BioSpace
NOVEMBER 21, 2021
Even before the drug's approval on June 7, there were cases of amyloid-related imaging abnormalities (ARIA-E), or cerebral edema, observed in the trials.
JAMA Internal Medicine
NOVEMBER 21, 2021
This cohort study examines mortality data from Texas, a racially and ethnically diverse state, to better understand excess mortality among adults aged 25 to 44 years during early months of the COVID-19 pandemic.
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BioSpace
NOVEMBER 21, 2021
?The recommendation comes after a thorough evaluation of both products' effectiveness and safety profiles, presented at the Advisory Committee on Immunization Practices last week.
JAMA Internal Medicine
NOVEMBER 21, 2021
This randomized clinical trial examines the efficacy of the inhaled steroid ciclesonide in reducing the time to alleviation of all COVID-19–related symptoms among nonhospitalized participants with symptomatic COVID-19 infection.
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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
BioSpace
NOVEMBER 21, 2021
?News on COVID-19 vaccine developments and disease studies continue to deliver highs and lows. Here are some of the more recent happenings.
JAMA Internal Medicine
NOVEMBER 21, 2021
This cross-sectional study characterizes the prevalent use of medications that may raise BP and examine their associations with BP control and antihypertensive use
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
NOVEMBER 21, 2021
PISCATAWAY, NJ — More rideshare trips mean fewer alcohol-involved accidents, according to a new study in the Journal of Studies on Alcohol and Drugs. The finding adds to a growing body of work suggesting that ridesharing may take the place of drunk driving. Credit: Rutgers Center of Alcohol & Substance Use Studies PISCATAWAY, NJ — […].
BioSpace
NOVEMBER 21, 2021
After indicating it might entertain a sale, Novartis may receive an offer from investment group EQT and the Struengmann family for its generic unit Sandoz.
Scienmag
NOVEMBER 21, 2021
ANN ARBOR, Mich. – As families prepare to celebrate a holiday focused on gratitude, many parents say their children aren’t as thankful as they should be. Credit: C.S. Mott Children’s Hospital National Poll on Children’s Health at University of Michigan Health ANN ARBOR, Mich. – As families prepare to celebrate a holiday focused on gratitude, […].
BioSpace
NOVEMBER 21, 2021
Twist Bioscience snapped up in vivo antibody discovery company Abveris Inc. in a deal valued at up to $190 million. The acquisition is expected to bolster Twist’s biopharma antibody capabilities.
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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
Scienmag
NOVEMBER 21, 2021
After studying the effectiveness of varying layers of masks in stopping respiratory droplets from escaping face masks, a team of international researchers has now turned their attention to modeling what happens to droplets when they come in contact with wet masks. Their results show that damp masks are still effective at stopping these droplets from escaping the […].
BioSpace
NOVEMBER 21, 2021
CStone forged a licensing agreement with Jiangsu Hengrui Pharmaceuticals that grants the company access to a monoclonal antibody aimed at multiple forms of cancer.
JAMA Internal Medicine
NOVEMBER 21, 2021
This meta-analysis uses data from randomized clinical trials to assess the time to benefit of bisphosphonate therapy for the prevention of nonvertebral fractures among postmenopausal women with osteoporosis.
BioSpace
NOVEMBER 21, 2021
The FDA has granted Cambridge-based bluebird Bio a Priority Review of its Biologics License Application for betibeglogene autotemcel (beti-cel).
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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.
The Pharma Data
NOVEMBER 21, 2021
Today, the U.S. Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five years of age and older with achondroplasia and open epiphyses (growth plates), meaning these children still have the potential to grow. Achondroplasia is the most common form of dwarfism. “Today’s approval fulfills an unmet medical need for more than 10,000 children in the United States and underscores the FDA’s commitment to help make new therapies available for rare diseases,
BioSpace
NOVEMBER 21, 2021
The U.S. Food and Drug Administration has a few PDUFA dates for the Thanksgiving Holiday week. Here’s a look.
BioTech 365
NOVEMBER 21, 2021
Agra Ventures Issues Shares as Regular Payment of Partial Amount of Interest on Debt Agra Ventures Issues Shares as Regular Payment of Partial Amount of Interest on Debt VANCOUVER, British Columbia, Nov. 21, 2021 (GLOBE NEWSWIRE) — Agra Ventures Ltd.
BioSpace
NOVEMBER 21, 2021
Before going for a pharmacy job interview, you should be prepared to give the best answers possible. Here are six questions you should be ready for.
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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.
BioTech 365
NOVEMBER 21, 2021
Germany’s Thuringian Court of Appeal issues Final Judgment on September 17, 2021 in favor of Samix/Medisca’s successful defense of its proprietary design and knowhow of its compounding systems against Gako Germany’s Thuringian Court of Appeal issues Final Judgment on September … Continue reading →
BioSpace
NOVEMBER 21, 2021
With the last full week before the Thanksgiving week in the U.S., companies had a fair amount of clinical trial news. Here’s a look.
BioTech 365
NOVEMBER 21, 2021
Vifor Pharma to spearhead development of vascular calcification field, through acquisition of Sanifit Therapeutics and Inositec AG Vifor Pharma to spearhead development of vascular calcification field, through acquisition of Sanifit Therapeutics and Inositec AG Sanifit Therapeutics and Inositec AG, both … Continue reading →
BioSpace
NOVEMBER 21, 2021
Switzerland-based Vifor Pharma is acquiring Spain’s Sanifit Therapeutics and another Swiss company, Inositec.
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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.
BioTech 365
NOVEMBER 21, 2021
GenSight Biologics to Host Key Opinion Leader Webcast on Outcomes Among Compassionate Use Patients Treated Bilaterally with LUMEVOQ® in the US GenSight Biologics to Host Key Opinion Leader Webcast on Outcomes Among Compassionate Use Patients Treated Bilaterally with LUMEVOQ® in … Continue reading →
BioSpace
NOVEMBER 21, 2021
“I hope to thread the needle between pricing responsibly and achieving profitability," Jarrett said.
BioTech 365
NOVEMBER 21, 2021
NOXXON: New Phase 1/2 Data On NOX-A12 & Radiotherapy Combination in Brain Cancer Presented at the Society for Neuro-Oncology Annual Meeting 2021 NOXXON: New Phase 1/2 Data On NOX-A12 & Radiotherapy Combination in Brain Cancer Presented at the Society for … Continue reading →
Drug Patent Watch
NOVEMBER 21, 2021
This chart shows the drugs with the most patents in Yugoslavia. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Yugoslavia? appeared first on DrugPatentWatch - Make Better Decisions.
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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.
BioTech 365
NOVEMBER 21, 2021
Mesoblast and Oaktree Capital Enter Into Refinancing and Expansion of Senior Debt Facility Mesoblast and Oaktree Capital Enter Into Refinancing and Expansion of Senior Debt Facility NEW YORK, Nov.
BioTech 365
NOVEMBER 21, 2021
Zenas BioPharma Acquires Exclusive Worldwide Rights to Obexelimab from Xencor Zenas BioPharma Acquires Exclusive Worldwide Rights to Obexelimab from Xencor — Xencor receives rights to additional equity in Zenas as upfront payment and is eligible for up to $480 million … Continue reading →
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