Fierce Pharma
DECEMBER 2, 2024
Robert F. Kennedy Jr.’s appointment last month to lead the U.S. Department of Health and Human Services immediately sent waves of speculation swirling throughout the biopharma industry. | The former FDA Commissioner pointed to the threat of measles if vaccination rates were to decline by 5%.
Bio Pharma Dive
DECEMBER 2, 2024
At the center of a new licensing deal is an experimental medicine, PTC518, which is currently being tested in a roughly 250-person study that should produce results next year.
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Rethinking Clinical Trials
DECEMBER 2, 2024
From left to right: Drs. David Wetter, Guilherme Del Fiol, and Ken Kawamoto, principal investigators for LungSMART The NIH Pragmatic Trials Collaboratory is pleased to welcome LungSMART (Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers) to its portfolio of innovative NIH Collaboratory Trials. Lung cancer is the leading cause of cancer-related deaths in the United States, but only 6.5% of eligible individuals were screened for lung cancer in 20
Bio Pharma Dive
DECEMBER 2, 2024
Next-generation sequencing allows for critical insights into gene therapy products, which can help streamline and accelerate everything from process development and production to regulatory approval.
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
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 2, 2024
(Ivan Rodriguez Alba/E+/Getty Images) Nearly half of adolescents and three-quarters of adults in the US were classified as being clinically overweight or obese in 2021. The rates have more than doubled compared with 1990.
Bio Pharma Dive
DECEMBER 2, 2024
The ADA recommended doctors avoid prescribing unapproved, off-brand versions of drugs like Wegovy, wading into a dispute that has gripped the FDA and compounding pharmacies over the past few months.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
DECEMBER 2, 2024
Using tumor-treating fields alongside chemotherapy improved patient survival, Novocure said. Elsewhere, Cytokinetics got a key PDUFA date and Fate Therapeutics swapped CEOs.
Pharmaceutical Technology
DECEMBER 2, 2024
CBC Group has completed the strategic acquisition of UCB's mature neurology and allergy business in China for $680m.
Bio Pharma Dive
DECEMBER 2, 2024
Executives at Applied Therapeutics told analysts they were surprised by the agency’s refusal to approve the company’s treatment for classic galactosemia.
Pharmaceutical Technology
DECEMBER 2, 2024
The research team at UQ has secured a grant of $344,000 from the National Foundation for Medical Research and Innovation.
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 2, 2024
The Department Related Standing Committee on Chemicals and Fertilisers, recently reconstituted under the chairpersonship of Lok Sabha member Kirti Azad Jha, will be delving into various aspects of the pharmaceutical sector including the price rise of medicines, need for stringent regulatory reforms, among others as the main subjects during its tenure.
Pharmaceutical Technology
DECEMBER 2, 2024
The EMA’s CHMP has endorsed expanding the use of Palforzia to toddlers aged one to three years with peanut allergies.
Rethinking Clinical Trials
DECEMBER 2, 2024
Speaker Paul J. Karanicolas, MD, PhD, FRCSC Associate Professor of Emergency Medicine and Epidemiology The Edmond Odette Cancer Centre @ Sunnybrook Health Sciences Centre Professor of Surgery University of Toronto Slides Keywords Liver Cancer; Liver Resection; Blood Transfusions Key Points Liver resection is a major operation.
Pharmaceutical Technology
DECEMBER 2, 2024
The MHRA has also granted approval to Faron Pharmaceuticals to conduct the BEXMAB trial of Clevegen in the UK.
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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
Fierce Pharma
DECEMBER 2, 2024
Shortly after a similarly sized venture from Pfizer, French pharma juggernaut Sanofi has unveiled a major manufacturing outlay in China, marking its biggest investment in the country to date. | Sanofi is laying out roughly 1 billion euros ($1.04 billion) to establish a new production base in the Beijing Economic and Technological Development Zone. The new manufacturing site, which will become Sanofi’s fourth in China, is being designed to beef up local end-to-end insulin production.
Drug Patent Watch
DECEMBER 2, 2024
The traditional marketing models that once dominated the pharmaceutical industry are rapidly becoming obsolete, paving the way for innovative approaches that leverage technology, data, and patient-centricity. This comprehensive guide explores the new business models reshaping pharmaceutical marketing, offering insights into how companies can transform their strategies to achieve market domination.
Fierce Pharma
DECEMBER 2, 2024
The FDA is investigating reports of patients develo | The FDA is investigating reports of patients developing blood cancer after receiving bluebird bio’s gene therapy Skysona and is evaluating the need for “further regulatory action,” the U.S. agency said last week. The FDA notification came seven weeks after the New England Journal of Medicine (NEJM) published a report that seven of 67 children who received Skysona during clinical trials had developed blood cancer.
XTalks
DECEMBER 2, 2024
Grammy-winning artist Lil Jon has joined forces with Exact Sciences in a dynamic campaign to boost awareness about colon cancer screening. Dubbed “Get Low #2,” the initiative reimagines his iconic early 2000s hit to drive a critical message: encouraging the approximately 60 million Americans overdue for colon cancer screening to prioritize their health.
Fierce Pharma
DECEMBER 2, 2024
After a rough few months for Intercept and Advanz Pharma's Ocaliva on both sides of the Atlantic, the other shoe has dropped for the rare liver disease drug in Europe. | The General Court of the European Union decided not to extend a suspension of the European Commission’s decision to revoke Ocaliva’s marketing authorization. In turn, Intercept's liver disease drug, which is marketed by Advanz Pharma overseas, has lost its EU approval.
XTalks
DECEMBER 2, 2024
The US Food and Drug Administration (FDA) has approved AOP Health’s landiolol injection, marketed as Rapiblyk, for the treatment of atrial fibrillation (Afib) and atrial flutter in critical care settings. These conditions, collectively known as supraventricular tachycardias, involve the heart beating too fast or irregularly, leading to acute complications.
pharmaphorum
DECEMBER 2, 2024
Four years after buying US rights to GAIA's digital therapeutic to help people with depression, Swedish drugmaker Orexo has terminated the deal.
Pharma Times
DECEMBER 2, 2024
Race to create first oral drug for obesity intensifies
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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.
pharmaphorum
DECEMBER 2, 2024
Novartis has made a return to the Huntington's disease stage by licensing an oral mRNA splicer from PTC Therapeutics for $1 billion upfront
FDA Law Blog
DECEMBER 2, 2024
By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Kristy Katzenmeyer-Pleuss, Regulatory and Biological Safety Consultant* — We recently blogged on FDA’s draft guidance, Chemical Analysis for Biocompatibility Assessment of Medical Devices , which describes chemical characterization methods that may be used to demonstrate biocompatibility of a medical device as an alternative to conducting certain biological testing.
pharmaphorum
DECEMBER 2, 2024
Bristol-Myers Squibb has become the latest pharma in the US to file a legal challenge to a block on a 340B drug rebate model opposed by HRSA.
Antidote
DECEMBER 2, 2024
Launching a clinical trial is a complex and challenging process, with many moving parts to consider. From navigating regulatory requirements to recruiting the right patients, sponsors often face significant hurdles. One decision is selecting a vendor to support patient recruitment throughout the trial. While it might seem like a decision that can be made after the trial launches, there are compelling reasons why partnering with a dedicated patient recruitment vendor right from the beginning is a
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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
Intouch Solutions
DECEMBER 2, 2024
In the rapidly evolving landscape of direct-to-consumer (DTC) marketing, artificial intelligence (AI) is emerging as a transformative force. For large pharmaceutical companies and their senior brand marketers, understanding and leveraging AI can significantly enhance the effectiveness and efficiency of their marketing strategies. Here’s how AI is reshaping DTC marketing and what it means for the industry.
Pharmaceutical Commerce
DECEMBER 2, 2024
Predictive maintenance in pharmaceutical production can help reduce downtime and increase efficiency. Grundfos Machine Health (GMH) uses artificial intelligence (AI)-driven wireless sensors to monitor motor health in real-time, identifying potential issues. This approach not only reduces maintenance costs but also ensures compliance with industry standards.
Drug Discovery World podcast
DECEMBER 2, 2024
The latest episode of the DDW Highlights podcast is now available. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. This week’s leading news stories all feature early-stage clinical trials, including a short interfering RNA for cardiovascular disease, a new type of drug for type 2 diabetes, a gene therapy for Duchenne muscular dystrophy, a T cell therapy for hepatitis B, and a monoclonal antibody to prevent respiratory s
pharmaphorum
DECEMBER 2, 2024
Part Two: Understand the challenges faced by drug manufacturers when navigating the complexities of global market access for rare and complex conditions. Learn how to overcome these obstacles successfully.
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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.
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