Bio Pharma Dive
JUNE 22, 2021
New results from a key study show the treatment's benefit is holding up well over time. But the FDA wants to see more data, delaying when UniQure and partner CSL expect to file for approval.
Pharma Times
JUNE 22, 2021
An extra £40m will go toward enhancing mental health services for children and young people
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Bio Pharma Dive
JUNE 22, 2021
Results from a Phase 3 study could help Merck secure a full approval for use of Keytruda in the tumor type, potentially extending the therapy's edge over rival therapies.
pharmaphorum
JUNE 22, 2021
Sanofi and Translate Bio have started a first clinical trial of an mRNA-based seasonal flu vaccine, adding to the COVID-19 shot already in testing as part of their three-year old collaboration. Enthusiasm for mRNA vaccines is riding high amid the successful rollout of COVID-19 shots from Pfizer/BioNTech and Moderna, and attention is now turning toe the possibility of using the approach to tackle other infectious diseases.
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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
Bio Pharma Dive
JUNE 22, 2021
The new company aims to pair Intellia's CRISPR gene editing technology with a CAR-T cell therapy platform built by Cellex subsidiary GEMoaB.
pharmaphorum
JUNE 22, 2021
AstraZeneca’s SGLT2 inhibitor Farxiga has been growing fast thanks to a first-in-class approval in heart failure, but will now have to share the market with Boehringer Ingelheim and Eli Lilly’s rival therapy Jardiance. . The European Commission has become the first regulator to approved Jardiance (empagliflozin) as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), also known as systolic heart failure.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
JUNE 22, 2021
First oral blood thinning drug approved for paediatric patients in the US
Drug Patent Watch
JUNE 22, 2021
Annual Drug Patent Expirations for ARMONAIR+RESPICLICK Armonair Respiclick is a drug marketed by Teva Pharm and is included in one NDA. It is available from one supplier. There are nineteen…. The post New patent expiration for Teva Pharm drug ARMONAIR RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
JUNE 22, 2021
Cuba’s Abdala vaccine is 92% effective against the novel coronavirus, according to a recent analysis of late-stage trials.
Drug Patent Watch
JUNE 22, 2021
Annual Drug Patent Expirations for PROAIR+RESPICLICK Proair Respiclick is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from two suppliers. There are…. The post New patent expiration for Teva Branded drug PROAIR RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.
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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
Outsourcing Pharma
JUNE 22, 2021
The pharmaceutical company reports favorable results in a recent study exploring mobocertinib in treating certain non-small cell lung cancer patients.
Drug Patent Watch
JUNE 22, 2021
Annual Drug Patent Expirations for NOCDURNA Nocdurna is a drug marketed by Ferring Pharms Inc and is included in one NDA. It is available from one supplier. There are nine…. The post New patent for Ferring Pharms drug NOCDURNA appeared first on DrugPatentWatch - Make Better Decisions.
BioPharma Reporter
JUNE 22, 2021
BMS buys into co-development of Eisaiâs first ADC targeting advanced solid tumors.
Scienmag
JUNE 22, 2021
Rising temperatures and risky development contribute to heightened exposure to earthquakes, flooding, tornadoes, hurricanes and wildfire Credit: Inglesias et al. (2021) Earth’s Future [link] WASHINGTON–More than half of the structures in the contiguous United States are exposed to potentially devastating natural hazards–such as floods, tornadoes and wildfires–according to a new study in the AGU journal […].
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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.
BioSpace
JUNE 22, 2021
Please check out the biopharma industry's COVID-19 stories that are trending for June 22, 2021.
Scienmag
JUNE 22, 2021
Credit: L. Otsuki/IMP The spinal cord is an important component of our central nervous system: it connects the brain with the rest of the body and plays a crucial part in coordinating our sensations with our actions. Falls, violence, disease – various forms of trauma can cause irreversible damage to the spinal cord, leading to […].
BioSpace
JUNE 22, 2021
The drug was approved on June 7 under the agency’s accelerated approval pathway, despite the agency’s Peripheral and Central Nervous System Drugs Advisory Committee voting against the drug in November 2020 and having been assured at that time the agency was not considering an accelerated approval.
NY Times
JUNE 22, 2021
The Alzheimer’s treatment will cost $56,000 per patient, and millions may use it. The result: “crazy numbers” for Medicare.
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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
JUNE 22, 2021
A new research paper published by Alzheon suggests the inhibition of amyloid toxicity is the only clinically validated strategy for slowing Alzheimer’s disease progression.
Scienmag
JUNE 22, 2021
Credit: European Heart Journal Statin use among patients with heart failure is associated with a 16% lower risk of developing cancer compared with non-statin users during an average of four years of follow-up, according to new research published today (Wednesday) in the European Heart Journal [1]. In addition, the study found that statin use was […].
BioSpace
JUNE 22, 2021
?uniQure has acquired Corlieve with upfront cash of approx. $55 million and will center on the latter's lead program, AMT-260, an advanced treatment for TLE.
Scienmag
JUNE 22, 2021
Common OTC drugs for sore throat causing more harm than good Credit: Applied Biological Laboratories [Brooklyn, New York] – [June 21, 2021] – Applied Biological Laboratories (Applied Bio), a biopharmaceutical company focused on the respiratory disease market, announced that its study published online in Immunology, Inflammation and Disease was able to determine the mechanism behind […].
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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.
BioSpace
JUNE 22, 2021
CEO Emma Walmsley’s vision includes a projected $46 billion in annual sales from the stand-alone pharma company by 2031 and more than 10% operating profit over the next five years.
NY Times
JUNE 22, 2021
Restrictions on mifepristone mean patients are not getting the best treatment.
BioSpace
JUNE 22, 2021
It’s been a bumpy ride for Biogen as news swirls around its overall Alzheimer’s program… but not for its competitors with investigational therapies for that disease.
Scienmag
JUNE 22, 2021
Study from UNC-Chapel Hill shows a vaccine could be effective against COVID-19, SARS and other coronavirus-related diseases Credit: Jon Gardiner/UNC-Chapel Hill CHAPEL HILL, N.C. – Scientists at the University of North Carolina Gillings School of Global Public Health have developed a universal vaccine that protected mice not just against COVID-19 but also other coronaviruses and […].
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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.
Pharma Times
JUNE 22, 2021
Drug approved to treat children with neurofibromatosis type 1 and plexiform neurofibromas
Scienmag
JUNE 22, 2021
Rice team enhances models that will detect magnetospheres in distant solar systems Credit: Anthony Sciola/Rice University HOUSTON – (June 22, 2021) – We can’t detect them yet, but radio signals from distant solar systems could provide valuable information about the characteristics of their planets. A paper by Rice University scientists describes a way to better […].
BioSpace
JUNE 22, 2021
Crisis has a way of opening doors of opportunity for fraud around the globe. The COVID-19 pandemic has brought not only a fresh slew of financial schemes, but pharmaceutical fraud as well.
Scienmag
JUNE 22, 2021
High-resolution satellite imagery data unveiled a global correlation between urban green space and happiness in 60 countries Credit: Institute for Basic Science Urban green spaces, such as parks, backyards, riverbanks, and urban farmlands, are thought to contribute to citizen happiness by promoting physical and mental health. While a number of previous studies have reported the […].
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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