Drug Discovery and Development Archives - Page 2 of 158

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…

Anosmia to amyloidosis: nference’s AI is decoding healthcare data at scale

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The complexity of patient records, with their mix of unstructured notes and diverse data types, defies traditional analysis. While a thorough review of even a single patient’s file can be tedious for a human, AI tools offer the power to analyze tens or even hundreds of millions of records, unlocking data patterns that would otherwise remain hidden.

A burgeoning number of companies are popping up to address the tasks of amalgamating and deciphering patient records using AI tools. Among them is nference, which has attracted backing of notable institutions such as the Mayo Clinic, Duke Health, Emory Healthcare, Vanderbilt University Medical Center and The Bill & Melinda Gates Foundation. In 2020, the company was highlighted as one of the top digital startups in the world.

Nference’s AI platform has a vast array of data at its disposal. In all, it captures more 11 million patien…

New pharma and biotech manufacturing facilities and expansions announced worldwide for 2024

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The pharma and biotech sectors continue to rapidly transform in response to rising demand for innovative therapies. While less fortunate players are shedding jobs, in 2024, major players like AbbVie, AGC Biologics, and Amgen are investing heavily in new manufacturing facilities worldwide, from Singapore to Japan and the U.S. Companies expanding in North Carolina, Ohio, and Iceland signal a push to make innovative medicines and advanced therapies more accessible globally.

The map below shows select new plant openings and expansions announced in 2024, with 8 in North America and 15 in other regions

North America United States Amgen opened a new AI-enabled biomanufacturing facility in New Albany, Ohio, employing roughly 400 people. The $365 million investment features automation, AI, and data-driven manufacturing processes. Amgen also plans to advance drug discovery using AI models at deC…

Exploring the forces behind 2024 biotech layoffs: A visual journey

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Biotech layoffs continue to pummel the industry in early 2024 — albeit at a slightly lower clip than in 2023. Smaller firms continue to bear the brunt of funding woes and disappointing clinical data. From January to February, operational reorganizations fueled 45 layoff announcements, followed closely by strategic pivots in 37 events. Other common drivers of job cuts include funding challenges and project restructuring.

The Sankey diagram below highlights the web of factors driving the 2024 biotech layoffs for select companies, from operational changes to clinical failures. Think of it like a map tracking why employers let go of workers, which can span multiple reasons. The width of the lines is proportional to the number of employees affected by each layoff. Note, some of the layoff counts are estimated based on percentages and the most recent available employee counts.

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