Bio Pharma Dive
AUGUST 3, 2022
The success of Alnylam's treatment in a trial known as APOLLO-B could pave the way for the biotech to reach consistent profitability, should the FDA sign off on a planned approval application.
Pharmaceutical Technology
AUGUST 5, 2022
The development of therapeutics for transmissible spongiform encephalopathies (TSEs) continues to be challenged by the complex nature of these diseases. Also referred to as prion diseases, TSEs are rare and fatal neurodegenerative conditions. As per the prevailing prion theory, a misfolded version of a normal cell-surface protein acts as the chief infectious agent.
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World of DTC Marketing
AUGUST 3, 2022
At first, the opportunity to join a small biotech startup sounds excellent. Smaller staff usually means less bureaucracy and being on the ground floor of a potentially financially rewarding career. But there are risks. Leaving the comforts of a big company with a calcified infrastructure, laser-focused job roles, well-established SOPs, deeper pockets, and excellent job security for the scramble and chaos of a younger company isn’t for everyone. .
STAT News
AUGUST 1, 2022
Hospitals secured significantly larger payments from Medicare for 2023, after months of lobbying centered around arguments that inflation and the pandemic have crippled hospitals’ finances. The increase to the hospital “ market basket update ” — a key metric that determines the price growth of hospital goods and services — is the largest from Medicare since 1998, the Centers for Medicare & Medicaid Services said in the final rule that came out Monday evenin
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Bio Pharma Dive
AUGUST 3, 2022
The pharma has now signed two alliances with allogeneic drug developers since September, signalling its interest in CAR-T treatment alternatives.
Pharmaceutical Technology
AUGUST 1, 2022
Moderna has entered a new supply contract with the US Government to deliver 66 million doses of its Covid-19 vaccine booster candidate, mRNA-1273.222. The contract comprises a $1.74bn award to produce and supply these vaccine doses and options to further procure up to 234 million additional doses of the company’s booster candidates. A bivalent booster candidate, the mRNA-1273.222 vaccine comprises Spikevax along with the Omicron BA.4/5 strain messenger RNA (mRNA).
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NPR Health - Shots
JULY 31, 2022
An estimated 4 million workers in the U.S. are struggling to work due to debilitating symptoms from long COVID. The government is urging employers to provide accommodations to keep them on the job.
Bio Pharma Dive
AUGUST 5, 2022
MiroBio, which was spun out of the University of Oxford three years ago, drew Gilead’s interest with its autoimmune disease research.
Pharmaceutical Technology
AUGUST 2, 2022
Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Last year, the companies entered a strategic collaboration. Subsequently, technology transfer as well as scale-up from the lab bench to the commercial facility of Samsung were carried out in a period of seven months.
STAT News
AUGUST 1, 2022
Since the earliest days of the current global monkeypox outbreak, scientists and public health authorities have been calling for the disease to be renamed, arguing that it has racist overtones and carries a stigma that will hinder efforts to stop its spread. In mid-June, World Health Organization Director-General Tedros Adhanom Ghebreyesus said his agency agreed, and would be working with partners to rename the virus itself, the disease it causes, and the two clades or strains of the virus, each
NPR Health - Shots
JULY 30, 2022
Delta-8 is a hemp product designed to get users high, but misleading labels or added chemicals have caused people to get sick. And a lack of federal regulation or guidance has states stepping in.
Bio Pharma Dive
AUGUST 2, 2022
Founded by serial entrepreneur Alexis Borisy, the company comes equipped with two experimental medicines it licensed from Merck KGaA and Blueprint Medicines.
Pharmaceutical Technology
AUGUST 1, 2022
AbbVie has reported net revenues of $14.6bn for the second quarter (Q2) of 2022 as against $14bn in the year-ago quarter, indicating a 4.5% rise on a GAAP basis. Net revenue surged by 6.1% on an operational basis during the quarter. The GAAP diluted earnings per share (EPS) for the quarter ended 30 June grew by 21.4% to 0.51 from $0.42 in Q2 2021. An 11.2% surge in adjusted diluted EPS of $3.37 was reported in Q2 this year against $3.03 in the prior-year quarter.
Rethinking Clinical Trials
AUGUST 2, 2022
In this Friday’s PCT Grand Rounds, Dr. Jay JH Park of McMaster University will present “Economic Evaluation of Platform Trial Designs.” The Grand Rounds session will be held on Friday, August 5, 2022, at 1:00 pm eastern. Dr. Park is director of the Platform Trials Initiative in the Canadian Critical Care Trials Group and an assistant professor in the Department of Health Research Methods, Evidence, and Impact at McMaster University.
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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
NPR Health - Shots
AUGUST 1, 2022
An atlas showing how Alzheimer's changes individual brain cells could help researchers find new treatments for the disease.
Bio Pharma Dive
AUGUST 3, 2022
One week after striking a deal with Versant, the antibody specialist is teaming up with Atlas to provide drug candidates to an undisclosed startup backed by the biotech investor.
Pharmaceutical Technology
AUGUST 1, 2022
GreenLight Biosciences has entered a partnership with the US National Institutes of Health (NIH) for the development of Covid-19 vaccines, which offer broader protection against new variants and with durable effects. The company will jointly design and analyse messenger ribonucleic acid (mRNA) Covid-19 vaccines in partnership with the NIH unit National Institute of Allergy and Infectious Diseases’ Vaccine Research Center (VRC).
pharmaphorum
AUGUST 3, 2022
We all know that real-world data (RWD) from electronic health records (EHR) could boost clinical trial efficiency and improve patient outcomes – so what’s holding us back? It’s been more than two decades since the ground-breaking potential of using electronic health records (EHR) to inform clinical research was first mooted. Since then, progress has been slow, but the industry now has everything it needs to close the feedback loop between science, evidence, and care, said speakers at a recent Co
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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.
NPR Health - Shots
AUGUST 5, 2022
Just as human counts are incomplete, so are animal counts. But the first worldwide compilation of animal cases is a start at understanding the extent of human-to-animal transmission, scientists say.
Bio Pharma Dive
AUGUST 1, 2022
The biotech plans to file an application with the FDA in the first half of next year for clearance in alopecia areata, potentially positioning it to compete with Eli Lilly and Pfizer for market share.
Pharmaceutical Technology
AUGUST 5, 2022
Amgen has signed a definitive agreement to acquire biopharmaceutical company ChemoCentryx for $52 for each share in cash or a total enterprise cost of nearly $3.7bn. ChemoCentryx focuses on orally administered therapeutics for the treatment of inflammatory disorders, autoimmune ailments and cancer. For discovering, developing and marketing such treatments, the company targets the chemokine and chemoattractant systems.
Pharma Times
AUGUST 2, 2022
System improves management for people with diabetes by offering finger prick-free monitoring
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.
NPR Health - Shots
AUGUST 2, 2022
A person at least six weeks pregnant on or after July 20 through Dec. 31, 2022, can submit the fetus as a dependent on their state tax returns starting next year.
Bio Pharma Dive
AUGUST 5, 2022
The pharma disclosed Thursday the FDA had accepted its application for donanemab, starting a six-month assessment for potential accelerated approval.
Pharmaceutical Technology
AUGUST 1, 2022
Before the Covid-19 pandemic, government-led investment and engagement in life sciences was relatively restricted worldwide, with the industry mostly funded via private investment. The pandemic forced governments to acknowledge that this status quo had to change. Since 2020, government agencies have provided funding for expensive late-stage vaccine development and the expansion of manufacturing capacity, as well as other key pharmaceutical activities.
Clinical Trial Podcast
JULY 31, 2022
In this episode, I’m excited to talk about medical imaging in clinical trials. . We’ll discuss the role of a medical imaging CRO, imaging endpoints in clinical trials, expensive mistakes to avoid as a trial Sponsor/ CRO, saving money on medical imaging services, imaging data collection process, and more. The guest for today’s show is a long time friend of mine, Elizabeth Hartunian Dalton, Vice President at Calyx.
NPR Health - Shots
AUGUST 2, 2022
Heat wave researcher Gulrez Shah Azhar grew up in Uttar Pradesh, India, without an A/C unit. He shares tips on how to deal with the heat — including wearing a wet scarf around your neck.
Bio Pharma Dive
AUGUST 4, 2022
The deals hands Amgen a few clinical programs and a marketed therapy in Tavneos, which was approved last year to treat a group of autoimmune diseases.
Pharmaceutical Technology
AUGUST 4, 2022
Sinovac Biotech has reported that its Covid-19 vaccine, CoronaVac, obtained approval from the Health Bureau of the Government of the Hong Kong Special Administrative Region of the People's Republic of China for usage in children of the age six months to three years. The consensus interim recommendations on Covid-19 vaccine use in children aged six months or above in Hong Kong were released by the Scientific Committee on Vaccine Preventable Diseases and the Scientific Committee on Emerging and Zo
STAT News
AUGUST 4, 2022
Briana Lawson was ready to knock her diabetes into remission. For years, the 47-year-old health care consultant had treated her high blood sugar with metformin. But to avoid a lifetime of medication, she knew she’d need to lose weight. She’d tried fad diets, Weight Watchers, Nutrisystem, and had even considered surgery when the results didn’t stick.
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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.
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