Bio Pharma Dive
FEBRUARY 21, 2023
There comes a time when companies with platforms need to focus on their most advanced prospects, Morrison said, rather than sink all of their funds into building the technology.
Pharmaceutical Technology
FEBRUARY 21, 2023
Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, had a phenomenal year with forecast sales of $37bn in 2022. Comirnaty is expected to maintain the sales dominance it saw during the Covid-19 pandemic going into the future, with the average annual sales forecast rising by 19% between H1 and H2 2022, according to GlobalData’s Coronavirus Disease 2019 (Covid-19) Sector Forecast: H2 2022 Global Analyst Consensus Sales Forecast report.
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Bio Pharma Dive
FEBRUARY 21, 2023
The proposed model could help state Medicaid agencies explore different kinds of outcomes-based payment schemes, but may come too late to prepare for the first sickle cell gene therapy.
Pharmaceutical Technology
FEBRUARY 21, 2023
The US Food and Drug Administration (FDA) has accepted a priority review of the biologics license application (BLA) for Regeneron Pharmaceuticals ’ pozelimab to treat children and adults with ultra-rare CHAPLE disease. Currently, there are no approved treatments for CHAPLE, a life-threatening hereditary immune disease caused by an overactivation of the complement system.
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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 21, 2023
Many current top-selling products will lose patent protection by the end of the decade, putting pressure on companies to replace lost revenue with new medicines.
Pharmaceutical Technology
FEBRUARY 21, 2023
Japanese firm Teijin has announced its basic agreement on a capital and business alliance with Axcelead to establish a drug discovery research joint venture (JV) company. The new company will mainly use Teijin Group’s core healthcare company, Teijin Pharma’s drug discovery research capabilities, facilities, personnel, technologies, and equipment.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NPR Health - Shots
FEBRUARY 21, 2023
Petitions for compassionate release soared in the pandemic, but federal judges denied most requests. This week officials will review guidelines aimed at freeing imprisoned people who pose no threat.
Bio Pharma Dive
FEBRUARY 21, 2023
Real-world data and advanced analytics reveal patterns and insights into why patients stop therapies
STAT News
FEBRUARY 21, 2023
A bedrock of the U.S. mental health system — a nine-item questionnaire used to spot depression — began not with a doctor, but with a marketing man. Howard Kroplick, now 73 years old and living on Long Island, is obsessed with antique racing cars and, in his storied career in the pharmaceutical industry, crucially urged Pfizer to avoid the word “impotence” when promoting Viagra.
NPR Health - Shots
FEBRUARY 21, 2023
As fentanyl deaths soar, political pressure is growing to stop Mexican cartels that smuggle the drug. Experts on drug trafficking say trying to lock down the Mexican border is an impossible goal.
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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
FEBRUARY 21, 2023
The Danish-US biotech Hemab Therapeutics bags $135m to finance the clinical development of prophylactic treatments for genetic bleeding disorders including Glanzmann thrombasthenia and von Willebrand disease.
NPR Health - Shots
FEBRUARY 21, 2023
Reckitt says despite contamination fears, the recalled formula tested negative for Cronobacter, which can cause rare but deadly infections in infants. Here's how to identify and prevent them. (Image credit: U.S.
STAT News
FEBRUARY 21, 2023
This year could shape up to be a historic one for tobacco control — or one in which Big Tobacco accelerates its steady transformation into Big Nicotine. We are hoping for the former, but aren’t betting against the latter. For the last few years, the tobacco industry has publicly endorsed harm reduction. This public health strategy includes efforts designed to reduce, though not eliminate, risks for people who engage in harmful behaviors.
Pharma Times
FEBRUARY 21, 2023
Final draft guidance from NICE ensures people at highest risk will have access to COVID-19 therapies
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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.
Medical Xpress
FEBRUARY 21, 2023
Infants outperform artificial intelligence in detecting what motivates other people's actions, finds a new study by a team of psychology and data science researchers. Its results, which highlight fundamental differences between cognition and computation, point to shortcomings in today's technologies and where improvements are needed for AI to more fully replicate human behavior.
STAT News
FEBRUARY 21, 2023
An experimental antibody that delivers lethal radiation directly to the bone marrow improved the outcomes of stem cell transplants for older patients with relapsed leukemia — and may change the way transplant medicine is practiced. The antibody-radiation treatment, called Iomab-B, is being developed by Actinium Pharmaceuticals, a small drugmaker based in New York.
Pfizer
FEBRUARY 21, 2023
In Their Own Voices: A Song By and For Those Touched by Rare Disease kimkevin Tue, 02/21/2023 - 15:20 In Their Own Voices: A Song By and For Those Touched by Rare Disease Monday, February 27, 2023 - 10:00am Share Although individually they are classified as “rare,” considered together, rare diseases affect as many as 1 in 10 people in the United States. 1 Globally, rare diseases impact 3.5%-5.9% of the world’s population. 2 That’s one of the reasons that Rare Disease Day, which occurs annually o
STAT News
FEBRUARY 21, 2023
BEIJING — Hong Kong on Tuesday revoked a visa it granted to a Chinese scientist who set off an ethical debate five years ago with claims that he made the world’s first genetically edited babies, pulling it hours after he announced his research plans in the financial hub. He Jiankui shocked the world in 2018 when he announced he had altered the embryos of twin girls, with many in the scientific community criticizing his work as unethical.
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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.
Antidote
FEBRUARY 21, 2023
Did you know that February is American Heart Month ? This month is dedicated to raising awareness for and providing education on heart health, high blood pressure, and cardiovascular disease.
STAT News
FEBRUARY 21, 2023
Good morning, everyone, and welcome to another working week. Like many on this side of the pond, we are returning from an extended weekend respite, which we hope was invigorating and relaxing, thanks to a holiday. Now, though, the time has come to return to the usual routine of deadlines, meetings and online calls. But what can you do? The world, such as it is, keeps spinning.
BioPharma Reporter
FEBRUARY 21, 2023
The US Food and Drug Administration (FDA) has accepted Pfizerâs Biologics License Application (BLA) for its maternal RSV vaccine under priority review. If approved, the vaccine will become the first RSV vaccine for pregnant women to protect against RSV in infants.
STAT News
FEBRUARY 21, 2023
A Dutch public interest group has filed a lawsuit claiming AbbVie breached a duty to human rights by using unfair and excessive pricing to bolster sales of its Humira drug and dominate the market at the expense of the health care system in the Netherlands. In making its case, the Pharmaceutical Accountability Foundation argued AbbVie allegedly overcharged the Dutch health care system by up to $1.2 billion by “abusing” its position in the marketplace and keeping prices high.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
Cloudbyz
FEBRUARY 21, 2023
A Trial Master File (TMF) is a comprehensive collection of documentation that provides a complete record of a clinical trial and proves that a clinical trial has been conducted following Good Clinical Practice (GCP) guidelines and all regulatory requirements and also demonstrates that the integrity of trial data has been maintained. The TMF contains all essential documents related to the trial, such as study protocols, informed consent forms, investigator brochures, monitoring reports and others
Medical Xpress
FEBRUARY 21, 2023
An international team of medical scientists has found more evidence of infections in pregnant women raising the risk of leukemia developing in babies. In their paper published in JAMA Network Open, the group analyzed data from several Danish medical registries looking for ties between various types of infections in pregnant women and whether they increase the risk of babies developing leukemia.
Pharma Times
FEBRUARY 21, 2023
Boost for effected patients as HEMGENIX receives green light from European Commission
Medical Xpress
FEBRUARY 21, 2023
During the fetal stage, a number of so-called cell programs run that are vital to the development of the fetus. In a study published in Cell Reports, researchers from Lund University demonstrate that one of these fetal programs appears to protect against acute myeloid leukemia (AML).
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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
FEBRUARY 21, 2023
Three months after receiving the US green light, CSLâs candidate Hemgenix has become the first gene therapy to gain EU approval for the treatment of hemophilia B.
Medical Xpress
FEBRUARY 21, 2023
Residing in border regions was linked with a higher risk of dying within five years among children with acute lymphoblastic leukemia, the most common type of pediatric cancer.
NPR Health - Shots
FEBRUARY 21, 2023
Dr. Farzon Nahvi spent the first few months of the pandemic as an emergency room physician in Manhattan. He talks about trying to improvise treatments during that time. His new book is Code Gray.
Medical Xpress
FEBRUARY 21, 2023
For parents, the decision to vaccinate their kids against SARS-CoV-2 is complex, influenced by scientific evidence, political and social pressures, and views about individual versus collective benefits of vaccination, according to a new study published in CMAJ (Canadian Medical Association Journal).
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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