Much of the world is grappling with a mental health crisis — with soaring rates of depression and anxiety. Last year, the startup Gate Neurosciences emerged with a novel approach. While the Carmel, Indiana–based company is focused on synaptic plasticity like many other contemporary CNS companies, it diverges in its strategy. Rather than using a…
Exploring future cancer therapies: Designing linkers to increase ADC efficacy and reduce toxicity
Antibody-drug conjugates (ADCs) represent a significant paradigm shift in cancer treatment, marrying the precise target recognition of monoclonal antibodies with the potent cell-killing capabilities of cytotoxic agents. In contrast to traditional small-molecule therapies, ADCs are multifaceted structures with three distinct components — i.e., antibody, cytotoxic payload and a linker — each playing a crucial role…
How data-savvy are you in drug discovery?
Hey there, drug discovery professionals: Ever wondered where you stand in the grand scheme of drug discovery data-savviness? We’ve created a short quiz to help you get an idea. Drug discovery and development is an increasingly data-intensive field, underscoring the need for data science to be a core drug discovery discipline. The industry has taken…
Anebulo wins positive FDA feedback to Advance phase 3 program for cannabis
The clinical stage biopharma Anebulo Pharmaceuticals recently shared that it received positive FDA feedback after a Type B meeting in July, where the regulatory agency indicated a path to approval for ANEB-001, a competitive CB1 antagonist with a high affinity for the human CB1 receptor. Overstimulation of this receptor by cannabinoids such as THC causes…
New study sheds light on Eliquis and Xarelto switching
For patients with an elevated stroke risk, switching anticoagulant medications could be a health gamble. Those who change from Eliquis (apixaban) to Xarelto (rivaroxaban) could face almost double the risk of stroke or severe bleeding. Conversely, sticking with Eliquis or transitioning from rivaroxaban to Eliquis appears to be a safer option. Those are key takeaways…
Nvidia exec: Generative AI can turn every biologist into a computer scientist — and vice versa
On a recent visit to Nvidia’s headquarters in Santa Clara, I had the chance to speak with Kimberly Powell, the company’s vice president and general manager of healthcare. After asking about the pharma industry’s surging interest in AI, Powell remarked, “Every pharma knows who Nvidia is now.” Curious, I asked her, “How long has that…
Ketabon GmbH eyes KET01’s potential as an at-home option for treatment-resistant depression
A joint venture between HMNC Brain Health and Develco Pharma in Switzerland, Ketabon GmbH recently released top-line results from its phase 2 KET01-02 study of KET01, a slow-release formulation of oral ketamine, for treatment-resistant depression (TRD). KET01 was associated with improvements in depression severity as early as day 1, but the results were not statistically…
How synthetic data accelerates oncology research and drug development
Synthetic data in oncology is transforming how researchers and developers approach real-world evidence. They often need this evidence to test hypotheses, predict outcomes and develop algorithms. But privacy constraints and access related to patient data can create delays and lengthen project timelines. Oncology drug researchers and developers have recently begun using synthetic data in oncology…
Legacy Healthcare aims to upend alopecia areata treatment with a botanical drug
Imagine a world where botanical drugs could shape the future of medical treatment. Saad Harti, CEO of Swiss company Legacy Healthcare, doesn’t just imagine it; he’s on a mission to make it a reality. With an initial focus on alopecia areata in children and adolescents, Legacy Healthcare believes the plant extract Coacillium could be a…
Aiming to tame psychedelics’ wild side in pursuit of FDA approval
Doors of perception: Psychedelic renaissance or Pandora’s box? In one sense, psychedelics have always been divisive in mainstream Western culture. During their heyday in the 1960s, proponents lauded psychedelics’ virtues for psychological healing and exploration. Troubling reports also emerged — stories of bad trips, psychological breaks, and mostly apocryphal yet sensationalized reports of individuals leaping…
Biotech bloodbath? Nearly 100 companies announce layoffs in the first half of 2023, but job openings also surge
The first half of 2023 brought job cuts to roughly 100 biotech and pharma companies. But while that may indicate an unstable employment landscape, it is not a universal trend. Since March, appetite for life sciences talent has gathered steam. According to data from real-estate firm JLL, June 2023 had the sixth highest number of…
A checklist for unlocking the promise of AI in clinical trials
AI algorithms offer a myriad of advantages for clinical trials. AI techniques can, for instance, support patient enrollment and site selection, improve data quality and enhance patient outcomes. AI algorithms — combined with an effective digital infrastructure — can also help aggregate and manage clinical trial data in real time, as Deloitte has noted. Last…
FDA approves zuranolone for postpartum depression but issues complete response letter for major depressive disorder
FDA’s approval of Zurzuvae for PPD could mark a significant shift in the fight against postpartum depression (PPD). On August 4, the agency gave the green light for the oral medication, although it declined its use for major depressive disorder (MDD), citing insufficient evidence of effectiveness. The former approval represents a milestone as the first ever…
New AI tool InClinico predicts clinical trial outcomes with 79% accuracy: A closer look with InSilico CEO, Alex Zhavoronkov
Roughly nine out of ten clinical trials fail as a result of factors such as lack of efficacy and unmanageable toxicity, as the journal Pharma Excipients has noted. After seven years of development, Insilico Medicine has scored a breakthrough with its generative AI tool, inClinico. In particular, the tool demonstrated 79% accuracy in predicting the…
A-Alpha Bio attracts $51M in total funding to advance machine-learning-driven protein interaction research
A central hurdle in computational protein design is the mismatch between proteins designed in silico and their actual behavior after synthesis. “You can design millions of proteins on a computer over the course of a week or a month, but computational approaches are just not good enough,” explained David Younger, co-founder and CEO of A-Alpha…
Eversana partners with AWS to accelerate generative AI in pharma
Life sciences commercial services company Eversana is one of the latest to throw its hat into the generative AI ring. Tapping a partnership with Amazon Web Services (AWS), Everasana is focusing on developing generative AI technologies in the pharmaceutical industry. Also this month, the startup Synthetica Bio announced it would use generative AI to boost…
In data we trust: AI’s growing influence on drug development
The journey to developing a successful drug, theoretically, may appear linear: you discover the right drug, find the suitable patient and administer it at the right time. The reality, however, often deviates from this straightforward path. Aligning these three variables remains notoriously difficult, often leading to elongated timelines strewn with failures, sometimes extending over a…
Phase 3 trial shows donanemab reduces Alzheimer’s symptoms by 35%
According to results from the Phase 3 TRAILBLAZER-ALZ 2 study published in JAMA, the monoclonal antibody donanemab significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s disease by approximately 35% at one year compared to placebo. The trial enrolled 1736 patients across 277 research centers in 8 countries. Another monoclonal antibody, Leqembi…
AbbVie and Janssen receive positive CHMP opinions for novel cancer therapies
The European Medicines Agency (EMA) could soon change the face of cancer treatment with its potential approval of two novel bispecific antibodies, epcoritamab and talquetamab. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting conditional marketing authorization for two novel cancer therapies — AbbVie’s epcoritamab and Janssen’s talquetamab. Epcoritamab for relapsed/refractory…
QuantHealth taking a data-driven predictive approach to simulate clinical trials
In drug discovery, the process of shooting for regulatory approval can feel less like a sprint and more like a marathon, but with no guarantee of crossing the finish line. Despite the hefty investment of time, effort and resources, the success rate for bringing new drugs to market hasn’t improved in recent decades. The American…
Apitegromab shows sustained benefits in phase 2 SMA trial
Cambridge, Massachusetts–based biopharma Scholar Rock has been making encouraging progress in the development of apitegromab, a potential new therapy for spinal muscular atrophy (SMA), a genetic disease characterized by progressive muscle weakness and atrophy. Apitegromab, a novel monoclonal antibody, works through a unique mechanism of action — it binds to and inhibits the precursor form…
eClinical Solutions Q&A: The quest to transform raw data into drug discovery gold
Top pharmaceutical companies sponsor over a hundred clinical trials annually, generating vast amounts of data. Harnessing this deluge is a monumental task. eClinical Solutions, led by CEO Raj Indupuri, tackles this through advanced applications of data analytics and machine learning with an emphasis on AI in clinical trials optimization. Specifically, eClinical Solutions taps AI/ML for…
Microsoft details how its technology is advancing drug discovery and biomedical research
As cloud technology matures, life-sciences companies are finding new avenues for business value in life sciences, extending beyond the cost efficiencies typically associated with cloud migrations, as McKinsey noted. In an email statement, Microsoft outlined how its own cloud computing, AI and research capabilities are driving similar innovation for biopharma companies. This article explores Microsoft…
Microsoft goes all in on Azure Quantum to accelerate scientific discovery
In the rapidly evolving landscape of quantum computing, Microsoft is pushing the boundaries with its Azure Quantum platform. As Microsoft CEO Satya Nadella recently announced, “Our goal is to compress the next 250 years of chemistry and material science progress into the next 25,” Nadella said. The executive also noted that, thanks to recent advances…
Bridging bioanalytical gaps: Examining validation methods across species
Bioanalytical method validation is the backbone of effective drug discovery and development. Its pivotal role ensures the generation of reliable and reproducible data from diverse species, leading to safe and effective therapeutics. As critical as this process is, scientists face many challenges, particularly regarding validation across different species in preclinical and clinical studies. Accommodating species…