Bio Pharma Dive
MAY 27, 2021
By June 7, the FDA will decide on whether to approve aducanumab, a decision that could have far-reaching consequences for patients, Biogen and Alzheimer's research.
Pharma Mirror
MAY 27, 2021
The second week of CPhI Discover is open amid news that both the Italian and French governments have confirmed they will allow trade shows to resume – providing formal confirmation for both CPhI Worldwide and Pharmapack Europe. The last year has seen pharma evolve its approach to meeting new partners and existing customers, with wider pools of suppliers now needed, and remote and virtual networking being used to begin conversations much earlier than in the past.
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Bio Pharma Dive
MAY 27, 2021
Safety monitors cleared the company to test a higher dose after reviewing data from 10 patients, providing some hopeful news after recent setbacks for experimental drugs targeting the genetic disease.
pharmaphorum
MAY 27, 2021
Concert Pharmaceuticals has started the second of two planned phase 3 trials of its drug candidate for alopecia areata (AA), a common cause of hair loss, and says it hopes to report results in the second half of 2022. The two studies – THRIVE-AA1 and THRIVE-AA2 – are testing oral JAK1/2 inhibitor CTP-543 in adults with moderate-to-severe AA, an autoimmune disease that leads to loss of hair in patches on scalp and body.
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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
MAY 27, 2021
Vir's sotrovimab arrives months after similar treatments from Eli Lilly and Regeneron. But the drug could still play a role due to its apparent potency against variants that have challenged Lilly's drugs.
XTalks
MAY 27, 2021
In the age of better-for-you beverages, Limitless Sparkling Water checks off all the boxes. With no calories, sugar or artificial sweeteners, the sparkling water has the potential to be the next soda substitute. So, what separates Limitless Sparkling Water from other sodas and where does it fit into the beverage industry? Beverage titan Keurig Dr Pepper (KDP) purchased Chicago-based Limitless Sparkling Water back in January 2020, betting on sparkling water to fill the void created by decreasing
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
MAY 27, 2021
Myovant has chalked up a second approval for its flagship drug relugolix from the FDA, becoming the first once-daily oral drug in the US to treat heavy menstrual bleeding associated with uterine fibroids. . The drug will be sold as Myfembree (relugolix) for the uterine fibroids indication, and is already available to treat prostate cancer under the Orgovyx brand name.
XTalks
MAY 27, 2021
To help boost production of its COVID-19 vaccine, Moderna has enlisted the services of Samsung Biologics , a contract development and manufacturing organization (CDMO) based in South Korea. The companies entered a Manufacturing Services and Supply Agreement in which Samsung will provide large-scale, commercial fill-finish manufacturing for Moderna’s mRNA-based COVID-19 vaccine (mRNA-1273).
Scienmag
MAY 27, 2021
Getting the conclusive lead with investigative genetic genealogy – A successful case study of a 16 year old double murder in Sweden Credit: Edis Portori The technology using DNA-based genealogy that solved a double murder in Linköping opens completely new possibilities in investigating serious crime. LiU researchers are now involved in spreading new knowledge about […].
BioPharma Reporter
MAY 27, 2021
Germanyâs Merck KGaA has launched a new synthetic cholesterol product that it says will boost capacity for its lipid delivery tools by 50 times.
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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
MAY 27, 2021
Credit: Photo courtesy of Alisse Pratt/UTHealth Neurosciences New research has determined that the window of opportunity to provide possible treatments for patients suffering from traumatic brain injuries (TBIs) differs depending on whether the patient is male or female. Building on this, scientists from The University of Texas Health Science Center at Houston (UTHealth) and Arizona […].
Drug Patent Watch
MAY 27, 2021
Annual Drug Patent Expirations for EYSUVIS Eysuvis is a drug marketed by Kala Pharms Inc and is included in one NDA. There are eleven patents protecting this drug. EYSUVIS drug…. The post New patent for Kala Pharms drug EYSUVIS appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
MAY 27, 2021
$2.3 million renewal grant to UC Riverside will support a five-year project Credit: Stan Lim, UC Riverside. RIVERSIDE, Calif. — Viji Santhakumar, an associate professor of molecular, cell and systems biology at the University of California, Riverside, has received funding from the National Institute of Neurological Disaster and Stroke of the National Institutes of Health […].
BioSpace
MAY 27, 2021
A real-world study published by the FH Foundation confirms COVID-19 increased heart attack rates significantly in patients with these conditions.
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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.
Drug Patent Watch
MAY 27, 2021
Annual Drug Patent Expirations for KYLEENA Kyleena is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are four patents…. The post New patent for Bayer Hlthcare drug KYLEENA appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
MAY 27, 2021
Several biotech executives provided their thoughts on lessons learned from the pandemic and what they hope or expect to see moving forward in the industry.
Scienmag
MAY 27, 2021
Credit: Real et al. Researchers have mapped in fine detail the genetic changes malaria parasites go through as they prepare to infect people. The atlas maps the malaria parasite Plasmodium falciparum in unprecedented cellular detail as it develops inside a mosquito and prepares to infect humans through a bite. This detailed investigation could lead to […].
BioSpace
MAY 27, 2021
Fennec is looking for a second chance to approve PEDMARK, its pediatric chemotherapy-induced hearing loss prevention drug, as it resubmits its NDA for the agent to the U.S. FDA.
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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.
Scienmag
MAY 27, 2021
Credit: Adam Porter Plastic pollution has been found in seawater, on beaches and inside marine animals at the Galapagos Islands. A new study – by the University of Exeter, Galapagos Conservation Trust (GCT) and the Galapagos Science Center – found plastic in all marine habitats at the island of San Cristobal, where Charles Darwin first […].
BioSpace
MAY 27, 2021
The FDA has a massive backlog of site inspections due to the pandemic. To address the problem, the agency made its Resiliency Roadmap outlining its priorities.
Scienmag
MAY 27, 2021
Credit: SFU SFU computing science professor Ghassan Hamarneh is using his medical imaging analysis expertise to help UBC researchers understand the role of caveolin-1 (CAV1) in certain cancer types. CAV1 is a protein associated with poor outcomes in aggressive breast and prostate cancer. It is also associated with tumor metastasis and tumor suppression, but it […].
Pharma Times
MAY 27, 2021
Once-daily treatment has been approved for the management of heavy menstrual bleeding
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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.
Scienmag
MAY 27, 2021
First three years of survey data uses observations of 226 million galaxies over 1/8 of the sky Credit: DOE/FNAL/DECam/R. Hahn/CTIO/NOIRLab/NSF/AURA In 29 new scientific papers, the Dark Energy Survey examines the largest-ever maps of galaxy distribution and shapes, extending more than 7 billion light-years across the Universe. The extraordinarily precise analysis, which includes data from […].
JAMA Internal Medicine
MAY 27, 2021
This cohort study examines the rate of SARS-CoV-2 reinfection among people in Lombardy, Italy, who previously recovered from COVID-19.
Scienmag
MAY 27, 2021
New tool uses AI technology to assess the severity of lung infections and inform treatment Credit: University of Waterloo Artificial intelligence (AI) technology developed by researchers at the University of Waterloo is capable of assessing the severity of COVID-19 cases with a promising degree of accuracy. A study, which is part of the COVID-Net open-source […].
BioPharma Reporter
MAY 27, 2021
Sanofi and GSK have started the Phase 3 study for their COVID-19 vaccine candidate: eying up potential regulatory authorization in Q4, 2021.
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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.
Scienmag
MAY 27, 2021
Machine learning is being applied to gauge which vocalizations are predictive of ASD Credit: The University of Texas Health Science Center at San Antonio SAN ANTONIO (May 27, 2021) — One-fifth of babies who inherit a genetic variant located on chromosome 16 will develop autism spectrum disorder (ASD) by age 3. The variant is called […].
BioSpace
MAY 27, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
Scienmag
MAY 27, 2021
Credit: Ron LeValley Many seabirds in the Northern Hemisphere are struggling to breed — and in the Southern Hemisphere, they may not be far behind. These are the conclusions of a study, published May 28 in Science, analyzing more than 50 years of breeding records for 67 seabird species worldwide. The international team of scientists […].
Pharma Times
MAY 27, 2021
Strategy “marks a shift away from organisations and towards service improvement”
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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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