-primary endpoints of the study (67.7% vs 49.0%). Most of this was derived from improvement versus imatinib treatment, but there was a numerically higher rate of major molecular response for asciminib compared with second-generation TKIs, as well (66.0% vs 57.8%). Asciminib was also associated with lower rates of grade 3 or higher adverse events, particularly those AEs leading to treatment interruption or discontinuation.

These findings suggest that asciminib could well be the frontline Abl inhibitor of choice for the future of CML management, and further follow-up will provide us more information on that front. In an investor event , the NVS Head of Oncology Jeff Legos had this to say in summary and comment:

Scemblix had demonstrated superior efficacy with a favorable and safety tolerability profile. In particular, the data that we presented and highlighted demonstrated that Scemblix had superior major molecular response rates relative to the investigator selected TKIs and also relative to imatinib alone. ...And then lastly, in terms of our regulatory progress overall, we have actually completed the process or the package for the FDA submission. It is being reviewed under real time oncology review. And then lastly, we will continue our global submissions planned in the second half of 2024 and into 2025.

The update of MANIFEST-2, focusing on MorphoSys AG's ( MOR ) pelabresib, continued to affirm the combo's ability to reduce the spleen size in patients with myelofibrosis, although symptom score reductions continue to not meet statistical significance. There is ongoing discussion about the limitations of symptom score assessment, and time will tell if failing to meet this endpoint will be a big problem for approval of pelabresib. I'm sanguine, personally, since key opinion leaders feel like the symptom score endpoint was a more regulatory add-on, and not necessarily one that tells us whether pelabresib has a real place in myelofibrosis management.

Breast Cancer

Eli Lilly and Company's ( LLY ) abemaciclib was the subject of the first late-breaker for the breast sessions. In postMONARCH, adding abemaciclib to fulvestrant was shown to improve progression-free survival compared with fulvestrant alone in patients with hormone-positive metastatic breast cancer and progression on prior treatment, including a CDK4/6 inhibitor. This is the first randomized indication that a continuing with CDK4/6 inhibition beyond progression can be a benefit for patients.

In a late-breaking abstract, addition of pembrolizumab to sacituzumab govitecan did not improve progression-free survival in patients with hormone-positive advanced breast cancer following at least 1 prior line of endocrine therapy. However, there was a signal of benefit in patients who had PD-L1 positive tumors (median PFS, 11.1 vs 6.7 months), suggesting a way forward for this combination in future studies.

Another big study of focus at the meeting was DESTINY-Breast06, which indicated that Daiichi Sankyo Company, Limited's ( OTCPK:DSNKY ) trastuzumab deruxtecan could improve median PFS over treatment of physician's choice in patients with metastatic HER2-low and -ultralow breast cancer. These patients had to have no prior chemotherapy, but they could have received endocrine therapy and/or CDK4/6 inhibitors. This marks what is likely going to be yet another label expansion for the blockbuster HER2 drug, and it adds more fuel to the fire that a well-designed antibody-drug conjugate can have activity even outside the context of high tumor expression of the antigen of interest.

Developmental Therapies

Novel ADCs were featured fairly prominently in this session, including entries from Merck ( MRK ), AbbVie ( ABBV ), and Shanghai Miracogen. The MRK entry, M9140, is a CEACAM5-directed ADC with an exatecan payload, which differs from Sanofi's terminated entry in the space.

M9140 was studied here in patients with metastatic CRC, showing a disease control rate of 65% and 7.5% response rate among 40 patients. No ocular toxicities were noted, and tolerability was mainly limited to GI adverse events that were mild.

There were quite a few other early projects covered in this session, but the KRAS inhibitors were a notable highlight. First was Lilly's KRAS G12C inhibitor olomorasib, a second-generation inhibitor. 184 patients were enrolled in their phase 1 study across a number of cohorts, mainly lung, colorectal, and pancreatic cancers. These included patients with prior exposure to a KRAS inhibitor. The drug was well tolerated, with no grade 4 or 5 adverse events. In non-CRC tumors, the response rate was 35%, indicating encouraging early activity for this agent. Olomorasib also had preliminary activity against brain metastases.

The KRAS inhibitor developed by Jacobio Pharmaceuticals Group Co., Ltd. ( OTCPK:JBPHF ), glecirasib, was presented in combination with a SHP2 inhibitor. This presentation focused on updated safety and efficacy in frontline NSCLC with a KRAS G12C mutation. The confirmed response rate for this population was 64.7% across all dosage groups, suggesting substantial clinical activity for this combination. However, there was a high rate of grade 3/4 adverse events, occurring in 43.8% of these patients. This combination is now the subject of a phase 3 study comparing against chemo-IO for patients with metastatic NSCLC in China.

Highlights in the immunotherapy developmental therapeutics session included a CAR-T cell therapy against Claudin-18.2, being developed by CARsgen Therapeutics Holdings Limited ( OTCPK:CRTHF ). In this group of patients with Claudin-18.2-positive GI cancers, almost everyone had grade 1 or 2 cytokine release syndromes, as well as high-grade adverse events related to the conditioning regimen. Across all treatment cohorts, the response rate was 38.8%, with 91.8% achieving disease control. For a distant reference, the Claudin antibody zolbetuximab plus chemotherapy in Claudin-positive gastric adenocarcinoma had a 53.8% response rate in the GLOW study .

Another agent of interest is Regeneron's ( REGN ) bispecific antibody targeting EGFR and CD28 in combination with cemiplimab in patients with advanced solid tumors, with microsatellite stable CRC as a point of focus. Disease control was noted in this population, including one patient with liver metastases (which typically corresponds with poor outcomes).

Colorectal Cancer

One of my favorite studies from a few years ago (you may remember the reporting on it in newspapers) was the Memorial Sloan-Kettering Cancer Center experience using GSK plc's ( GSK ) dostarlimab in patients with locally advanced rectal cancer that has mismatch repair deficiency. 100% of the first handful of patients achieved a complete clinical response, and we've been waiting since then to see how the results shaped up. Dr. Cercek presented an update of this study as part of the rapid oral abstracts, showing that now there have been 42 patients treated in this setting, and all of them continue to have achieved complete remission. No patient to date has had a disease recurrence.

It's incredibly interesting, to say the least, and it bodes well for a future role of dostarlimab in this setting, even though the results are from a single-arm trial. The potential to have surgery/chemo/radiation-free cure of this very specific form of rectal cancer is incredible.

NEOPRISM-CRC operates on a similar premise, taking patients with mismatch repaired deficient, high-risk stage 2 or 3 colorectal cancer and giving neoadjuvant pembrolizumab.

Another study of high importance was CheckMate 8HW, which enrolled patients with mismatch repair deficient metastatic colorectal cancer to receive chemotherapy, nivolumab, or nivolumab plus ipilimumab. Nivo-ipi is the only arm we have results for so far, and this yielded a 24-month PFS rate of 72%, compared with 14% for chemotherapy alone. We still need to see the results of the nivolumab-only arm to get a clearer picture of whether the combo is worth the toxicity in terms of benefit.

A final colorectal cancer study worth touching on was ARC-9, looking at the Arcus Biosciences, Inc. ( RCUS ) drug etrumadenant in previously treated metastatic CRC. The combination of etrumadenant, zimberelimab, chemotherapy, and bevacizumab was shown to improve progression-free survival compared with regorafenib in patients with at most 2 prior lines of therapy in the metastatic setting (median PFS, 6.24 vs 2.07). The benefit was also present in patients who had baseline liver metastases, which I mentioned before is a feature predicting poor outcomes.

So we're seeing an important theme continue to evolve, finding the right spots for immunotherapy in colorectal cancer. It's welcome news in a space that has always had many setbacks, particularly with immunotherapy to date.

Other GI Tumors

There were quite a few studies of medical interest, and smaller studies asking specific questions in tumors like cholangiocarcinoma and pancreatic cancer. However, nothing that really moved the needle toward drug approvals just yet. One particular abstract of interest was LBA4008, which detailed findings from CheckMate 9DW. This phase 3 study takes patients with unresectable liver cancer (specifically HCC) and randomizes them to standard TKI therapy (sorafenib or lenvatinib) or nivolumab plus ipilimumab, followed by nivolumab maintenance.

Nivolumab-ipilimumab significantly improved overall survival for patients in this study, with medians of 23.7 and 20.6 for experimental and control arms, respectively. At 36 months, 38% of patients in the nivolumab-ipilimumab arm were still alive, compared with 24% for the standard of care arm. These findings suggest that the combo should be in the treatment option mix along with the TKIs, atezolizumab-bevacizumab (what many would argue is the real standard of care today), or the STRIDE regimen (single dose of tremelimumab followed by ongoing durvalumab).

Head and Neck Cancer

Anti-PD-1 therapies featured prominently in the head and neck session, with findings from DIPPER being presented as a late-breaking abstract. This study assessed the benefit of giving Elevar Therapeutics' camrelizumab (provided by Jiangsu Hengrui Pharmaceuticals) after chemoradiation therapy for nasopharyngeal carcinoma. Camrelizumab improved event-free survival with a hazard ratio of 0.56, though interestingly, it took until 12 months after randomization for the curves to start to separate. Camrelizumab also showed signs of preventing distant metastasis and locoregional relapse.

Conclusion: Drinking from the fire hose

This was far from a comprehensive roundup of the studies at ASCO, even if we just tried to focus on those that are practice-changing or -informing. Posters were a notable absence, and a lot of potentially hidden gems can be found there (every approved drug seems to start as a poster at ASCO at some point). Obviously, immunotherapy continues to play a dominant role in cancer medicine, and interest remains high here, explaining the various surges we've seen over the course of 2024 regarding novel approaches that are showing promise.

Did you see anything that caught your attention at ASCO? I'd be happy to discuss in the comments section. Meanwhile, we're going to be picking apart these trial results for a long time to come, and it was definitely another successful year.

Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. Please be aware of the risks associated with these stocks.

This article was written by

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Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

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Vanda Pharmaceuticals has another suitor

Meghana Keshavan

By Meghana Keshavan June 7, 2024

Money between two pieces of blue paper. -- coverage from STAT

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Well, this wraps up one of the most eventful weeks of the biotech year — ASCO, followed by BIO. Anyone else as zonked as I am? Today, we discuss the impact that the BIOSECURE Act is already having on the industry, preview what FDA reviewers want to know about donanemab, and more.

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The need-to-know this morning

  • The FDA approved  Geron ‘s drug  imetelstat  for certain patients with myelodysplastic syndromes, a type of slow-moving blood cancer.  Marketed as Rytelo, it’s the first drug to emerge from the once-ballyhooed company since its founding in 1990.

BIOSECURE shaking up partnerships at BIO

Although it isn’t yet a law, the BIOSECURE Act is already making waves in the biotech industry — as evidenced by some notable shifts at this week’s BIO International Convention in San Diego. STAT’s Jonathan Wosen and I were on site, and found that, with the possible blacklisting of certain Chinese suppliers looming, biotechs are scrambling to find alternatives to manufacturers like WuXi. Meantime, an executive at one U.S.-based CDMO said “month to month, new business has gone through the roof.”

The convention this year, despite billing itself as an international gathering, focused heavily on the importance of national security in biotech.

“Our customers are mainly small biotechs, and they’re very worried about whether they’ll be able to afford the U.S. CDMOs,” one China-based CDMO employee said. “They’re worried about backlogs, since the U.S. companies are suddenly so busy. My customers are telling me they’re already waiting in line to get a slot, in case we are put on the BIOSECURE list next.”

What FDA reviewers want to know about donanemab

On Monday, an FDA advisory committee will discuss the merits of donanemab, an experimental Alzheimer’s drug from Eli Lilly. Ahead of the meeting, FDA reviewers have posed some questions: Should the drug only be given to patients who are given PET scans to confirm the presence of tau proteins? That could reduce access to the drug substantially. And, of course, they ask, do the benefits outweigh the risks?

STAT’s Matthew Harper and Elaine Chen dive into what regulators seek to learn in the upcoming ad comm. It was a bit of a surprise that the meeting was called at all — the expectation was that donanemab would have a relatively simple FDA review process, given that Leqembi, a similar drug and a rival, has already been approved.

Psychedelics at the FDA, ASCO recap, & Morphosys

How did advisers react to the first psychedelic therapy to go before the Food and Drug Administration? And did the American Society of Clinical Oncology meeting surpass expectations? We discuss that and more in this week’s episode of “The Readout LOUD.”

Yours truly joined the podcast to dissect Lykos Therapeutics’ meeting with an FDA advisory committee. Adam and Allison also discussed the latest news in the health and life sciences, including stories from major biotech conferences.

Listen here.

A public bidding war is underway: Cycle Pharmaceuticals has offered $466 million — or $8 per share — to acquire Vanda Pharmaceuticals. Just a month back, the CDMO FuturePak offered $7.25 per share for the company, and then raised it to $7.75. Shares in Vanda rose 27% on news of its being courted again.

After not making a deal with the board behind closed doors, Cycle Pharma is attempting to force Vanda’s hand in a public arena: “While we would have preferred to reach an agreement privately, Cycle is publicly disclosing our proposal for the benefit of Vanda shareholders,” it said in a  statement .

  • Italy opens antitrust case against Novartis, Roche and others, claiming collusion to delay biosimilar launch,  FiercePharma
  • Nine years and four generics later, the HIV drug at the center of the Shkreli controversy still has a high price,  Endpoints
  • Moderna’s mRNA candidate joins FDA’s accelerator program for rare diseases,  BioSpace

About the Author Reprints

Meghana keshavan.

Biotech Correspondent

Meghana Keshavan covers biotech and contributes to The Readout newsletter .

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Environmental biotechnology articles from across Nature Portfolio

Environmental biotechnology is the branch of biotechnology that addresses environmental problems, such as the removal of pollution, renewable energy generation or biomass production, by exploiting biological processes.

Latest Research and Reviews

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Photocatalytic, antimicrobial and antibiofilm activities of MgFe 2 O 4 magnetic nanoparticles

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Bottlenecks in biobased approaches to plastic degradation

The way we generate and treat plastic waste is a key consideration in the transition from a take-make-waste model to a truly circular economy. Here, authors discuss their views on how biotechnology could contribute to solving the plastic problem, and the barriers we need to overcome to make such approaches a reality.

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Engineering natural microbiomes toward enhanced bioremediation by microbiome modeling

Engineering natural microbiomes for biotechnological applications remains challenging. Here, the authors present a combinatory top-down and bottom-up framework to engineer natural microbiomes for the construction of function-enhanced synthetic microbiomes.

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The link between ancient microbial fluoride resistance mechanisms and bioengineering organofluorine degradation or synthesis

Microbial degradation and biosynthesis of fluorinated compounds is a field of increasing importance, but is hampered by the significant toxicity of fluoride. Here authors discuss emerging ideas on microbial defluorination/fluorination and fluoride resistance mechanisms, providing guidance on how this knowledge can guide future bioengineering approaches.

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Dual-mode harvest solar energy for photothermal Cu 2-x Se biomineralization and seawater desalination by biotic-abiotic hybrid

Biotic-abiotic photosynthetic systems hold great promise to innovate solar-driven chemical transformation. Here, the authors construct a biotic-abiotic hybrid system composed of Shewanella oneidensis MR-1 and biogenic Se 0 nanoparticles for photothermal Cu 2-x Se biomineralization and then for seawater desalination.

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Successful cultivation of edible fungi on textile waste offers a new avenue for bioremediation and potential food production

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The impact of a graduate training and career outlook program on diversity in the biotechnology sector

An intensive summer training program increased enrollment in a Master of Science in Biotechnology degree program, increasing awareness and opportunities among under-represented and underserved groups as a first step to transforming the biotech industry.

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Designer catalytic nanopores meet PET nanoparticles

The search for novel biocatalysts for plastic degradation has recently become a hot topic. Now, multiple catalytic triads of well-known serine esterases were introduced into non-catalytic protein nanopores to enable the hydrolysis of PET nanoparticles.

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Bottlenecks and opportunities for synthetic biology biosafety standards

The lack of innovative standards for biosafety in synthetic biology is an unresolved policy gap that limits many potential applications in synthetic biology. We argue that a massive support for standardization in biosafety is required for synthetic biology to flourish.

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Constructive principles for gene editing oversight

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Responsible governance of gene editing in agriculture and the environment

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CO 2 fixation gets a second chance

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    Nature Biotechnology ( Nat Biotechnol) ISSN 1546-1696 (online) ISSN 1087-0156 (print) Read the latest Research articles from Nature Biotechnology.

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    Rajko Reljic. First published: June 01, 2024. Open Access. New vaccine technologies are needed to combat many existing infections and prepare better for those that may emerge in the future. The conventional technologies that rely on protein-based vaccines are still severely restricted by the sparsity and poor accessibility of available adjuvants.

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  9. Human Molecular Genetics and Genomics

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  10. Current Research in Biotechnology

    Discoverability - Articles get high visibility and maximum exposure on an industry-leading platform that reaches a vast global audience. Current Research in Biotechnology ( CRBIOT) is a new primary research, gold open access journal from Elsevier. CRBIOT publishes original papers, reviews, and short communications (including viewpoints and ...

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    Brandon Mu, Pawel Sadowski, Junior Te'o, Bharat Patel, ... Kevin Dudley. Article e00840. View PDF. Article preview. Previous vol/issue. Next vol/issue. Read the latest articles of Biotechnology Reports at ScienceDirect.com, Elsevier's leading platform of peer-reviewed scholarly literature.

  12. Cell Press: Trends in Biotechnology

    We are pleased to announce that Trends in Biotechnology—the multidisciplinary journal from Cell Press—will publish original research across applied life sciences that examines bio-based solutions to real-world problems.. Trends in Biotechnology is a high-impact journal with a 40-year legacy. Our highly-cited review articles provide a foundation for an exciting new chapter for the journal.

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    Selection of aptamer for creatine Kinase-MM as a marker for muscular dystrophy and myocardial infarction. Albert M Liao, Shailaja Agrawal, James Cory Benson, G. Thomas Caltagirone. In Press, Journal Pre-proof, Available online 25 May 2024. View PDF. Article preview.

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