Following the recent expansion of Amazon Omics, as covered in our previous article “Ready, set, analyze: Amazon Omics unveils new Ready2Run workflows”, we wanted to explore the role of third-party providers in shaping the landscape of genomic analysis and bioinformatics. NVIDIA is one of these providers. The GPU company has worked to integrate their Parabricks…
A timeline of Merck’s legal battle over Medicare negotiation
Marking the first legal challenge of its kind, pharma giant Merck & Co. took to the courts on Tuesday, directly contesting the U.S. government over the Medicare drug price negotiation program. The Big Pharma company’s lawsuit, filed in the U.S. District Court for the District of Columbia, contends the program’s basis — the Inflation Reduction…
Beyond the trip with non-hallucinogenic psychoplastogens in neuropsychiatry
Interest in ketamine and psilocybin as potential therapies for mood disorders has surged since around 2010. A groundbreaking 2000 study at Yale revealed the powerful antidepressant effects of ketamine, a dissociative anesthetic. Unlike traditional antidepressants which can take weeks or months to have an impact, a single dose of ketamine led to significant improvements in…
Decoding Bayer’s digital health leap and its implications on drug discovery and personalized medicine
The German multinational pharma and biotech colossus Bayer is taking further steps to ramp up its focus on digital health by launching a new business unit. In 2022, Bayer invested $9.5 million in Woebot Health, an AI-powered behavioral health platform company. In 2020, it launched a venture known as G4A Digital Health Partnership Program to…
Guselkumab offers sustained improvements for psoriatic arthritis patients in phase 3b trial
Data from Janssen’s phase 3b COSMOS clinical trial reveals that guselkumab (Tremfya), an inhibitor of interleukin-23 (IL-23), provides improvements in all minimal disease activity (MDA) domains for adults with active psoriatic arthritis (PsA). The benefits persist through week 48, even in patients who have seen inadequate responses to one or two tumor necrosis factor inhibitors…
CLN-619 antibody therapy offers a new hope for patients with advanced solid tumors
Boston-based Cullinan Oncology has unveiled data for its new monoclonal antibody therapy, CLN-619, ahead of the American Society of Clinical Oncology (ASCO) 2023 meeting scheduled for June 2–6 in Chicago. The drug could potentially offer a new treatment option for patients with advanced solid tumors. Dr. Judy Wang, Associate Director of Drug Development at the…
Insilico Medicine wins IND approval for AI-designed USP1 inhibitor for cancer trials in U.S. and China
Insilico Medicine has made a significant breakthrough with its AI-designed USP1 inhibitor, ISM3091. The US Food and Drug Administration (FDA) has accepted Insilico’s Investigational New Drug (IND) application for this promising drug, marking a significant milestone for AI-assisted drug discovery. “The FDA’s acceptance of our IND for ISM3091 signifies that the FDA recognizes its potential…
PsychoGenics’ SmartCube prompts a reevaluation of CNS drug discovery
In an era of rapid AI progress, the quest to pioneer the first AI-developed drug candidates has led to an increasing number of these drug candidates entering clinical trials. One contender is ulotaront, an antipsychotic drug, that fared well in a phase 3 schizophrenia study published in NEJM in 2020. Sunovion discovered the drug in…
A current perspective on machine learning’s role in advancing clinical trials diversity
The year 2020 was a watershed moment for many reasons, but notably, it cast a light on the pervasive health and social inequities that have long marred the U.S. The COVID-19 pandemic hit diverse populations disproportionately hard, as Deloitte and others have noted. Additionally, the tragic deaths of George Floyd, Breonna Taylor and others provoked…
Data integrity scandals in biomedical research: Here’s a timeline
While scientific progress hinges on data integrity, plagiarism, data fabrication and image manipulation and other biomedical research scandals are ongoing concerns. An article in Science recently made waves by revealing startling conclusions from the research of the German neuropsychologist Bernhard Sabel, who developed a fake-paper detector. Publishing his findings in a preprint, Sabel concluded that there…
Ready, set, analyze: Amazon Omics unveils new Ready2Run workflows
Amazon Web Services (AWS) recently announced a significant expansion of Amazon Omics at the annual AWS Life Sciences Executive Symposium in Boston. Amazon Omics, which the company introduced last year, helps life science organizations to store, query and analyze genomic, transcriptomic and other omics data. While other tools such as Qlucore Omics Explorer, Genospace, StrandOmics,…
Codagenix taps synthetic biology and machine learning in vaccine development
In the quest to outsmart viral foes such as SARS-CoV-2, RSV and influenza, Codagenix, a clinical-stage biotech firm based in Farmingdale, New York, has engaged a unique arsenal: the intersection of synthetic biology and machine learning. Their weapon of choice is a blend of live-attenuated virus design and codon deoptimization technology. Their process involves introducing…
Drug Discovery & Development’s Brian Buntz clinches 2023 Azbee national gold award
Our own pharma editor, Brian Buntz, has won national gold in the 2023 Azbee Awards of Excellence. The accolade from the American Society of Business Publication Editors (ASBPE) recognized Buntz’s coverage for Drug Discovery & Development, which was highlighted in the sister print publication of Medical Design & Outsourcing. ASBPE is a widely recognized professional…
The big spenders: The top 25 pharma companies in R&D investments
In the throes of the COVID-19 pandemic, when the world was desperate for a lifeline, the global pharma sector’s R&D prowess was thrust into the limelight. Now, as the pandemic begins to loosen its grip, the sector continues to make aggressive investments in research and development (R&D). At the tip of the spear of this…
FDA approves expanded use of Farxiga (dapagliflozin) for heart failure patients regardless of ejection fraction status
FDA has approved an expanded indication for AstraZeneca’s Farxiga (dapagliflozin). This decision, marking a significant milestone in Farxiga’s development, opens up its use in patients with heart failure, regardless of their ejection fraction status. This brings the total number of Farxiga’s approved indications to five. Ejection fraction in heart failure Ejection fraction is a key measure…
Delix Therapeutics launches phase 1 study for novel neuroplasticity-promoting therapeutic
Boston-based Delix Therapeutics has won regulatory approval to commence a study of the non-hallucinogenic psychoplastogen DLX-001. Psychoplastogens are a class of drugs that have the potential to promote neuroplasticity, which refers to the brain’s ability to adapt and form new connections between neurons. That capability could enable improvements in conditions such as depression, anxiety and…
FDA places clinical hold on Sun Pharma’s dermatology drug as a result of blood clot risk
Sun Pharmaceuticals (NSE:SUNPHARMA) has received a clinical hold from the FDA on its experimental dermatological drug deuruxolitinib over the potential for thromboembolic incidents. The hold pertains to patients taking a 12-mg dose of the Janus kinase (JAK) inhibitor. Reuters was the first to report the news. Sun Pharma maintains confidence in deuruxolitinib despite FDA clinical…
An overview of the RSV vaccine landscape: What comes after GSK’s approval of Arexvy?
GSK (NYSE:GSK) has secured FDA approval for its respiratory syncytial virus (RSV) vaccine Arexvy, marking a significant milestone in the RSV vaccine landscape. RSV is common and usually results in mild infections, but can be dangerous in the immunocompromised as well as in younger and older populations. The GSK vaccine targets adults aged 60 and…
The growing influence of digital pathology in preclinical R&D: Spotlight on Proscia’s Concentriq
As drug discovery evolves, digital pathology platforms are playing a vital role in streamlining preclinical R&D processes and accelerating drug discovery. Proscia‘s Concentriq for Research reflects this trend. Earlier this year, we profiled PathAI’s AISight, a digital pathology platform designed to support AI-driven research. To learn more about Proscia’s digital pathology technology, we caught up with…
Spotlight on the top 10 pharma employers of 2023
This roundup explores the top 10 pharma employers of 2023, highlighting their strengths and areas for improvement based on employee reviews and industry trends. In our ranking of top employers, we combined data from multiple sources using a weighted approach, emphasizing employee satisfaction, company benefits and industry recognition. Topping the list are Recursion Pharmaceuticals and…
Discover the 25 top pharma employers of 2023
The pharma and biotech sectors continue to face rapid change. On one hand, top pharma employers have continued to face talent shortages as demand increases for experienced workers. But on the other, the pharma sector has not been immune to layoffs. One factor driving the trend is the increased clip of mergers and acquisitions (M&A)…
The future of rapid and enduring neuropsychiatric treatments: From psychedelics to non-hallucinatory psychoplastogens
Neuropsychiatric disorders, such as depression and anxiety, are among the leading causes of disability worldwide. Almost one billion people globally — roughly one out of eight individuals — live with a mental disorder, with anxiety and depressive disorders the most common, according to the World Health Organization. Yet current therapies such as selective serotonin reuptake…
Pharma M&A resurgence: An overview of recent deal-making trends
After something of a slow year in 2022, mergers and acquisition (M&A) activity is ramping back up in the pharma and biotech sector. There have been several especially large M&A deals in the past few months. Examples include Pfizer’s (NYSE:PFE) $43 billion acquisition of Seagen, and Merck’s (NYSE:MRK) $11 billion purchase of Prometheus Biosciences. In December…
Unraveling the impact of FDORA and PREVENT Pandemics Acts on the life sciences
As the world continues to grapple with global health challenges, the role of science and biotech law has taken center stage in shaping public health policy and innovation. The FDORA and PREVENT Pandemics Acts are poised to help shape the landscape. In a recent interview, life sciences attorney Barbara Binzak Blumenfeld offers insights into significant…
Development challenges and regulatory changes for cell and gene therapies
Cell and gene therapies are the fastest growing area for drug development. The groundwork for this category was laid with the mapping of the human genome in 2003, and the field has developed rapidly in the intervening decades. These powerful therapies have significant potential for the treatment of cancer and other previously “undruggable” diseases. But…