Biologics

Cell therapies hold immense promise but, traditionally, carry a similarly large price tag often linked to complex, manual manufacturing. In its latest move to help make these life-saving  and -enhancing treatments more scalable and potentially accessible, Cellares is partnering with the University of Wisconsin School of Medicine and Public Health to automate the clinical-scale manufacturing…

The market for monoclonal antibodies (mAbs) is worth over $330 billion and is expected to more than double by 2030. As the research pipeline continues to grow, developers are facing numerous challenges, not the least of which is measuring and maintaining critical quality attributes (CQAs).  One CQA that has drawn an increasing amount of attention…

The FDA’s approval of Omvoh (mirikizumab-mrkz) for Crohn’s disease—its second IBD authorization since 2023—establishes it as the first biologic in >15 years with Phase 3 two-year efficacy data at launch. In the pivotal VIVID-1 trial, 53% of Omvoh-treated patients achieved clinical remission at one year versus 36% on placebo*, with early endoscopic response tripling placebo…

Imagine a shape-shifting pathogen invisible to the naked eye, armed with toxin-laced barbs that rupture human cells. This isn’t fiction—it’s Clostridioides difficile, a superbug causing 29,000 U.S. deaths annually through severe diarrhea and colitis. After an initial infection, up to 35% of patients experience recurrence, with subsequent episodes becoming increasingly likely—up to 60% of these…

American Association of Pharmaceutical Scientists (AAPS) has announced that the program for its National Biotechnology Conference (NBC) is now available. The full agenda for the event, which will take place from May 4–7, 2025, spans a combination of live and pre-recorded sessions. The event will convene biopharma scientists, researchers, and industry professionals from around the…

To the untrained eye, psoriasis might look like a simple skin condition, marked by itching, scaly patches. Yet psoriasis is an immune-mediated disease with systemic consequences. As Dr. Graham Heap, vice president and global program leader at Takeda, explained during a recent interview, “Psoriasis might manifest as plaques on the skin, but it’s an immune…

YTD 2024 FDA approvals: By the numbers 44 Novel Drug Approvals As of December 5, 2024, the FDA had approved a total of 44 novel drugs, spanning a diverse array of therapeutic areas and patient populations. These new treatments address both widespread public health concerns, such as cardiovascular disease and COPD, and more narrowly defined…

The development of Proteolysis Targeting Chimeras, or “PROTACs*,” has garnered significant attention in the pharmaceutical industry due to their potential to target and degrade disease-causing proteins previously considered undruggable. As a novel therapeutic modality, PROTACs offer a promising alternative to traditional small-molecule inhibitors and biologics. However, despite the excitement around these therapies, preclinical evaluations of…

Beckman Coulter Life Sciences has announced a new automated clone screening platform for biologic drug development. The Cydem VT system integrates several established technologies — microbioreactor arrays, liquid handling, and analytical measurements — into a single platform capable of monitoring up to 96 parallel bioreactors. The system provides continuous monitoring of pH, dissolved oxygen, and…

Large molecule therapies hold immense promise for treating an array of diseases, but their development presents unique challenges in preclinical testing. Toxicology studies form a cornerstone of this process, providing essential data on the drug’s biological effects. While small molecule drugs have been the focus of drug development for decades, large molecule therapies present unique challenges…

[Updated May 10, 2024] In the face of rising R&D costs and growing pricing pressures from payers, the pharma and biotech sectors continue to transform to adapt to an evolving landscape. While workforce reductions persist in 2024 for some companies, major players like AbbVie, AGC Biologics, Amgen, Novartis and Thermo Fisher Scientific are demonstrating confidence…

The pharmaceutical industry is at a critical juncture: AI and other technological advances offer unprecedented potential, yet the cost of developing new drugs has ballooned for decades, surpassing $2 billion in recent years with the projected return on investment (ROI) falling to a mere 1.2% in 2022, according to Deloitte. Another dimension of the problem…

In 2023, a year of accelerated regulatory success, a significant number of biotech labs sat empty in major hubs like San Francisco and Boston. The FDA approved 55 novel therapies in 2023, including Leqembi for early Alzheimer’s and Zurzuvae for postpartum depression. The approval number marked the second highest count in three decades (see graph…

Biotech startup Lindus Health just made a big splash by adding MIT professor and Moderna co-founder Robert Langer,  Sc.D., to its advisory board. Lindus aims to shake up the world of clinical trials with its “anti-CRO” approach that promises faster and more reliable trials for life sciences companies. The addition of Langer, described as the…

Houston boasts many world-class assets that have made it a formidable player on the global stage. From the world’s largest medical complex to mission control for the cosmos, few other cities can compete with its diverse strengths. Houston is also home to the prestigious Rice University, renowned for its leading science and engineering programs. Houston,…

Clostridioides difficile, commonly known as C. diff, is a significant health threat in the U.S. Recent estimates suggest that C. diff, a common bacteria, can cause infection in roughly 500,000 patients annually in the U.S., with around 30,000 of these cases resulting in death. “Actually, it’s more like 5 million when you think about it…

In late 2023, Eli Lilly, whose stock is now up close to 80% over the past year, inked a deal with the Emeryville, California–based Fauna Bio potentially worth $494 million that focuses on the discovery of novel drug targets for treating obesity. In 2020, Fauna entered into an obesity-focused collaboration with Novo Nordisk, Lilly’s primary…

As the year draws to a close, it is clear that molecular science and diagnostics is the hottest funding area in the biotech industry. In an analysis of 50 of the best-funded biotechs of 2023 focused on human health, molecular and science and diagnostics startups collectively attracting roughly $945 million, dwarfing the figures in other…

At its annual re:Invent event, Amazon Web Services (AWS) announced expanded alliances with two leading drug developers, Amgen and Merck, to create generative artificial intelligence (AI) technologies aimed at accelerating drug discovery and increasing efficiencies in manufacturing processes. Merck has been working with AWS and Accenture for several years whereas Amgen and AWS have collaborated…

Johnson & Johnson’s nipocalimab, which works by targeting the neonatal Fc receptor (FcRn), has the potential to treat an array of autoimmune conditions. But the antibody recently hit a snag in the first-ever clinical study of an FcRn inhibitor in rheumatoid arthritis (RA), missing its primary endpoint. The development has sparked debate within the rheumatology…

Drug development is often a vast and intricate journey. Each phase signifies an advancement in the process, always with an eye toward patient safety and efficacy. But before any therapeutic finds itself on the bedside tables of hopeful patients, it faces a formidable challenge: preclinical toxicology testing. As the gateway to clinical trials, this early…

Next generation therapies and vaccine research have recently dominated headlines and scientific discovery. This research and its ability to treat previously untreatable conditions has rightfully excited the scientific and medical communities worldwide. But the complexities involved require a nuanced approach to ensure the treatment is safe and effective. Integrating cell culture into cellular immunity testing…

Time magazine’s most recent roundup of 200 inventions included an array of product types, spanning household gadgets and AI applications. Five distinct pharmaceuticals also made the list, not counting a shipping container for biologics and a vaccine for bees. Among the notable pharmaceutical advances on the list are a novel postpartum depression drug, a novel…

Prix Galien names 2023 winners in pharma and biotech In the world of medical innovation, few accolades carry as much weight as the Prix Galien Awards, which highlight the advances in biotech, pharmaceuticals, and other domains. The 2023 winners include Bristol Myers Squibb’s Camzyos (mavacamten) as the best biotechnology product and Lilly’s Mounjaro (tirzepatide) and…

Traditionally, the tech and biotech sectors in the U.S. have been concentrated in a handful of regions — most notably in areas such as Boston, Seattle, Silicon Valley and Southern California. But the Biden administration aims to distribute innovation more evenly through the U.S. To that end, the administration has designated 31 tech hubs across…