Thu.Dec 07, 2023

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The Power of Personalization Amid the Changing CRO Landscape

Worldwide Clinical Trials

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. As a result, various CROs have undergone significant consolidations and acquisitions of specialized capabilities to address the escalating complexity in clinical trials.

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Radiopharma startup Artbio raises $90M in sign of field’s momentum

Bio Pharma Dive

The funding is indicative of investor interest in an area of drug research that involves at least a dozen startups and multiple publicly traded companies.

Drugs 334
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FDA fast tracks Solid Biosciences’s Duchenne gene therapy

Pharmaceutical Technology

The FDA has granted fast track designation to Solid Biosciences’s gene therapy SGT-003 for the treatment of DMD.

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Lung cancer screening recommended in Scotland, Wales and Northern Ireland

Pharma Times

The disease is one of the leading causes of cancer deaths in the UK - News - PharmaTimes

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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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Japan approves BMS’ Abecma for multiple myeloma treatment

Pharmaceutical Technology

Japan has granted approval for the sBLA of Bristol-Myers Squibb (BMS) for Abecma to treat relapsed or refractory multiple myeloma (RRMM).

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Novartis hit with FDA letter detailing 'significant' Kymriah manufacturing shortfalls

Fierce Pharma

When it comes to manufacturing cell therapies, it's often said that the "process is the product." But churning out these complex, individualized drugs has routinely tripped up even the industry's l | In recent months, Novartis has faced scrutiny from the FDA over Kymriah production shortfalls, a newly posted letter shows. The company says it's working to address the situation.

More Trending

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Partnerships for prevention: Biopharma, patients, and digital technology

pharmaphorum

Partnerships for prevention: Biopharma, patients, and digital technology Mike.

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Calcitonin Gene Related Peptide Type 1 Receptor drugs in development, 2023

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the Calcitonin Gene Related Peptide Type 1 Receptor pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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What is chronic spontaneous urticartia (chronic hives)?

Antidote

Chronic spontaneous urticaria, also called chronic idiopathic urticaria, is a type of chronic hives that come and go unexpectedly. These hives persist daily for a minimum of six weeks without a clear cause or trigger. While this condition can affect anyone at any point, women experience it twice as often as men , and it’s most common between the ages of 20 and 40.

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Calcitonin Gene Related Peptide Type 1 Receptor drugs in development, 2023

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the Calcitonin Gene Related Peptide Type 1 Receptor pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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

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Trial finds Lilly’s Olumiant could treat type 1 diabetes

pharmaphorum

Treatment with Eli Lilly’s JAK inhibitor Olumiant has been shown to preserve the function of insulin-producing pancreatic beta cells in patients with type 1 diabetes, potentially opening up a whole new avenue of therapy.

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Pfizer and Arvinas plan vepdegestrant programme expansion after data at SABCS  

Pharmaceutical Technology

The companies presented positive Phase Ib data at the 2023 SABCS meeting, and announced plans to expand the protein degrader programme.

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AbbVie swoops on Pfizer spin-out Cerevel with $8.7bn offer

pharmaphorum

AbbVie has announced its second major takeover deal in the space of a few days, offering $8.7 billion to buy central nervous system drug specialist Cerevel Therapeutics which spun out of Pfizer in 2018.

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LTS wins $1.2m grant to develop mRNA therapy patches

Pharmaceutical Technology

The Bill & Melinda Gates Foundation grant will fund the development of dissolvable microneedle array patches for administering mRNA therapies.

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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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Bringing women’s health up to speed for 21st century human healthcare

pharmaphorum

In this latest instalment of the pharmaphorum podcast, web editor Nicole Raleigh speaks with David Solomon, CEO of Mithra Pharmaceuticals, about the current women’s health landscape and what Mithra is doing on an international scale to ameliorate that.

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Strategies and innovations for reducing drug product loss in sterile filling  

Pharmaceutical Technology

Sterile filling is a critical step in pharmaceutical primary packaging. However, during this process, some drug product loss is inevitable.

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Biofidelity’s ASPYRE: The future is bright for oncology

pharmaphorum

Biofidelity’s ASPYRE: The future is bright for oncology Mike.

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Synplogen and Ginkgo Bioworks sign MoU for DNA manufacture

Pharmaceutical Technology

Synplogen and Ginkgo Bioworks have signed an MOU to expedite DNA manufacturing and gene therapy platform services in Japan.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA Weighs Gene-Editing Treatments’ Curative Possibilities Against Potential Risks

BioSpace

As Vertex and CRISPR Therapeutics’ exa-cel and Verve Therapeutics’ VERVE-101 move forward, questions remain about possible drawbacks of such therapies.

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Ipsen and Genfit secure FDA priority review for chronic liver disease drug

Pharmaceutical Technology

If approved in June 2024, Ipsen and Genfit’s elafibranor will compete with Intercept’s Ocaliva as second-line treatment options for PBC.

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Medtronic drops $738m takeover of wearable insulin pump firm

pharmaphorum

Medtech giant Medtronic has decided not to go ahead with a planned acquisition of EOFlow, a developer of patch-based insulin pumps, saying that there have been “multiple breaches” of their takeover agreement.

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AbbVie to acquire Cerevel Therapeutics for $8.7bn

Pharmaceutical Technology

AbbVie has signed a definitive agreement for the acquisition of Cerevel Therapeutics for a deal value of nearly $8.7bn in cash.

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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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What it Takes to Build a World-Class SEO and Content Strategy Team

Intouch Solutions

We are fortunate that our leadership at EVERSANA INTOUCH strives to grow and develop forward-thinking and innovative teams, all while keeping an eye on business growth and providing top-notch services to our clients. Nathan Stewart, SVP, SEO & Content Strategy, is one of those leaders, and was recently highlighted in “20 to Know in Advertising in KC,” published by the Kansas City Business Journal.

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Dr Reddy’s and Coya sign licence for ALS combination therapy

Pharmaceutical Technology

Dr Reddy's Laboratories has signed a licence agreement with Coya Therapeutics to develop and commercialise COYA 302 to treat ALS.

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Sanofi's quiet Sarclisa chalks up a first-in-class win with eyes on a first-line multiple myeloma nod

Fierce Pharma

In the currently mismatched CD38 antibody race, Sanofi’s Sarclisa has delivered a pivotal trial win, which might help the lagging follower level the playing field a little. | In the currently mismatched CD38 antibody race, Sanofi’s Sarclisa has delivered a pivotal trial win, which might help the lagging follower level the playing field a little with Johnson & Johnson.

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Sanofi says new drugs can add €10bn to sales by 2030

pharmaphorum

Sanofi said this morning that its pipeline includes 12 potential blockbuster drugs that could generate more than €10 billion ($11 billion) in annual sales by the end of the decade, a sharp increase on earlier predictions.

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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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For Merck, Lynparza fails to improve on Keytruda in first-line lung cancer

Fierce Pharma

Merck has called it quits on another attempt to enhance its powerful PD-1 inhibitor Keytruda in non-small cell lung cancer (NSCLC). | Merck has called it quits on another attempt to enhance its powerful PD-1 inhibitor Keytruda in non-small cell lung cancer just as its TIGIT program goes up in flames.

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Study reveals reducing oxygen levels for children in ICUs will save lives

Pharma Times

Around 20,000 children are admitted to ICUs every year in the UK - News - PharmaTimes

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Bristol Myers' Opdivo-Yervoy combo shows success in first-line colorectal cancer

Fierce Pharma

It’s been more than three years since Bristol Myers Squibb’s powerhouse immuno-oncology combination treatment of Opdivo and Yervoy has scored a combined FDA approval. | It’s been more than three years since Bristol Myers Squibb’s powerhouse immuno-oncology combination treatment of Opdivo and Yervoy has scored a combined FDA approval. But the duo could be on its way to a new endorsement based on a phase 3 trial that shows it can keep certain first-line colorectal cancer patients alive longer than

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Alpha 2C Adrenergic Receptor drugs in development, 2023

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the Alpha 2C Adrenergic Receptor pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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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.