Fri.Oct 04, 2024

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An Alzheimer’s drugmaker is accused of data manipulation. Should its trials be stopped?

Bio Pharma Dive

An experimental Alzheimer’s therapy from Cassava Sciences is still being tested in two Phase 3 studies, even as the company has come under regulatory scrutiny.

Trials 360
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Editas trades part of Vertex CRISPR therapy licencing rights deal for $57m

Pharmaceutical Technology

Amidst the long-running Cas9 patent battle, Editas Medicine has struck a deal to sell a portion of its future revenue…

Medicine 245
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Sanofi’s rare disease drug finds yet another home

Bio Pharma Dive

Having already been on a winding journey, Enjaymo, which Sanofi acquired through a 2018 buyout of Bioverativ, is now headed to Recordati as part of a deal announced Friday.

Drugs 167
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Teva and mAbxience partner to develop biosimilar candidate for oncology

Pharmaceutical Technology

Teva Pharmaceuticals International and mAbxience have entered into a worldwide licencing agreement to develop an anti programmed cell death protein 1 oncology biosimilar candidate.

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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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Opdivo gets ‘perioperative’ approval; pharmas cut jobs in New Jersey, Ireland

Bio Pharma Dive

Bristol Myers' immunotherapy can now be used before and after surgery in the U.S. Elsewhere, J&J, Bayer, Bristol Myers Squibb and Pfizer are trimming staff.

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Recordati to acquire worldwide rights to Sanofi’s antibody Enjaymo

Pharmaceutical Technology

Recordati has reached an agreement with Sanofi for acquiring the worldwide rights to Enjaymo, the only approved treatment specifically targeting cold agglutinin disease (CAD), a rare B-cell lymphoproliferative disorder.

Antibody 130

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BMS receives FDA approval for Opdivo to treat NSCLC

Pharmaceutical Technology

Bristol Myers Squibb (BMS) has received approval from the US Food and Drug Administration (FDA) for Opdivo to treat adults with resectable non-small cell lung cancer (NSCLC).

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US' top IV fluid maker Baxter voices uncertainty about recovery timeline at NC facility hit by Helene

Fierce Pharma

After announcing the closure of its biggest manufacturing site Sunday due to flooding caused by Hurricane Helene, Baxter International—the U.S.’ top supplier of hospital IV fluids—is laying out det | While progress is already being made after Hurricane Helene, which resulted in water “permeating” Baxter’s large IV fluid production plant in North Carolina, the company cautioned that it does not yet have a timeline for when operations will be back online.

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Resilience secures funds to enhance production of essential medicine components

Pharmaceutical Technology

National Resilience’s subsidiary Resilience Government Services has received around $17.5m in funding for expanding critical medicine components manufacturing.

Medicine 130
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FDA approval give BMS an edge in NSCLC treatment

pharmaphorum

Bristol Myers Squibb (BMS) has been granted approval by the US Food and Drug Administration (FDA) for Opdivo to treat adults with resectable non-small cell lung cancer (NSCLC).

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

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FDA lifts clinical hold on Avidity’s lead antibody conjugate therapy trial

Pharmaceutical Technology

Two years after the FDA placed partial clinical hold, Avidity can resume research of del-desiran as a treatment for myotonic dystrophy type 1.

Antibody 130
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Women in Science - SCIEX Rebekah Sayers' on encouraging curiosity

BioPharma Reporter

Rebekah's father passed on his passion for science and problem solving to her and much her of childhood was spent doing fun hands-on activities from taking apart household mechanics to building rockets.

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The benefits of using a nimble platform from phase to phase

Pharmaceutical Technology

It is common for sponsors to switch digital platforms between clinical trial phases, but sponsors can achieve much by using the same one.

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Mounjaro and Zepbound shortages over, declares FDA

pharmaphorum

FDA declares an end to tirzepatide shortage, the active ingredient in Eli Lilly’s popular weight loss medication Zepbound and diabetes drug Mounjaro.

Drugs 110
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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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NHS proposes phased launch for Eli Lilly’s Mounjaro

Pharmaceutical Technology

The roadmap suggests those with the greatest clinical need will get priority access, according to the NHS national medical director.

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Creating Inclusive Clinical Trials: Why Authenticity and Patient Stories Are Essential

XTalks

The push to increase diversity in clinical trials has gained momentum, but true progress requires more than regulatory mandates. It involves building trust, fostering authentic relationships and amplifying the voices of those most impacted by health inequities. While the pharmaceutical industry has made strides in improving patient diversity in clinical trials, a recent webinar moderated by Kevin Aniskovich, CEO of Jumo Health, underscored that much work remains to ensure trials are truly inclus

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WuXi debates sale of pharma operations as BIOSECURE Act advances

Pharmaceutical Technology

WuXi is considering the sale of some US and European operations to mitigate the impact of upcoming restrictions.

Sales 130
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Cologuard Plus Gains FDA Nod, Offers Enhanced Colorectal Cancer Detection

XTalks

The US Food and Drug Administration (FDA) has approved Exact Sciences’ Cologuard Plus, a next-generation, non-invasive colorectal cancer (CRC) screening test for adults aged 45 and older at average risk for CRC. Cologuard Plus builds on the original Cologuard test by incorporating enhanced biomarkers and laboratory processes, offering a more effective way to detect CRC at earlier, treatable stages and identify advanced precancers.

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

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In sustained rare disease push, Recordati lays out $825M upfront to acquire Sanofi's CAD drug Enjaymo

Fierce Pharma

As Sanofi continues to clean out its medicine chest, Italy’s Recordati is getting in on the action. | Recordati is floating $825 million upfront—plus another $250 million in potential commercial milestones—to get its hands on the global rights to Sanofi’s rare disease biologic Enjaymo. In 2022, Enjaymo became the first and only therapy specifically approved by the FDA for treating patients with the uncommon blood disorder cold agglutinin disease.

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How specialized vendors improve patient recruitment success

Outsourcing Pharma

Patient recruitment is a critical and often challenging aspect of clinical trials, particularly for biopharmaceutical companies seeking to accelerate drug development.

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Innovative Models for Improving Access and Visibility for Specialty-Lite and Retail Therapies

Drug Channels

Today’s guest post comes from Timothy Nielsen, Vice President of Customer Success at AssistRx. Timothy discusses the affordability and patient journey challenges of specialty-lite products for patients, manufacturers, and health care providers. He explains how AssistRx's Advanced Access Anywhere (AAA) solution streamlines processes for specialty-lite products and facilitates enrollment via a digital hub.

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From CDMOs to artificial intelligence - what's the latest in the world of outsourcing?

Outsourcing Pharma

Outsourcing Pharma sat down ahead of CPHI with Dr Andreas Raabe, CEO of Adragos Pharma, to explore the evolving world of pharmaceutical outsourcing.

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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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EVERSANA INTOUCH Shines at the 2024 PM360 Trailblazer Awards with Five Wins 

Intouch Solutions

The 16th annual PM360 Trailblazer Awards was a night to remember for EVERSANA INTOUCH! Our team was honored at Gotham Hall in New York City, taking home five awards across several categories: Gold: Marketing Team of the Year – Corcept Therapeutics Gold: Consumer Website/Online Initiative – Eczema Skin Gallery, Sanofi, Regeneron Pharmaceuticals, Inc.

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KOL Collaboration Series: Pharmacy Desert Prevalence

Pharmaceutical Commerce

In this video interview with Pharma Commerce Editor Nicholas Saraceno, John Stefankiewicz, VP of Analytics, Cencora, details why these pharmacy deserts have become so widespread.

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Advances in Imaging of Rheumatoid Arthritis

WCG Clinical

Rheumatoid arthritis (RA) is the most common of the inflammatory arthropathies, affecting nearly 1% of the population with a female preponderance. Onset is typically between 45 and 65 years of age. While the etiology RA is unknown, it is thought to be largely autoimmune. Lack of treatment results in rapid progression of disease with significant joint destruction, pain, and loss of function.

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Modulating the Code: The Promise of Epigenetic Therapeutics in Alcohol-Associated Hepatitis ft. DURECT President and CEO Dr. James Brown

XTalks

In this episode, Ayesha spoke with James E. Brown, DVM, co-founder, President and CEO of DURECT. DURECT is pioneering a therapeutic strategy by leveraging the potential of epigenetic modulation to alter the trajectory of severe and life-threatening conditions like acute organ injury and cancer. The company is specifically focused on the development of an epigenetic modulator, larsucosterol (DUR-928) for the treatment of alcohol-associated hepatitis (AH).

Doctors 52
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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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Strengthening the Chain

Pharmaceutical Commerce

Headlining our October issue of Pharmaceutical Commerce is a look inside an emerging key component of cold chain transport and management—ensuring the safety and control of novel injectable drugs through to their "last mile.

Drugs 52
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World Cerebral Palsy Day 2024: Uniquely CP

XTalks

October 6 is World Cerebral Palsy Day , an annual global event that helps raise awareness about cerebral palsy, and celebrate the lives and accomplishments of individuals living with the condition. Many will wear green to celebrate World Cerebral Palsy Day 2024. The theme of this year’s World Cerebral Palsy Day is “Uniquely CP,” which encourages individuals with the condition, their family members and supporters to share stories about their achievements and passions, highlighting how cerebral pa

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LSX 2024 - Luba Greenwood and Hakim Yadi

pharmaphorum

LSX 2024 features an insightful interview with Hakim Yadi and Luba Greenwood, discussing innovation, healthcare, and more. Learn from their expertise and perspectives in this exclusive discussion.

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Three new life science start-ups thrive at Discovery Park

Drug Discovery Today

Sandwich, Kent, UK. 24th September 2024 A group of former Pfizer employees have successfully created their own businesses based at and supported by Discovery Park, a thriving life sciences community in Kent.

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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.