Wed.Apr 03, 2024

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Diagonal starts up with $128M to make better ‘activator’ antibody drugs

Bio Pharma Dive

The startup claims to have a more efficient way to develop biologic drugs that treat disease by turning on cellular pathways, rather than blocking them.

Antibody 299
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Large Review Finds CBD Products Don’t Relieve Chronic Pain After All

AuroBlog - Aurous Healthcare Clinical Trials blog

Evidence does not support the use of cannabidiol (CBD) products as a treatment for chronic pain, a new review found.

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Strategies for Successful Navigation of Complex Radiopharmaceutical Trials

Worldwide Clinical Trials

By: Sue Batchelor, Executive Director, Oncology Project Management Radiopharmaceuticals represent a cutting-edge frontier in oncology treatment, offering the promise of highly targeted therapy with the potential to revolutionize cancer care. As with other targeted therapies, radiopharmaceutical development requires unique and specialized strategies to ensure successful execution.

Trials 204
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Genmab buys ProfoundBio for $1.8B, adding to ADC dealmaking flurry

Bio Pharma Dive

The buyout continues a surge in M&A for developers of antibody-drug conjugates and gives Genmab a potential competitor to a medicine AbbVie recently purchased in a multibillion-dollar acquisition.

Antibody 189
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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

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April 3, 2024: In This Week’s PCT Grand Rounds, a New Look at P Values for Randomized Trials

Rethinking Clinical Trials

Dr. Erik van Zwet In this Friday’s PCT Grand Rounds, Erik van Zwet of Leiden University Medical Center will present “A New Look at P Values for Randomized Clinical Trials.” The Grand Rounds session will be held on Friday, April 5, 2024, at 1:00 pm eastern. Dr. van Zwet is an associate professor in the Department of Biomedical Data Sciences at Leiden University Medical Center in the Netherlands.

Trials 189
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DCC asks SLAs to set deadline for manufacturers to add product details to Sugam portal

AuroBlog - Aurous Healthcare Clinical Trials blog

The Drugs Consultative Committee (DCC), the advisory committee of the Central government to advise the Central and state governments on matters that require uniform implementation of drug laws across the country, has recommended to all the States to set a deadline for the manufacturing companies to upload all the formulation details in the Sugam portal, […]

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Study reveals new liquid biopsy test could benefit thousands of lung cancer patients

Pharma Times

The third most common and serious form of cancer affects over 43,000 people every year in the UK

DNA 139
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Medicare price negotiations carry on as HHS responds to Big Pharma's IRA counteroffers

Fierce Pharma

Medicare drug price negotiations under the Inflation Reduction Act are steadily progressing after drugmakers recently submitted their counteroffers to the government's initial pricing proposals.

Drugs 110
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Researchers suggest form of Alzheimer’s is transmissible via bone marrow transplants

Pharma Times

The progressive neurodegenerative disease is estimated to affect 24 million people globally

Research 112
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A critical year for drug discount management

pharmaphorum

This critical year for drug discount management includes changes to the 340B programme, implications for Medicare, and updates on the Inflation Reduction Act.

Drugs 110
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Vanda secures FDA approval for Fanapt to treat bipolar I, 15 years after schizophrenia nod

Fierce Pharma

Fifteen years after gaining its first FDA approval for Fanapt (iloperidone) to treat schizophrenia, Vanda Pharmaceuticals has scored again with the same antipsychotic drug. | Fifteen years after gaining its first FDA approval for Fanapt (iloperidone) to treat schizophrenia, Vanda Pharmaceuticals has scored again with the same antipsychotic drug. The FDA has signed off on Fanapt tablets to treat adults with manic or mixed episodes associated with bipolar I disorder.

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Cell Therapies for Chronic Kidney Disease: Featuring Bruce Culleton, CEO, ProKidney – Xtalks Life Science Podcast Ep. 153

XTalks

This episode features an interview with Bruce Culleton, MD, CEO, ProKidney , a late clinical-stage biotech company focused on the development of a pioneering cell therapy candidate that aims to transform the treatment landscape for chronic kidney disease. Prior to joining ProKidney in 2023, Dr. Culleton served as Vice President and General Manager at CVS Kidney Care and also worked in leadership roles at Becton Dickinson and Baxter healthcare.

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Thermo Fisher plots layoffs at California plasmid manufacturing site as demand swings

Fierce Pharma

Demand fluctuations have spurred Thermo Fisher Scientific to downsize at the plasmid DNA manufacturing facility the company opened a little less than three years ago, putting jobs on the chopping b | Demand fluctuations have spurred Thermo Fisher Scientific to downsize at the plasmid DNA manufacturing facility the company opened a little less than three years ago, putting jobs on the chopping block.

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Basilea completes ceftobiprole marathon with FDA approval

pharmaphorum

Basilea Pharmaceutica gets US approval for its ceftobiprole antibiotic, around 15 years after the drug was first turned down by the FDA.

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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

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AstraZeneca’s Voydeya Scores FDA Approval, Adding to Company’s Multi-Billion Dollar PNH Franchise

XTalks

The US Food and Drug Administration (FDA) has given the nod to AstraZeneca’s Voydeya (danicopan) as an add-on therapy to the company’s standard-of-care C5 inhibitors Ultomiris (ravulizumab) or Soliris (eculizumab) for the treatment of extravascular hemolysis (EVH) in adults with the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH). PNH is characterized by the destruction of red blood cells (RBCs) within blood vessels (known as intravascular hemolysis, or IVH) and white blood cell (WB

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Basilea Wins FDA Approval for Antibiotic Ending 15-Year Regulatory Quest

BioSpace

Basilea Pharmaceutica received FDA approval for its antibiotic Zevtera in three indications Wednesday, finally getting the drug across the finish line a decade and a half after the agency rejected an earlier submission.

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SimBioSys and General Inception unite to revolutionize cancer drug development

Outsourcing Pharma

Precision oncology innovator SimBioSys and General Inception have joined forces in a strategic partnership aimed at revolutionizing cancer drug development.

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Judge Rules Against Moderna in COVID-19 Patent Fight with Roivant Subsidiary

BioSpace

A Delaware judge on Wednesday agreed with Roivant subsidiary Arbutus and Genevant’s interpretation of specific patent claims regarding the lipid nanoparticle delivery system used by Moderna’s COVID-19 vaccine.

Vaccine 91
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Women in Science: Dr Laura Trotta – ‘I joined CluePoints because of the research but also the mindset’

BioPharma Reporter

Dr Laura Trotta joined CluePoints in 2015 and moved into her current role as vice president of research in January 2022, where she leads a team of research scientists responsible for developing new statistical and machine learning algorithms to assess the quality of clinical trial data.

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Companies Detail Potential Fallout as Pressure on WuXi AppTec Builds

BioSpace

Three Biopharma firms disclosed concerns about how emerging geopolitical tensions between the U.S. and China might impact their business with the contract manufacturer.

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A Conversation About Modular Content and the Relationship with MLR

Intouch Solutions

When we hear the topic “Modular Content and MLR Relationship,” we think and hear of the challenges with medical, legal and regulatory (MLR). Marketers are under immense pressure because omnichannel puts more demands on marketing to produce more content. But what’s really exciting is that AI is going to create the efficiencies that finally enable us to pull through that content.

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AstraZeneca, BMS, Pfizer Among Big Pharma to Present at Inaugural AACR Event

BioSpace

The American Association for Cancer Research has invited drug developers and investors to intermingle with the academics who typically attend its annual conference.

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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.

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Setting the standard for sustainability in pharma

pharmaphorum

Discover how James Choi, of Samsung Biologics, is setting the standard for sustainability in the pharmaceutical industry. Learn about the company's initiatives and commitment to environmental responsibility.

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Sanofi Agrees to Settle 4,000 Zantac Cancer Lawsuits in US State Courts

BioSpace

Sanofi has in principle reached a settlement related to its discontinued heartburn drug Zantac, though the French pharma did not disclose the financial terms of the deal.

Drugs 87
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The Big Three PBMs’ 2024 Formulary Exclusions: Biosimilar Humira Battles, CVS Health’s Weird Strategy, and the Insulin Shakeup (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for Friday’s live video webinar: Drug Channel Implications of the Inflation Reduction Act. The 2024 formularies described below should boost biosimilar adoption. As a new Biosimilar Council report shows , Humira retained 99% of market share in late 2023, despite being more expensive than its biosimilars.

Insulin 52
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How to Manage Your Manager: Tips for Managing Up

BioSpace

There are several ways you can maintain a good working relationship with your boss, starting with learning your manager’s work style, preferences and priorities.

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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

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Cartherics partners with TiCARos to spearhead CLIP-CAR technology

BioPharma Reporter

Cartherics has entered a collaborative research agreement with TiCARos, to assess the company's proprietary CLIP-CAR technology in its induced pluripotent stem cell (iPSC)-derived natural killer (NK) cells.

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Moderna Moves Cambridge Employees Into New Headquarters

BioSpace

The new Cambridge, Mass.–based facility is about 460,000 square feet. Labs occupy nearly 50% of the space.

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Molecure reports accelerated progress in clinical and preclinical programs for 2023

BioPharma Reporter

Molecure S.A., a leading biotechnology company focused on drug discovery and development, has unveiled its annual report for 2023 at the start of the new financial year.

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Merck KGaA, Caris Sign Potential $1.4B Deal to Develop First-in-Class ADCs for Cancer

BioSpace

Amid a flurry of deals in the antibody-drug conjugate space, Merck KGaA is getting in on the action with a partnership with Caris Life Sciences to accelerate the discovery and development of first-in-class ADCs for oncology.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.