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
The US FDA has granted fast track designation for iECURE’s ECUR-506 for the treatment of neonatal onset ornithine transcarbamylase deficiency.
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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
BioVersys and GSK have announced the expansion of their partnership to expedite the clinical development of alpibectir for tuberculosis (TB).
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.
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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
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
TerSera has obtained Health Canada approval for ZOLADEX LA 10.8mg to manage oestrogen receptor-positive (ER+) early breast cancer.
BioSpace
MAY 8, 2024
While Teva missed Wall Street expectations in the first quarter of 2024, it reported Wednesday a 5% increase in Q1 revenues while reporting that the company’s schizophrenia candidate scored a late-stage trial victory
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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
Pharmaceutical Technology
MAY 8, 2024
Coinfections can complicate disease management and hence continued surveillance and targeted intervention strategies are needed.
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.
Pharmaceutical Technology
MAY 8, 2024
AstraZeneca has begun the global withdrawal of its Covid-19 vaccine Vaxzevria, citing a surplus of updated vaccines.
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.
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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
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
Regeneron Pharmaceuticals on Wednesday revealed that its investigational gene therapy DB-OTO restored hearing in two young children, according to an oral presentation at the American Society of Gene & Cell Therapy annual meeting.
Fierce Pharma
MAY 8, 2024
As U.S. drug shortages run rampant, lawmakers are getting creative with their attempts to ease the situation. | Under the framework, hospitals, purchasers and generic drugmakers could earn incentive payments after meeting new contracting and purchasing standards. The lawmakers proposed supply contracts with longer timelines, greater supply commitments and contingency deals with alternative manufacturers.
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.
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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
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.
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.
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.
Drug Discovery World
MAY 8, 2024
Fiona Maini , Senior Director Global Compliance & Strategy, at Medidata looks at the rise of artificial intelligence (AI) and machine learning (ML) within life sciences and the applications for the technology in clinical trials. The benefits that AI and machine learning (ML) can bring to society and their potential to radically change the world we live in can sometimes feel a little intangible, futuristic or even far-fetched.
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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.
Pharma Times
MAY 8, 2024
Gossamer’s seralutinib is designed to treat pulmonary arterial hypertension and other indications
pharmaphorum
MAY 8, 2024
Selective serotonin reuptake inhibitors (SSRIs) are the first-line drug therapy of choice for most people suffering from depression but often fail to work effectively. Now, a study suggests simple blood test could help predict those who will benefit.
BioSpace
MAY 8, 2024
As interest in psychedelic therapies ramp up, Lykos Therapeutics will go in front of the FDA’s Psychopharmacologic Drugs Advisory Committee on June 4 to present its investigational treatment for post-traumatic stress disorder.
Pharma Times
MAY 8, 2024
The findings could potentially lead to new therapies and could stop the growth of cancers
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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.
Fierce Pharma
MAY 8, 2024
Apellis’ geographic atrophy drug Syfovre delivered what CEO Cedric Francois called “robust” growth in the first quarter, as its sales topped analysts’ expectations. | Apellis’ geographic atrophy drug Syfovre delivered what CEO Cedric Francois called “robust” growth in the first quarter, as its sales topped analysts’ expectations. But investors still dragged the company’s shares down by 10% on Tuesday.
Drug Discovery World
MAY 8, 2024
The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. The ongoing innovation and development in the drug discovery sector relies on a number of moving parts, one of which is financial support and backing.
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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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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