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.
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,
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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?
pharmaphorum
MARCH 4, 2021
Radiologists in Europe could soon have help keeping children calm as they have MRI scans from Disney favourites like Micky Mouse, Winnie the Pooh and the Little Mermaid. Healthcare tech company Philips has teamed up with Walt Disney Corp to develop custom ambient animations – featuring some of the most-lived characters from Disney, Marvel and Star Wars shows – that can be played to children during the procedure.
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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
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.
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
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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.
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.
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.
NY Times
MARCH 4, 2021
Johnson & Johnson’s one-shot vaccine is allowing states to rethink distribution, even as health officials and experts worry some will view it as inferior.
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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
XTalks
MARCH 1, 2021
Dry eye disease may sound innocuous, but it’s a condition that affects between 25 and 35 percent of individuals in the US, and pandemic-related lifestyle changes may be pushing that percentage up. Reports of a new condition dubbed “mask-associated dry eye” have been coming out of vision care centers in the country, prompting researchers to look at the effects of face masks on the delicate tear film responsible for protecting the eye.
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.
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?
pharmaphorum
MARCH 3, 2021
Novavax hopes its COVID-19 vaccine could be filed in the US in the second quarter, following a potential approval from the UK regulator in the coming weeks. The timetable for approval from the FDA depends on whether the regulator accepts data from the company’s trial in the UK, which could set up a potential Emergency Use Authorisation. Following an upbeat Q4 results announcement CEO Stanley Erck told CNBC that discussions with the FDA are ongoing but the hope is that the regulator will accept t
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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.
BioSpace
MARCH 4, 2021
Days after vaccine-maker Bharat Biotech released interim Phase III efficacy data for a COVID-19 vaccine already in use in India, a pulmonary expert is expressing enthusiasm for the company’s next-generation intranasal vaccine on track to enter clinical testing this quarter.
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.
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.
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.
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.
BioSpace
MARCH 2, 2021
Recent research suggests that it may be possible to categorize GBM into different subtypes based on the underlying biological mechanisms driving tumor development and growth.
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.
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.
NY Times
FEBRUARY 28, 2021
The company’s coming trials will also involve pregnant women and people whose immune systems are compromised.
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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.
BioSpace
MARCH 4, 2021
The U.S. FDA approved Genentech’s Actemra (tocilizumab) for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Bio Pharma Dive
MARCH 3, 2021
The results could help baricitinib become the first treatment for alopecia areata, a leading cause of hair loss. Safety concerns have diminished the drug's prospects in arthritis, however.
XTalks
MARCH 1, 2021
Pfizer Inc. (NYSE: PFE ) and BioNTech SE (Nasdaq: BNTX ) have announced that they are beginning a trial to evaluate the safety and efficacy of a third booster dose for their COVID-19 vaccine (BNT162b2), as well as new vaccine variants. The study is part of a broad development plan to assess the durability of the immunogenic responses elicited by its vaccine and the emergence of new SARS-CoV-2 variants.
BioPharma Reporter
MARCH 1, 2021
New data may have serious implications for the development of vaccination strategies for COVID-19, particularly in individuals with obesity.
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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.
BioSpace
MARCH 2, 2021
Across the Pharm Country Hotbed, the agency has provided hundreds of millions of dollars to universities, research institutes and pharmaceutical companies.
Bio Pharma Dive
MARCH 5, 2021
Reports from three large pharmaceutical companies indicate increasing rebate payments and discounts to insurers more than offset the average price increases they took on their medicines.
pharmaphorum
MARCH 4, 2021
UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with vaccine development, pharma and life sciences playing a key role. The ongoing fight against COVID-19 was a top-line feature of the budget announcement, with an extra £1.65bn to ensure the vaccination roll-out continues to be a success.
BioPharma Reporter
MARCH 1, 2021
The Pfizer/BionTech COVID-19 vaccine â which requires ultra-cold storage â will now be allowed to be transported and stored at standard freezer temperatures for up to two weeks in the US.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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