Mon.Mar 21, 2022

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Bristol Myers melanoma drug approved by FDA in immunotherapy advance

Bio Pharma Dive

Opdualag is first approved drug that works by targeting a protein called LAG-3 and the third type of "checkpoint inhibitor" the agency has cleared for cancer.

Drugs 255
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Telehealth: Supply exceeds demand

World of DTC Marketing

An increasing number of headlines amplifying many incomplete data around telehealth have led industry stakeholders to extrapolate discrete data points about telehealth to the entire U.S. population. Using an economic framework to analyze national telehealth data. Only 25.6% of Americans utilized telehealth during the two years of the pandemic. Said another way, investments in the telehealth market have been made on the thesis that telehealth is preferred among most Americans.

Marketing 206
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Four key considerations to help prepare for the next public health threat

Bio Pharma Dive

As Omicron cases continue to decline and hopes for a return to normalcy rise once again, it's tempting to let your guard down. Emergent team members reflect on lessons learned through COVID-19 and share four considerations to help prepare for the next public health threat.

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NHS fast-tracks new targeted drug for rare lung cancer

Pharma Times

Patients eligible to receive Takeda’s Exkivity (mobocertinib) have a rare form of lung cancer that cannot be removed by surgery

Drugs 138
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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

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FDA approves new epilepsy drug, handing Marinus a long-awaited victory

Bio Pharma Dive

Nearly 20 years since its founding, Marinus Pharmaceuticals will make the leap to a commercial-stage biotechnology company with Friday's approval of Ztalmy.

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Study identifies and addresses US cancer screening deficits due to the COVID-19 pandemic

Scienmag

Deaths from cancer are expected to increase over the next decade as a result of screening deficits due to the COVID-19 pandemic. New research published by Wiley online in CANCER, a peer-reviewed journal of the American Cancer Society, reveals the extent of screening deficits in breast, colorectal, lung, and cervical cancers across the United States […].

Research 109

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Moderna inks COVID-19 booster supply deals, asks FDA to approve fourth shot for all adults

BioPharma Reporter

Moderna announced a new supply agreement with the Swiss federal government today for seven million doses of its COVID-19 booster vaccine for anticipated delivery in 2023.

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Wind, solar could replace coal power in Texas

Scienmag

HOUSTON – (March 21, 2022) – Texas can be a model for the nation on how to effectively replace coal with wind and solar for the state’s energy needs while meeting environmental goals, according to new research by Rice University engineers. Credit: Wikipedia HOUSTON – (March 21, 2022) – Texas can be a model for […].

Engineer 102
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Plant-Based Ice Cream Brand Coconut Bliss Adds Dairy to Product Lineup

XTalks

After 17 years as a plant-based brand, Coconut Bliss has added a dairy-based ice cream to its product lineup. Founded in 2005, Coconut Bliss was once ahead of its time with recognizing the power and soon-to-be popularity of plant-based dairy options. Now, rebranded as Cosmic Bliss, the brand is attempting to boost sustainable dairy with its organic, grass-fed, clean-label dairy ice cream line. .

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NHS grants fast-track access to Takeda’s lung cancer drug Exkivity

pharmaphorum

Takeda has secured UK approval for its lung cancer therapy Exkivity, with an NHS access deal that could see it prescribed to patients within the next few weeks. The Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation to Exkivity (mobocertinib) as a monotherapy for non-small-cell lung cancer (NSCLC) patients whose tumours have EGFR exon20 insertion mutations, after first-line chemotherapy.

Drugs 98
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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

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Alnylam Files Lawsuits Against Pfizer and Moderna Over Patent Infringement of RNA Delivery Technology

XTalks

Credited as a pioneering RNA interference (RNAi) therapeutics company, Alnylam Pharmaceuticals is taking Pfizer and Moderna to court, claiming that the companies’ use of the lipid nanoparticle (LNP)-based RNA delivery technology in their mRNA COVID-19 vaccines infringes on a patented technology. Alnylam filed lawsuits against each company in a Delaware federal court on Thursday.

RNA 98
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IVRHA 2022: Exhibiting pioneers of medical XR

pharmaphorum

The International Virtual Reality Healthcare Association (IVRHA) held its 6th annual conference in Nashville, Tennessee, showcasing medical extended reality (XR) experiences and the companies impacting the healthcare ecosystem. As Adam Elsesser, CEO of Penumbra, stated in his keynote, when many people think of virtual reality, they often think of gaming.

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Tiny magnets could hold the secret to new quantum computers

Scienmag

Magnetic interactions could point to miniaturizable quantum devices. Credit: (Image by Yi Li/Argonne National Laboratory.) Magnetic interactions could point to miniaturizable quantum devices. From MRI machines to computer hard disk storage, magnetism has played a role in pivotal discoveries that reshape our society. In the new field of quantum computing, magnetic interactions could play a role in […].

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New research suggests women less likely to receive support for cardiogenic shock

Pharma Times

Research analysed differences in treatment and survival between women and men with a heart attack and cardiogenic shock

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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.

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Transforming space and society in Kiruna

Scienmag

When the Swedish government and mining company LKAB (Luossavaara-Kiirunavaara AB) first shared responsibility for developing the city of Kiruna over a hundred years ago, they focused mostly on practical issues. How does one build a city in a “desolate wilderness”? How does one attract settlers to a new place, far away in the Arctic north? […].

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Warped Incentives Update: The Gross-to-Net Bubble Exceeded $200 Billion in 2021

Drug Channels

Time for Drug Channels Institute’s annual update on the gross-to-net bubble —the ever-growing dollar gap between sales at brand-name drugs' list prices and their sales at net prices after rebates and other reductions. We estimate that the gross-to-net bubble reached $204 billion for patent-protected brand-name drugs in 2021. If we include brand-name drugs that have lost patent protection and face competition from generic equivalents, the bubble was even higher, at $236 billion.

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CHOP and Penn Medicine to lead Philadelphia Regional Center for Children’s Environmental Health

Scienmag

PHILADELPHIA, March 21, 2022 – Children in the Greater Philadelphia area face a number of environmental threats to their health, including lead poisoning, asthma from air pollution, and exposure to endocrine disrupting chemicals. Now, with funding from the National Institute of Environmental Health Sciences, researchers from Children’s Hospital of Philadelphia (CHOP) and Penn Medicine have come […].

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BMS buys into Volastra’s cancer expertise with $1.1bn alliance

pharmaphorum

Bristol-Myers Squibb is the first big pharma to strike a deal with Volastra Therapeutics, a start-up that has developed a drug discovery platform based on chromosomal instability (CIN), a common but under-investigated feature of solid tumours. BMS is paying $30 million into the collaboration upfront, with a total deal value of $1.1 billion, for programmes addressing up to three undisclosed targets in cancer therapy.

Drugs 75
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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.

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Nature study: Ocean life may adapt to climate change, but with hidden costs

Scienmag

Suppose that we could watch twenty generations of whales or sharks adapting to climate change—measuring how they evolve and how their biology changes as temperatures and carbon dioxide levels rise. That could tell us a lot about how resilient life in the oceans might be to a warmer world. But it would also take hundreds […].

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Pharmaceutical Forecasting: Supply and Demand

Client Pharma

Supply and demand of pharmaceuticals are mutually exclusive. The supply chain is wholly reliant upon pharmaceutical companies being able to effectively forecast demand for a particular product. The process of forecasting is often made difficult when a new medicine has just been brought to market or rapid deployment of a drug needs to happen in response to a pandemic due to a lack of concrete evidence to base estimations on.

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New screening tool IDs 95 percent of stage 1 pancreatic cancer

Scienmag

A novel screening platform has flagged more than 95 percent of stage 1 cancers, according to a pilot study published in Nature Communications Medicine. If validated by future studies, the approach offers a new way to detect the third-leading cause of U.S. cancer deaths in 2020. Credit: UC San Diego Health Sciences A novel screening platform […].

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Subcutaneous Biologics: The Unmet Requirement in the Pharmaceutical Space

Roots Analysis

Over the years, the incidence and prevalence of chronic diseases, have increased significantly. Presently, the recommended treatment options for such clinical conditions are mostly biologics, which need to be administered via parenteral routes to ensure maximum therapeutic benefit. Given the inherent requirement for frequent medication, patients suffering from such long-lasting clinical conditions generally end up spending high amounts on the prescribed therapeutic regimen, and numerous hospital

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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.

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Taste, temperature and pain sensations are neurologically linked, University of Oklahoma study finds

Scienmag

If you have eaten a chili pepper, you have likely felt how your body reacts to the spicy hot sensation. New research published by biologists at the University of Oklahoma shows that the brain categorizes taste, temperature and pain-related sensations in a common region of the brain. The researchers suggest the brain also groups these […].

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On World TB day WHO calls for increased investments into TB services and research

The Pharma Data

On World TB Day, WHO calls for an urgent investment of resources, support, care and information into the fight against tuberculosis (TB). Although 66 million lives have been saved since 2000, the COVID-19 pandemic has reversed those gains. For the first time in over a decade, TB deaths increased in 2020. Ongoing conflicts across Eastern Europe, Africa and the Middle East have further exacerbated the situation for vulnerable populations.

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The Duke of Lennox, a preternatural political talent, spotlighted in new book

Scienmag

LAWRENCE, KANSAS – Think of the Duke of Lennox as a politician who appears on “Dancing With the Stars.” Ludovic Stuart, the duke, did much the same thing when he capered at 17th-century masques — that is, elaborate royal court performances — in the Banqueting Hall he helped build in London for his patron, King […].

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New interim order continues expedited authorization pathway for COVID-19 medical devices

Pharma in Brief

The Minister of Health has issued a new interim order regarding expedited authorizations for COVID-19-related medical devices. Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 ( IO No. 3 ) maintains all of the flexibilities of its predecessor, including the consideration of urgent public health needs ( UPHN ).

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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.

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Scientists put CRISPR on safer path to patient treatments with new process for evaluating impacts of gene edits that alter rather than “knock out” DNA code

Scienmag

Wilmington, DE, (MARCH 21, 2022) – A new study from scientists at ChristianaCare’s Gene Editing Institute is advancing the safety and efficacy of using CRISPR gene editing in patient treatments by demonstrating how to identify and evaluate the broad-based biological impact of gene editing on targeted tissues, where the edits are designed to fully disable […].

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ACCURETIC™ (quinapril HCl/hydrochlorothiazide), quinapril and hydrochlorothiazide Tablets, and quinapril HCl/hydrochlorothiazide Tablets Due to N-Nitroso- Quinapril Content

The Pharma Data

Pfizer is voluntarily recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide) to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, above the Acceptable Daily Intake (ADI) level.

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Antibody shows promise for developing hantavirus treatment

Scienmag

An international research team discovered the first human antibody to effectively neutralize two types of hantaviruses in animal models, according to a study published online Mar. 16 in Science Translational Medicine. Based on their initial results, the antibody appears to be a promising candidate for developing a “pan-hantavirus” therapy to protect against outbreaks caused by […].

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FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters

The Pharma Data

Today, the U.S. Food and Drug Administration is announcing a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Wed., April 6, to discuss considerations for future COVID-19 vaccine booster doses and the process for selecting specific strains of the SARS-CoV-2 virus for COVID-19 vaccines to address current and emerging variants.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.