Drug Discovery and Development Archives - Page 3 of 159

Lantern Pharma aims to take drug to phase 3 for $100-200 million with AI-powered approach

Lantern Pharma’s AI-powered sprint

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Lantern Pharma (NASDAQ: LTRN), a publicly traded clinical-stage biotech company with a market cap of around $79 million as of mid-March 2024, is shooting for developing $200 million drugs with a machine learning-based platform.

The oncology-focused firm Lantern Pharma, profiled last year, has developed a new drug (LP-284) in less than three years for under $3 million, which CEO Panna Sharma notes is “unheard of.” By using AI, Sharma projects that the company could develop a drug from concept to phase 3 trials for a price tag of $100–200 million — a small fraction of the typically $2.3 billion drug development price tag.

“We’re developing new drugs in less than two and a half years, from an idea through GMP manufacturing, to orphan indications, and multiple publications at ASH [American Society of Hematology] and SOHO [Society of Hem…

In 2023, Roche and Novartis led the pack in drug pipeline scale

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When reviewing R&D spending trends for 2023, Merck & Co. is a clear outlier given its decision to count its $10.3 billion Prometheus acquisition as an R&D charge. In all, the company committed more than half of its revenue to R&D. But Swiss giants Roche and Novartis remain frontrunners in terms of their pipeline of potential new medications. Both have more than 190 drugs in their pipelines.

Roche’s diversified approach ranges from oncology to ophthalmology

Roche’s focus spans oncology, immunology, neuroscience, and cardiovascular diseases. The company’s oncology portfolio stands out with candidates such as inavolisib and giredestrant that target novel mechanisms in breast cancer. Additionally, Inavolisib, a PI3K inhibitor, targets the PI3Kα isoform, involved in the pathways that drive cell growth and survival. It shows potential not only in breast cancer but also i…

Navigating the cancer progression pathway with liquid biopsy

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Tumor heterogeneity analysis is a challenging but critical step for the advancement of cancer therapy research. DNA mutation interrogation and gene expression pattern evaluation are crucial for predicting a tumor’s response or resistance to specific drug or hormone treatments. Liquid biopsy has emerged as a promising tool, offering a rapid, minimally invasive method for early detection, prognosis, monitoring solid tumor status, and predicting responses to cancer therapy. The concept of liquid biopsy initially centered on the detection of circulating tumor cells (CTCs), and later expanded to include the utilization of circulating tumor DNA (ctDNA) to extract tumor information.

Assessing CTC abundance and phenotypic changes, along with measuring ctDNA concentration, holds the potential for real-time tracking of disease progression, tumor burden and recurrence. Additio…

FDA fast-tracks psilocybin-based CYB003 for depression

The FDA continues to signal openness to psychedelic-based therapies. Following its recent Breakthrough Therapy Designation (BTD) for a potential LSD-based anxiety treatment, the agency has extended the same status to Cybin Inc.‘s CYB003 for major depressive disorder (MDD). The move marks the first FDA Breakthrough Therapy Designation for an adjunctive, psychedelic-based Major Depressive Disorder treatment. This move expedites CYB003’s review process and provides increased FDA guidance throughout development.

“I think there’s a positive attitude at the FDA,” said Doug Drysdale, CEO of Cybin. He noted that a significant number of agency representatives attended their end of Phase 2b meeting, indicating strong interest across departments. “They seem excited about the potential of these new treatments.”

FDA’s Breakthrough Designations for psychedelic and MDMA therapies

The FDA has previously granted Breakthrough Therapy Designation (BTD) to psiloc…

How Novo Nordisk’s Wegovy cardiovascular benefits could drive further growth

Semaglutide was already one of the best-selling drugs of recent memory. And Novo Nordisk the fastest-growing Big Pharma firm. Now, the FDA’s decision to expand the label of its weight-loss version of the drug to include cardiovascular benefits could help unlock more growth momentum for Novo Nordisk. This positions Wegovy as the first weight-loss medication also cleared for reducing the risk of heart attack, stroke, or heart-related death in at-risk individuals. The approval, based on a 17,600-patient SELECT study demonstrating a 20% lower risk of cardiac events with Wegovy versus placebo, could have a material impact on sales. The study also found that patients lost an average of 15% of their weight.

The expanded FDA label sanctions the use of Wegovy for reducing the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease who are obese or overweight. This marks a significa…

Novo Nordisk achieves 74% growth surge, clinching fastest-growing pharma title

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No longer just a diabetes company, Novo Nordisk’s semaglutide-based therapies have fueled its rise to pharma powerhouse status. From 2021 to 2023, the company cemented its position as the fastest-growing Big Pharma player, reaching a 35% year-over-year growth rate in 2023 and 74% growth from 2020 to 2023 when measured in U.S. dollars. While Pfizer saw even more explosive growth (94%) in 2021 (see second graph below), the trajectory was not sustainable leading to a 41.69% drop in 2023.

The strong demand for Novo Nordisk’s semaglutide-based products Ozempic, Rybelsus, and Wegovy fueled the company’s rapid growth. In 2023, sales of obesity care products, including Wegovy, skyrocketed by 154% to DKK 41.6 billion ($6.0 billion). The 24% sales increase in the diabetes care segment, amounting to DKK 173.5 billion ($25.2 billion) in 2023, was heavily driven by the growth of GLP-1-based pr…

Why Merck shelled out $30B+ on R&D in 2023

In 2023, Merck & Co. made a considerable investment in research and development, spending more than $30 billion. This figure represents more than double the company’s R&D spending ($13.5 billion) in 2022.

The closest competitor in terms of R&D investment was Roche Pharmaceuticals, with a 2023 R&D expenditure of roughly $14.7 billion. This sum is less than half of Merck’s spending. Next in line was Novartis, which spent approximately $13.7 billion on R&D. Next in line was Johnson & Johnson Innovative Medicine, which spent about $12 billion.

In 2023, Merck’s revenue narrowly eclipsed that of Pfizer, which fell 41.7% from 2022 levels owing largely to collapsing demand for COVID-19 products.

In 2023, Merck invested roughly half of its revenue in R&D.

The chief drivers of Merck’s R&D spending included the following:

Prome…

Could LSD change the game in anxiety treatment?

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A once-controversial psychedelic substance could potentially be a promising treatment for generalized anxiety disorder (GAD). That’s the view of Dr. Rakesh Jain, a psychiatrist with extensive experience in clinical practice, research, and education, affiliated with Texas Tech University School of Medicine. Jain expressed optimism in LSD-based therapy while acknowledging the challenges inherent in such a radical shift, in a recent MindMed analyst briefing on the heels of its MM-120 winning a breakthrough designation for an LSD-based treatment for GAD, based on promising topline data from a phase 2b study.

A once-controversial psychedelic substance could hold the key to treating Generalized Anxiety Disorder (GAD). This is the view of Dr. Rakesh Jain, a prominent psychiatrist who serves as a clinical professor at the Department of Psychiatry at Texas Tech University School of Medicine. While ack…

FDA grants breakthrough status to LSD-based anxiety treatment

In a major shift away from decades of stigma, the FDA has granted Breakthrough Therapy Designation to MindMed‘s MM120, an LSD-based treatment for Generalized Anxiety Disorder (GAD). This milestone not only underscores the growing recognition of the therapeutic potential of psychedelics but also could point to a potential turning point for the struggling psychedelic sector and specifically bolsters the future of MindMed.

[Related: Could LSD change the game in anxiety treatment?]

Psychedelic stocks: A long, strange trip continues

As with many psychedelic companies, MindMed’s stock (NASDAQ: MNMD) has been on a rollercoaster ride in recent years, briefly reaching close to $60 per share in early and mid-2021 amid peaking investor enthusiasm for the potential of psychedelic-based treatments. But the stock, like many others in the sector, has faced significant declines as investor enthusiasm waned later in 2021 and 2022.

The breakthrough therapy des…

Are Big Pharma giants getting the right ROI on their R&D investments? A visual exploration

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While annual reports show broadly similar R&D strategies among Merck & Co., Pfizer, Johnson & Johnson and AbbVie, their 2020–2023 financial metrics reveal a concerning trend. Merck & Co. may be the new top dog of Big Pharma, but the firm’s 1.4% revenue growth in 2023 represents a significant slowdown. Pfizer’s 41.7% revenue decline from its COVID-inflated $100.3 billion peak in 2022 is even more stark. Similarly, J&J’s modest 4.2% growth and AbbVie’s 6.4% revenue dip also signal a departure from previous patterns.

In raw numbers, R&D spending in the pharmaceutical industry has surged over the past few decades, jumping from about $30 billion across the industry to more than $200 billion annually by the 2020s. Despite record-breaking R&D spending hitting $161 billion in 2023, marking a nearly 50% increase since 2018, as IQVIA has noted, …

Debiopharm’s multilink technology and partnerships drive oncology pipeline strategy

Debiopharm, an independent Swiss biopharmaceutical company based in Lausanne, seeks to carve a niche in the competitive oncology and infectious disease markets. Its business model focuses on in-licensing promising drug candidates from universities and smaller biotechs, aiming to add value through development. (The company is also partnering with AI-focused firms like VeriSIM Life.) Sandra von Meier, its head of business development, highlights the company’s exploration of DNA damage response pathways, with Debio 0123, a Wee1 kinase inhibitor, as a notable Phase I asset. Debiopharm also emphasizes its proprietary Multilink linker technology for antibody-drug conjugates, a field with potential to improve therapeutic outcomes.

We’ve lightly edited the responses for brevity.

Can you provide a broad overview of Debiopharm and its drug discovery and development strategy?

Sandra von Meier

Sandra von Me…

Biotech layoffs in 2024: Identifying common threads among affected companies

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Companies across the industry have contributed to biotech layoffs in early 2024, driven by factors ranging from operational restructuring to strategic pivots and clinical trial failures, with major hubs like California and Massachusetts bearing the brunt of the impact. A recent analysis assembled with the help a machine learning technique known as clustering reveals a pattern of job cuts across various groups, from diversified biotechs to strategic pivots.

1. Diversified biotechs seek operational efficiency

Companies within this cluster, including giants such as Illumina and Thermo Fisher Scientific but also smaller players like NanoString Technologies, encountered layoffs primarily as a result of operational reorganizations. Illumina’s significant layoffs were a part of a $100M cost-cutting initiative following the failed acquisition of cancer test maker Grail. Nano…