Bio Pharma Dive
DECEMBER 23, 2021
The decision follows worrisome results in lab studies that indicated omicron can evade both drugs and leaves the U.S. with fewer treatments to respond to the variant's spread.
World of DTC Marketing
DECEMBER 22, 2021
With days to go before Christmas, Americans are sick and tired of being sick and tired. Of reworking plans to adapt to the latest virus risks. Of searching for at-home tests and not finding them. Of wondering whether, after two years of avoiding Covid-19, or surviving it, or getting vaccinated and maybe even boosted, Omicron is the variant they inevitably catch.
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Camargo
DECEMBER 20, 2021
One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA VII , as the reauthorization is commonly known, will cover the fiscal years 2023-2027. Many of the advancements included in PDUFA VII are driven in large part by an increase in the development of innovative products such as cell and gene therapies.
Pharma Mirror
DECEMBER 24, 2021
Getting bariatric surgery is a lifesaver for many people. It can dramatically improve the quality of life of those that are having problems because of their obesity. It reduces and even eliminates diabetes in many people and seriously reduces the risk of heart disease. The weight loss can be dramatic as well. Starting almost immediately after the surgery, the pounds fall away with ease.
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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
DECEMBER 22, 2021
Leqvio, which Novartis acquired for nearly $10 billion two years ago, arrives with high sales expectations. But uptake could be slow as insurers and doctors weigh the drug's safety and cost-effectiveness.
World of DTC Marketing
DECEMBER 20, 2021
According to the Kaiser Family Foundation (KFF), in 2021, the average cost of employee health insurance premiums for family coverage increased by 4% from the previous year to $22,221. The average annual premiums for an individual’s plan also increased 4% to $7,739 this year. Why haven’t more employers addressed the rising costs of employee healthcare with value-based care?
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
DECEMBER 21, 2021
Sanofi has bolstered its immuno-oncology pipeline with a $1 billion agreement to acquire Amunix Pharma of the US – its fourth bolt-on deal of 2021. South San Francisco-based Amunix specialises in T-cell engager and cytokine-based treatments for solid tumours, and is planning to advance its lead programme AMX-818 – a cell-based therapy which targets HER2-expressing cancers – into the clinic next year.
Bio Pharma Dive
DECEMBER 20, 2021
As a result of new laboratory data, the biotech company is deemphasizing more complex "multivalent" booster shots in favor of further study of its existing formulation and an omicron-specific version.
Pharma Times
DECEMBER 22, 2021
Calls for booster vaccinations in order to combat the rising cases brought about by winter and the recent Omicron variant have intensified, in the midst of record case rates.
Outsourcing Pharma
DECEMBER 20, 2021
According to an expert from the clinical insights company, prejudice in AI can impact patient outcomes as well as the ability to develop effective treatments.
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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
pharmaphorum
DECEMBER 22, 2021
A group of 15 digital health startups have joined a programme set up by the US federal government to address health inequality and mitigate the effects if the COVID-19 pandemic. The PandemicX accelerator, launched by the Department of Health and Human Services, is focused on “using digital tools and publicly accessible data to eliminate disparities and tackle drivers of inequity exacerbated by COVID-19.” Companies that have been invited to take part will get “curriculum, mentor
Bio Pharma Dive
DECEMBER 20, 2021
Study enrollment and treatment of sickle cell patients under 18 will be paused for safety reasons, another hurdle in a series of setbacks for the company.
Pharma Times
DECEMBER 21, 2021
The DETERMINE trial aims to discover whether existing ‘licensed’ drugs could also benefit patients with rare cancer types that the drug is not currently licensed for.
Outsourcing Pharma
DECEMBER 21, 2021
The organization is working to give oncology professionals the chance to hear directly from patients about their unique experiences, concerns, and hopes.
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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.
pharmaphorum
DECEMBER 23, 2021
The FDA has published draft guidance on how digital health technologies (DHTs) like smart and wearable devices can be used to capture data remotely from patients in clinical trials – an approach that has come to the fore since the start of the pandemic. The new guidance sets out the regulator’s current thinking on how trial sponsors to incorporate DHTs in the design of studies of drugs or medical devices.
Bio Pharma Dive
DECEMBER 21, 2021
The French drugmaker is interested in Amunix Pharmaceuticals' technology, which could allow for more precise delivery of biologic drugs into cancerous tissue.
Pharma Times
DECEMBER 22, 2021
With authorisation, Pfizer’s oral antiviral candidate Paxlovid is an investigational SARS-CoV-2 protease inhibitor could be prescribed at the first sign of COVID-19 infection.
Outsourcing Pharma
DECEMBER 22, 2021
It has been a pleasure for the OSP team to connect with a long list of fascinating industry minds and share the stories; here are a few of our favorites.
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.
pharmaphorum
DECEMBER 21, 2021
In early 2020, health officials were cautious about forecasting a COVID-19 vaccine timeline to the public, as vaccine discovery was a historically laborious process that took years (if not decades). Yet a successful COVID-19 vaccine gained emergency approval in just 11 months, a blistering pace that likely saved millions of lives. Such a fast turnaround would not have been possible without advanced analytics and the troves of intelligence that scientists had at their disposal.
Bio Pharma Dive
DECEMBER 22, 2021
Paxlovid is the first oral treatment for COVID-19, a potentially valuable new tool as the fast-spreading omicron variant fuels a sharp surge in cases across the U.S.
BioPharma Reporter
DECEMBER 22, 2021
Live biotherapeutic product (LBP) developer, 4D Pharma, which has been NASDAQ listed since March this year, has announced positive topline results for the first part of its Phase I/II trial of an LBP strain for the treatment of asthma.
Drug Patent Watch
DECEMBER 22, 2021
Annual Drug Patent Expirations for CORLANOR Corlanor is a drug marketed by Amgen Inc and is included in two NDAs. It is available from one supplier. There are eight patents…. The post New patent for Amgen Inc drug CORLANOR appeared first on DrugPatentWatch - Make Better Decisions.
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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.
pharmaphorum
DECEMBER 24, 2021
Biogen and Eisai head towards the end of the year with some much-needed good news in their Alzheimer’s programmes, as the FDA awards a fast-track designation to lecanemab, their follow-up to recently approved Aduhelm. The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of early-stage Alzheimer’s disease.
Bio Pharma Dive
DECEMBER 22, 2021
The deal for Gyroscope Therapeutics, worth up to $1.5 billion, gives the Swiss pharma access to a treatment for a type of age-related blindness as well as new means of delivering drugs into the eye.
BioPharma Reporter
DECEMBER 22, 2021
As 2021 draws to a close, we take a look at the COVID-19 vaccine development landscape and some of the candidates progressing through clinical trials.
Pharma Marketing Network
DECEMBER 20, 2021
R.J. Lewis, Founder and CEO of eHealthcare Solutions and Tap Native and the Chief Collaborator at Pharma Marketing Network, moderated a deep dive discussion on the topic of physician-level data (PLD) with a focus around drivers for the tool, its usage, and successes learnings about its function in pharma, and the where it’s heading. Guests of the panel included experts from GSK, Ispen, BioPharm Communications, and CMI, who all spoke to the importance of incorporating and leveraging PLD ins
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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.
pharmaphorum
DECEMBER 24, 2021
The World Health Organization (WHO) recently held a virtual panel discussion during Digital Health Week with speakers from around the world to talk about global strategy on digital health and collective opportunities for catalysing collaborative action. The panel focused on the objectives of the WHO’s Global Strategy on Digital Health 2020-2025 , which aims to develop partnerships at national, regional and global levels to align resources and investments to focus on sustainability and grow
Bio Pharma Dive
DECEMBER 20, 2021
The flurry of decisions from the regulator clears for market Amgen and AstraZeneca's asthma treatment Tezspire, Argenx's rare disease drug Vyvgart and Intra-Cellular's Caplyta for bipolar depression.
BioPharma Reporter
DECEMBER 22, 2021
The pandemic has focused biopharma industry minds on digital innovation, finds a Deloitte report.
Drug Patent Watch
DECEMBER 22, 2021
Annual Drug Patent Expirations for VIBERZI Viberzi is a drug marketed by Allergan Holdings and is included in one NDA. It is available from one supplier. There are sixteen patents…. The post New patent for Allergan Holdings drug VIBERZI appeared first on DrugPatentWatch - Make Better Decisions.
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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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