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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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

NPR Health - Shots

FEBRUARY 10, 2023

After three years, the Johns Hopkins Coronavirus Resource Center is ceasing operations. Its data dashboards and maps became go-to sources for information from the early days of the pandemic.

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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

Medicine

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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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 334

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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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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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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Sales Drugs 312

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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Clinical Supply

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

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 7, 2023

The company said the experimental injection matched Soliris in a Phase 3 study and would soon be submitted to regulators around the world.

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Regulation 276

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

Clinical Trials

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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Vaccine Vaccination Production Marketing 144

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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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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Pharma Times

FEBRUARY 9, 2023

The companies anticipate that the EMA could also recommend marketing authorisation for AVT04

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Marketing 136

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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

NPR Health - Shots

FEBRUARY 9, 2023

Homosexuality was considered a mental disorder and "sexual deviation" until 1973 — months after Silverstein gave a presentation challenging the classification.

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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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Production Antibody Development 246

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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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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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

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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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 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

Pharma Times

FEBRUARY 10, 2023

Collaboration has created method for heart failure patients to receive at-home treatment

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Clinical Supply

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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Pharmaceutical Technology

FEBRUARY 9, 2023

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.

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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

Pharma Times

FEBRUARY 10, 2023

Study involves the treatment of adults with moderate-to-severe chronic hand eczema

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Trials 133

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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