Fri.Oct 11, 2024

article thumbnail

Tissue Iron Deposition : MRI Quantitation in Clinical Trials

WCG Clinical

During the last decade, MRI techniques have been developed which allow noninvasive detection and quantitation of iron in body tissues such as liver, heart, and pancreas. Quantitation of cardiac iron is especially important, as this is the key predictor of cardiac dysfunction and these measurements inform decisions about the effectiveness of iron chelation therapy.

article thumbnail

Sanofi may have found a buyer for its consumer health business

Bio Pharma Dive

The French pharmaceutical giant said it’s in negotiations to sell a controlling stake of Opella to the private equity firm CD&R, in a deal that reportedly could be worth more than $16 billion.

296
296
Insiders

Sign Up for our Newsletter

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

article thumbnail

Activist investor Starboard cries foul play in exec U-turn at Pfizer

Pharmaceutical Technology

Starboard has accused Pfizer of “coercive conduct” after executives who initially backed the hedge fund retracted their support.

147
147
article thumbnail

FDA clears Roche breast cancer drug; Turnstone lays off 60% of staff

Bio Pharma Dive

Itovebi is part of a push by Roche to make new inroads in breast cancer. Elsewhere, Turnstone is trimming preclinical research and Gritstone bio is working on a bankruptcy deal.

Drugs 162
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

South Korean company Dong-A ST wins FDA approval for Stelara biosimilar

Pharmaceutical Technology

Imuldosa is the latest FDA-approved biosimilar of J&J’s blockbuster therapy for the treatment of certain autoimmune diseases.

article thumbnail

Pfizer doubles down with its 2nd FDA hemophilia approval in 6 months

Fierce Pharma

Six months after scoring FDA approval for hemophilia B gene therapy Beqvez, Pf | For the second time in six months, the FDA approved a Pfizer treatment for hemophilia. On Friday the U.S. regulator signed off on Hympavzi, an anti-tissue factor pathway inhibitor for patients age 12 and older with hemophilia A or B.

More Trending

article thumbnail

Lawmaker asks FTC to probe Novo/Catalent deal

pharmaphorum

US Senator Elizabeth Warren asks FTC to scrutinise $16.5bn Novo Holdings/Catalent merger and sale of manufacturing plants to Novo Nordisk.

Sales 114
article thumbnail

Global awareness and geographic variations of plaque psoriasis

Pharmaceutical Technology

Plaque psoriasis is a chronic condition that affects millions yet is often misunderstood or underappreciated in terms of its broader impact

130
130
article thumbnail

Evonik telegraphs another 260 layoffs amid multiyear reorganization

Fierce Pharma

Earlier this year, Evonik unveiled a restructuring project that will result in up to 2,000 layoffs. | After Evonik in March unveiled a restructuring project that will result in up to 2,000 layoffs, the company is now announcing another round of job cuts as it retools portions of its drug ingredients and nutrition businesses.

Drugs 111
article thumbnail

FDA AdCom votes in favour of Stealth’s Barth syndrome drug

Pharmaceutical Technology

The Cardiovascular and Renal Drugs Advisory Committee voted 10-6 in support of Stealth’s elamipretide for the ultra-rare disorder.

Drugs 130
article thumbnail

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

article thumbnail

Roche gets FDA green light for breast cancer drug Itovebi

pharmaphorum

FDA gives Roche the first approval for PI3K inhibitor Itovebi, clearing the drug for certain types of advanced breast cancer

Drugs 111
article thumbnail

XtalPi’s AI biologics discovery platform licensed to Janssen Biotech

Pharmaceutical Technology

XtalPi's AI biologics discovery platform, XtalFold, has been licensed to Janssen Biotech for advanced biotherapeutics development.

Licensing 130
article thumbnail

Facing Potential Drug Shortages, FDA Delays Enforcement of DSCSA Compliance Deadline, with Stipulations

Pharmaceutical Commerce

The now-11-year odyssey to track drugs by item through the supply chain will be under a regulatory exemption for up to two years.

article thumbnail

Booster Therapeutics to develop proteasome activator medicines

Pharmaceutical Technology

Booster Therapeutics has announced its inception to develop a new class of proteasome activator medicines for neurodegenerative diseases.

Medicine 130
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

Arexvy Shows Strong Efficacy Over Three RSV Seasons in New Phase III Data

XTalks

GSK’s latest Phase III AReSVi-006 trial data — presented at the CHEST 2024 Annual Meeting — showed that a single dose of Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) offers sustained protection over three full respiratory syncytial virus (RSV) seasons in adults aged 60 and older, including those at higher risk due to underlying conditions.

Vaccine 103
article thumbnail

CPHI Europe: Overcoming the unique challenges with high-concentration mAbs

Pharmaceutical Technology

High-concentration monoclonal antibodies (mAbs) are gaining prominence given the compliance and cost advantages.

article thumbnail

Updating of England’s budget impact test threshold

pharmaphorum

Stay updated on the impact test threshold for England's budget, particularly as it relates to the NHS. Learn how changes may affect healthcare funding and services.

98
article thumbnail

CPHI Milan: Targeting supply chain bottlenecks key for cell and gene therapies

Pharmaceutical Technology

At CPHI Europe, Angela Vollstedt, global director of Cell & Gene Therapies at Novartis discussed scale up strategies for cell therapies.

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

How to build a measurement framework to enable digital product success

pharmaphorum

Building a measurement framework is crucial for assessing the success of digital products. Learn how to create an effective measurement framework for UX to enhance product performance and user satisfaction.

article thumbnail

KeyBioscience and Eli Lilly extend partnership for obesity treatments

Pharmaceutical Technology

KeyBioscience and Eli Lilly have extended their partnership to develop a new class of treatments for obesity and associated disorders.

article thumbnail

Changing Faces – Board appointments September 2024

pharmaphorum

Changing Faces announces the appointment of new board members for Closed Loop Medicine, ARTIDIS, Roche and more in September 2024. Stay updated on the latest developments in these innovative organisations.

article thumbnail

Jane Koo on leading regulatory affairs at CTMC: A journey from mAbs to cellular therapies

BioPharma Reporter

Jane Koo, head of regulatory affairs at CTMC, plays an important role in accelerating the development and commercialization of innovative cellular therapies.

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

Hologic’s #BustTheMyth Breast Cancer Awareness Campaign

XTalks

To mark Breast Cancer Awareness Month, women’s health focused company Hologic has launched a patient education campaign called #BustTheMyth to debunk common myths about breast cancer, mammograms and breast density. The campaign focuses on empowering women with the tools and information they need to fight breast cancer. It emphasizes the importance of early detection and regular screening, a message particularly crucial in light of rising breast cancer rates.

article thumbnail

Women in Science: Sharmeen Roy - 'pharmacy is the perfect blend of all my favourite subjects'

BioPharma Reporter

At the forefront of precision dosing, Sharmeen leads DoseMe's efforts to transform personalized medicine from lab research to bedside application.

article thumbnail

Fierce Pharma Asia—AstraZeneca-CSPC heart med deal; Astellas' gene therapy pact, new cell therapy site

Fierce Pharma

AstraZeneca has bagged a cardiovascular disease candidate from China's CSPC Pharma in a deal potentially worth $2 billion. | AstraZeneca has bagged a cardiovascular disease candidate from China's CSPC Pharma in a deal potentially worth $2 billion. Astellas is shuffling its cell therapy research team and investing in a dementia gene therapy candidate.

article thumbnail

Pharma Pulse 10/11/24: Leverage AI to Lower Cost, Barriers to Cell Therapies & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

59
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

article thumbnail

Sanofi enters talks with private equity firm to sell controlling stake in consumer health unit Opella

Fierce Pharma

With reports swirling about potential interest in Sanofi’s consumer health business, the French pharma has confirmed that a deal is indeed brewing. | Sanofi has entered negotiations with private equity outfit Clayton, Dubilier & Rice to potentially sell a 50% controlling stake in its consumer health business, Opella. Sanofi first telegraphed plans to separate its consumer health arm last October.

105
105
article thumbnail

BIO-Europe's 30th Anniversary Landmark Event in Stockholm

pharmaphorum

BIO-Europe™ celebrates 30 years of facilitating partnerships this Fall. In 1994, BIO-Europe launched with the mission to drive biotech innovation and dealmaking forward through one-to-one partnering. Today, it proudly holds the mantle as Europe’s flagship partnering event.

52
article thumbnail

World Thrombosis Day 2024: Move Against Thrombosis

XTalks

World Thrombosis Day, observed on October 13, 2024, brings awareness to a global health issue that accounts for one in four deaths worldwide. This year’s theme , “Move Against Thrombosis,” emphasizes the critical role of physical movement in reducing the risk of thrombosis, particularly for those at risk due to immobility or sedentary lifestyles.

Trials 52
article thumbnail

LogiPharma USA 2024: Confronting Conflicting Priorities Between Supply Chain Partners

Pharmaceutical Commerce

Lucy Alexander, capabilities lead, global supply chain and strategy, AstraZeneca, discusses how to handle opposing concerns between supply chain teams and offers communication solutions.

52
article thumbnail

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.