Fri.Oct 11, 2024

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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.

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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.

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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.

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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 159
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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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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.

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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.

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More Trending

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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
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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

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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.

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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
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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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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.

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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.

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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.

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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.

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

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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.

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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.

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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.

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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.

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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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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.

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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.

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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.

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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.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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.

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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.

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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.

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

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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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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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.

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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.

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Baxter’s Latest Update on North Carolina Facility in Hurricane Helene Aftermath

XTalks

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.

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Sanofi in talks to sell stake in consumer health spinout

pharmaphorum

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).

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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