Sat.Feb 04, 2023 - Fri.Feb 10, 2023

article thumbnail

Feinstein Institutes researchers discover new protein for sepsis treatment

Pharmaceutical Technology

Researchers at the Feinstein Institutes for Medical Research have discovered a new protein that can be a potential therapeutic target for lethal sepsis. Led by Feinstein Institutes researcher Haichao Wang, the new study focuses on detecting protein mediators that might contribute to uncontrolled immune responses to lethal infections. It explores the monoclonal antibody detection that may work against procathepsin-L (pCTS-L), a pro-inflammatory protein mediator, as the potential remedy.

Protein 263
article thumbnail

Pfizer begins plan to challenge Shingrix with an mRNA vaccine

Bio Pharma Dive

The pharma and partner BioNTech have kicked off the first human trial of a messenger RNA shot for shingles, believing there’s room to clear the high bar set by GSK’s rival vaccine.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Gas stove makers have a pollution solution. They're just not using it

NPR Health - Shots

Gas utilities and cooking stove manufacturers knew for decades that burners could be made that emit less pollution in homes, but they chose not to. That may may be about to change.

article thumbnail

Chronic fatigue syndrome is associated with distinct changes in the microbiome

Medical Xpress

Over the past three years, the emergence of long-term effects associated with COVID-19 has led to increased focus on a disease with similar hallmarks and symptoms—myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Two studies publishing February 8 in the journal Cell Host & Microbe are taking a closer look at ME/CFS as it relates to the microbiome and the metabolites that microbial species produce.

Research 145
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

4D Molecular’s Fabry gene therapy program on FDA clinical hold

Pharmaceutical Technology

4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310). 4DMT had paused enrollment of patients to two of its trials for 4D-310 last month following a significant adverse event where three patients experienced kidney issues; however, these were treated and resolved in a four-week period. 4DMT has stated that

article thumbnail

Cigna restricts coverage of new ALS drug, deepening fears about access

Bio Pharma Dive

The health insurer’s national formulary considers Amylyx Pharmaceuticals’ Relyvrio to be "experimental, investigational or unproven for any use,” and now does not recommend covering it.

Drugs 328

More Trending

article thumbnail

Telomeres, mitochondria, and inflammation: Three hallmarks of aging work together to prevent cancer

Medical Xpress

As we age, the end caps of our chromosomes, called telomeres, gradually shorten. Now, Salk scientists have discovered that when telomeres become very short, they communicate with mitochondria, the cell's powerhouses. This communication triggers a complex set of signaling pathways and initiates an inflammatory response that destroys cells that could otherwise become cancerous.

Scientist 143
article thumbnail

UK MHRA approves Takeda’s dengue vaccine Qdenga

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]). The vaccine candidate has been approved for active immunisation against the infection in people from four years of age. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes.

article thumbnail

Eisai gives first glimpse into Alzheimer’s drug launch

Bio Pharma Dive

In the month since its U.S. approval, Leqembi has had its first sale, its first prescription written and its first administration to a patient.

Sales 300
article thumbnail

Activist Alice Wong reflects on 'The Year of the Tiger' and her hopes for 2023

NPR Health - Shots

In the Year of the Tiger: An Activist's Life , Alice Wong shares pieces of her story and experience as a disabled Asian American through a collection of essays, interviews, photos and illustrations.

145
145
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

Opinion: Mindstrong’s demise and the future of mental health care

STAT News

One of the shinier entrants to have emerged in the world of mental health startups abruptly announced last week it would wind down, right in the middle of an ongoing crisis in mental health care. Mindstrong, which had raised a total of $160 million from a who’s-who of blue-chip investors, and was led for a while by a former National Institute of Mental Health director, simply couldn’t find a way to make money delivering the low-cost, high-quality care it had promised.

137
137
article thumbnail

Risk-sharing agreements are growing at a rate of 24%

Pharmaceutical Technology

On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for hemophilia B, with a staggering manufacturer price of $3.5 million, according to GlobalData’s Price Intelligence (POLI), making it the most expensive drug in the world. This is not the first treatment to come with a high price tag.

article thumbnail

Medicare to collect drug price rebates starting in 2025

Bio Pharma Dive

CMS laid out how it plans to implement a key provision of the Inflation Reduction Act, which requires drugmakers to pay rebates on price hikes within Medicare that are greater than inflation.

Drugs 246
article thumbnail

COVID test kits, treatments and vaccines won't be free to many consumers much longer

NPR Health - Shots

Insurers, employers, taxpayers and other consumers will all be affected as drugmakers move these products to the commercial market in May. How much you'll pay depends on your health insurance.

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

Tracking the bird flu, experts see a familiar threat — and a virus whose course is hard to predict

STAT News

Veteran influenza epidemiologist Keiji Fukuda remembers vividly when he first became fearful that a virulent bird flu virus, H5N1, might be on the verge of triggering a devastating pandemic. The virus, seemingly out of nowhere, did something bird flu viruses were thought not to be able to do. It infected 18 people, killing six of them. That happened in 1997, in Hong Kong.

136
136
article thumbnail

AbbVie reports rise in full-year 2022 net revenues

Pharmaceutical Technology

AbbVie has reported full-year 2022 net revenues of $58.054bn, representing a 3.3% rise on a reported basis and 5.1% on an operational basis. The company reported an increase of 1.6% on a reported basis in global net revenues to $15.121bn for the fourth quarter (Q4) of 2022. For the full-year, worldwide net revenues from the Immunology portfolio stood at $28.924bn, increasing 14.4% on a reported basis.

Antibody 246
article thumbnail

Bayer begins key tests for closely watched blood thinner

Bio Pharma Dive

The company has begun enrolling patients in one of the largest Phase 3 programs in its history, a pair of trials that will test an anticoagulant it believes can be a future blockbuster.

Trials 246
article thumbnail

Florida high school athletes won't have to report their periods after emergency vote

NPR Health - Shots

The Florida High School Athletic Association's board of directors has voted to remove questions about athletes' menstrual history from a required health form for participation in school sports.

141
141
article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

article thumbnail

Study finds mushrooms magnify memory by boosting nerve growth

Medical Xpress

Researchers from The University of Queensland have discovered the active compound from an edible mushroom that boosts nerve growth and enhances memory.

Research 145
article thumbnail

Teva Pharmaceutical reports 5% fall in Q4 2022 revenue

Pharmaceutical Technology

Teva Pharmaceutical Industries has reported $3.9bn revenue in the fourth quarter (Q4) of 2022, representing a 5% decline in US dollars or a 1% increase in local currency terms, from $4.1bn in the same quarter of the previous year. During the quarter, higher revenues from Anda, generic products in the Europe segment, AJOVY and AUSTEDO were partially offset by fewer revenues from COPAXONE, generic products and certain respiratory products in the North America segment.

article thumbnail

Astellas switches CEOs amid plans to pursue ‘aggressive’ growth

Bio Pharma Dive

Naoki Okamura, currently Astellas’ chief strategy officer, will replace current CEO Kenji Yasukawa as the company attempts to “further accelerate growth.

257
257
article thumbnail

Here's why you should make a habit of having more fun

NPR Health - Shots

Happiness can sometimes feel just out of reach. But having more fun? You've got this — and those giggles and playful moments can make a big difference to your health and well-being.

141
141
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

COVID vaccination in pregnancy found to protect infants against infection and hospital admission

Medical Xpress

Two doses of mRNA COVID-19 vaccine during pregnancy are highly effective against delta and moderately effective against omicron infection, and are linked to a lower risk of hospital admission in infants under six months of age, finds a Canadian study published by The BMJ today.

article thumbnail

ReviR Therapeutics partners with Asieris to develop new oncology therapies

Pharmaceutical Technology

ReviR Therapeutics has signed a research collaboration and option-to-license agreement with Asieris Pharmaceuticals to discover new oncology therapeutics. The collaboration is aimed at discovering and developing new advanced treatments for genitourinary (GU) tumours as well as other related serious diseases using ReviR’s RNA-targeted technologies.

article thumbnail

GSK wins full approval for cancer immunotherapy, looks to expand use

Bio Pharma Dive

The drugmaker converted Jemperli’s accelerated approval in endometrial cancer, while outside advisers endorsed its plan to study the Keytruda rival in rectal tumors.

246
246
article thumbnail

Family caregivers of people with long COVID bear an extra burden

NPR Health - Shots

When a case of COVID-19 morphs into the mysterious, chronic condition known as long COVID, the specialists, appointments, medications and daily need for family care can overwhelm everyone involved.

139
139
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.

article thumbnail

Study: Cannabis has same effect on adolescents and adults, and CBD doesn't dampen effects

Medical Xpress

The short-term effects of vaporized cannabis do not differ between adolescents and adults, while cannabidiol (CBD) does not dampen the effects of the drug, finds a new study led by UCL and King's College London researchers.

Drugs 130
article thumbnail

Opinion: The fungal crisis is here and desperately needs addressing

STAT News

Fungus-caused infections — real ones, not the ones sparking the zombie apocalypse on the popular show “The Last of Us” — pose a growing threat in the United States and around the world. Mississippi has become the latest state to report residents infected with Candida auris, a highly contagious fungus that thrives in hospitals and nursing homes.

Nurses 122
article thumbnail

AstraZeneca sees run of growth continuing in 2023

Bio Pharma Dive

While 2022 revenue came in slightly below analyst expectations, the pharma’s forecast puts within reach a sales target set nearly a decade ago by CEO Pascal Soriot.

Sales 240
article thumbnail

One state looks to get kids in crisis out of the ER — and back home

NPR Health - Shots

At many U.S. hospitals, children and teens are stuck in the emergency department for days or weeks because psychiatric beds are full. Massachussets has a simple, yet promising solution.

137
137
article thumbnail

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.