Tue.Aug 20, 2024

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Lilly’s tirzepatide cuts diabetes risk, study data show

Bio Pharma Dive

Treatment with the GLP-1 drug, which Lilly sells as Mounjaro and Zepbound, lowered the risk of Type 2 diabetes progression by 94% versus placebo.

Drugs 278
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A Vital Fluid Protects Your Most Important Organ. What Happens if It Fails?

AuroBlog - Aurous Healthcare Clinical Trials blog

Cerebrospinal fluid, or CSF, is a clear, colorless liquid that plays a crucial role in maintaining the health and function of your central nervous system. It cushions the brain and spinal cord, provides nutrients and removes waste products. Despite its importance, problems related to CSF often go unnoticed until something goes wrong.

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Emergent joins mpox fight with 50,000 vaccine dose donation to Africa

Pharmaceutical Technology

Supplies of Emergent’s smallpox vaccine ACAM2000 will accompany Bavarian Nordic’s vaccine to African countries.

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J&J drug combo for lung cancer approved by FDA

Bio Pharma Dive

Approval of Rybrevant and Lazcluze was supported by results from a study that compared the regimen to AstraZeneca’s widely used drug Tagrisso.

Drugs 190
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Top 20 biopharmas’ market cap up 4.3% in Q2 2024 as GLP-1 drug innovators hold top spots

Pharmaceutical Technology

The top 20 biopharmaceutical companies demonstrated resilience during the second quarter (Q2) of 2024 as global markets and investor optimism improved with anticipation of a potential interest rate cut from the US Federal Reserve.

Marketing 147
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Avidity, Kymera raise fresh funds; Walgreens partners with BARDA

Bio Pharma Dive

In addition to new stock offerings, this week saw Merck license an antibody drug conjugate and BARDA further work trying to innovate remote clinical trials.

Licensing 144

More Trending

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August 20, 2024: NIH Pragmatic Trials Collaboratory Launches New Self-Paced Learning Path on Pragmatic Trial Study Design

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory has launched a new interactive learning path that provides essential knowledge to research teams on how to choose the most appropriate study design for a pragmatic clinical trial. The learning path is a series of self-paced training modules that include expert videos, reference materials, and knowledge checkpoints.

Trials 130
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J&Js Rybrevant plus Lazcluze combination gets FDA approval in NSCLC

Pharmaceutical Technology

J&J said the drug combination is now the first and only multitargeted, chemotherapy-free combination regimen proven to be superior to Tagrisso.

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India’s nutraceuticals bank on biotech & nanotech to set new benchmarks for scientifically-backed health solutions

AuroBlog - Aurous Healthcare Clinical Trials blog

The integration of biotechnology and nanotechnology into the Indian nutraceutical industry is setting a new standard for scientifically-backed health solutions, said Karthik Kondepudi, partner, Herbochem. The industry is on a trajectory of rapid growth and innovation, driven by technological advancements, changing consumer preferences, and a supportive regulatory framework.

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GLP-1R market: a two-horse race

Pharmaceutical Technology

As obesity rates rise and trust in GLP-1R products grows, sales are forecast to increase four-fold from 2023 to 2030.

Marketing 147
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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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Lawmakers urge FDA to investigate clinical trials run in tandem with China's military

Fierce Pharma

As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China's biopharma ecosystem. | As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China's biopharma ecosystem.

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NMPA approves Astellas’ PADCEV for advanced urothelial cancer

Pharmaceutical Technology

China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved Astellas’ PADCEV (enfortumab vedotin).

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J&J to buy heart failure implant maker V-Wave for up to $1.7B

Bio Pharma Dive

J&J has agreed to pay $600 million upfront for the private company as it works to expand its portfolio of cardiovascular devices.

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ReAlta secures FDA orphan drug and fast track designations for GvHD therapy

Pharmaceutical Technology

ReAlta’s pegtarazimod is being developed to treat acute graft-versus-host disease (GvHD) for patients unresponsive to steroid therapies.

Drugs 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Targeting AZ's Tagrisso, Johnson & Johnson's Rybrevant combo wins key FDA nod in first-line lung cancer

Fierce Pharma

A new FDA approval has vaulted a Johnson & Johnson lung cancer drug combination into a key territory already dominated by AstraZeneca’s Tagrisso. | A new FDA approval has vaulted a Johnson & Johnson lung cancer drug combination into a key territory already dominated by AstraZeneca’s Tagrisso. But the real battle against the EGFR king has yet to start.

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Liquidia’s YUTREPIA inhalation powder gains tentative FDA approval

Pharmaceutical Technology

Liquidia has received tentative approval from the US Food and Drug Administration (FDA) for YUTREPIA (treprostinil) inhalation powder.

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Lilly adds to tirzepatide's impressive pedigree with new data showing the med helps stave off diabetes

Fierce Pharma

Already wildly popular in type 2 diabetes and obesity, Eli Lilly’s tirzepatide can help prevent one of the very diseases it’s meant to treat, new data show. | Already wildly popular in type 2 diabetes and obesity, Eli Lilly’s tirzepatide can help prevent one of the very diseases it’s meant to treat, new data show.

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Accenture invests in Earli to advance early cancer detection tech

Pharmaceutical Technology

Accenture has made an investment in biotechnology company Earli for advancing early cancer detection technologies.

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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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The future of drug discovery: Using AI to optimise the hit-to-lead process

Drug Discovery World

Mirit Eldor , Managing Director, Life Sciences Solutions, Elsevier, looks at how artificial intelligence (AI) can improve the hit-to-lead process for small molecules. Early drug discovery takes an average of three-to-six years and accounts for 42% of total costs 1 in the development of a new drug. It’s therefore no surprise that pharmaceutical companies are increasingly interested in using artificial intelligence (AI) to accelerate development and reduce costs.

Drugs 109
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EC approves AbbVie’s TEPKINLY for follicular lymphoma

Pharmaceutical Technology

The European Commission (EC) has granted conditional marketing authorisation for AbbVie’s TEPKINLY (epcoritamab).

Marketing 130
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Lilly says tirzepatide staves off diabetes in phase 3 trial

pharmaphorum

Eli Lilly's latest clinical readout for dual GIP/GLP-1 agonist tirzepatide is a big one, with data suggesting the drug can reduce the risk of developing type 2 diabetes in overweight and obese adults with pre-diabetes.There's plenty of evidence to show that prediabetes – a higher-than-normal blood sugar level resulting from a level of insulin resistance that isn't high enough to be considered full-blown diabetes – can be reversed if patients commit to an intensive regimen of dietary restriction

Insulin 107
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Adcendo and Multitude ink ADC deal potentially worth $1bn

Pharmaceutical Technology

Adcendo will acquire ex-China global rights for Multitude’s tissue factor-targeting ADC.

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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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Bavarian Nordic readies 2 million vaccine doses to fight mpox outbreak

BioPharma Reporter

The Danish company Bavarian Nordic plans to supply up to 2 million vaccine doses this year in response to the World Health Organizationâs declaration of mpox as a Public Health Emergency of International Concern (PHEIC) earlier this month.

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Expert says supplies of mpox vaccine unlikely to suffice

pharmaphorum

Emergent BioSolutions has agreed to donate 50,000 doses of its mpox vaccine for use in the current outbreak, but an expert has warned supplies are unlikely to meet demand

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New study suggesting suicidal ideation risk for Novo's Ozempic adds to ongoing safety debate

Fierce Pharma

Regulators in both the U.S. and Europe have looked into the potential link between suicidal thoughts and Novo Nordisk’s blockbuster semaglutide franchise after reports sounded the alarm last year. | Researchers found that users of Novo's semaglutide who were logged in a WHO database were more likely to report suicidal ideation.

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CDK9 inhibitors: Disrupting cancer cell growth and the treatment paradigm

pharmaphorum

Learn about the exciting potential of CDK9 inhibitors in disrupting cancer cell growth and changing the treatment landscape for cancer patients. Stay updated on the latest research and developments in this promising field.

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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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What Is Price Gouging? Harris’ Proposed Ban Sparks Debate

XTalks

The recent call for a federal ban on price gouging by Vice President Kamala Harris has ignited a significant debate within the food industry and among economists. As Harris prepares to formally accept her nomination as the Democratic candidate for the 2024 Presidential Election, her proposal is drawing both support and criticism, particularly from those who believe it may do more harm than good for consumers.

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GSK bags breakthrough status for B7-H3 ADC for lung cancer

pharmaphorum

GSK gets FDA breakthrough status for its B7-H3 directed ADC, licensed from Hansah Pharma in a $1.

Licensing 129
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Teva faces fresh Copaxone kickbacks case from Medicare providers as it defends against DOJ claims

Fierce Pharma

For years, Teva has been defending itself against allegations that it used illegal Medicare co-pay schemes to fuel sales of its multiple sclerosis drug Copaxone. | The new lawsuit, filed in a Kansas court, comes as Teva defends against similar allegations made by the U.S. government.

Sales 85
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Buoyed by muscular dystrophy data, Avidity raises $345m

pharmaphorum

Avidity Bio raises $345m from its second big public offering of 2024, after reporting encouraging Duchenne muscular dystrophy data.

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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.