FDA authorizes J&J's one-shot coronavirus vaccine
Bio Pharma Dive
FEBRUARY 27, 2021
The agency's emergency clearance makes J&J's vaccine the third available in the U.S., adding much-needed reinforcements at a critical time.
Sat.Feb 27, 2021 - Fri.Mar 05, 2021
352 
The true cost of COVID-19?
World of DTC Marketing
MARCH 4, 2021
SUMMARY: COVID-19 has killed many people worldwide, but how many really died from COVID, and how many died because they had an underlying chronic health problem as a major factor? We may never know, but we can not afford to do anything while our population becomes more obese and unhealthy. According to CNN “a team examined mortality data from Johns Hopkins University (JHU) and the World Health Organization (WHO) and found that of 2.5 million Covid-19 deaths reported by the end of February,
Join 21,000+
Insiders
Sign Up for our Newsletter
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Johnson & Johnson Will Test its Vaccine in Infants
NY Times
FEBRUARY 28, 2021
The company’s coming trials will also involve pregnant women and people whose immune systems are compromised.
Inside the Pfizer/BioNTech COVID-19 vaccine trial: ‘We knew the world was watching and waiting for results’
BioPharma Reporter
MARCH 3, 2021
The 2020 Pfizer/BioNTech COVID-19 vaccine trial recruited more than 44,000 participants and reached submission for emergency authorization in 248 days: showing unprecedented speed and agility in the context of a global pandemic. So what have been the learnings from the trial â and how could they be applied to vaccine development in the future?
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Takeda takes full control of drug for rare epilepsies
Bio Pharma Dive
MARCH 3, 2021
A new agreement with Ovid Therapeutics has Takeda paying almost $200 million to secure global rights to soticlestat, an experimental treatment for certain brain diseases, including Dravet syndrome and Lennox Gastaut syndrome.
Pharma on a digital hiring spree?
World of DTC Marketing
MARCH 2, 2021
SUMMARY: Almost every pharma company seems to be posting open digital marketing positions on LinkedIn but are they really hiring? A quick check of three open positions found that they “were on hold” due to budget constraints. Pharma acknowledges the need to get better in digital marketing, which starts with hiring the right people. The open positions for emarketing people seem to be everywhere, but almost every industry is adding more digital marketing people as people shift to buyin
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
EMA launches rolling review of Russia’s Sputnik V COVID-19 vaccine
Pharma Times
MARCH 4, 2021
Rolling review begins based on lab and clinical studies in adults
Biogen to spend $200M on gene therapy plant in North Carolina
Bio Pharma Dive
MARCH 4, 2021
The planned factory is a strong sign of Biogen's interest in gene therapy, an area of research it has invested in through dealmaking over the past few years.
Earning trust and building trust need to occur at the same time
World of DTC Marketing
MARCH 1, 2021
SUMMARY: Trust is earned every day. Today, because of the Internet, a lot of attention is placed on day-to-day activities. Pharma has to undress, and that trust is an ongoing process, and leaders cannot rest on the work they have completed, like developing vaccines. More support and improvement of processes are needed. The employees at J&J are saying, on LinkedIn, how proud they are that their company developed a COVID vaccine.
India's Covaxin Covid-19 Vaccine, Already in Use, Shows Promise in Trials
NY Times
MARCH 4, 2021
Interim results from clinical trials suggested that Covaxin could be safe and effective, potentially removing one hurdle to New Delhi’s ambitious campaign to inoculate a vast population.
New Drug Approval for in-House Developed Anti-Insomnia Drug Dayvigo (Lemborexant) in Hong Kong
Pharma Mirror
MARCH 2, 2021
Eisai Co., Ltd. announced that its Hong Kong subsidiary Eisai (Hong Kong) Co., Ltd. has obtained approval for the in-house-discovered and developed orexin receptor antagonist DAYVIGO (generic name: lemborexant) for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. This approval is the first approval for DAYVIGO in Asia outside of Japan.
A closely watched schizophrenia drug fails key test
Bio Pharma Dive
MARCH 2, 2021
Though a mid-stage study read out negative, Neurocrine still sees a path forward for the drug, which it licensed from Takeda last summer.
Can J&J’s vaccine approval erase bad pharma?
World of DTC Marketing
FEBRUARY 28, 2021
SUMMARY: Pharma companies, like J&J, have received criticism for engaging in illegal activities, such as providing kickbacks and bribes, knowingly shipping adulterated or contaminated drugs to pharmacies, and marketing drugs for unapproved uses. Johnson & Johnson has paid $2.7 billion in penalties. Can a COVID-19 vaccine approval suddenly erase that?
How accidental advocacy is amplifying the GM1 voice
pharmaphorum
MARCH 3, 2021
Rare disease families need to stand up and be counted if they want things to change said mum and advocate Christine Waggoner. She spoke to pharmaphorum as part of our Patients Insights series. Like many “rare disease mums”, Christine is an accidental advocate. After her daughter, Iris, was diagnosed with a rare disease at five, friends, family, and strangers donated so much to a research fund-raising campaign that she had to set up a non-profit to deal with it all.
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
I Holland Announces a New Leadership Team
Pharma Mirror
MARCH 2, 2021
I Holland, leaders in the manufacture of tablet tooling for the pharmaceutical and nutraceutical markets, has announced a series of appointments to form a new senior management team to lead the company moving forward. The new Board of Directors consists of six highly-experienced team members many of which remain from the previous management team. David Hinds has handed over the baton of Managing Director to Javier Raposo but will continue to serve on the Board as Non-Executive Director.
Lilly says diabetes shot outperformed rival Novo drug in study
Bio Pharma Dive
MARCH 4, 2021
The results are a boost for Lilly's drug, tirzepatide, which is being prepared for regulatory submissions later this year. But long-term heart data won't be available for some time.
As pharma abandons the antibiotic market patients are at risk
World of DTC Marketing
MARCH 3, 2021
SUMMARY: According to Pew Internet “Despite antibiotics’ vital role in cancer care, companies have abandoned their development in favor of more profitable drugs. A pull strategy is needed with financial incentives to repair the broken market for antibiotics and make it worthwhile for the pharma industry to bring promising drugs to market. Drug resistance is a silent threat that could end up killing as many as 10m people in 2050.
NHS prescription charges set to rise in England
Pharma Times
MARCH 2, 2021
Charge will increase to £9.
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.
Novartis Piqray(R) – First and only treatment specially for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer receives HSA approval
Pharma Mirror
FEBRUARY 28, 2021
Novartis announced the Health Sciences Authority (HSA) has approved* Piqray®, an ?-specific class I phosphatidylinositol-3-kinase (PIK3CA) inhibitor, for the treatment of postmenopausal women, and men, with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2-) negative, advanced breast cancer with a PIK3CA mutation in combination with fulvestrant after disease progression following an endocrine-based regimen.
Merck withdraws Keytruda in type of lung cancer amid 'industry-wide' review by FDA
Bio Pharma Dive
MARCH 2, 2021
Since December, three drugmakers have withdrawn immunotherapies from indications previously granted fast-tracked approvals, suggestive of broader FDA concerns.
The most important website metrics
World of DTC Marketing
MARCH 5, 2021
SUMMARY: Your product website is a window between your brand and target audience. You might not be able to talk to one another, but what your audience does behind that window can tell you a lot about how they’re thinking about your brand. I really don’t care about website visitors when I examine analytics because they don’t mean that much.
Genomics plc scores $30m to expand patient-centric health platform
Pharma Times
MARCH 1, 2021
Latest funding round includes investments from Foresite Capital and F-Prime Capital
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
Accelerating Investigator Recruitment with NLP
Pharma Mirror
FEBRUARY 28, 2021
NLP and social graphs are effective instruments to speed up investigator recruitment and ensure timely pharmaceutical product releases. Read how NLP can leverage the power of unstructured data and help find doctors-influencers that can substantially provide assistance to a clinical trial. Igor Kruglyak is a Senior Advisor at the global IT service provider Avenga and a 35+ year veteran executive of global key development and deployment projects.
Vir shares tumble after apparent setback for COVID-19 drug
Bio Pharma Dive
MARCH 3, 2021
The NIH stopped enrolling patients hospitalized with coronavirus disease into a study of Vir's antibody drug after data monitors questioned its effectiveness.
How advanced technology can streamline the COVID-19 vaccine rollout
pharmaphorum
MARCH 2, 2021
Zebra Technologies healthcare lead Chris Sullivan discusses the COVID-19 vaccine rollout and how technology can streamline the process to combat new variants. . While the rollout of the COVID-19 vaccine has signified the first signs of light at the end of the tunnel, the reality is that this public health crisis is still far from over. More than 100 million people worldwide have been vaccinated thus far, but several new variants of the virus have emerged in South Africa, Brazil and the United Ki
Modified COVID-19 vaccines can avoid ‘lengthy’ clinical studies, says MHRA
Pharma Times
MARCH 5, 2021
UK’s regulatory authority will fast-track jabs modified to new variants
AstraZeneca COVID-19 vaccine age limits: France will now use the vaccine for ages 65 plus - but Canada won’t
BioPharma Reporter
MARCH 2, 2021
This week France has raised the age limit for the AstraZeneca COVID-19 vaccine; but Canada, conversely, has put a 65-year-old limit into its recommendations.
Amgen, with rare buyout, pays $1.9B for cancer biotech Five Prime
Bio Pharma Dive
MARCH 4, 2021
The acquisition marks a dramatic turnaround for Five Prime, which has in recent years struggled through setbacks, executive departures and layoffs.
How clinical trial software can be used to optimize clinical trials
pharmaphorum
MARCH 2, 2021
Clinical trial software facilitates clinical trials from conception to finish. For example protocol management, CRF design , metadata management, and the collection, analysis, and submission of compliant clinical study data to regulatory authorities. The aim is to get quality clinical products to the market faster. Traditionally spreadsheets have been used to record and manage all the various aspects of clinical trials.
ConserV Bio partners with eTheRNA on mRNA vaccine development
Pharma Times
MARCH 4, 2021
Collaboration will focus on vaccines for infectious diseases
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.
Let's personalize your content