Novartis pays $150M for access to UCB's Parkinson's drug
Bio Pharma Dive
DECEMBER 2, 2021
UCB's experimental pill is one of the most advanced projects that's aimed at blocking accumulation of an abnormal protein in patients' brains.
Thu.Dec 02, 2021
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A scientific approach to irrational consumer choices
World of DTC Marketing
DECEMBER 2, 2021
GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. Since when is consumer behavior ever scientific? According to Science Direct “participants who saw exaggerated images (in DTC ads) were more likely than those who saw no image or accurate images to overestimate efficacy.
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A startup led by Novartis veteran raises $80M to develop gene therapies for the brain
Bio Pharma Dive
DECEMBER 2, 2021
AviadoBio, which was built around research from the lab of Christopher Shaw at King's College London, is backed by venture firms NEA and Monograph Capital.
Will High Vaccination Rates Help Spain Weather Omicron?
NY Times
DECEMBER 2, 2021
Spain surpassed others in Europe by avoiding politicized debate about Covid shots. Citizens also largely heeded the health guidance from their leaders.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
GSK sets sights on brain diseases through Oxford partnership
Bio Pharma Dive
DECEMBER 2, 2021
Equipped with $40 million in funding, a new institute from GSK and Oxford will initially focus on developing treatments for Alzheimer's, Parkinson's, ALS and other neurological conditions.
Possible identification of blood clot trigger for AstraZeneca COVID-19 vaccine
Pharma Times
DECEMBER 2, 2021
Researchers have identified in those patients experiencing blood clots after vaccination a subsequent condition referred to as vaccine-induced immune thrombotic thrombocytopenia (VITT).
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In Head-to-Head Comparison, Moderna Bests Pfizer by a Nose
BioSpace
DECEMBER 2, 2021
Researchers from Harvard University and the U.S. Department of Veterans Affairs (VA) found that the Moderna mRNA vaccine was slightly better than the Pfizer-BioNTech vaccine.
MHRA okays GSK’s Xevudy as data suggest it works against Omicron
pharmaphorum
DECEMBER 2, 2021
The UK medicines regulator has approved GlaxoSmithKline and Vir Biotech’s antibody for COVID-19, Xevudy, which has been shown to be effective against the new Omicron strain of SARS-CoV-2 in lab testing. Xevudy (sotrovimab) is the second COVID-19 antibody to be approved by the MHRA after Roche/Regeneron’s Ronapreve (casirivimab and imdevimab), which got a green light during the summer.
UK orders extra 114 million COVID-19 vaccines to combat Omicron
Pharma Times
DECEMBER 2, 2021
Scientists and health experts have cautioned that the new variant could have the ability to bypass the effectiveness of vaccines that are currently available.
Novartis takes aim at risky Parkinson’s target with $1.5bn UCB deal
pharmaphorum
DECEMBER 2, 2021
Novartis has licensed a potential drug for Parkinson’s from Belgium’s UCB that it thinks could be the first oral, disease-modifying drug for the disease – if it can avoid the fate of earlier drugs in the class. The drug – called UCB0599 – targets a protein called alpha synuclein that tends to get misfolded and accumulates into clumps in the brains of Parkinson’s patients, and is thought to damage neurons – somewhat analogous to amyloid and tau proteins in Alzheimer’s dise
The New Age of Decentralized Clinical Trials
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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
Study: Adenovirus Could be Cause of Rare Blood Clots in AstraZeneca Vaccine
BioSpace
DECEMBER 2, 2021
?Scientists from Cardiff University and the Arizona State University believe they have found the likely cause of blood clotting in some recipients of the Oxford-AstraZeneca COVID-19 vaccine.
Decentralized format dramatically transforming clinical research: ICON
Outsourcing Pharma
DECEMBER 2, 2021
An expert from the ]contract research organization discusses the impact virtual trials have had on the industry, and how that transformation is likely to continue.
Bayer Looks to Prostate Cancer Drug for Next Blockbuster
BioSpace
DECEMBER 2, 2021
Bayer has high hopes of driving its prostate cancer drug into blockbuster status, meaning over $1 billion in annual sales. This week's ARASENS trial results should help pave the road.
Combined heat and power as a platform for clean energy systems
Scienmag
DECEMBER 2, 2021
The state of Georgia could dramatically reduce its greenhouse gas emissions, while creating new jobs and a healthier public, if more of its energy-intensive industries and commercial buildings were to utilize combined heat and power (CHP), according to the latest research from Georgia Tech’s School of Public Policy. Credit: Robert Felt, Georgia Tech The state […].
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
New patent for Supernus Pharms drug OXTELLAR XR
Drug Patent Watch
DECEMBER 2, 2021
Annual Drug Patent Expirations for OXTELLAR+XR Oxtellar Xr is a drug marketed by Supernus Pharms and is included in one NDA. It is available from one supplier. There are nine…. The post New patent for Supernus Pharms drug OXTELLAR XR appeared first on DrugPatentWatch - Make Better Decisions.
Dyno attracts $1.6bn gene therapy deal with Astellas
pharmaphorum
DECEMBER 2, 2021
Astellas has signed another bolt-on deal to build its gene therapy pipeline, agreeing a deal with Dyno Therapeutics to tap into its adeno-associated virus (AAV) vector platform for delivering genes to skeletal and cardiac muscle. The Japanese drugmaker is paying $18 million upfront to exercise an option on the AAV platform – which my help avoid safety issues that have emerged with other AAV-based gene therapies – with milestone and royalty payments that could exceed $1.6 billion.
Embryo-Like Model Could Advance Research in Early Human Development
BioSpace
DECEMBER 2, 2021
?Called "iBlastoids," the alternative embryo-like structures are grown for up to 13 days in the lab for use in different types of studies on the behavior of human embryos.
GSK and University of Oxford launch new institute, embracing advanced technologies for drug discovery
BioPharma Reporter
DECEMBER 2, 2021
The Oxford-GSK Institute of Molecular and Computational Medicine has been created via a five-year collaboration between GlaxoSmithKline and the University of Oxford.
The New Age of Decentralized Clinical Trials
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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.
Mouse study suggests manipulation of certain nerve cells can help regenerate lost heart muscle
Scienmag
DECEMBER 2, 2021
FOR IMMEDIATE RELEASE Credit: Photo courtesy of Emmanouil Tampakakis FOR IMMEDIATE RELEASE Human heart muscle cells cease to multiply after birth, making any heart injury later in life a permanent one, reducing function and leading to heart failure. Now, however, Johns Hopkins Medicine researchers say they have new evidence from mouse experiments that manipulating certain […].
GSK pumps £30m into a new Oxford University partnership
pharmaphorum
DECEMBER 2, 2021
GlaxoSmithKline has formed a five-year partnership with Oxford University to set up a new institute that will apply machine learning and functional genomics to the discovery of new medicines. The Oxford-GSK Institute of Molecular and Computational Medicine – based at Oxford’s Nuffield Department of Medicine – is being set up with £30 million (around $40 million) in funding by the UK pharma group.
A dinosaur trove in Italy rewrites the history, geography, and evolution of the ancient Mediterranean area
Scienmag
DECEMBER 2, 2021
Italy is not exactly renown for dinosaurs. In comparison to its excellent artistic and archaeological heritage, dinosaur fossils are very rare. Not surprisingly, the discovery of the first isolated remains from these animals, in the early 1990s, generated quite an excitement, but were shortly after considered nothing more than an exception to a general rule. […].
CDMO deals roundup: AGC Biologics, Halix and BioConnection support monoclonal antibody, gene therapy and vaccine projects
BioPharma Reporter
DECEMBER 2, 2021
Several contract development and manufacturing organization (CDMO) supported biopharma projects have been flagged in the past month. We take a closer look.
Accelerating Clinical Supply Through Integrated Drug Development
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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.
Language used by researchers to describe human populations has evolved over the last 70 years
Scienmag
DECEMBER 2, 2021
National Institutes of Health researchers have found that the words that scientists use to describe human populations – such as race, ancestry, and ethnicity — significantly changed from 1949 to 2018. Such changes and their timing, along with new descriptors for certain population groups, may be linked to structural racism, social trends, and how people […].
Lilly’s Monoclonal Antibody Combo Wins EUA for Patients Under Age 12
BioSpace
DECEMBER 2, 2021
This afternoon, the U.S. Food and Drug Administration expanded the Emergency Use Authorization for Eli Lilly’s monoclonal antibody treatment combination of bamlanivimab and etesevimab.
Hospitals have ethical obligation to care for unvaccinated severe COVID-19 patients
Scienmag
DECEMBER 2, 2021
Credit: ATS Dec. 02, 2021? A new opinion piece published online in the Annals of the American Thoracic Society provides an exhaustive examination of the ethics of using hospital resources on unvaccinated-by-choice COVID-19 pneumonia patients, versus patients with other serious illnesses whose diseases are not progressing as quickly. In “Caring for the Unvaccinated,” William F. […].
Former Immunomedics CFO Charged with Insider Trading
BioSpace
DECEMBER 2, 2021
The SEC announced charges against Usama Malik and his former live-in girlfriend Lauren S. Wood regarding an FDA decision during a trading black out.
How Machine Learning Drives Clinical Trial Efficiency
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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.
It takes guts to make a heart
Scienmag
DECEMBER 2, 2021
SAN FRANCISCO, CA—December 2, 2021—At the earliest stages of a new human life, cells that seem identical begin to divide into distinct types that eventually grow into a diverse array of tissues and organs. During this process, neighboring tissues exchange chemical signals that prompt different steps of each other’s development. But this crosstalk is complex […].
Research Roundup: A Potential Cause of Alzheimer’s Disease and More
BioSpace
DECEMBER 2, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
Lab-grown ‘mini-stomachs’ could shed light on COVID symptoms in children
Scienmag
DECEMBER 2, 2021
The team, led from Great Ormond Street Hospital (GOSH), UCL Great Ormond Street Institute of Child Health (UCL GOS ICH) and the Istituto Zooprofilattico Sperimentale delle Venezie (Legnaro, Italy), have built on recent advances to grow ‘mini-organs’ in a laboratory, known as organoids. These organoids provide researchers with invaluable tools to study how organs function […].
Mix-and-Match Vaccine Platform May Boost Immune Response & Duration
BioSpace
DECEMBER 2, 2021
IDRI is working with a newly-formed consortium to develop a next-gen COVID-19 vaccine that will be stable at routine temperatures and that may be able to confer immunity for a longer duration.
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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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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