Bio Pharma Dive
MAY 8, 2024
Intellectual property is the foundation of the drug industry’s business model. This database will track key patent expiry dates for 30 top-selling medicines.
Pharmaceutical Technology
MAY 8, 2024
AstraZeneca has begun the global withdrawal of its Covid-19 vaccine Vaxzevria, citing a surplus of updated vaccines.
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Bio Pharma Dive
MAY 8, 2024
The move ends a turbulent saga for AstraZeneca, which successfully developed a coronavirus shot but struggled to sell it amid competition and the emergence of rare but serious side effects.
Pharmaceutical Technology
MAY 8, 2024
Coinfections can complicate disease management and hence continued surveillance and targeted intervention strategies are needed.
Bio Pharma Dive
MAY 8, 2024
The results add to an early but growing body of evidence suggesting gene therapy may improve outcomes in young kids with a genetic form of deafness.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 8, 2024
Indian medical care providers are exploring Health Exchange (HCX) platforms for reducing administrative tasks in insurance claims. It maximises cloud computing, allowing access in real-time, and secure information related to insurance claims. It enables seamless interoperability of health claim data between different systems, whilst safeguarding sensitive medical information at all costs.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 8, 2024
A previously unknown mechanism for inactivating genes that suppresses tumor formation helps explain why cancer risk is associated with an unhealthy diet or unmanaged metabolic conditions like diabetes.
Pharmaceutical Technology
MAY 8, 2024
BioVersys and GSK have announced the expansion of their partnership to expedite the clinical development of alpibectir for tuberculosis (TB).
Fierce Pharma
MAY 8, 2024
Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U. | Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U.S. state courts, according to Bloomberg.
Pharmaceutical Technology
MAY 8, 2024
Zenas signed a licencing deal for Asia-Pacific territories for the bispecific antibody, obexelimab, with Bristol Myers Squibb in September.
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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
MAY 8, 2024
Once hailed as a landmark accomplishment for the speed with which it was developed and a shining example of British innovation, the AstraZeneca coronavirus vaccine has been grounded by the European | Once hailed as a landmark accomplishment and a shining example of British innovation, the AstraZeneca coronavirus vaccine has been grounded by the European Medicines Agency (EMA).
Pharmaceutical Technology
MAY 8, 2024
We look at the top six most important trends in pharmaceutical milling and how they are shaping the industry.
Fierce Pharma
MAY 8, 2024
After Orchard Therapeutics’ gene therapy for a rare genetic disease was approved in March, Peter Marks, M.D., Ph.D., received a simple email from Commissioner Robert Califf, M.D. | After Orchard Therapeutics’ gene therapy for a rare genetic disease was approved in March, Peter Marks, M.D., Ph.D., received a simple email from Commissioner Robert Califf, M.D.
Pharmaceutical Technology
MAY 8, 2024
TerSera has obtained Health Canada approval for ZOLADEX LA 10.8mg to manage oestrogen receptor-positive (ER+) early breast cancer.
Fierce Pharma
MAY 8, 2024
Amid a U.S. | In a letter to FDA Commissioner Robert Califf, M.D., the House Committee on Oversight and Accountability chairman argued that China’s influence over global pharmaceutical supply chains constitutes an act of economic warfare against the United States.
Pharmaceutical Technology
MAY 8, 2024
At the London Biotechnology Show, Microsoft’s senior director of life sciences discussed the ethical use of GenAI.
BioSpace
MAY 8, 2024
In a fireside chat at the American Society of Gene & Cell Therapy conference, CBER Director Peter Marks spoke with Takeda’s Kristin Van Goor about how the regulator is approaching the exploding gene therapy space.
pharmaphorum
MAY 8, 2024
Regeneron’s gene therapy for otoferlin-related hearing loss restored hearing to normal levels in one profoundly deaf child within just 24 weeks
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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.
BioSpace
MAY 8, 2024
AstraZeneca announced that it will voluntarily pull Vaxzevria from the global market amid a sharp decline in demand and following the company’s recent admission that its vaccine is linked with a rare side effect.
Intouch Solutions
MAY 8, 2024
There are no shortage of detailed recaps coming out of the 2024 Adobe Summit – and no shortage of presentation recordings to view in post if you’ve found yourself abundant with extra hours – so rather than a play-by-play, here instead are some observations from the floor and a synthesis (and a few predictions) of what all that was abuzz at Adobe Summit may indicate for the work we all do.
BioSpace
MAY 8, 2024
Pfizer’s investigational Duchenne muscular dystrophy gene therapy fordadistrogene movaparvovec has been hit with another patient death, forcing the pharma to pause dosing in its Phase III study.
BioPharma Reporter
MAY 8, 2024
Courtney Noah works in scientific affairs at BioIVT and after an amazing biology teacher in grade nine gave her a passion for science, she then followed the same teacher through her education.
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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
MAY 8, 2024
The first commercial sales of Spectral AI's DeepView wound imaging system for burns are due to start in the UK, its first market, later this year
XTalks
MAY 8, 2024
In this episode, Ayesha spoke with William Schaffner, MD, Professor of Preventive Medicine Health Policy and Professor in the Division of Infectious Diseases at Vanderbilt University; and Kelly Moore, MD, MPH, President and CEO at Immunize.org and Associate Professor of Health Policy at Vanderbilt University. Dr. Schaffner and Dr. Moore discussed the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommendation of a trivalent influenza vaccine strain selection,
BioSpace
MAY 8, 2024
A new BioSpace report finds that life science professionals are prioritizing diversity less when job hunting. Still, DEIB programs don’t appear to be going anywhere.
pharmaphorum
MAY 8, 2024
Get to know Ariel Buda-Levin from the IPG Health Network better with these 12 insightful questions. Learn more about her background, expertise, and experiences.
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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.
BioSpace
MAY 8, 2024
AAVs and accelerated approval are just two of the topics being discussed at ASGCT. Meanwhile, the race between Vertex and bluebird bio’s gene therapies Casgevy and Lyfgenia is heating up.
Pharma Times
MAY 8, 2024
Gossamer’s seralutinib is designed to treat pulmonary arterial hypertension and other indications
BioSpace
MAY 8, 2024
As Sarepta Therapeutics moves closer to full approval and an expanded label for its gene therapy, some experts push back on clinical efficacy and cost while others note the hope it provides patients with Duchenne muscular dystrophy.
Fierce Pharma
MAY 8, 2024
After bringing slow-release schizophrenia drug Uzedy to market last year, Teva and France’s MedinCell are using the same playbook for a similar candidate. | The companies second go at a long-acting schizophrenia med uses popular antipsychotic olanzapine, which Eli Lilly first marketed in the 90s but found safety issues with its own long-acting version.
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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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