FDA clears AstraZeneca to restart large coronavirus vaccine study
Bio Pharma Dive
OCTOBER 23, 2020
The drugmaker's U.S. trial has been on pause since early September after an unexplained illness in one participant triggered safety reviews worldwide.
Fri.Oct 23, 2020
294 
Novartis launches digital health hub in Canada
pharmaphorum
OCTOBER 23, 2020
Novartis is opening a new digital health innovation hub in Canada to help develop “scalable, digital solutions” for patients and healthcare providers. The Canadian Biome Digital Innovation Hub will be based in Montreal at the artificial intelligence research institute, Mila. The institute formed a strategic alliance with Novartis in 2019. Canada is the latest country to join a global network of hubs opened by Novartis.
Join 32,000+
Insiders
Sign Up for our Newsletter
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
At key meeting, FDA advisors debate if early coronavirus vaccine approvals may compromise trials
Bio Pharma Dive
OCTOBER 23, 2020
An emergency clearance is expected for the first vaccine proven effective. But early availability of a shot could jeopardize ongoing studies, and may make tests of other candidates more difficult.
Novartis Sees Glimmer of Hope for Branaplam in Huntington’s Disease
BioSpace
OCTOBER 23, 2020
After discovering promising indicators on the path to the development of Branaplam (LMIO70) for spinal muscular atrophy, Novartis now hopes to repurpose the drug for the treatment of Hungtington’s disease.
Ultragenyx expands into Duchenne gene therapy with Solid Bio deal
Bio Pharma Dive
OCTOBER 23, 2020
The rare disease drug developer is betting it can create a better DMD treatment by combining Solid's research with its manufacturing and gene delivery technology.
A Creative Origin Story in a Newspaper Clipping
Intouch Solutions
OCTOBER 23, 2020
What's your career origin story? In this post, we look at Intouch SVP, Executive Creative Director Brent Scholz's very first advertisement and how it inspired his lifelong passion. The post A Creative Origin Story in a Newspaper Clipping appeared first on Intouch Solutions.
Sign up to get articles personalized to your interests!
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
More Trending
FDA Greenlights Restart of AstraZeneca’s Phase III COVID-19 Vaccine Study
BioSpace
OCTOBER 23, 2020
After nearly a month in limbo, AstraZeneca will resume Phase III testing of its COVID-19 vaccine candidate in the United States.
Moderna signals diversity of its US COVID-19 vaccine trial cohort
BioPharma Reporter
OCTOBER 23, 2020
Moderna has flagged the diversity of the US-based Phase 3 trial of its COVID-19 vaccine candidate, mRNA-1273, for which enrollment, now at 30,000, has completed.
Catalent Boosts Supply Chain Transparency in Response to COVID-19 Manufacturing Urgency
BioSpace
OCTOBER 23, 2020
The pharmaceutical supply chain is being pushed to its limit as it prepares to deliver COVID-19 vaccines and therapeutics to the entire world as soon as possible, while continuing to produce and deliver all the usual medications and products.
Data hackathon analyses truth behind TB vaccine and COVID-19
pharmaphorum
OCTOBER 23, 2020
Is a century-old vaccine a ‘game-changer’ for COVID-19? Anita de Waard from Elsevier and Radoslav Kirkov from Estafet tells us how a hackathon is harnessing data science to look beyond the hype and seek definitive clinical evidence. Today, the notion of ‘data science’ has permeated almost every area of society. Words like machine learning, artificial intelligence and deep learning have entered the everyday business lexicon.
The New Age of Decentralized Clinical Trials
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
FDA COVID-19 Vaccine Advisory Committee: Lots of Talk, No Decisions, Some Reassurance
BioSpace
OCTOBER 23, 2020
In the meeting, both the FDA and the U.S. Centers for Disease Control and Prevention presented details about COVID-19 and the requirements for a vaccine.
New patent for Celgene drug POMALYST
Drug Patent Watch
OCTOBER 23, 2020
Annual Drug Patent Expirations for POMALYST Pomalyst is a drug marketed by Celgene and is included in one NDA. It is available from one supplier. There are eleven patents protecting…. The post New patent for Celgene drug POMALYST appeared first on DrugPatentWatch - Make Better Decisions.
Retrophin Buys Orphan Technologies for $517 Million to Gain Enzyme Replacement Therapy
BioSpace
OCTOBER 23, 2020
OT-58 is Orphan’s novel investigational enzyme replacement therapy. It is currently in Phase I/II development for classical HCU, a rare metabolic disorder marked by increased levels of plasma homocysteine.
BMS partners with Sensyne Health for rare blood disease research
Pharma Times
OCTOBER 23, 2020
Collaboration will involve applying machine learning for research into rare blood diseases
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
Advertisement
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
Former Indivior CEO Heading to Prison Over Role in Opioid Crisis
BioSpace
OCTOBER 23, 2020
Shaun Thaxter, the former chief executive officer of Indivior, was sentenced in federal court Thursday, four months after pleading guilty to one misdemeanor count of sharing false information about the addictive properties of Suboxone Film, an opioid-based product.
Examining association of stay-at-home orders, state-level African American population with COVID-19 case rates
Scienmag
OCTOBER 23, 2020
What The Study Did: Researchers investigated whether state-imposed stay-at-home orders and the proportion of African American population in a state were associated with the state-level COVID-19 cases from March to May 2020. Authors: Bisakha Sen, Ph.D., of the University of Alabama at Birmingham, is the corresponding author. To access the embargoed study: Visit our For […].
New patent for Therapeuticsmd Inc drug IMVEXXY
Drug Patent Watch
OCTOBER 23, 2020
Annual Drug Patent Expirations for IMVEXXY Imvexxy is a drug marketed by Therapeuticsmd Inc and is included in one NDA. It is available from one supplier. There are eight patents…. The post New patent for Therapeuticsmd Inc drug IMVEXXY appeared first on DrugPatentWatch - Make Better Decisions.
Metal deposits from Chinese coal plants end up in the Pacific Ocean, USC research shows
Scienmag
OCTOBER 23, 2020
Emissions from coal-fired power plants in China are fertilizing the North Pacific Ocean with a metal nutrient important for marine life, according to new findings from a USC-led research team. The researchers believe these metals could change the ocean ecosystem, though it’s unclear whether it would be for better or worse. The study shows that […].
The New Age of Decentralized Clinical Trials
Advertisement
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.
insitro Bolsters Machine-Learning Platform with Haystack Sciences Acquisition
BioSpace
OCTOBER 23, 2020
Bay Area-based insitro snapped up neighboring Haystack Sciences to bolster its machine-learning drug discovery programs with that company’s higher resolution dataset-producing technology.
ASTRO highlights Winship study showing increased failure-free survival in prostate cancer
Scienmag
OCTOBER 23, 2020
Imaging agent fluciclovine invented at Emory/Winship A study from Winship Cancer Institute of Emory University (Winship) has the potential to change how patients whose prostate cancer recurs after prostatectomy are treated. The study will be featured in both the plenary session and press program of the American Society for Radiation Oncology (ASTRO) Annual Meeting on […].
Merck KGaA, IAVI and Serum Institute link up to develop COVID-19 mAbs
Pharma Times
OCTOBER 23, 2020
Agreement will see partners develop SARS-CoV-2 neutralising monoclonal antibodies
New imaging method reveals HIV’s sugary shield in unprecedented detail
Scienmag
OCTOBER 23, 2020
The technique should help in the design of vaccines against HIV, SARS-CoV-2 and other viruses that cloak their outer proteins with sugars to evade antibodies. Credit: Zachary Berndsen, PhD, Ward lab at Scripps Research LA JOLLA, CA–Scientists from Scripps Research and Los Alamos National Laboratory have devised a method for mapping in unprecedented detail the […].
Roles and Responsibilities of Specialized Clinical Supply Experts
Advertisement
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 Vertex Pharms drug KALYDECO
Drug Patent Watch
OCTOBER 23, 2020
Annual Drug Patent Expirations for KALYDECO Kalydeco is a drug marketed by Vertex Pharms Inc and Vertex Pharms and is included in two NDAs. It is available from one supplier.…. The post New patent for Vertex Pharms drug KALYDECO appeared first on DrugPatentWatch - Make Better Decisions.
Mathematical modeling suggests optimal timing for antiviral therapies against COVID-19
Scienmag
OCTOBER 23, 2020
Potency and timing of antiviral therapy as determinants of duration of SARS-CoV-2 shedding and intensity of inflammatory response A new mathematical modeling study by Ashish Goyal and colleagues, informed by data collected from 25 patients hospitalized with COVID-19 in 4 different countries, offers some important new insights into the optimal timing of 4 different antiviral […].
Gilead’s remdesivir finally gets US approval
pharmaphorum
OCTOBER 23, 2020
Gilead’s Veklury (remdesivir) has become the first COVID-19 drug approved in the US following a nod from the FDA. As an antiviral drug, remdesivir works to stop replication of SARS-CoV-2, the virus that causes COVID-19. Originally intended as a treatment for Ebola virus, remdesivir made headlines early on in the pandemic as the first drug to show significant improvements in recovery time in patients.
Fipronil, a common insecticide, disrupts aquatic communities in the U.S.
Scienmag
OCTOBER 23, 2020
Credit: Photo courtesy of Janet Miller The presence of insecticides in streams is increasingly a global concern, yet information on safe concentrations for aquatic ecosystems is sometimes sparse. In a new study led by Colorado State University’s Janet Miller and researchers at the United States Geological Survey, the team found a common insecticide, fipronil, and […].
How Machine Learning Drives Clinical Trial Efficiency
Advertisement
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.
NICE changes stance on Keytruda for first-line head and neck cancer
pharmaphorum
OCTOBER 23, 2020
As recently as June, NICE was minded not to back routine NHS of MSD’s Keytruda as a first-line treatment for advanced head and neck cancer , but it has had a partial change of heart on the drug after the company submitted new data. Just-published draft final guidance from the cost-effectiveness agency gives a green light for NHS use of Keytruda (pembrolizumab) as a monotherapy for adults with untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumou
Cyanobacteria: Small candidates as great hopes for medicine and biotechnology
Scienmag
OCTOBER 23, 2020
Credit: Paul D’Agostino In order to unlock the genetic potential of unusual cyanobacteria for the production of new active agents and to explore the potential for applications in biotechnology, the team headed by Dr Paul D’Agostino has been awarded a competitive whole-genome sequencing grant from the Joint Genome Institute (JGI) in the USA.
American College of Surgeons, Oct. 3-7
The Pharma Data
OCTOBER 23, 2020
The 105th Annual American College of Surgeons Clinical Congress. The annual meeting of the American College of Surgeons was held virtually this year from Oct. 3 to 7 and attracted participants from around the world, including surgeons, medical experts, allied health professionals, and administrators. The conference included hundreds of general and specialty sessions, postgraduate courses, scientific paper presentations, video-based education presentations, and posters focusing on the latest adva
Elkhorn coral actively fighting off diseases on reef, study finds
Scienmag
OCTOBER 23, 2020
Findings showed coral has core immune response regardless of disease type Credit: Photo: Margaret Miller, SECORE International MIAMI–As the world enters a next wave of the ongoing COVID-19 pandemic, we are aware now more than ever of the importance of a healthy immune system to protect ourselves from disease. This is not only true for […].
Accelerating Clinical Supply Through Integrated Drug Development
Advertisement
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.
Let's personalize your content