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…

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…

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…

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…

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…

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…

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 a strong emphasis on AI in clinical trials optimization. Specifically, eClinical Solutions taps AI/ML…

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…

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…

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 (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…

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…

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…

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…

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…

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…

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…

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…

In a sign of shifting attitudes, the FDA has released draft guidance to facilitate the development of psychedelic drugs. Historically, psychedelics have a long history of use in certain cultures, such as the indigenous tribes of the Amazon Basin and Native American communities, for millennia as sacraments.These substances were used not only recreationally but also…

Quantum computing — described by pop astrophysicist Neil deGrasse Tyson as “computing with atoms” — is an emerging technology with a potential for immense computational speed and power. For some problems, quantum computers can be exponentially faster than classical computers, while for others the speedup may be more measured. The promise for drug discovery could…

Big Pharma and researchers are sharpening their focus on AI to speed drug discovery. But the path to fully AI-driven drug discovery faces substantial hurdles, according to Adityo Prakash, CEO of Verseon. “When it comes to drug discovery, AI has a data problem with which the pharmaceutical industry has not yet come to terms,” he…

Johns Hopkins researchers have made strides in a study focusing on multiple sclerosis. By applying microparticles to activate regulatory T cells, they were able to reverse MS-like symptoms in mice. There is no cure for multiple sclerosis (MS). But a recent study by Johns Hopkins Medicine shows encouraging progress towards: They have demonstrated the ability…

The fact that the biopharmaceutical industry has a large carbon footprint is well established. A 2022 study from My Green Lab confirmed that biotech and pharma are still among the globe’s top polluters. The research highlights that a mere 4% of the largest publicly-traded biotech and pharmaceutical firms have climate commitments in line with the…

Janssen continues to strengthen the case that its interleukin-23 inhibitor TREMFYA (guselkumab) offers promise to many patients with psoriatic arthritis (PsA). The company’s phase 3b COSMOS clinical trial involving 189 patients with active PsA and an inadequate response to one to two previous tumor necrosis factor (TNF) inhibitors, guselkumab showed sustained improvements in measures of…

Biotech firm iBio (NYSEA:IBIO) has incorporated EngageTx, a machine learning-driven technology, into its development roadmap. This T-cell engaging antibody panel assists in generating bispecific antibodies targeting cancer cells. In particular, the firm is developing a novel Trophoblast Cell Surface Antigen 2 (TROP-2) bispecific molecule to target TROP-2-positive cancers. In addition to their focus on oncology,…