Bio Pharma Dive
JUNE 15, 2021
Hahn's appointment as chief medical officer of Flagship Pioneering is another example of FDA officials joining industry after their government service. Hahn's predecessor, Scott Gottlieb, sits on Pfizer's board of directors.
World of DTC Marketing
JUNE 15, 2021
QUICK POINTS: Telemedicine claims as a proportion of all commercial health insurance claims decreased by 5.1% nationwide from February to March, after a steeper decline of 15.7% from January to February as vaccination efforts increased and COVID-19 increased. Cases declined as a result. Telehealth claims accounted for 7% of all medical claims positions in January, before falling to 5.9% in February and 5.6% in March, suggesting a steady slowdown in virtual care demand this year.
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pharmaphorum
JUNE 16, 2021
Developers of mobile health apps are comprehensively failing to safeguard the privacy of users, according to a study by researchers in Australia. The team from Macquarie University compared 15,000 free mobile health (mHealth) apps available on the Google Play store and compared their privacy practices to those found in 8,000 non-health apps, finding “serious problems with privacy and inconsistent privacy practices.” The range of apps put under scrutiny included tools for managing hea
BioSpace
JUNE 13, 2021
Retinal tissue has been regrown in three patients with age-related macular degeneration with geographic atrophy or dry (atrophic) AMD in a Phase I/IIa study conducted by Lineage Cell Therapeutics.
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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
JUNE 14, 2021
Highly anticipated results from a Phase 3 study testing the biotech company's shot showed it to be strongly protective and safe, a potential boon for the world's vaccination efforts.
World of DTC Marketing
JUNE 18, 2021
SKIMMERS SUMMARY: According to a GAO Report “Medicare Parts B and D and beneficiaries spent $560 billion on drugs from 2016 through 2018, $324 billion of which was spent on advertised drug” GAO’s review of four advertised drugs found that drug manufacturers changed their DTCA spending during key events, such as increasing spending when a drug was approved to treat additional conditions or decreasing spending following the approval of generic versions.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JUNE 14, 2021
People working on business development are the ones responsible for dealing with the business side of the organization. Dealing with a lot of people, clients and a huge team is part of this job.
Bio Pharma Dive
JUNE 16, 2021
The biotech said it will seek an expanded FDA clearance after results from the RECOVERY trial showed its antibody can lower mortality among certain hospitalized COVID-19 patients.
World of DTC Marketing
JUNE 17, 2021
SKIMMERS SUMMARY: Health experts, including those on an external advisory committee to the FDA, are skeptical that Biogen’s drug will even successfully slow the progression of Alzheimer’s after late-stage clinical trials yielded mixed results and are angry the FDA approved the product. The FDA’s recent approval of aducanumab (Aduhelm) shows just how badly the agency has failed the public.
pharmaphorum
JUNE 16, 2021
As biopharmaceutical products have become increasingly complex, both in design and in regulatory requirements, we need a new way of working. Markus Gershater looks at how automation and artificial intelligence (AI) can transform pharma R&D. Due to increasing complexity in R&D, pharma teams are under pressure to drive down costs and speed up time to market whilst improving outcomes, and most recognise that incorporating automation and AI into their workflows will be game-changing.
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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
Pharma Times
JUNE 15, 2021
New real world data from PHE shows vaccines can protect against hospitalisation caused by variant
Bio Pharma Dive
JUNE 18, 2021
The U.S. drugmaker is the latest to invest large sums of money in antibody-drug conjugates, following recent deals by Gilead, Merck and AstraZeneca.
BioSpace
JUNE 18, 2021
The data showed that both experimental therapies restored function in the cystic fibrosis transmembrane conductance regulator gene.
pharmaphorum
JUNE 17, 2021
While the heroic abilities of the NHS have been on display throughout the COVID-19 pandemic, the last year has also exposed the longstanding limitations and frailties of our underfunded healthcare system, says Maya Ward. With an estimated 100,000 unfilled posts and staff turnover expected to increase due to emotional exhaustion, the health service’s workforce stands to be further stretched by an ageing population.
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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.
BioPharma Reporter
JUNE 15, 2021
Ocugen has chosen Jubilant HollisterStier of Spokane, Washington as its manufacturing partner for COVID-19 vaccine candidate COVAXIN, ready for potential commercial manufacture for the US and Canadian markets.
Bio Pharma Dive
JUNE 18, 2021
Compared to vaccines, development of antiviral drugs for the coronavirus has progressed more slowly, although data are expected soon from Merck, Pfizer and Atea.
BioSpace
JUNE 15, 2021
Repurposed drugs became the front-line defense against COVID-19 within a few months of the pandemic’s emergence. Now bucillamine, currently in Phase III trials in the U.S., may be poised to join them.
pharmaphorum
JUNE 15, 2021
When Biogen acquired Nightstar Therapeutics in 2019, it added a pair inherited retinal disorder (IRD) gene therapies that it hoped would accelerate a push into the fast-evolving category. . Just over two years later, both of those candidates have failed late-stage clinical trials, leaving Biogen’s $800 million investment in Nightstar looking like a poor deal.
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.
Pharma Times
JUNE 16, 2021
New antibody tests can detect if an individual has been exposed to COVID-19 variants, including Alpha and Delta variants
Bio Pharma Dive
JUNE 16, 2021
The consumer group wants Janet Woodcock, Patrizia Cavazzoni and Billy Dunn to step down over last week's controversial approval of Aduhelm, which is expected to put immense strain on healthcare budgets.
BioSpace
JUNE 14, 2021
A sense of urgency, powerful science, relentless ingenuity, hope and trust drove the development of Pfizer and BioNTech’s mRNA vaccine during the height of the COVID-19 pandemic. As the crisis appears to lessen, Pfizer is preparing for the next pandemic.
pharmaphorum
JUNE 14, 2021
Accord Healthcare has introduced a new app in the UK designed to help people undergoing treatment for cancer maintain their physical and mental wellbeing. The Unify Health app helps patients understand their illness, track symptoms and treatment progress, receive tips on health habits and importantly can also be used to connect patients with local pharmacists who can provide additional advice and support.
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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.
Pharma Times
JUNE 14, 2021
CTX001 is being evaluated as a one-time treatment for transfusion dependent beta thalassemia and sickle cell disease
Bio Pharma Dive
JUNE 14, 2021
The British drugmaker has become the latest large pharmaceutical company to make a sizable investment in a drug targeting TIGIT, following deals from Bristol Myers Squibb, Gilead and others.
Drug Patent Watch
JUNE 18, 2021
Annual Drug Patent Expirations for CLARINEX Clarinex is a drug marketed by Merck Sharp Dohme and is included in five NDAs. It is available from two suppliers. There are four…. The post New patent expiration for Merck Sharp drug CLARINEX appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
JUNE 14, 2021
Rebecca Sanders from Lipodystrophy UK tells us how the patient voice helped convince NICE to approve a much-needed drug for this rare disease, and explores how regulators and pharma companies can help make patient involvement in HTA more impactful. This article appears in our free digital magazine Deep Dive: Market Access 2021. Read below for a preview!
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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
JUNE 17, 2021
In the report to the Committee on the Judiciary in the U.S. Senate, the GAO says drug makers have spent nearly $8.2 billion on DTC drug ads in three therapeutic areas from 2016 to 2018.
Bio Pharma Dive
JUNE 15, 2021
A deal with biotech startup Capsida, which recently raised $140 million, gives CRISPR access to a Caltech technology that aims to improve the delivery of genetic medicines.
Drug Patent Watch
JUNE 17, 2021
Annual Drug Patent Expirations for SOLOSEC Solosec is a drug marketed by Lupin and is included in one NDA. It is available from one supplier. There are four patents protecting…. The post New patent for LUPIN drug SOLOSEC appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
JUNE 18, 2021
Japan’s Eisai has hit the jackpot with its first ever antibody-drug conjugate (ADC) drug candidate, attracting a licensing deal from Bristol-Myers Squibb that could top out at more than $3.1 billion. . BMS is making a hefty $650 million upfront payment to Eisai for global co-development and co-commercialisation rights to MORAb-202, which couples an anti-folate receptor alpha (FR?
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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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