Biotech

The U.S. Senate on Dec. 16 passed the FDA Modernization Act 3.0 (S.355) by unanimous consent, sending legislation to the House that would require the FDA to update its regulations to reflect changes Congress enacted in 2022. The bill instructs HHS, acting through the FDA commissioner, to publish an interim final rule no later than…

Eli Lilly launched “TuneLab,” an AI/ML platform that gives selected biotechs access to drug-discovery models trained on years of Lilly research data. Initial public partners include Circle Pharma and insitro. Lilly says the first release reflects more than $1B worth of internal data investment. Lilly says biotechs run its models locally on their own infrastructure…

Novartis has signed a global licensing agreement with Arrowhead Pharmaceuticals for the preclinical RNA interference (RNAi) therapy ARO-SNCA, targeting alpha-synuclein in Parkinson’s disease and related disorders. The deal, announced Tuesday and reported by Reuters, includes a $200 million upfront payment to Arrowhead, with up to $2 billion in potential milestones, plus tiered royalties (capped in…

Lilly recently reported topline results from the ATTAIN-1 phase-3 trial evaluating orforglipron, a once-daily oral glucagon-like-peptide-1 (GLP-1) receptor agonist for adults with obesity or overweight without diabetes. GLP-1 receptor agonists mimic gut hormones to curb appetite and slow digestion, a mechanism driving the success of therapies from Novo Nordisk (Ozempic for diabetes and Wegovy for…

AI agents have moved from pilots to practice: 14% of large enterprises report partial or full deployments and 23% are piloting, according to the “Rise of agentic AI” report from Capgemini. But as adoption ticks up, trust in fully autonomous agents slid from 43% to 27% over the past year. What does that mix mean…

Demand for next-generation GLP-1 drugs is fueling a boom in peptide research, prompting companies like Sai Life Sciences to expand capabilities amid a hot market for obesity and diabetes treatments. “The GLP-1 agonists have exploded the peptide field,” said Maneesh Pingle, Ph.D., executive vice president and head of discovery services at Sai Life Sciences, in…

Genmab, a Danish company focused on developing antibody therapies for patients with cancer, opened a new site in Plainsboro, NJ. The company was awarded $8.4 million in tax credits over seven years by the Murphy Administration to develop the new location.  Expanding presence in NJ “Our extension at the Princeton Forrestal Center will strengthen our…

Five minutes of hands-on bench time now separates researchers from purified plasmid DNA using a new automated system from Thermo Fisher Scientific. The company’s cartridge-based KingFisher PlasmidPro automates the traditionally hours-long maxi-prep process. The KingFisher PlasmidPro benchtop instrument offers walk-away operation. Kevin Lowitz, vice president and general manager for sample prep at Thermo Fisher Scientific,…

AP Biosciences is building the protocol around one key objective: confirm that conditional CD137 agonism, a tumor-restricted T-cell costimulation, can be delivered safely in patients whose HER2-positive solid tumors express the p95HER2 variant, a truncated, drug-resistant form of HER2. To that end, it recently dosed the first patient in the Phase 1/2 trial of its…

Targeted Protein Degradation (TPD) has  emerged as a promising modality in drug discovery, hijacking the body’s natural disposal systems to eliminate disease-causing proteins. While bivalent degraders like PROTACs have pioneered the field, demonstrating clinical promise, attention is increasingly turning toward a new upstart — Molecular Glue Degraders (MGDs). These smaller, simpler molecules offer advantages but…

Spatial biology is revolutionizing our understanding of how cells interact with their natural environments. Although that may sound like an overstatement, it isn’t.  Spatial biology involves the use of advanced imaging and molecular techniques to visualize and map the location of cells, transcripts, proteins and their interactions within tissues. Traditional biological studies have long focused…

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…

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…

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…

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…

In 2025, genetic validation is poised to emerge as a high-stakes litmus test in cardiovascular R&D, investors will continue to get better at funneling cash into proven science, and patients will continue their evolution to become more-active partners shaping their healthcare. To hear more about each of these trends, we considered feedback from three industry…

After establishing her lab at Cornell in 2019 and achieving notable success with publications in top journals, Liz Kellogg, Ph.D., associate member in the department of Structural Biology at St. Jude Children’s Research Hospital received a unique opportunity. St. Jude Children’s Research Hospital had embarked on a major expansion of its structural biology and genome…

 “Nearly all diseases stem from a molecular mechanism going wrong,” writes Sergei Yakneen, chief technology officer of Alphabet’s Isomorphic Labs in a recent blog post. “Whether it’s an infectious agent disrupting our cellular machinery or a breakdown in processes like DNA repair, identifying the right protein and finding molecules to interact with it is…

 The biotech industry continues to be in something of a “hangover period” where everyone realizes that there was “probably just a little bit too much enthusiasm” in circa 2020 and 2021, said Matthias Kleinz, DVM, Ph.D., executive vice president, translational sciences at UPMC Enterprises, the innovation and commercialization arm of University of Pittsburgh Medical…

[Last updated, July 13, 2024] The biotech industry is witnessing a stark paradox in 2024. On one hand, there’s a group of biotech startups that are thriving, attracting nearly $3 billion in funding in Q1 2024 alone. Job openings in the sector are also considerable in several parts of the U.S., especially in the Greater…

 Over the past year, North American biotech firms continued to lear the world in funding by a significant margin in an analysis that included a various equity fundraising types drawn from Crunchbase. Argenx, a publicly traded Dutch biotech, raised $1.1 billion from investors in July 2023 through a global offering. Next in line was…

The same week that BenevolentAI announced it was cutting 30% of its staff, AI-focused biotech Xaira Therapeutics debuted with a $1 billion funding round with little precedent in healthcare over the past year — or beyond that. A survey of the biggest fundraising rounds over the past year revealed that the absolute largest investments were…

Many smaller biotech companies continue to face a cash crunch as a result of a challenging funding climate and a difficult IPO market. In the past couple of years, many smaller biotechs are running out of cash and being forced to cut jobs or shut down entirely. Median deal sizes for seed, Series A and Series B rounds…

The top 20 healthcare-focused biotech companies collectively raised $2.9 billion in the first quarter of 2024, according to data sourced from Crunchbase. That represents a 161% increase compared to the $1.1 billion raised by the 20 largest funding rounds involving healthcare-focused biotech companies in Q1 2023, indicating more confident bets on the market viability of…

Companies across the industry have contributed to biotech layoffs in early 2024, driven by factors ranging from operational restructuring to strategic pivots and clinical trial failures, with major hubs like California and Massachusetts bearing the brunt of the impact. A recent analysis assembled with the help a machine learning technique known as clustering reveals a pattern of job…