WCG Clinical
OCTOBER 11, 2024
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.
Bio Pharma Dive
OCTOBER 11, 2024
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.
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Pharmaceutical Technology
OCTOBER 11, 2024
Plaque psoriasis is a chronic condition that affects millions yet is often misunderstood or underappreciated in terms of its broader impact
Bio Pharma Dive
OCTOBER 11, 2024
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.
Pharmaceutical Technology
OCTOBER 11, 2024
At CPHI Europe, Angela Vollstedt, global director of Cell & Gene Therapies at Novartis discussed scale up strategies for cell therapies.
Fierce Pharma
OCTOBER 11, 2024
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
OCTOBER 11, 2024
Rumours that Sanofi was in discussion with private equity groups over the sale of its consumer health business Opella have been confirmed – at least partially.The French pharma group confirmed this morning that it has entered into talks with US-based Clayton Dubilier & Rice to sell a controlling 50% stake in the unit for what has been estimated by Reuters to be in the region of €15 billion ($16.4 billion).
Pharmaceutical Technology
OCTOBER 11, 2024
XtalPi's AI biologics discovery platform, XtalFold, has been licensed to Janssen Biotech for advanced biotherapeutics development.
pharmaphorum
OCTOBER 11, 2024
US Senator Elizabeth Warren asks FTC to scrutinise $16.5bn Novo Holdings/Catalent merger and sale of manufacturing plants to Novo Nordisk.
Pharmaceutical Technology
OCTOBER 11, 2024
KeyBioscience and Eli Lilly have extended their partnership to develop a new class of treatments for obesity and associated disorders.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Drug Channels
OCTOBER 11, 2024
Today’s guest post comes from Angie Franks, Chief Executive Officer of Kalderos. Angie discusses how the Maximum Fair Price provision of the Inflation Reduction Act of 2022 will challenge providers, pharmacies, and manufacturers. She explains how Kalderos’ Truzo platform could reduce duplicate claims and address compliance issues. To learn more, register for Kalderos’ October 25 webinar Cracking the MFP Code: How Flexible Technology Helps You Navigate an Evolving Landscape.
Pharmaceutical Technology
OCTOBER 11, 2024
The Cardiovascular and Renal Drugs Advisory Committee voted 10-6 in support of Stealth’s elamipretide for the ultra-rare disorder.
BioPharma Reporter
OCTOBER 11, 2024
Jane Koo, head of regulatory affairs at CTMC, plays an important role in accelerating the development and commercialization of innovative cellular therapies.
Pharmaceutical Technology
OCTOBER 11, 2024
Imuldosa is the latest FDA-approved biosimilar of J&J’s blockbuster therapy for the treatment of certain autoimmune diseases.
pharmaphorum
OCTOBER 11, 2024
FDA gives Roche the first approval for PI3K inhibitor Itovebi, clearing the drug for certain types of advanced breast cancer
Pharmaceutical Technology
OCTOBER 11, 2024
Starboard has accused Pfizer of “coercive conduct” after executives who initially backed the hedge fund retracted their support.
Pharmaceutical Commerce
OCTOBER 11, 2024
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.
Pharmaceutical Technology
OCTOBER 11, 2024
The US FDA approved Itovebi in combination with Pfizer’s Ibrance and AstraZeneca’s Faslodex for certain breast cancer patients.
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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.
Fierce Pharma
OCTOBER 11, 2024
A little over four years after being sued by the United States, Teva is putting longstanding allegations that it paid kickbacks on a popular multiple sclerosis drug to bed. | Teva Pharmaceuticals USA and Teva Neuroscience have agreed to pay a combined $450 million to resolve claims that the company violated the United States' Anti-Kickback Statute and the False Claims Act, the U.S.
Pharmaceutical Technology
OCTOBER 11, 2024
High-concentration monoclonal antibodies (mAbs) are gaining prominence given the compliance and cost advantages.
BioPharma Reporter
OCTOBER 11, 2024
At the forefront of precision dosing, Sharmeen leads DoseMe's efforts to transform personalized medicine from lab research to bedside application.
Fierce Pharma
OCTOBER 11, 2024
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.
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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
pharmaphorum
OCTOBER 11, 2024
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.
Fierce Pharma
OCTOBER 11, 2024
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.
XTalks
OCTOBER 11, 2024
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.
Fierce Pharma
OCTOBER 11, 2024
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.
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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.
Pharmaceutical Commerce
OCTOBER 11, 2024
Lucy Alexander, capabilities lead, global supply chain and strategy, AstraZeneca, discusses how to handle opposing concerns between supply chain teams and offers communication solutions.
XTalks
OCTOBER 11, 2024
In its latest update on its North Carolina manufacturing facility in the aftermath of Hurricane Helene, Baxter International said it aims to gradually resume production at its North Cove facility in North Carolina. In a securities filing on Wednesday, October 9, Baxter announced the company expects to restore production to 90 percent to 100 percent of the allocated supply for certain intravenous (IV) solution products by the end of 2024.
pharmaphorum
OCTOBER 11, 2024
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.
XTalks
OCTOBER 11, 2024
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.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
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