BioSpace
SEPTEMBER 26, 2021
?The initiative marks a milestone in the biopharmaceutical industry's COVID-19 response efforts as it now seeks to protect not just those who had contracted the virus but also those who are around them.
NY Times
SEPTEMBER 26, 2021
Calls to poison control centers have soared across the country as misinformation spreads touting the anti-parasite drug as a Covid treatment.
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BioSpace
SEPTEMBER 26, 2021
With Pfizer expected to submit its COVID-19 vaccine data for children five to 11 years to regulators, a study showed just how damaging the pandemic has been to life expectancy. Here’s a look.
JAMA Internal Medicine
SEPTEMBER 26, 2021
This cohort study uses Medicare data to measure and report low-value care use across and within individual health systems and identify system characteristics associated with higher use.
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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
SEPTEMBER 26, 2021
Diabetes player Novo Nordisk cut a deal this week, announcing a settlement agreement to put an end to a lawsuit filed in January 2017 by American Depository Receipt investors.
pharmaphorum
SEPTEMBER 26, 2021
US biopharma company Acceleron is the next company heading for a takeover by a big pharma group – according to a Bloomberg report citing people close to the matter. Rumours of a deal have been bubbling away for a few days, driving Acceleron’s stock upwards, even before Bloomberg reported that a large pharma group is close to agreeing a $180 per share bid for the company that would value it at $11 billion.
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Drug Patent Watch
SEPTEMBER 26, 2021
Annual Drug Patent Expirations for BELEODAQ Beleodaq is a drug marketed by Acrotech and is included in one NDA. There are two patents protecting this drug and one Paragraph IV…. The post New patent expiration for Acrotech drug BELEODAQ appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
SEPTEMBER 26, 2021
The rumors had already been percolating as Acceleron’s stock has risen over the past 10 days from $130-a-share in mid-September to $167.65 as the market closed on Friday.
Scienmag
SEPTEMBER 26, 2021
Abu Dhabi, UAE, September 24, 2021: Ultrasound continues to be a critical tool, often in conjunction with mammography, for the screening, detection and characterization of breast cancer. However, ultrasound can have high false-positive rates, which then lead to unnecessary biopsies, increased costs, and discomfort to patients. In a new study, a team of researchers from […].
BioSpace
SEPTEMBER 26, 2021
There was still some carryover from the European Society of Medical Oncology Congress 2021, but there was plenty of other clinical trial news last week. Here’s a look.
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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
SEPTEMBER 26, 2021
Finger tracing has been used by teachers to help students learn for more than a century. In the early 1900s, education pioneer Montessori encouraged young children to trace over letters of the alphabet made from sandpaper with their index fingers, based on the intuition that a multi-sensory approach (i.e., visual, auditory, tactile, and kinesthetic) to […].
BioSpace
SEPTEMBER 26, 2021
Less than a month after appointing a new chief executive officer, Ziopharm Oncology announced a restructure that has resulted in over 50% of its workforce being axed.
Clinical Trial Gurus
SEPTEMBER 26, 2021
Investigational Product Accountability is an activity that every clinical research associate has to make when it comes to interim monitoring visits. In this video I discuss 5 key components of this critical function.
BioSpace
SEPTEMBER 26, 2021
The analysis showed a 52-week glucose remission rate of 65.2% among the 69 patients being followed.
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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
SEPTEMBER 26, 2021
VUMERITY may be a next-generation oral fumarate with a well-characterized efficacy and safety profile Data from the Phase 3 EVOLVE-MS-2 study have demonstrated that treatment with VUMERITY leads to low discontinuation rates thanks to its gastrointestinal (GI) tolerability profile Upon approval, VUMERITY will offer a replacement oral option for MS patients as they consider treatment initiation within the context of the COVID-19 environment Medicinal Products for Human Use (CHMP), a part of the ec
BioSpace
SEPTEMBER 26, 2021
The company aims to treat different forms of mental illness and brain disorders with its pipeline.
BioTech 365
SEPTEMBER 26, 2021
BIOCORP and NOVO NORDISK Sign Global Partnership Within Diabetes on Digital Health BIOCORP and NOVO NORDISK Sign Global Partnership Within Diabetes on Digital Health Biocorp and Novo Nordisk partner in the smart pen area, Biocorp leveraging Mallya platform for the … Continue reading →
BioSpace
SEPTEMBER 26, 2021
Nanotechnology has the potential to make immunotherapy/chemotherapy combinations dramatically effective, even against aggressive tumors.
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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
SEPTEMBER 26, 2021
TAE Life Sciences Announces Installation of First Accelerator-based Neutron Beam System for Biologically Targeted Radiation Therapy at Xiamen Humanity Hospital in China TAE Life Sciences Announces Installation of First Accelerator-based Neutron Beam System for Biologically Targeted Radiation Therapy at Xiamen … Continue reading →
BioSpace
SEPTEMBER 26, 2021
Intra-Cellular Therapies published its Study 404 Phase III trial of lumateperone as monotherapy for major depressive episodes associated with bipolar I or bipolar II disorder.
BioTech 365
SEPTEMBER 26, 2021
Transplant Genomics Launches OmniGraf™, the Only Combination Biomarker Panel That Provides the Earliest Indication of Rejection in Kidney Transplant Recipients Transplant Genomics Launches OmniGraf™, the Only Combination Biomarker Panel That Provides the Earliest Indication of Rejection in Kidney Transplant Recipients … Continue reading →
BioSpace
SEPTEMBER 26, 2021
Here’s a look at a few of the industry expansions that have been announced so far this month.
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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
SEPTEMBER 26, 2021
Santhera Completes Subsequent Capital Increase for Financing Arrangements Santhera Completes Subsequent Capital Increase for Financing Arrangements NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN THE UNITED STATES OR ANY OTHER JURISDICTION IN WHICH IT WOULD BE UNLAWFUL TO DO SO.
BioSpace
SEPTEMBER 26, 2021
?Biohaven Pharma's latest update on its Phase III clinical trial to use verdiperstat as a potential treatment for multiple system atrophy showed that it did not meet its expected outcomes.
BioTech 365
SEPTEMBER 26, 2021
ReveraGen and Santhera Announce FDA Orphan Grant Funding for Clinical Trial with Vamorolone in Becker Muscular Dystrophy ReveraGen and Santhera Announce FDA Orphan Grant Funding for Clinical Trial with Vamorolone in Becker Muscular Dystrophy Rockville, MD, USA, and Pratteln, Switzerland, … Continue reading →
Drug Patent Watch
SEPTEMBER 26, 2021
This chart shows the drugs with the most patents in Ukraine. 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 Ukraine? 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
SEPTEMBER 26, 2021
Evolva Holding SA / Key word(s): Miscellaneous 27-Sep-2021 / 07:01 CET/CEST Release of an ad hoc announcement pursuant to Art. 53 LR The issuer is solely responsible for the content of this announcement.
BioSpace
SEPTEMBER 26, 2021
Industry watchers question why Elizabeth Holmes has been singled out for failing to deliver what she promised while other tech executives are given a pass.
BioTech 365
SEPTEMBER 26, 2021
Sensorion Reports 2021 First Half Results Sensorion Reports 2021 First Half Results SENS-401 trial protocol for SSNHL successfully amended, clinical trial application filing in CIO in adults confirmed for H2 2021 Plans to file Clinical Trial Application (CTA) in H1 … Continue reading →
BioTech 365
SEPTEMBER 26, 2021
VFMCRP announces approval for TAVNEOS® (avacopan) for the treatment of ANCA-associated vasculitis in Japan VFMCRP announces approval for TAVNEOS® (avacopan) for the treatment of ANCA-associated vasculitis in Japan First orally administered therapy for the treatment of two types of ANCA-associated … Continue reading →
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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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