Bio Pharma Dive
OCTOBER 21, 2021
The biotech won EU approval for two gene therapies, Zynteglo and Syksona, both of which it's now said it will pull from market after difficulties negotiating reimbursement.
World of DTC Marketing
OCTOBER 21, 2021
SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found. More than $170 million of this spending was for products voluntarily withdrawn by their manufacturers after clinical trials showed that they did not improve overall survival in people with various types of cancer.
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Bio Pharma Dive
OCTOBER 21, 2021
A third dose was 96% effective in preventing COVID-19 compared to a placebo in a Phase 3 trial of previously vaccinated adults. Missing details, however, leave some questions unanswered.
Pharma Mirror
OCTOBER 21, 2021
Post-workout protein intake has numerous benefits. For a long time, fitness experts and nutritionists have recommended taking protein after your workout. Though the health benefits of pre-workout protein intake are in question, the post-workout protein intake helps recover muscle after intense exercise. A pre-training shake is a drink that you can consume before any workout or physical activity to improve the body’s performance.
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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
OCTOBER 21, 2021
New guidance for the rival shots didn't favor Pfizer's, as analysts had expected, giving Merck a better chance to gain ground in one of the most lucrative market opportunities for vaccines.
NY Times
OCTOBER 21, 2021
The company said that in a study, boosters cut down the number of breakthrough infections among fully vaccinated people by more than 95 percent.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
OCTOBER 21, 2021
Twitter has been used by health professionals for over a decade to share medical knowledge and education. Until late-2018 they had only 140 characters to do this, increasing to 280 at that time. There have been some collaborative ways to have meaningful interactions on the platform including Twitter journal clubs. Four ways HCPs are using Twitter for medical education.
Pharma Times
OCTOBER 21, 2021
Givlaari uses ‘gene silencing’ RNA interference technology, to target the production of pathogenic compounds in people AHP
pharmaphorum
OCTOBER 21, 2021
Analysts were predicting sales of Biogen’s recently approved Alzheimer’s therapy Aduhelm may start to gather a little momentum in the third quarter, but the drug seems to be going into reverse. As it turned out, Aduhelm (aducanumab) made just $300,000 in the three-month period from July to September, against analysts’ estimates of $12 million, suggesting that few patients are being treated with the $56,000 a year therapy.
BioPharma Reporter
OCTOBER 21, 2021
Novartis has signed a new initial agreement with BioNTech for COVID-19 vaccine manufacturing: with its sterile manufacturing facilities in Ljubljana, Slovenia, to fill at least 24 million doses in 2022.
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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
pharmaphorum
OCTOBER 21, 2021
UK cost-effectiveness watchdog NICE is set to recommend NHS use of Alnylam’s gene-silencing therapy Givlaari in England and Wales for the rare disease acute hepatic porphyria (AHP), after its advisors issued a positive verdict on the drug. Givlaari (givosiran) has been recommended as a treatment option for people aged 12 and over with AHP, a rare life-threatening genetic condition that causes attacks of severe abdominal pain, vomiting and nervous system disorders, such as seizures, depress
BioSpace
OCTOBER 21, 2021
Two months after being ousted by the Whitehead Institute over allegations of sexual harassment, prominent cell biology researcher David Sabatini has filed a counter lawsuit.
pharmaphorum
OCTOBER 21, 2021
CAR-T therapies have revolutionised the treatment of some blood cancers, but so far haven’t been able to repeat that success in solid tumours. UK startup Leucid Bio hopes to change that – and has just raised £11.5 million in first-round financing to take its plans forward. The London-based biotech has been set up to develop a CAR-T developed by Dr John Maher at King’s College London, who serves as its chief scientific officer.
BioPharma Reporter
OCTOBER 21, 2021
Absci Corporation says its newly opened campus in Vancouver, Washington, in the US, expands its ability to accelerate discovery and development of biologic drugs.
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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
OCTOBER 21, 2021
Numerous biopharma and life sciences companies have sought to put their stocks up for sale, but this week, two companies opted to pull out their IPO due to concerns over market stability.
Scienmag
OCTOBER 21, 2021
In cities growing in both size and thirst across the globe, sustainability is constrained by the gray of dams and water treatment facilities. In this week’s Nature Sustainability, research by Michigan State University scientists advocate going green to ensure water supplies. Credit: Michigan State University In cities growing in both size and thirst across the globe, sustainability […].
BioSpace
OCTOBER 21, 2021
Lexington, Mass.-based Agenus withdrew its Biologics License Application for balstilimab from the U.S. FDA. The drug is a PD-1 inhibitor or checkpoint inhibitor.
Scienmag
OCTOBER 21, 2021
Scientists studying the most common and aggressive type of brain tumour in adults have discovered a new way of analysing diseased and healthy cells from the same patient. Credit: Credit to Brain Tumour Research Centre of Excellence at Queen Mary University of London. Scientists studying the most common and aggressive type of brain tumour in […].
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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
OCTOBER 21, 2021
Winter is quickly approaching in the U.S. Vaccine makers aren’t taking a wait-and-see approach but actively preparing for what may come next.
Scienmag
OCTOBER 21, 2021
Stem cell researchers may soon have a new way to identify and develop novel, personalized therapies for patients with Cystic Fibrosis (CF) who lack effective treatments. Credit: Christine Bear, Hospital for Sick Kids and University of Toronto, Canada Stem cell researchers may soon have a new way to identify and develop novel, personalized therapies for […].
BioSpace
OCTOBER 21, 2021
?A growing number of studies show that though natural immunity can work, hybrid immunity through vaccination could be better.
Scienmag
OCTOBER 21, 2021
Cambridge, UK, 21 Oct 2021: Toshiba Europe Ltd today announced it has developed the world’s first chip-based quantum key distribution (QKD) system. This advance will enable the mass manufacture of quantum security technology, bringing its application to a much wider range of scenarios including to Internet of Things (IoT) solutions. Credit: Toshiba Corporation Cambridge, UK, […].
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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.
NY Times
OCTOBER 21, 2021
The agency will also allow vaccine recipients to pick which vaccine they want as a booster, endorsing a mix-and-match approach.
Scienmag
OCTOBER 21, 2021
Columbia Psychiatry faculty in partnership with avoMD a next-gen clinical decision support platform, have developed an interactive smartphone application that provides point-of-care treatment algorithms for major depression. Credit: avoMD Columbia Psychiatry faculty in partnership with avoMD a next-gen clinical decision support platform, have developed an interactive smartphone application that provides point-of-care treatment algorithms for major […].
BioSpace
OCTOBER 21, 2021
The experimental drug, NTLA-2001, is being developed for the treatment of transthyretin (ATTR) amyloidosis.
Scienmag
OCTOBER 21, 2021
In the early 2000s, a fungus infected hundreds of animals and people in British Columbia and Washington State. Scientists found that the disease also killed porpoises and dolphins in the Salish Sea–perhaps affecting cetaceans even earlier than people. A study published today in Diseases of Aquatic Organisms explores how human-caused changes on land can affect […].
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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.
BioPharma Reporter
OCTOBER 21, 2021
Locus Biosciences has entered a credit facility of up to US$25m with Hercules Capital, which it says will support the expansion of its precision engineered bacteriophage discovery platform engine and in-house manufacturing capacity.
Scienmag
OCTOBER 21, 2021
A researcher at The University of Texas at Arlington is developing technology that would allow virtual reality users to see the facial expressions of the person they are interacting with online. Credit: UT Arlington A researcher at The University of Texas at Arlington is developing technology that would allow virtual reality users to see the […].
BioSpace
OCTOBER 21, 2021
?Skin health logged major wins this week after two companies announced positive clinical trial results.
Scienmag
OCTOBER 21, 2021
Between 2.5 and 4 billion years ago, a time known as the Archean eon, Earth’s weather could often be described as cloudy with a chance of asteroid. Credit: SwRI/Dan Durda, Simone Marchi Between 2.5 and 4 billion years ago, a time known as the Archean eon, Earth’s weather could often be described as cloudy with […].
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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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