Bio Pharma Dive
NOVEMBER 17, 2020
The therapy's developer, Brainstorm Therapeutics, blamed the setback on better-than-expected results from placebo-treated patients. The biotech still sees a path forward, however.
Bio Pharma Dive
NOVEMBER 23, 2020
Data from two late-stage trials showed the shot to be, on average, 70% effective against COVID-19, an encouraging finding. The lower dose tested, however, outperformed a higher dose.
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NY Times
NOVEMBER 30, 2020
The first shots could be given as early as Dec. 21, if authorization is granted.
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percent effectiveness is very impressive, but the rate is based on a relatively small number of people and the data has not been peer-reviewed but today headlines rule the news, not content.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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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
NOVEMBER 23, 2020
As the Pfizer-BioNTech COVID-19 vaccine is being evaluated by the U.S. FDA and the Moderna vaccine is soon to follow, here’s a look at several of the top COVID-19 vaccine candidates and where they stand as of today.
The Pharma Data
NOVEMBER 9, 2020
DAEGU, KOREA, November 09, 2020 /24-7PressRelease/ — South Korean religious group Shincheonji Church of Jesus has announced their third convalescent plasma donation drive to take place for 3 weeks starting November 16th at an Indoor Athletics Center in Daegu. Approximately 4,000 members of the group are expected to participate. This comes after two previous donation drives that took place in July and September.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
NOVEMBER 19, 2020
The deal, which has Pfizer paying as much as $70 million, is the latest in a series of moves by big pharma companies to forge a stronger position in the world's second-largest drug market.
NY Times
NOVEMBER 27, 2020
Court filings reveal consultants’ talk of a records purge during the opioid crisis, and shed new light on sales advice given to the billionaire Sackler family and their drug company, Purdue Pharma.
World of DTC Marketing
NOVEMBER 24, 2020
SUMMARY : In a 2019 Pew Research Center poll, more Americans said they consider made-up news a bigger problem than terrorism, illegal immigration, racism, and sexism. And 68% said disinformation greatly impacts people’s confidence in government institutions. No matter the form, inaccurate health information is a danger to public health. While psychological factors leave people unguarded against misinformation, people in the U.S. are particularly vulnerable to health misinformation because the l
BioSpace
NOVEMBER 12, 2020
Researchers at Washington University School of Medicine in St. Louis published the results of a clinical trial evaluating an antidepressant, fluvoxamine, for early treatment for COVID-19.
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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 16, 2020
Johnson & Johnson has launched a second global Phase 3 trial for its Janssen COVID-19 vaccine candidate: this time exploring a 2-dose regimen (its existing Phase 3 trial explores a 1-dose regimen).
pharmaphorum
NOVEMBER 11, 2020
Abid Rahman from Intouch Group tells pharmaphorum how AI-based technology is solving challenges across healthcare systems, pharmaceutical companies, and patient treatment. With AI already the key engine for a growing list of consumer devices, the trend has created exciting opportunities for pharma and healthcare. “We have now entered a new phase of AI implementation where AI-based technology is expected to be foundational and not just a novel technology,” Abid Rahman, vice president, innovation,
Bio Pharma Dive
NOVEMBER 3, 2020
On Friday, a panel of experts and FDA staff will weigh in on a closely watched Alzheimer's drug from Biogen. Their feedback could affect how the disease is treated for years to come.
NY Times
NOVEMBER 21, 2020
The furious race to develop a coronavirus vaccine played out against a presidential election, between a pharmaceutical giant and a biotech upstart, with the stakes as high as they could get.
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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.
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.
BioSpace
NOVEMBER 22, 2020
COVID-19 is a cardiac condition as much as it is a pulmonary or respiratory disease. This knowledge is so recent that it often is overlooked by non-cardiologists, according to physicians speaking at Demy-Colton Virtual Salon, “COVID-19: Surprising Cardiac Findings & Concern about the Potential Im.
BioPharma Reporter
NOVEMBER 9, 2020
Agenus Inc, an immuno-oncology company with a pipeline of agents designed to activate immune response to cancers and infectious diseases, has reported the dosing of the first COVID-19 patient with agenT-797, an allogeneic cell therapy, through its subsidiary, AgenTus Therapeutics.
pharmaphorum
NOVEMBER 24, 2020
A merger involving two US digital health specialists and a blank cheque company has created a telemedicine player, called UpHealth, that is valued at more than $1.3 billion. The three-way deal combines UpHealth – which provides patient care management, telemedicine and digital pharmacy services and gives its name to the new group – with CloudBreak, which provides a video consultation platform for doctors and patients.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Bio Pharma Dive
NOVEMBER 11, 2020
The biotech won a grant from the foundation two days after dosing the first patient in a study of an in vivo CRISPR medicine, a milestone for the company and the technology.
NY Times
NOVEMBER 23, 2020
The billionaire is working with the W.H.O., drugmakers and nonprofits to defeat the coronavirus everywhere, including in the world’s poorest nations. Can they do it?
XTalks
NOVEMBER 26, 2020
MIT researchers developed an algorithm that has correctly identified asymptomatic people with COVID-19 by the sound of their forced coughs using their smartphone devices. The researchers have found that asymptomatic people may differ from healthy people in the way that they cough. These differences are not identifiable by the human ear, but the researchers have developed an AI that can detect this difference.
BioSpace
NOVEMBER 22, 2020
Maryland-based vaccine company Novavax said its COVID-19 vaccine candidate, NVX?CoV2373, prevented SARS-CoV-2 infection in monkeys, hinting that the product could likewise prove effective in humans.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
BioPharma Reporter
NOVEMBER 17, 2020
The future of treatment for many of the most challenging diseases in the world is said to reside in personalized cell and gene therapy (CGT). These expensive and complex therapies have proven highly effective in multiple cases, but a challenge remains around producing them at scale and at a reasonable cost.
pharmaphorum
NOVEMBER 27, 2020
A new EMA approval has expanded the use of Vertex Pharma’s exon-skipping cystic fibrosis therapy Symkevi to children as young as six if they have specific gene mutations. The regulator has given a green light to use of Symkevi (tezacaftor/ivacaftor) with Vertex’ Kalydeco (ivacaftor) in patients ages six years and older who have two copies of the F508del mutation in the CFTR gene, or one F508del copy and one of 14 other so-called “minimal function” mutations in CFTR.
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.
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.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
Outsourcing Pharma
NOVEMBER 12, 2020
A leader from the AI technology firm discusses how life-sciences pros are harnessing AI to help continue their work in the face of the pandemic.
BioSpace
NOVEMBER 2, 2020
Three biopharma companies recently shuttered their clinical programs after either their compounds failed clinical trials or interim futility analysis suggested they were unlikely to meet their clinical endpoints. Here’s a look.
BioPharma Reporter
NOVEMBER 16, 2020
Modernaâs mRNA COVID-19 vaccine candidate has reported vaccine efficacy of 94.5% in the first Phase 3 interim analysis, released this morning. "This is a pivotal moment," says Moderna's CEO.
pharmaphorum
NOVEMBER 27, 2020
Amanda Barrell explores how a perfect storm of changing economics, advances in technology, and the increasing volume of the patient voice is stoking change in the rare disease space. New models of drug development are fuelling life-changing advantages in the rare disease space, previously an economic no-go area for pharma and biotech companies. That was among the discussion points during Fighting Rare Diseases – The Science, Economics and the Patients , a webinar hosted by o2h Group.
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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.
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