Mon.Mar 31, 2025

article thumbnail

Cell, gene therapy makers lose a champion at FDA with exit of Peter Marks

Bio Pharma Dive

Marks’ resignation leaves the field without a regulator many view as “integral” to its progress over the last decade.

article thumbnail

Google-backed Isomorphic Labs raises $600m to advance AI drug discovery

Pharmaceutical Technology

The funding is set to accelerate the development of Isomorphics AI drug design engine and advance clinical programmes.

Engineer 200
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA official’s ouster sends shares of vaccine makers sliding

Bio Pharma Dive

Shares in Moderna, Vaxcyte, Novavax and BioNTech all fell Monday after Peter Marks, head of the FDA office that reviews vaccines, resigned on Friday.

Vaccine 250
article thumbnail

Saving shelved ultra-rare therapies through unorthodox funding

Pharmaceutical Technology

Non-profit organisations provide an alternative to rescue stalled orphan drugs for biotechs struggling against a lethargic investment climate.

Drugs 147
article thumbnail

Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

article thumbnail

How discoverable, comparable and explorable is your data?

Bio Pharma Dive

Accelerate biomarker research with high-quality, expert-curated data to drive precision medicine.

Medicine 246
article thumbnail

ACC 2025: Imbria’s ninerafaxstat data shows potential for cardiometabolic HFpEF

Pharmaceutical Technology

Based on the Phase II data, Imbria Pharmaceuticals inerafaxstat could complement existing treatments rather than replace them.

130
130

More Trending

article thumbnail

Ukraine ramps up cost-containment measures to “stabilise” retail drug market

Pharmaceutical Technology

The Ukrainian government has instigated rapid cost-cutting measures across the drug retail sector, triggered by reports of overpricing.

article thumbnail

Isomorphic raises $600M on big ambitions for AI drugmaking tech

Bio Pharma Dive

The drug discovery company, which has partnerships with Eli Lilly and Novartis, is developing AI models to design drugs and predict molecular structures.

Drugs 143
article thumbnail

Cell and gene therapy collections: The need for consistency

Pharmaceutical Technology

For cell and gene therapy, a consistent supply of quality starting material is vital that is maintained throughout the treatment life cycle.

article thumbnail

Lilly to appeal after CHMP rejects Alzheimer's drug Kisunla

pharmaphorum

The CHMP has advised against EU approval of Eli Lilly's Alzheimer's drug Kisunla, potentially handing an advantage to Eisai/Biogen's rival drug

Drugs 98
article thumbnail

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

article thumbnail

Sanofi’s Qfitlia approved by FDA as first haemophilia therapy for all patients

Pharmaceutical Technology

Despite a haemophilia market bustling with rivals, Qfitlias broad label and favourable dosing regimen could give it an upper hand.

Marketing 130
article thumbnail

ACC25: Ozempic shows its value in PAD

pharmaphorum

Novo Nordisk's Ozempic has been shown to improve walking distance in people with diabetes and peripheral artery disease in the STRIDE trial

Trials 78
article thumbnail

Vertex halts development of diabetes cell therapy after trial failure

Pharmaceutical Technology

Vertex continues to develop type 1 diabetes therapy, zimislecel, which is being investigated in a Phase III trial.

article thumbnail

Industry alarm as FDA's CBER head Peter Marks resigns

pharmaphorum

Industry organisations are alarmed by the resignation of senior FDA official Peter Marks, citing "misinformation and lies" by HHS Secretary Kennedy

76
article thumbnail

Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

article thumbnail

Biopharma IPOs showed signs of recovery in 2024

Pharmaceutical Technology

Completed biopharma IPOs that raised more than $100 million witnessed an almost twofold increase during 2024.

130
130
article thumbnail

Alphabet's Isomorphic raises $600m for AI drug discovery

pharmaphorum

Isomorphic Labs has raised a whopping $600 million to refine its artificial intelligence-powered drug discovery engine and advance its pipeline.

article thumbnail

Hubs East 2025: Balancing Technology, Personalization, and Human Connection in Patient Support

Pharmaceutical Commerce

Jen Butler, chief commercial officer, Pleio, discusses the importance of balancing technology and personalization in patient support.

52
article thumbnail

New Boehringer US Head Brian Hilberdink talks GLP-1s, DtX, and more

pharmaphorum

Watch the exclusive interview with Brian Hilberdink, the new head of Boehringer US, as he discusses GLP-1s, DtX, and more in this insightful video discussion.

59
article thumbnail

The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

article thumbnail

Embarking on the CAR-T Journey

Pharmaceutical Commerce

Renier Brentjens, MD, PhD outlines the evolution of the space, while offering ways to boost patient access to these treatments.

52
article thumbnail

Accelerating Breakthroughs in Immunodermatology Drug Development

pharmaphorum

Accelerating Breakthroughs in Immunodermatology Drug Development Sara.

article thumbnail

Pharma Pulse 3/31/25: Bridging the HCP-Patient Divide, Kennedy Proposes Massive Reorganization, Staff Cuts at HHS & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

52
article thumbnail

The Home of Accelerating Microbiome R&D

pharmaphorum

The Home of Accelerating Microbiome R&D Sara.

52
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

ACC 25: Oral semaglutide reduces cardiovascular events in T2D patients

Pharmaceutical Technology

Use of GLP-1RA therapies in CV/CKD disease with T2D will likely rise as physicians view them as addressers of cardiometabolic syndrome.

130
130
article thumbnail

For the continuum of mental health we need a whole system, holistic 'healthspan'

pharmaphorum

At Anthropy 2025: Rebooting Britain, web editor Nicole Raleigh sat down with Dr Sebastian Vaughn, CEO of Phytome Life Sciences, for an en plein air and explorative conversation around the topic of mental health, live onsite at The Eden Project in Cornwall, following the Adelphi sponsored panel, Revolutionary Thinking for Mental Health.

article thumbnail

Federal District Court Vacates FDA’s Laboratory Developed Tests Final Rule

FDA Law Blog

By Steven J. Gonzalez On March 31, 2025, U.S. District Judge Sean D. Jordan ordered that FDAs Laboratory Developed Tests (LDT) Final Rule be vacated and set aside, in its entirety. That Rule sought to codify FDAs view that LDTs are medical devices subject to FDA regulation under the Food, Drug, and Cosmetic Act (FDCA) and then phase out, over a four-year period, FDAs purported policy of enforcement discretion for such tests.

article thumbnail

ACC25: Positive results with Lilly's Lp(a)-lowering drug

pharmaphorum

Eli Lilly's lepodisiran has been shown to reduce Lp(a) levels by more than 90% for at least six months with a single injection in a phase 2 trial

Drugs 45
article thumbnail

The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

article thumbnail

The Top Pharmacy Benefit Managers of 2024: Market Share and Key Industry Developments

Drug Channels

Threes still company in the world of pharmacy benefit managers. For 2024, nearly 80% of all equivalent prescription claims were processed by three familiar companies: the CVS Caremark business of CVS Health, the Express Scripts business of Cigna, and the Optum Rx business of UnitedHealth Group. The names havent changed, but shifting relationships and contract shakeups have altered the plot, with Express Scripts stepping into a new lead role.

article thumbnail

Visby Medical’s At-Home STI Test for Women Gets FDA Nod

XTalks

The FDA has granted De Novo authorization to the Visby Medical Womens Sexual Health Test. The PCR-based test detects three of the most common and curable STIs: chlamydia, gonorrhea and trichomoniasis. The single-use test, designed for women and regardless of symptom presence, delivers results in approximately 30 minutes. It includes a self-collected vaginal swab and a powered testing device.

article thumbnail

IQED-Foot Information Meeting audit 8

Sciensano

Event type: closed meeting Audience: health professionals Description: You are kindly invited to the IQED -Foot Information Meeting of audit 8, organised by Sciensano in collaboration with the Group of Experts IQED -Foot, on behalf of the National Institute of Health and Disability Insurance ( NIHDI ). Programme 18.00 19.30 : Registration and walking dinner 19.30-22.15 : Presentations and discussion 22.30 : End Registration Please register before 10 June using this form Contact If you have any

52
article thumbnail

Fresenius Gets FDA Nod for Denosumab Biosimilars, Reaches Patent Settlement with Amgen

XTalks

Fresenius Kabi received FDA approval for its Prolia and Xgeva biosimilars, Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht), respectively. The FDA granted authorization to the denosumab biosimilars for all indications corresponding to their reference products. The agency approved Conexxence for use in adult patients at high risk for fractures.

article thumbnail

Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud