Pharmaceutical Technology

FEBRUARY 6, 2023

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.

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Bio Pharma Dive

FEBRUARY 10, 2023

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.

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Vaccination Vaccine RNA Trials 358

NPR Health - Shots

FEBRUARY 4, 2023

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.

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Manufacturing 145

Medical Xpress

FEBRUARY 8, 2023

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.

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Research 145

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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.

Clinical Trials

Pharmaceutical Technology

FEBRUARY 10, 2023

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

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Gene Therapy Gene FDA Approval Trials 264

Bio Pharma Dive

FEBRUARY 7, 2023

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.

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Drugs 330

Medical Xpress

FEBRUARY 8, 2023

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.

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Pharmaceutical Technology

FEBRUARY 7, 2023

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.

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Vaccination Vaccine Genetics Trials 264

Bio Pharma Dive

FEBRUARY 6, 2023

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.

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Drugs Sales 303

NPR Health - Shots

FEBRUARY 4, 2023

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.

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The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others. Choosing the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors

Clinical Trials

STAT News

FEBRUARY 6, 2023

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.

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Pharmaceutical Technology

FEBRUARY 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients. Trodelvy has been approved for HR+/HER2- breast cancer adult patients who have previously received endocrine-based therapy and a minimum of two additional systemic therapies

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Bio Pharma Dive

FEBRUARY 6, 2023

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

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NPR Health - Shots

FEBRUARY 8, 2023

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.

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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.

Clinical Trials

STAT News

FEBRUARY 8, 2023

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.

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Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases.

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Gene Therapy Gene Trials Clinical Trials 264

Bio Pharma Dive

FEBRUARY 10, 2023

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.

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Drugs 246

NPR Health - Shots

FEBRUARY 9, 2023

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.

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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.

Clinical Research

Medical Xpress

FEBRUARY 10, 2023

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

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Research 145

Pharmaceutical Technology

FEBRUARY 10, 2023

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.

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Gene Therapy Drugs FDA Approval Gene 263

Bio Pharma Dive

FEBRUARY 8, 2023

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.

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Trials 246

NPR Health - Shots

FEBRUARY 4, 2023

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.

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Advertiser: FourKites

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

Research

Medical Xpress

FEBRUARY 8, 2023

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.

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Vaccination Vaccine 131

Pharmaceutical Technology

FEBRUARY 10, 2023

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.

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Bio Pharma Dive

FEBRUARY 10, 2023

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

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NPR Health - Shots

FEBRUARY 6, 2023

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.

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As demand for advanced therapies increases, so does the need for more specialized supply chain support, as these products have strict transportation and handling requirements. Deviations from the intended supply chain can delay timelines and affect these high value products, which can be detrimental to budgets, but more importantly can have dire effects on the patients whose lives depend on receiving these critical doses safely and on time.

Gene Therapy

Medical Xpress

FEBRUARY 7, 2023

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.

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Drugs Research 130

Pharmaceutical Technology

FEBRUARY 9, 2023

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.

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Production 242

Bio Pharma Dive

FEBRUARY 9, 2023

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.

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Sales 240

NPR Health - Shots

FEBRUARY 9, 2023

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.

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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.

Clinical Trials