One of the largest unmet needs in modern medicine is the effective treatment of osteoarthritis (OA)—a degenerative joint disease afflicting more than 30 million Americans and costing the healthcare system $459.5 billion in all-cause medical costs, according to a 2020 study in the Archives of Physical Medicine and Rehabilitation. “We see this as one of…
Landmark Bio’s mission to prevent cell therapy ‘do-overs’
In the classic Bill Murray comedy Groundhog Day, the main character is stuck reliving the same day—again and again. Biotech startups often face a similar fate when they sprint to first-in-human trials without planning for the realities of large-scale manufacturing. “Many times, researchers rush to get their product tested in humans with processes that are…
How Capsida’s unconventional funding strategy and capsid technology promise to reshape CNS treatments
Capsida Biotherapeutics, a gene therapy startup that has quietly amassed a network of Big Pharma partnerships, announced in January that its partner AbbVie will exercise its option on their first neurodegenerative disease program, triggering a $40 million license payment. The five-year-old company, which has built its war chest primarily through pharma collaborations rather than traditional…
How 3T Biosciences’ platform targets immunologically cold solid tumors
Immunotherapy resistance in solid tumors remains one of oncology’s most significant therapeutic challenges, with multiple cancer types showing limited response to current approaches. Microsatellite stable colorectal cancer (MSS CRC) exemplifies this challenge, with over 90% of MSS CRC cases failing to respond to checkpoint inhibitor monotherapy, while resistance patterns also emerge in many other immunologically…
Lilly’s FDA approval for Omvoh close up: Nearly 90% of one-year responders maintained remission through two years
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…
How an engineered algae-based biologic aims to break the annual $5B cycle of c. diff reinfection
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…
From Graz to global — Innophore’s journey with NVIDIA’s BioNeMo
When a 30-person Austrian startup gets showcased by Jensen Huang, CEO of the trillion-dollar tech giant NVIDIA, schedules tend to fill up fast. That’s precisely the case for Innophore, a biotech company tapping NVIDIA’s computational clout with its Catalophore platform to accelerate AI-driven drug safety screening and binding-site analysis. This year, the company was highlighted…
How atogepant trials are capturing migraine’s real-world impact
Migraines, like many diseases, are not monolithic. In that regard, they are something like weather — they can shift suddenly, and predicting when they might arise can be elusive. Clinical trials traditionally capture a snapshot of the migraine storm, often failing to reflect the dynamic, lived experience of patients. Yet recent studies, including the phase…
At JPM, Shasqi highlights how click chemistry can tackles ADC’s ‘1% problem’
Three years after demonstrating the first-ever in vivo use of click chemistry by safely delivering 12 times the standard dose of doxorubicin directly to tumors, Shasqi is again pushing boundaries. Its CAPAC platform, which initially relied on intratumoral injections, now targets CEACAM5, a cell-surface antigen overexpressed in lung, gastric, pancreatic, colorectal, esophageal/HNSCC, and cervical cancers,…
5 trends on display at JPM 2025: Deals, data, and the future of precision medicine
After several muted years, the 2025 J.P. Morgan Healthcare Conference signaled a return to big-ticket deals. J&J’s proposed $14.6 billion acquisition of Intra-Cellular Therapies and GSK’s $1 billion purchase of IDRx catapulted this year’s meeting to the largest M&A showing since at least 2019. But behind those high-profile acquisition announcements, JPM speakers and insiders also…
AAPS announces lineup for the National Biotechnology Conference (NBC)
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…
NVIDIA allies with IQVIA, Mayo Clinic and Illumina on healthcare AI
NVIDIA today announced at JP Morgan partnerships with IQVIA, Illumina, Mayo Clinic and Arc Institute that center on accelerating biomedical AI across genomics, drug development, and clinical diagnostics. The collaborations aim to tap advanced computing across the healthcare sector, with IQVIA deploying AI agents for clinical trials, Illumina integrating genomic analysis tools, Mayo Clinic developing…
QuantHealth bolsters leadership to accelerate enterprise-grade clinical AI
Tel Aviv-based QuantHealth is on a roll. In August 2024, it surpasses the 100th mark in simulated clinical trials with an 85% accuracy rate and reported cost savings upwards of $215 million for one major pharmaceutical partner. In March of the same year, Fast Company recognized QuantHealth as one of the most innovative companies in…
Menarini and Insilico ink $550M deal for AI-discovered cancer therapy
Second collaboration builds on rapid progress of AI-designed KAT6 inhibitor licensed in 2024 Agreement includes $20 million upfront payment with potential total value exceeding $550 million plus tiered royalties New preclinical asset demonstrates broad anti-tumor activity across multiple solid tumor types Less than a year after their first collaboration, pharmaceutical giant Menarini Group and AI-driven…
Merck taps Atropos Health to accelerate real-world evidence generation
Building on existing integrations with cloud leaders AWS and Google Cloud and collaborations with Arcadia and TD2, Atropos Health is now partnering with Merck. This new collaboration will tap Atropos Health’s GENEVA OS (Generative Evidence Acceleration Operating System) and related tools with the aim of speeding the generation of real-world evidence. Under the agreement, Merck’s…
Compounders and drugmakers clash over compounded weight-loss drugs with FDA in the middle
A flurry of recent FDA announcements and legal maneuvers has placed two popular weight-loss drugs — tirzepatide (marketed as Mounjaro and Zepbound by Eli Lilly) and semaglutide (marketed as Ozempic and Wegovy by Novo Nordisk) — at the center of a growing squabble. Patients are desperate for affordable access, compounding pharmacies see a market opportunity,…
How a ‘rising tide’ of inclusivity is transforming clinical trials
Let’s say there’s a Black female patient with an aggressive form of breast cancer. She meets with her oncologist to discuss a promising targeted therapy that recently won FDA approval. The drug showed strong efficacy in clinical trials, with a 65% response rate. Yet when she asks about efficacy data specific to Black women, she…
TAK-279, an oral small-molecule TYK2 inhibitor offering the convenience of a once-daily pill and biologic-like clinical responses
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…
4 trends in FDA novel approvals in 2024
An analysis of FDA approvals across these five years shows small molecules remain central to modern therapeutics, even as complex biologics—particularly monoclonal antibodies (mAbs), antibody–drug conjugates (ADCs), and next-generation modalities—are on the rise. Steady R&D investment in these advanced approaches reflects growing clinical confidence in targeted therapies that address difficult or rare disease pathways. 1.…
Novartis announces positive phase 3 data for intrathecal gene therapy in older SMA patients
Novartis has released positive topline results from the phase 3 STEER trial evaluating OAV101 IT (intrathecal onasemnogene abeparvovec) in treatment-naïve patients with spinal muscular atrophy (SMA) Type 2, aged two to under 18 years. The STEER trial is a pivotal, sham-controlled study designed to evaluate OAV101 IT against a procedure that mimics drug administration without…
100 cell and gene therapy leaders to watch in 2025
As 2024 drew to a close, the cell and gene therapy sector has witnessed a string of recent approvals and some positive clinical trial data such as Mesoblast’s Ryoncil receiving FDA authorization for pediatric graft-versus-host disease in December, Adaptimmune’s Tecelra gaining approval for synovial sarcoma in August, and the landmark clearance of Casgevy (Exagamglogene Autotemcel)…
Top 25 global leaders in cell and gene therapy patents
The cell and gene therapy (CGT) patent landscape reveals a perhaps surprising leader: the German biopharmaceutical company, Immatics Biotechnologies GmbH. As GlobalData has noted, the firm is one of the top filers of patents for CAR-T cell-based therapies. This contrasts with the broader oncology patent space, where well-known Swiss companies like Novartis and Roche have…
Mary Marcus appointed CEO of NewAge Industries
Press release: Southampton, PA – NewAge Industries, Inc., parent company of AdvantaPure™ and NewAge Performance Products, a global leader in fluid transfer systems solutions for the biopharma and industrial markets, is pleased to announce the appointment of Mary Marcus to the position of CEO. “Since her arrival in 2008, Mary has been a vital part…
By 2025, clinical research and patient care converge: Data integration, validation, and evolving markets
A growing chorus of experts agree: 2025 signals a year when AI and its generative variants (genAI) move beyond early experimentation into a period of tangible, large-scale impact — including in the life sciences. While challenges remain as EY recently noted, the future will likely be one where the focus shifts from anticipating breakthrough genAI…
FDA drug approvals holding steady at 44 YTD in 2024
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…