The Fc receptor (FcRn) inhibitor market, led by promising candidates such as efgartigimod, promises to reshape the autoimmune disease treatment landscape. Sales projections for the market top $10 billion, as Driehaus Capital Management estimates. The addressable U.S. patient base spans more than 228,500 individuals across various conditions including myasthenia gravis, warm autoimmune hemolytic anemia (wAIHA)…

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…

Today, Boston-based Ginkgo Bioworks’ recently unveiled a deal with Pfizer on RNA-based drug candidates, reflecting the growing interest in RNA therapies. Additionally, Carlsbad, California–based Ionis Pharmaceuticals inked a pact with Roche focused on RNA-targeted therapies for Alzheimer’s and Huntington’s diseases. This development underscores the resilience of prominent biotech hubs. According to data from real estate…

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…

Over the last decade, drugs that bind to allosteric sites have emerged as an attractive approach in small molecule drug design, offering new possibilities for targeting various diseases, including conditions historically known as “undruggable”. Unlike traditional small molecules that bind to a target protein’s endogenous orthosteric or active site, allosteric small molecules selectively bind and…

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),…

Vraylar (cariprazine), which recently scored FDA approval as an adjunctive treatment for Major Depressive Disorder (MDD), could have positive implications for healthcare resource utilization. A new analysis suggests that this atypical antipsychotic, initially developed by Allergan (now AbbVie), could curb healthcare spending of MDD treatment. In the economic analysis, patients who received cariprazine as their…

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,…

Note: This feature on the best-selling pharmaceuticals of 2023 will be updated regularly as new data becomes available. Stay tuned for our ongoing coverage of the pharma sector’s sales dynamics. In 2023, as the grip of the COVID-19 pandemic began to loosen, the pharma sector returned to relying on immunology and oncology as sales drivers.…

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…

In the wake of the COVID-19 pandemic, the U.S. has witnessed a surge in litigation. One factor driving the uptick in the pharmaceutical sector is the rise of copycat litigation. As mass tort activity amplifies, plaintiff lawyers are treating previously filed lawsuits as templates for new claims. Examples of the trend include steadily increasing nitrosamines…

The traditional drug discovery approach is broken, but so too are the approaches of many AI-focused organizations seeking to reboot the process. That’s the perspective of Fabrice Chouraqui, CEO of Cellarity and CEO Partner at the investment firm Flagship Pioneering, which played a role in launching Moderna in 2010. Chouraqui joined Flagship in 2020. While…

 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…

Global pharma and medical device giant Johnson & Johnson (J&J) has ditched its iconic cursive logo that dates back to the late 19th century, and rebranded its Janssen pharma division as Johnson & Johnson Innovative Medicine. The move underscores the company’s push to prioritize higher-margin prescription drugs. This strategic move comes amidst a backdrop of…

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…

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…

As the biotech industry matures, several North American cities are emerging biotech hubs, aiming to become the next epicenters of innovation and growth. While traditional hubs like Boston and San Francisco continue to dominate, a new wave of cities is making strides in biotech. For instance, Pittsburgh, an up-and-coming biotech hub, is tapping its biomanufacturing…

The FDA has accepted Sanofi’s supplemental Biologics License Application (sBLA) for ALTUVIIIO, a novel, high-sustained factor VIII replacement therapy for adults and children with hemophilia A. The FDA based the decision on positive final data from the pivotal Phase 3 XTEND-Kids trial in children under 12 with hemophilia A. ALTUVIIIO (efanesoctocog alfa) is the first…

As Pfizer and Moderna receive the FDA nod for COVID-19 boosters, their 2023 global sales projections appear to be just a fraction of the previous year’s. In 2022, Pfizer and its partner BioNTech jointly sold $56 billion worth of their Comirnaty COVID-19 vaccine, marking the best-selling drug of the year. Moderna’s Spikevax COVID-19 vaccine wasn’t…

When Keri Yale, the company’s head of patient affairs and engagement at Boehringer Ingelheim (BI), joined more than 25 years ago, she recognized a need to put patients at the center of the pharmaceutical industry. Since then, she has spearheaded a transformation towards greater patient centricity at the company that started with HIV/AIDS community engagement…

As obesity rates continue to soar across the globe, analysts anticipate that the market for anti-obesity drugs will skyrocket in the coming years. Goldman Sachs projects the market to be worth $44 billion by 2030. That’s an almost 16-fold expansion from its valuation of approximately $2.82 billion in 2022. Barclays is even more upbeat on…

With updated COVID-19 boosters set to launch in the near future and COVID-related hospitalizations on the rise again, scrutiny is on the rise of emerging variants and the benefit-safety profile of COVID-19 vaccines. We performed a retrospective analysis of data from the Vaccine Adverse Event Reporting System (VAERS), focusing on the period covering the launch…

[Updated September 7. Article originally posted on July 21, 2023. Updates follow in bold:] The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is backing a significant shift in the current COVID-19 vaccine strategy: a move from multivalent to monovalent vaccines focusing on the XBB lineage strains. More recently, the emergence of new variants such…

Against the backdrop of a nearly 16% spike in COVID-19 hospitalizations in late August, according to CDC data, federal authorities are gearing up to greenlight updated boosters. Moderna announced that its latest COVID vaccine is effective against this new strain. Meanwhile, Pfizer revealed positive preclinical data for its vaccine, developed in collaboration with BioNTech. In…

To date, there have been more than 770 million confirmed COVID-19 cases and nearly 7 million deaths from the virus, according to the World Health Organization (WHO). Vaccines remain one of the most potent tools in blunting the severity of SARS-CoV-2 infection, and vaccine developers have distributed more than 13.5 billion vaccine doses to date.…