Wed.Mar 08, 2023

article thumbnail

Eli Lilly places price cap of $35 on out-of-pocket insulin cost

Pharmaceutical Technology

Eli Lilly has announced that it will reduce the price of its most commonly used insulin, Humalog, in the US, by 70% and cap the out-of-pocket cost for those on commercial insurance at $35. This follows on from recent US federal action, the Inflation Reduction Act, that legislated reducing the Medicare beneficiary insulin out-of-pocket costs at $35 a month.

Insulin 264
article thumbnail

Controversial drug for preterm birth to be withdrawn, maker says

Bio Pharma Dive

The decision by Covis Pharma closes a yearslong battle over continued use of Makena, the only treatment available for prevention of early labor.

Drugs 263
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

US FDA approves Shorla’s oncology drug for T-cell leukaemia

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Shorla Oncology’s Nelarabine Injection, an oncology drug, to treat T-cell leukaemia, an aggressive blood and bone marrow cancer that progresses quickly. The oncology drug has been approved to treat T-cell Lymphoblastic Lymphoma (T-LBL) and T-cell Acute Lymphoblastic Leukemia (T-ALL).

article thumbnail

Children With Autism ‘See’ This Optical Illusion in a Unique Way, Experiment Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

To transform reality into the mental landscape that occupies out minds, our brain performs a multitude of operations. Some are short-cuts; assumptions that become obvious the moment we attempt to make sense of the conflict presented in an optical illusion.

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Danaher and University of Pennsylvania partner for cell therapies

Pharmaceutical Technology

Global science and technology innovator Danaher has entered a strategic collaboration with the University of Pennsylvania for cellular immunotherapies to address manufacturing challenges impacting cell therapy uptake. The multi-year collaboration aims to develop new technologies which will help in improving clinical outcomes for patients. The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products.

article thumbnail

Computational chemistry helps in prediction of toxic behavior of Nitrosamine for drug safety: Experts

AuroBlog - Aurous Healthcare Clinical Trials blog

Computational chemistry is today very much required for pharmaceutical compliance including prediction of toxic behaviour of nitrosamine for drug safety, according to experts. Identification and determination of toxic behaviour of a molecule is one of the most difficult challenges faced in ensuring drug safety.

More Trending

article thumbnail

Low-dose radiation linked to increased lifetime risk of heart disease

Medical Xpress

Exposure to low doses of ionizing radiation is associated with a modestly increased excess risk of heart disease, finds an analysis of the latest evidence published by The BMJ today.

144
144
article thumbnail

Where there's gender equality, people tend to live longer

NPR Health - Shots

Researchers used data from more than 150 countries to connect gender equality and life expectancy. They hope their findings can help policymakers set priorities in public health and other areas.

Research 128
article thumbnail

Digital rectal examination is not useful to early detect prostate cancers, says new research

Medical Xpress

A common method of detecting prostate cancer may not be accurate enough as a reliable screening tool by itself, scientists have warned.

Scientist 145
article thumbnail

2 more eyedrop brands are recalled due to risks of injury and vision problems

NPR Health - Shots

The FDA posted recall notices for certain eyedrops distributed by Pharmedica and Apotex, including an over-the-counter product, Purely Soothing 15% MSM Drops, "that could result in blindness.

Branding 125
article thumbnail

The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

article thumbnail

Long COVID is much less likely after omicron than after initial pandemic variant, finds new research

Medical Xpress

The omicron variant of SARS-CoV-2 is much less likely to lead to long COVID than the variant circulating at the start of the COVID-19 pandemic, new research being presented at this year's European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2023, Copenhagen, April 15-18) suggests.

Research 124
article thumbnail

Moderna's COVID vaccine gambit: Hike the price, offer free doses for uninsured

NPR Health - Shots

Once U.S. stockpiles of COVID-19 vaccine run out, Moderna says it might charge as much as $130 per dose, but give people who lack health insurance a break. Critics say that's not enough help.

article thumbnail

Spinal cord stimulation doesn't help with back pain, says new review

Medical Xpress

Spinal cord stimulation, a medical technology suggested to treat people with chronic back pain, does not provide long-term relief and may cause harm, according to a Cochrane Review released today.

122
122
article thumbnail

Opinion: How cross-state licensure reform can ease America’s mental health crisis

STAT News

Teletherapy has made mental health care more accessible than ever before, making care possible for people who otherwise would never have been able to get it. But the antiquated system of licensure in the United States is creating a huge barrier to realizing the potential for telehealth. I’ve seen the benefits of teletherapy firsthand. As the founder and CEO of Alma, a mental health company that helps independent mental health providers run their private practice and accept insurance, we s

116
116
article thumbnail

Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

article thumbnail

Polygenic risk scores may miss the mark when predicting aggressive prostate cancers

Medical Xpress

According to a research letter published in JAMA Internal Medicine, prostate cancer screening frequently results in biopsies that find clinically insignificant cancer or no cancer at all.

Medicine 115
article thumbnail

The 4 kidnapped Americans are part of a large wave of U.S. medical tourism in Mexico

NPR Health - Shots

Before the pandemic halted travel, some 1.2 million American citizens visited Mexico for health care. The number is rising quickly again, with border restrictions eased.

115
115
article thumbnail

AI-powered ultrasound imaging that detects breast cancer

Medical Xpress

Breast cancer undisputedly has the highest incidence rate in female patients. Moreover, out of the six major cancers, it is the only one that has shown an increasing trend over the past 20 years.

114
114
article thumbnail

FDA issues rare comment on approval of Covid and flu home test from company that went bankrupt

STAT News

Last week, the Food and Drug Administration issued an emergency authorization for the first at-home Covid-19 and flu combination test. The news came just days after the test’s maker, Lucira, filed for bankruptcy, blaming the FDA’s “protracted” approval process for its financial problems. Now the FDA has released a rare comment clarifying what happened during its authorization process.

article thumbnail

The New Age of Decentralized Clinical Trials

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.

article thumbnail

Blood pressure greater than 130/85 mmHg can cause heart damage in adolescents

Medical Xpress

Elevated blood pressure and hypertension can cause early cardiac damage during adolescence which is worsened by young adulthood, a paper published in the Journal of Pediatrics concludes. The study was conducted in collaboration between the University of Bristol in the U.K. and the University of Eastern Finland.

article thumbnail

STAT+: Many doctors spend their days battling insurers. Why do some go to work for ‘the dark side’?

STAT News

Gastroenterologist Alin Botoman had been on hold for almost an hour. The drone of muzak taunted him on speaker phone. It was the second day in a row he’d spent trying to get insurance to cover a dual CT/PET scan he’d already performed for his patient with esophageal cancer. The day before, after the insurance company unexpectedly denied the request, he’d called to contest the decision and spent an hour on hold.

Doctors 105
article thumbnail

New approach to improving clinical trial enrollment and diversity

Medical Xpress

Before new therapies can reach patients, they must be tested in clinical trials in representative populations to show that they work and are safe. Failure to enroll enough participants in trials can delay the arrival of new therapies in the clinic and inflate their eventual price tags. Failure to recruit diverse patients could diminish the relevance and generalizability of trial findings.

article thumbnail

HHS secretary signals support for new restriction on addiction treatment

STAT News

WASHINGTON — A federal proposal to impose new restrictions on a key addiction-treatment medication has caused an uproar in certain segments of the medical community. But health secretary Xavier Becerra seems to be on board. The new Drug Enforcement Administration proposal would require that patients receive an in-person examination before obtaining refills of buprenorphine , a key drug used to treat opioid use disorder.

Drugs 98
article thumbnail

Roles and Responsibilities of Specialized Clinical Supply Experts

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.

article thumbnail

Gene variants linked to cerebral arachnoid cysts overlap with developmental disorders, autism, and epilepsy

Medical Xpress

The most common type of brain cyst (arachnoid) has no known cause. New research investigating patients with these cysts has found something unexpected—a potential genetic link.

article thumbnail

‘A different type of fatigue’: One woman’s Parkinson’s diagnosis is a test of flexibility and gratitude

STAT News

“Living With” explores the contours of life with chronic illness, from the prelude to diagnosis to new patterns of living, to wrestling with big questions about illness and health. In 2020, Sandra Coplin, now 66, moved her life from her native New York — at the time, an epicenter of Covid’s devastation — to North Haven, Conn., to be close to family.

98
article thumbnail

Upward trend in 'deaths of despair' linked to drop in religious participation, economist finds

Medical Xpress

Over the past 20 years, the death rate from drug poisonings in the U.S. has tripled and suicide and alcoholic liver disease death rates have increased by 30%—particularly among middle-aged white Americans, according to studies by the National Center for Health Statistics.

Drugs 98
article thumbnail

Greater digital biomarklers adoption in clinical studies as Koneksa and SSI Strategy collaborate

Outsourcing Pharma

The two partners will pool capabilities to provide an expanded service to their clients, which will see Koneksa provide its digital biomarkers tools and SSI Strategy its expertise in drug development.

article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

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.

article thumbnail

World's most comprehensive study on COVID-19 mental health finds limited effects for most people

Medical Xpress

COVID-19 has taken a relatively limited toll on the mental health of most people around the globe, according to a paper published today in The BMJ by a McGill University-led research team involving collaborators from McMaster University, the University of Toronto, and other institutions.

article thumbnail

STAT+: Pharmalittle: FDA head wants to get rid of advisory panel votes; premature-birth drug is finally withdrawn

STAT News

Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a delightful cup of stimulation. Our choice today is caramel apple, a sweet treat.

Drugs 98
article thumbnail

Scientists develop new targeted therapeutic strategies to fight liver metastasis

Medical Xpress

The research group led by Prof. Zeng Zhutian from the Division of Life Sciences and Medicine of the University of Science and Technology of China (USTC) revealed a new mechanism of immune surveillance by liver-resident macrophages called Kupffer cells (KCs) that prevent liver metastasis from occurring. They also developed a new method for in situ targeted expression and remodeling of KCs' anti-tumor function, which successfully cleared tumors in various animal models with end-stage liver metasta

article thumbnail

STAT+: Medicare chief on the new drug price negotiation program’s operations, hiring, and timelines

STAT News

WASHINGTON — Medicare officials are still hammering out the technical specifics of how the massive program will start to negotiate drug prices — let alone the substantive ones, Medicare chief Meena Seshamani said at a STAT event Tuesday. “There are operations that need to be stood up both on the [Medicare] side and on the manufacturer side,” she said, describing “monthly technical calls.

Drugs 98
article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

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.