Bio Pharma Dive
NOVEMBER 10, 2020
An early analysis found the companies' shot more than 90% effective in preventing COVID-19. Beyond that highly encouraging number, however, there were few other details.
World of DTC Marketing
NOVEMBER 10, 2020
SUMMARY : Pfizer’s 90 percent effectiveness is very impressive, but the rate is based on a relatively small number of people and the data has not been peer-reviewed but today headlines rule the news, not content. You need to ask yourself why in the hell Pfizer’s CEO would say that their vaccine is 90% effective when there is a lot more testing and review of data needed.
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Bio Pharma Dive
NOVEMBER 10, 2020
Along with an equity investment, Pfizer will get first dibs on any potential transaction involving Homology's lead programs, which the biotech is developing for a rare metabolic disorder.
Drug Patent Watch
NOVEMBER 10, 2020
We prefer simple flat-rate unrestricted subscriptions — we’ll work on your terms, and with your favorite subscription contract template, to find a solution that fits. If your colleagues would like to…. The post Thinking of signing your company up for DrugPatentWatch? appeared first on DrugPatentWatch - Make Better Decisions.
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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
NOVEMBER 10, 2020
A late-stage study found Amgen's tezepelumab benefited a variety of patients with severe asthma, results that one analyst called a "best-case outcome.
NY Times
NOVEMBER 10, 2020
The German company BioNTech, founded by two scientists, has teamed up with Pfizer on a vaccine that was found to be more than 90 percent effective.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
NOVEMBER 10, 2020
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for Novavaxâs COVID-19 vaccine. Novavax plans to start Phase 3 trials for the candidate in the US and Mexico by the end of the month.
BioSpace
NOVEMBER 10, 2020
San Francisco-based Vir Biotechnology and its chief executive officer, George Scangos, believe it has a terrific antibody therapy against SARS-CoV-2, the virus that causes COVID-19. But is it too late to the game?
XTalks
NOVEMBER 10, 2020
Despite enhanced safety measures brought on by the COVID-19 pandemic, consumers are still skeptical about the safety, source and quality of the foods they buy, according to a new survey. And although global food supply chains have allowed for efficient international distribution, the food and beverage industry’s biggest concern is food safety, especially amid the global pandemic.
BioSpace
NOVEMBER 10, 2020
After months of urging the public to wear masks and facial coverings to help stop infected people from spreading COVID-19, the Centers for Disease Control and Prevention now states in newly released guidance that masks also protected the mask wearer from being infected.
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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
BioPharma Reporter
NOVEMBER 10, 2020
Lilly's monoclonal antibody therapy, bamlanivimab (LY-CoV555), has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the treatment of adults and children with recently diagnosed, mild to moderate COVID-19.
BioSpace
NOVEMBER 10, 2020
Moderna released interim data from the expansion cohort of its ongoing Phase I trial of its mRNA personalized cancer vaccine, mRNA-4157.
Scienmag
NOVEMBER 10, 2020
Credit: Radiological Society of North America OAK BROOK, Ill. – Digital breast tomosynthesis (DBT), in combination with synthetic mammography, improves cancer detection over digital mammography alone, according to a study from Italy published in the journal Radiology. The study results add further support to the use of DBT in population-based breast cancer screening programs.
BioSpace
NOVEMBER 10, 2020
Pfizer announced today that it has received positive top-line results from the Phase III JADE REGIMEN study, examining abrocitinib for the treatment of severe atopic dermatitis.
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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.
BioPharma Reporter
NOVEMBER 10, 2020
Sinovacâs Phase 3 COVID-19 vaccine trial has been put on hold in Brazil after a serious adverse event. But in a statement this morning, the company says the event is not related to the vaccine.
BioSpace
NOVEMBER 10, 2020
Find out which biopharma companies are raking in cash this week, as companies from around the globe provide updates on their financing rounds and IPOs.
Scienmag
NOVEMBER 10, 2020
Credit: Jasper Ridge Biological Preserve When wolves returned to Yellowstone in 1995, no one imagined the predators would literally change the course of rivers in the national park through cascading effects on other animals and plants. Now, a Stanford University-developed approach holds the promise of forecasting such ecosystem changes as certain species become more prevalent […].
BioSpace
NOVEMBER 10, 2020
Days after Pfizer and BioNTech announced their mRNA vaccine for COVID-19 demonstrated 90% efficacy at an interim analysis, Russia is claiming the vaccine it authorized in the fight against the novel coronavirus is 92% effective following an interim analysis of its ongoing Phase III study.
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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
NOVEMBER 10, 2020
A study of how 98 million Americans move around each day suggests that most infections occur at “superspreader” sites, and details how mobility patterns help drive higher infection rates among minority and low-income populations. Credit: Serina Yongchen Chang A team of researchers has created a computer model that accurately predicted the spread of COVID-19 in […].
BioSpace
NOVEMBER 10, 2020
Jeff Dage, Ph.D., senior research adviser at Eli Lilly and Company, presented the case for P-tau in blood as an accurate biomarker.
pharmaphorum
NOVEMBER 10, 2020
DigitalHealth.London has announced the latest 20 small and medium sized businesses selected for its digital accelerator programme. The programme selects digital solutions or services with the highest potential to meet the city’s health and social care challenges. This the fifth year the event has been running and the NHS delivered programme will see funding matched by the European Regional Development Fund.
BioPharma Reporter
NOVEMBER 10, 2020
Biogen Incâs shares tumbled around 30% yesterday with the company hitting a roadblock late last week as it chases regulatory approval for its investigational Alzheimer's treatment.
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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
NOVEMBER 10, 2020
Findings from the largest and longest study exploring the benefits of walnuts show regular consumption in older adults may reduce the risk of heart disease by reducing the concentration of certain inflammatory biomarkers Credit: CWC FOLSOM, Calif., November 10, 2020 – Findings from a randomized controlled trial recently published in the Journal of the American […].
Pharma Times
NOVEMBER 10, 2020
Akcea’s Waylivra approved via ultra-orphan pathway
BioPharma Reporter
NOVEMBER 10, 2020
The EU has reached an agreement with Pfizer and BioNTech for their COVID-19 vaccine, which reported 90% efficacy earlier this week.
BioSpace
NOVEMBER 10, 2020
5AM Ventures and Wu Capital joined existing investors Frazier Healthcare Partners and Jubilant Biosys Limited.
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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.
Outsourcing Pharma
NOVEMBER 10, 2020
The two companies have joined forces to collaborate on the commercial launch of Gimoti, a nasal spray for patients suffering from diabetic gastroparesis.
BioSpace
NOVEMBER 10, 2020
Even if the vaccine is given the greenlight by regulatory agencies, it will still take some time for the vaccine to be distributed to a wide swath of the population.
Pharma Times
NOVEMBER 10, 2020
RECOVERY study will assess if drug can reduce risk of blood clots
Scienmag
NOVEMBER 10, 2020
In the Netherlands, whole genome sequencing of SARS-CoV-2 outbreaks on 16 mink farms has revealed virus transmission between human to mink, as well as from mink to human. The virus was initially introduced from humans, the study’s authors say, and it has since evolved. “More research in minks and other mustelid species is important to […].
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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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