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In an interview with STAT in October, the FDA’s Tala Fakhouri, who co-leads the Center for Drug Evaluation and Research’s AI Council, said the agency has received over 500 drug submissions with AI components since 2016, with a large number in the areas of oncology, neurology, and gastroenterology.
Twenty-three new Prosperity Partnerships – jointly funded by UK Research and Innovation’s Engineering and Physical Sciences Research Council (EPSRC), industry, and academic institutions […] The post New research partnerships aim to transform drugdevelopment and production appeared first on The Pharmacist.
The National Cancer Institute (NCI) has had a taxpayer-funded drugdevelopment program for nearly 70 years, initiated at a time when there was no private investment in oncology drugs.
In January, San Francisco’s Union Square was bustling with hordes of drugdevelopers and investors, pounding the pavement on their way from meeting to meeting. But But Rohan Ganesh, an investor at the VC firm Obvious Ventures, wasn’t among them. Morgan Healthcare Conference.
can stay competitive in science, biomedical innovation, and drugdevelopment. We’ve Sign up to get our biotech newsletter in your inbox. Good morning, there’s been a lot of discussion lately about how the U.S. We’ve got several pieces of news relevant to that issue today.
3] The ultimate objective of biosimilar development should be to enhance patient outcomes through accessible, effective, and user-friendly therapies. [4] The post Panel Discussion: Biologics and biosimilars: The next leap in patient-centric drugdevelopment appeared first on Express Pharma.
With the rise of advanced simulation and model-informed drugdevelopment (MIDD) techniques like digital twins, researchers can now transform their strategies by using models to duplicate biological systems.
Bruce Leuchter, CEO, Neurvati, discusses the vital role of public participation in healthcare policy, highlighting how patient and caregiver insights shape drugdevelopment, regulatory decisions, and payer considerations in rare diseases.
WASHINGTON — Legislation targeting Chinese biotechnology companies caused a ruckus early this year. None of that may matter if Congress doesn’t pass it in December. The BIOSECURE Act would restrict U.S.
In ongoing trials of Eli Lilly’s next-generation obesity drug, several trial participants are running into an issue they never expected: They are losing too much weight. One participant lost 22% of her weight in nine months — substantially faster than the rate seen with approved GLP-1 drugs like Wegovy or Zepbound.
Health data company Truveta said Monday it’s partnering with health systems and drugmakers to launch the Truveta Genome Project , a database of genetic data that is expected to accelerate personalized medicine and help discover new drugs.
Leading FDAs implementationof the Drug Competition Action Plan (DCAP). The DCAP was an initiative launched in 2017 to remove barriers to generic drugdevelopment, approval, and market entry (see our previous post here ). facilitating the twice annual updates to the Off-Patent, Off-Exclusivity List ).
For example, the company engages its patient advisory councils “on topics across the full continuum of drugdevelopment, from discovery to commercialization.” Now, she’s developing ways to operationalize the collection of patient stories to infuse them into every aspect of the business.
Johnson & Johnson said Monday it would buy Intra-Cellular Therapies in a deal worth $14.6 billion, another sign of large drugmakers’ reentry into neuroscience and a sizable purchase that will provide a boost as the industry gathers for one of its largest events of the year.
spending on prescription drugs was almost $800 billion. Although low-cost generic drugs filled 91% of all prescriptions, the 9% of prescriptions filled with a branded medicine accounted for 84% of drug spending. In 2024, total U.S.
Industry-wide, AI tools are reducing drugdevelopment time by as much as 10X and bringing greater efficiencies and momentum to the most time-consuming pharma process of all: clinical trials. The good news: AI is starting to unlock the progress the industry needs. Continue to STAT+ to read the full story…
Novo Nordisk’s next-generation obesity candidate led patients to lose a substantial amount of weight in a pivotal study but fell short of expectations, results that cast into doubt the future competitiveness of the company in the booming weight loss market.
1,2 EMA’s draft reflection paper – implications for drugdevelopers and manufacturers The proposed tailored approach offers opportunities for developers and manufacturers. In these cases, traditional clinical trials remain indispensable for ensuring patient safety and product efficacy.
And the findings may provide further impetus for legislative action to curb practices that critics say contribute to the rising cost of prescription drugs. For the second time in less than a year, the U.S.
The discussion wove notes of caution into an otherwise hopeful collection of conversations about the use of such technology in medical care and drugdevelopment.
SAN FRANCISCO — Next week brings the return of the J.P. Morgan Healthcare Conference, and with it another fabled opportunity for companies in the industry to court possible mergers, acquisitions, and licensing deals.
Dr Mahesh Bhalgat, Group CEO and Managing Director, Veeda Clinical Research Limited, said, “Our partnership will transform Veeda into an AI-driven oncology drugdevelopment organisation, meeting the growing demand for diversity in clinical trials, which is in line with the expectations of regulators and pharmaceutical companies.
Particularly beneficial in the early drug discovery phase, AI can help identify potential drug targets more effectively than traditional methods, accelerating the initial stages of drugdevelopment by quickly sifting through large volumes of data.
Jazz Pharmaceuticals said Wednesday it would spend nearly $1 billion to buy Chimerix and its experimental pill for a devastating brain tumor that primarily affects children and young adults. The tumor, known as diffuse midline glioma, or DMG (and sometimes as DIPG depending on where it’s found), has flummoxed researchers for decades.
The framework introduces 80 sector-agnostic and 27 healthcare sector-specific indicators, offering a method to assess risks such as biomedical waste, antimicrobial resistance, and unequal access to care, while also identifying opportunities in areas like green hospital infrastructure, digital health, and affordable drugdevelopment.
In a recent study, researchers at [link] demonstrated the power of precision and reproducibility in generic drugdevelopment, showcasing a 95% success rate in replicating complex formulations. At the heart of the matter lies a delicate balance of precision and reproducibility. But what does this mean for the future of healthcare?
Schrödinger CEO Ramy Farid wants you to know that his company isn’t an AI company…but he’ll call it that if you want to. The company, founded in 1990, started out by making software that used the basic laws of physics to laboriously and exactly predict how molecules will interact with each other in space.
The process is essential in protein engineering, particularly in drugdevelopment, where proteins must bind to specific biological targets. Inverse protein folding involves identifying amino acid sequences that form a desired 3D protein structure.
Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Bayer’s Eylea market grip set to slip as Alvotech biosimilar closes in Harbour BioMed partners Otsuka on new T-cell therapy Madrigal poised to enter European MASH market after CHMP endorsement Themes Sections Artificial Intelligence Cloud Corporate Governance (..)
Enabling personalised Alzheimer’s drugdevelopment with AI “… Making clinical trials faster, cheaper and better, guided by AI has strong potential to accelerate discovery of new precise treatments for individual patients, reducing side effects and costs for healthcare services,” explained Professor Kourtzi.
Simone Steiner, CTO, Transgene Permission granted by Trangene “In drugdevelopment the risks are high, and for anyone who has been in the industry for a period of time, they are likely to have experienced such failures,” Steiner said.
Fox Foundation’s annual meeting in New York — came from an unlikely source: Koneksa Health, which helps drugdevelopers use smartphone apps and wearables to study whether their treatments work. But amid all the jostling to find the next use case for GLP-1s, the proposition in October — the day before the Michael J.
Dipanwita Das, CEO and co-founder of Sorcero, chats with Pharma Commerce to dig into the evolving drugdevelopment landscape, being regulatorily compliant, and the rapid advancements in artificial intelligence.
Bridging the Information Gap There’s a growing information gap between drugdevelopers, doctors, and patients. Old-school pamphlets are being replaced by digital content to keep pace with both in-person and virtual care. Medical knowledge is expanding rapidly – doubling every 17 years!
link] Recent Videos Related Content FDA Voucher Program Provides Shorter Drug Application Review Time Susan Haigney June 18th 2025 Article The Commissioner’s National Priority Voucher can be used by drugdevelopers to participate in a novel priority program for shortened drug approval review time.
CMS is issuing unique J-codes for 505(b)(2) drugs, classifying them as sole-source products if not therapeutically equivalent. This pathway reduces submission denial risk, accelerates drugdevelopment, and offers potential market exclusivity for up to 7 years.
New data from a mid-stage study of an Amgen obesity drug showed that it helped participants lose a substantial amount of weight, but questions about how competitive it could be appear to be shaping the response to the news, with the company’s share price falling on the announcement.
13 Skylar Jeremias, “The IRA’s Unintended Consequences for Drug Pricing and Coverage,” The American Journal of Managed Care , April 2, 2025, [link] www.ajmc.com/view/the-ira-s-unintended-consequences- for-drug-pricing-and-coverage. Food and Drug Administration, FDA Patient-Focused DrugDevelopment Guidance Series , March 21, 2025.
based companies from scratch to test and ultimately seek to commercialize innovative drugsdeveloped in China. companies have long signed licensing deals with Chinese drugmakers. But increasingly American venture capitalists are building U.S.-based
The obesity medicine field has gained a new entrant, with AbbVie on Monday announcing it had licensed an experimental weight loss drug from a Danish company that is in a Phase 1 trial. The deal includes a $350 million upfront payment to the company, Gubra, for the rights to its drug, called for now GUB014295.
Vineeta Agarwala, a partner at Andreesen’s biotech arm, a16z Bio + Health, said the deal aims to combine “bleeding edge technology” in drugdevelopment from entrepreneurs with the “extraordinary depth in R&D experience” from Lilly’s executives.
SHOW MORE With robust pipelines, cell therapy remains the major driver for drugdevelopment. The field is expanding into autoimmune diseases, with nononcology trials representing 51% of the pipeline by late 2024.
Global pharma major Lupin has announced that the API manufacturing facility of its wholly owned subsidiary, Lupin Manufacturing Solutions (LMS), in Dabhasa, Gujarat, has received the Good Manufacturing Practice (GMP) certification from the Therapeutic Goods Administration (TGA), Australia’s medicines and medical devices regulator.
And there’s master’s programs, for example, I have an academic appointment at University of Cincinnati and they have a master’s of drugdevelopment program, which is fantastic. And the other thing I would say that helps is there’s certificate programs many universities offer.
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