Alzheimer’s disease research appears to be hitting its stride, thanks to recent therapeutic advances in drug development and the emergence of biomarkers to detect the condition. “All the pieces of the puzzle of precision medicine, which is already quite common in oncology, are now in place,” said Hartmuth Kolb, vice president, neuroscience biomarkers and R&D…
From FTC’s tightened grip to PULSE Coalition: A timeline of the life science M&A landscape
The biopharma industry is pushing back against increased scrutiny of mergers and acquisitions from the Federal Trade Commission (FTC). More than 30 biopharma companies and industry associations announced the formation of the Partnership for the U.S. Life Science Ecosystem (PULSE) to advocate for the role of M&A activity in the biopharma sector. A M&A landscape…
Do rising interest rates actually fuel pharma M&A? Sometimes, yes
Conventional wisdom holds that rising interest rates curb M&A activity, but an analysis of the pharma and biotech M&A data from 2018 to early October 2023 reveals a counterintuitive trend — at least over the short term. As interest rates have risen in 2023, pharma deal-making has remained strong although the deal size has dipped.…
More than a century after its synthesis, MDMA could be headed for FDA approval for PTSD
First synthesized in 1912 by Merck, the empathogenic drug 3,4-Methylenedioxymethamphetamine (MDMA) is inching toward FDA approval following the positive results of a phase 3 study. The recently concluded phase 3 study, MAPP2, published in Nature Medicine, found that MDMA-assisted therapy significantly outperforms traditional talk therapy in reducing PTSD symptoms. Participants receiving MDMA-AT had an 86.5%…
The multi-billion dollar promise of efgartigimod and the broader FcRn inhibitor market
Thanks to promising candidates such as efgartigimod, the Fc receptor (FcRn) inhibitor market is poised to reshape the autoimmune disease treatment landscape. Sales projections for the market top $10 billion, as Driehaus Capital Management estimated in 2020. The addressable U.S. patient base spans more than 228,500 individuals across various conditions including myasthenia gravis, warm autoimmune…
Moving beyond pilot purgatory: Scaling AI in drug discovery projects
The topic of AI in drug discovery and development may continue to garner significant attention, but harnessing AI effectively requires a nuanced strategy, and an ability to navigate between details and the bigger picture. Andrew Anderson, vice president of innovation and informatics strategy at ACD/Labs, likens it to boiling water. “On a small scale, it’s…
The balancing act of biotherapy: Be The Match BioTherapies’ Abby Waters on agility and beyond
Professionals in the biotherapy world are engaged in a sort of balancing act, juggling the nuances of product development, complex science, leadership dynamics, and patient-centricity. In a recent interview, Abby Waters, Ph.D., senior manager of solution owners at Be The Match BioTherapies, opens up about her decade-long journey navigating these multifaceted challenges. From embracing agile…
Molecular photoswitches: Illuminating the future of inherited retinal disease treatment
Vision, one of our most valued senses, is a complex orchestration of light-sensing photoreceptors, neurons, and intricate pathways leading to the brain. Central to this native biological system are the photoreceptors – the rods and cones – cells that are responsible for capturing light and initiating visual perception. For many with inherited retinal diseases (IRDs),…
AI in antibody drug discovery as a tool, not a magic wand
AI in drug discovery is a topic that gets an outsized amount of attention, observes Carl Hansen, CEO of AbCellera, a company specializing in antibody drug discovery. “It’s as if people are saying, ‘AI is here, it’s going to save us. Thank God, we’re finally gonna be able to create drugs,” he said. “To me,…
Early data suggest adjunctive cariprazine could be a promising tool for tackling stubborn anhedonia in MDD
The dopamine D3 receptor-targeting cariprazine could potentially be a new tool for managing anhedonia, one of the most stubborn symptoms of major depressive disorder (MDD). Characterized by a lack of enjoyment in previously pleasurable activities, anhedonia has been “difficult to address with traditional antidepressants,” said Dr. Vladimir Maletic, coauthor of a poster presented at the…
Data-driven insights into the leading causes of death, including cardiovascular disease and cancer
Data sourced from Our World in Data Cardiovascular disease and cancer remain the leading causes of death in the world, based on an analysis of data sources ranging from World Health Organization and Our World in Data. While respiratory illnesses were the third most common cause of death in 2019, deaths in this category…
Gate Neurosciences takes on depression with event-driven pharmacology
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…
Pharma giants make progress in pivot to mRNA technology in race for next-gen influenza vaccines, but hurdles remain
mRNA technology helped propel the development of some of the most successful drugs in pharma history — notably, the Comirnaty COVID-19 from Pfizer generated almost $56 billion in 2022 while Moderna’s Spikevax vaccine raked in $18.4 billion. But with demand for COVID-19 vaccines cooling, drug developers are aiming to extend the dominion of mRNA technology…
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…