Bio Pharma Dive
NOVEMBER 26, 2021
Final trial data for molnupiravir were less convincing than what Merck previously reported and could alter how the FDA views the drug, which will be evaluated at a meeting Tuesday.
World of DTC Marketing
NOVEMBER 24, 2021
SUMMARY: The U.S. needs to take substantial steps to address the high costs of cancer drugs. From 2009 to 2019, the median monthly treatment costs for new drugs at launch reached $11,755 in the U.S… Does the question become how much is a month(s) of other life worth? According to an analysis published by JAMA Oncology, prices for new drugs approved for use in the treatment of cancer in the United States more than doubled over the past decade.
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Camargo
NOVEMBER 22, 2021
“There are only four kinds of people in the world: Those who have been caregivers, those who are currently caregivers, those who will be caregivers, and those who will need caregivers.”. ~ Roslyn Carter. Each November, National Family Caregiver Month recognizes and honors all those who have dedicated themselves to caring for ailing loved ones. It also helps raise awareness of the often-overwhelming issues they face, so that we can work together as a society to alleviate them.
Pharma Mirror
NOVEMBER 26, 2021
In recent years, it has become more and more important to both consumers and investors that they support organisations which display a high level of social and environmental responsibility. This means that it’s no longer enough for businesses to manage their bottom lines and maintain profitability, they must also be conscious of the impact they have on the world around them.
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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
NOVEMBER 22, 2021
A new deal with Sosei Heptares hands Neurocrine a "broad portfolio" of drugs for schizophrenia, dementia and other neuropsychiatric disorders.
World of DTC Marketing
NOVEMBER 22, 2021
SUMMARY: CVS announced its plans to begin closing its doors –about 900 locations across the country. They know the future isn’t about selling 20 kinds of shampoos and vitamins. In the words of the company’s mission , its goal is to “make high-quality health and pharmacy services safe, affordable and easy to access.” Growth doesn’t mean getting more extensive; it means getting better.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
NOVEMBER 21, 2021
Even before the drug's approval on June 7, there were cases of amyloid-related imaging abnormalities (ARIA-E), or cerebral edema, observed in the trials.
Bio Pharma Dive
NOVEMBER 22, 2021
The regulator will decide whether to approve Bluebird's treatment by next May, but its evaluation begins more than a year later than the biotech first hoped.
pharmaphorum
NOVEMBER 25, 2021
A new variant of COVID-19 identified in Botswana with dozens of mutations is being watched closely, amid fears it could be resistant to the effect of currently-used vaccines. The B.1.1.529 variant has more mutations affecting the spike protein targeted by vaccines than any other strain identified to date, although it’s not yet clear if it is more or less transmissible.
Pharma Times
NOVEMBER 24, 2021
With the latest approval from the EC, patients in Europe suffering from metastatic triple-negative breast cancer can now receive Gilead Science’s Trodlevy as part of their treatment.
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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
NOVEMBER 25, 2021
A new clinical trial of heterologous â or âmix-and-matchâ â combinations of COVID-19 vaccines is set to start in Pakistan: seeking to add to research on the effectiveness of such combinations.
Bio Pharma Dive
NOVEMBER 24, 2021
Out of an "abundance of caution," the companies halted enrollment in a trial evaluating the combination of Merck's islatravir and Gilead's lenacapavir.
pharmaphorum
NOVEMBER 23, 2021
Genomics England, the Department of Health and Social Care’s genome-sequencing hub, has this year announced that support for whole genome sequencing (WGS) has reached a level at which its national rollout on the NHS may someday become a reality. The timing of this announcement is particularly opportune, as increasing knowledge and advances in WGS amongst scientists has resulted in the technology becoming increasingly affordable and effective, making its incorporation into the existing standardis
Scienmag
NOVEMBER 24, 2021
In sub-Saharan Africa, 7 million people with HIV live more than 10 minutes from health care services and 1.5 million people with HIV live more than 60 minutes from a healthcare facility, according to a new study published this week in the open-access journal PLOS Global Public Health by Diego Cuadros of the University of […].
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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.
Pharma Times
NOVEMBER 23, 2021
NICE has published draft guidance recommending risdiplam (Evrysdi) as part of a managed access agreement (MAA) for the treatment of the rare genetic disorder spinal muscular atrophy (SMA).
Bio Pharma Dive
NOVEMBER 23, 2021
Formally unveiled five years after originally planned, the $1 billion headquarters will become the British drugmaker's second-largest R&D center by headcount.
pharmaphorum
NOVEMBER 25, 2021
Health insurance is not enough to provide the necessary affordable access to care for the US’ most vulnerable, finds new PhRMA report. For too many Americans, insurance coverage is not providing the health security it’s meant to. The Pharmaceutical Research and Manufacturers of America’s (PhRMA) first Patient Experience Survey (PES) has found that three in ten people with medical insurance still face financial barriers to accessing healthcare and prescription medicines.
BioSpace
NOVEMBER 23, 2021
Bonus BioGroup’s product is back in the news again as its cell therapy promises to treat late-stage COVID-19.
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
NOVEMBER 26, 2021
The Food and Drug Administration (FDA) granted approval for emergency use of the Comirnaty vaccine in children in October 2021.
Bio Pharma Dive
NOVEMBER 22, 2021
Four months after vaccination, no 12- to 15-year-olds in the companies' clinical trial developed COVID-19, compared to 30 who received a placebo.
pharmaphorum
NOVEMBER 22, 2021
Skip Rizzo, PhD, research director for medical virtual reality at the University of Southern California’s Institute for Creative Technologies (USC ICT), tells us how its virtual reality (VR) therapy BRAVEMIND is changing PTSD treatment and how pharma can leverage clinical VR. “There’s a strong evidence base for VR applications in many areas, but it’s also breaking down barriers to care.
BioPharma Reporter
NOVEMBER 25, 2021
GreenLight Biosciences and CDMO Samsung Biologics have announced a partnership agreement, with Samsung Biologics to manufacture GreenLightâs messenger RNA COVID-19 vaccine candidate at commercial scale.
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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
NOVEMBER 25, 2021
The use of molnupiravir in COVID-19 cases aims to reduce the pressure on hospitals, in turn reducing the risk of patients developing more severe symptoms of the virus.
Bio Pharma Dive
NOVEMBER 23, 2021
GSK has secured rights to a genetic medicine in early-stage human testing for NASH, a disease thought to affect millions of people and which has proven to be a tough target for drugmakers.
pharmaphorum
NOVEMBER 23, 2021
After years of delays and rising costs, AstraZeneca has formally unveiled its $1 billion R&D facility in Cambridge, said to be the biggest science lab of its kind in the UK. The Discovery Centre (DISC) based in the Cambridge Biomedical Campus – first given the green light in 2015 – is being officially opened today by Prince Charles. It can accommodate more than 2,200 research scientists, has 19,000 square metres of lab space, and boasts “the most advanced robotics, high-throughput scre
BioSpace
NOVEMBER 21, 2021
?The recommendation comes after a thorough evaluation of both products' effectiveness and safety profiles, presented at the Advisory Committee on Immunization Practices last week.
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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.
JAMA Internal Medicine
NOVEMBER 21, 2021
This cohort study examines mortality data from Texas, a racially and ethnically diverse state, to better understand excess mortality among adults aged 25 to 44 years during early months of the COVID-19 pandemic.
Bio Pharma Dive
NOVEMBER 22, 2021
A versatile technique to ensure your drug is ready on time for your first-in-human clinical trial.
pharmaphorum
NOVEMBER 24, 2021
Takeda has scored the first-ever FDA approval of a treatment for refractory cytomegalovirus (CMV) infections in organ transplant patients, which can lead to an increased risk of complications and even death. Livtencity (maribavir) has been cleared for use in transplant patients aged 12 or over with CMV infections that do not respond to first-line treatment with current antiviral drugs for CMV, such as ganciclovir, valganciclovir, foscarnet and cidofovir.
BioSpace
NOVEMBER 23, 2021
A cardiovascular drug Pfizer licensed from Akcea Therapeutics in 2019 hit the mark in a Phase IIb dose-ranging study in patients with elevated non-HDL-C and triglycerides.
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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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