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The American Society of Gene & Cell Therapy (ASGCT) and Orphan Therapeutics Accelerator (OTXL), a biotech non-profit, have launched the CGTxchange, a jointly owned clearinghouse and marketplace designed to identify, evaluate and advance clinically validated cell and gene therapies (CGTs) for ultra-rare diseases that have been shelved due to commercial constraints.  This will serve as…

Big Pharma companies are still betting big on AI, with major players pouring resources into agent platforms. The goal: unify fragmented data, streamline operations from clinical trials to sales, and enable more personalized healthcare provider interactions. Novartis has selected Salesforce’s Agentforce Life Sciences for a global rollout over the next five years. The deal follows…

Ajinomoto, founded in 1909 after chemist Kikunae Ikeda isolated glutamate from kelp broth and commercialized it as MSG, has evolved from seasoning to cell culture media over more than a century Now, its Korean subsidiary Ajinomoto CELLiST Korea, which focuses on cell culture media development and manufacturing, announced the launch of CELLiSTTM AAV Production Supplement…

Lilly announced results from its Phase 3 TRIUMPH-4 trial of retatrutide, a first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, on Thursday. In the efficacy-estimand analysis, participants taking the highest dose (12 mg) lost an average of 28.7% of their body weight at 68 weeks, about 71.2 pounds from a baseline of 248.5 pounds.…

Is AI a risk or an opportunity? Is regulatory divergence a barrier or a catalyst for innovation? The answer depends on how prepared and how agile your organisation is. As regulatory frameworks shift beneath our feet, the question facing every drug developer is not ‘if’ but ‘how’ these macro trends will disrupt their strategy. In…

Novo Nordisk has laid off dozens of employees at its plant in North Carolina, an analysis of LinkedIn posts by Reuters found. The layoffs come after the company announced a plan to cut 9,000 jobs globally in an effort to compete with Eli Lilly last month. The exact number of layoffs at the Clayton plant…

Pathology labs still spend hours, and sometimes days, moving fragile tissue through reagent-intensive staining workflows that add cost, variability and waste. Virtual staining, an approach which uses AI models to transform label-free tissue images into counterparts that mimic chemical stains, aims to compress that process significantly while preserving scarce tissue and standardizing results across sites.…

Three days before the ACIP’s meeting last week, Robert F. Kennedy Jr. appointed five new members to the ACIP, a process that usually takes months. The panel now has a total of 12 members. The new members will “bring diverse expertise that strengthens the committee and ensures it fulfills its mission with transparency, independence, and…

Women’s Health Access Matters (WHAM) has opened nominations for its 2025 Edge Awards, providing $25,000 grants to early-career investigators studying sex-based differences in health outcomes. The awards target research in autoimmune diseases, brain health, cancer and heart health, conditions that often affect women differently than men. For the first time, WHAM is also accepting proposals…

Only 7.1% of U.S. adults with cancer enroll in treatment trials (JCO, 2024), a bottleneck that slows drug development and limits access to targeted therapies. Proscia, a Philadelphia-based digital pathology company, aims to address that dynamic with its new tool, Aperture, which uses AI to flag potential candidates right at the point of diagnosis by…

Evidence-based practices (EBPs) such as new treatments, improved surgical practices and updated screening programs drive healthcare forward and create better patient outcomes. However, healthcare organizations often struggle to adopt these promising medical advances, despite evidence supporting their efficacy and recommended use in routine care. Studies suggest that new practices can take years to be implemented…

A potential new strategy against Alzheimer’s disease is taking shape in the brain’s own defense system. By boosting a specific enzyme in the brain’s immune cells, researchers at Cedars-Sinai have dramatically reduced the hallmark plaques of Alzheimer’s and reversed cognitive decline in mice. The news opens the door to potential cellular therapies for a disease…

KEY TAKEAWAYS: Regeneron (#20 by revenue in FY2024) became the third company to launch a BCMAxCD3 bispecific for myeloma, following J&J (#3) and Pfizer (#2). Company spends 36.1% of revenue on R&D—highest in pharma—growing at 19.5% annually Patent portfolio shows 652 antibody patents (50.3% of total) with 31 bispecific-specific filings Tarrytown, New York–based Regeneron may…

Cambridge-based biotechnology company Parallel Bio has closed a $21 million Series A funding round led by AIX Ventures. The company develops a drug testing platform that uses human organoid technology as an alternative to animal testing. The funding round included new investors Amplo and Salesforce CEO Marc Benioff, along with existing backers Metaplanet, Humba Ventures,…

Pharma’s long winter of diminishing R&D returns may be thawing. Despite decades of increased spending yielding less bang for the buck, the industry is regaining ground. Deloitte’s closely watched annual analysis charted the slide, with average forecast IRR falling from just over 10% in Deloitte’s inaugural 2010 analysis to a trough of just 1.5% by 2019, a…

Sydney-based Recce Pharmaceuticals has secured A$5.0 million via private placement and launched a A$10.8 million entitlement offer to support Phase 3 trials of its synthetic anti-infectives for diabetic foot infections (DFI) and acute bacterial skin and skin structure infections (ABSSSI). In an April 10 announcement, the company said the combined A$15.8 million raise (before costs)…

Glucocorticoids, commonly referred to as steroids, are currently the standard of care for the treatment and management of many autoimmune disorders. They are highly effective at suppressing inflammation and the reducing the activity of the body’s immune system, providing rapid relief from associated symptoms. At the time of prescribing, steroids appear to be a low-cost,…

AnaptysBio has unveiled positive findings from its Phase 2b RENOIR clinical trial evaluating rosnilimab. Nearly 70% of participants achieved low disease activity (CDAI ≤10) by Week 14, with improvements persisting through Week 28. The investigational therapy met its primary endpoint by delivering statistically significant gains in DAS28‑CRP scores at Week 12 compared to placebo, alongside…

For years, a stash of ancient scrolls have been sitting in storage, still rolled up. They may have belonged to Julius Caesar’s father-in-law, before a volcano buried them — and Pompeii — in 79 CE. Since the scrolls were discovered in the 1800s, they have been carefully guarded. Researchers periodically pull out one scroll at…

Pharmaceutical companies could slash their pharmacovigilance costs by half while significantly improving accuracy through generative AI, according to IQVIA’s Global Practice Lead of Pharmacovigilance Technologies, Uwe Trinks. “The idea is: we can save 50% of the cost and get the quality to above 99%,” Trinks said. “That means when we have human verification, we only…

ChatGPT may be one of the quickest adopted tech platforms in recent memory, but the potential of it and other large language models ability transform the world has also been met with occasional provider outages, hallucinations, and memory problems. “There’s a lot of resentment towards the hype,” notes Christopher M. McSpiritt, head of life sciences…

What if physicians could predict which cancer treatments will work best for individual patients using just their tumor images? The precision oncology company Pangea Biomed made strides in that direction with the publication of its AI-powered ENLIGHT-DP method in Nature Cancer. This technology taps deep learning, an ever-more-popular type of machine learning with a large…

A new study, published by Frontiers in Space, reveals promising results from an experiment on the International Space Station (ISS) for treating and preventing post-traumatic osteoarthritis (PTOA). This condition affects roughly one-fifth of the 650 million people worldwide with osteoarthritis. Using a human tissue chip model on the International Space Station, the ISS researchers observed…

In 2023, the American Society of Anesthesiologists (ASA) issued guidelines advising patients to discontinue GLP-1 receptor agonists (GLP1-RAs) a week before surgery, citing concerns over potential operative complications, leading to delayed or rescheduled surgeries across the U.S. Dr. David Klonoff, a diabetes researcher and Endocrinologist at Mill Peninsula Medical Center, thought it was curious that…

  Sponsored by Diversigen, Inc. Quantitative Polymerase Chain Reaction (qPCR) — also known as real-time PCR — is a molecular biology lab assay technique based on the polymerase chain reaction (PCR). The significant difference in qPCR is the monitoring of amplification on a targeted gene or taxon during the PCR. This allows qPCR to be…