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…
Eli Lilly to acquire cardiometabolic disease treatment maker Versanis for $1.925B
Eli Lilly (NYSE:LLY) announced today that it entered into a definitive agreement to acquire Versanis, a private, clinical stage biopharmaceutical company. Versanis focuses on the development of new medicines for the treatment of cardiometabolic diseases. Its lead asset, bimagumab, is a monoclonal antibody. Bimagumab binds activin type II A and B receptors to block activin…
Leqembi could mark new era in Alzheimer’s treatment progress: An overview of the evolving drug development scene
Today, the FDA granted traditional approved to lecanemab (branded as Leqembi), a monoclonal antibody from Eisai and Biogen for adult patients with Alzheimer’s disease. The agency made the decision on the basis of a confirmatory trial that showed its clinical benefit. The drug, which reduces the formation of amyloid plaques in the brain, is the…
Seven biologics walking the approval tightrope in 2023
As we venture into the second half of 2023, the global biologics market continues to hover between robust growth and unpredictability. Valued at $461.74 billion in 2022, it’s projected to grow at a compound annual rate of 10.3% from 2023 to 2030, according to Grand View Research. In 2022, biologics edged past small molecules for…
Medical imaging AI startup Flywheel wins Series D round backed by NVIDIA, Microsoft and HPE
Minneapolis-based Flywheel has received $54 million in a Series D round backed by NVIDIA, Microsoft, Hewlett Packard Enterprise and other strategic investors. Flywheel will invest the cash to fuel growth in core verticals, the pharmaceutical and public sector healthcare sectors. A notable Big Pharma customer is Genentech. The company also aims to ramp up expansion…
Pharma 2023 half-year review reveals winners and losers
In many ways, the economic landscape of 2023 has been turbulent. High inflation? Talent shortages? Rising costs of doing business? Volatile currency markets? New regulatory hurdles? Check, check, check. To navigate the choppy waters, a significant number of companies have turned to strategic M&A to drive growth and strengthen product pipelines. Despite these challenges, a…
CEO: Insilico on how AI can ‘imagine the perfect molecules’ for drug targets
Insilico Medicine, an AI-based biotech startup, announced details of their first AI-designed drug candidate to enter human clinical trials. INS018_055 is an experimental treatment for idiopathic pulmonary fibrosis, a rare lung disease. Through their Insilico AI-driven drug discovery platform, they discovered and designed INS018_055 in just 30 months, significantly faster than the industry average. Phase…
Insilico’s AI-discovered INS018_055 graduates to phase 2
Roughly a year ago, Insilico Medicine announced that it had dosed the first patient in a phase 1 study of INS018_055, an AI-discovered, first-in-class small molecule inhibitor. Now, the company has progressed to the next stage, launching a phase 2 study for the drug candidate. Insilico, a founding member of NVIDIA Inception, developed its AI…
A deep dive into AWS’s strategy with generative AI and ML in life sciences
The AI market is witnessing meteoric growth, with projections hinting at a potentially staggering increase over the next decade. Against this backdrop of rapid AI evolution, we recently spoke with Tehsin Syed, general manager of AWS Health. Syed shared that Amazon Web Services (AWS) is seeing growing interest from Big Pharma firms. “Nine of the…