Trending Articles

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New NIH findings on talc use and ovarian cancer pose challenge to J&J's high-stakes defense

Fierce Pharma

The more than 53,000 women in the U.S. | The more than 53,000 women in the U.S. who have filed injury lawsuits against Johnson & Johnson have added ammunition for their claims as new research indicates there is an association between long-term use of talcum-based powders and an increased risk of developing ovarian cancer.

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Why Healthcare Data Is Vital for Employers

MedCity News

Employers need healthcare data in order to make decisions, but the data isn’t always easy to get, experts said on a panel at MedCity INVEST. The post Why Healthcare Data Is Vital for Employers appeared first on MedCity News.

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AstraZeneca, on fast track of growth, sets revenue target at $80B by 2030

Fierce Pharma

A decade ago, with AstraZeneca in decline and some investors urging the drugmaker to sell out to Pfizer, new CEO Pascal Soriot presented an audacious plan to hike revenue to $45 billion by 2023. | After AstraZeneca achieved Pascal Soriot's ambitious $45-billion-by-2023 revenue goal, the CEO is thinking big again. On Tuesday morning, AZ unveiled its new plan to swell its revenue to $80 billion by 2030.

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FDA competition seeks digital endpoints for Parkinson’s

pharmaphorum

FDA is asking artificial intelligence teams to develop a digital endpoint tool to study freezing of gait, a symptom of Parkinson’s that can have a serious impact on patients.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Why AlphaFold 3 is stirring up so much buzz in pharma

PharmaVoice

The “Nobel Prize-worthy invention” could be worth hundreds of billions commercially — and have a deep impact on drug R&D.

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Final report says UK infected blood scandal “should have been avoided”  

Pharmaceutical Technology

Nearly 30,000 people, including children in clinical trials, were infected with hepatitis C and HIV from contaminated blood products in the 1970s and 1980s.

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Novavax investor withdraws proxy fight after Sanofi deal

pharmaphorum

Shah Capital Management has withdrawn a proxy campaign against the re-election of director at vaccines firm Novavax in the wake of its $1.2 billion alliance with Sanofi. The top-three investor in Novavax – which has been steadily raising its stake in the company in recent weeks and now holds around 7.9% – said it welcomed the Sanofi deal but warned that “does not mean our engagement is at an end” and it still believes Novavax would benefit from a stockholder on its board of directors.

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Leading Through Change: Insights from a Keynote Inspirational Business Speaker

Scott Burrows

As a keynote inspirational speaker, I’ve had the privilege of addressing audiences from various industries and backgrounds, but there’s something uniquely invigorating about speaking at sales and leadership conferences. Recently, I had the opportunity to kick off a sales conference for a broker dealer that had just been acquired by the largest independent broker dealer in the U.S.

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Bristol Myers Squibb Plans 10-Year Strategy to Expand Access to Medications

PharmaTech

The company is collaborating with the Access to Oncology Medicines Coalition to expand patient access to immuno-oncology therapy Opdivo.

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Pfizer, busy with $4B savings drive, plots even more cuts out to 2027

Fierce Pharma

Pfizer has made frequent headlines in recent months as it moves forward with a campaign to save $4 billion in annual costs by the end of this year. | Pfizer has made frequent headlines in recent months as it moves forward with a campaign to save $4 billion in annual costs by the end of this year. Now, the company has unveiled another savings drive that will run longer.

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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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The Powerful Hospice Lessons of Jimmy Carter  

MedCity News

Carter entered hospice care in his home, more than a year ago, and has set an inspirational example of how to live your last days on Earth with hope, meaning, and vigor. The post The Powerful Hospice Lessons of Jimmy Carter appeared first on MedCity News.

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US senators accuse pharma firms of abusing patent system

pharmaphorum

Lawmakers across the political divide have accused the pharma industry of abusing the patent system to keep the prices of their products as high as possible.

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The Power of Grip: A Journey from Adversity to Success in the Consumer Goods Industry

Scott Burrows

In the world of motivational speaking, stories of triumph over adversity are not uncommon. But for me, the narrative goes beyond inspiration—it’s about embodying the very principles of vision, mindset, and grit that have shaped my journey. At the age of 19, a car accident left me with a broken neck and a daunting diagnosis of quadriplegia. But from the confines of a wheelchair, I refused to let my circumstances define me.

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Introducing the Clarivate Academic AI Platform

Clarivate

We have released the first version of the Clarivate Academic AI Platform, serving our suite of AI-powered Research Assistants. Discover how it is going to help address the needs of students, researchers and librarians for trusted AI. At Clarivate TM , we understand the transformative power of artificial intelligence (AI) in the academic realm and the imperative to introduce AI thoughtfully and responsibly into research, teaching and learning environments.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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In Big Pharma's growth rankings, Lilly took top spot from Novo Nordisk in Q1

Fierce Pharma

The momentum the biopharma industry showed in the fourth quarter of 2023 has continued into this year. | The momentum the biopharma industry showed in the fourth quarter of 2023 has continued into this year. With 18 of the industry’s top 25 companies achieving year-over-year revenue gains, Q1 came close to matching the final quarter of last year, when 21 of the top 25 companies showed increases.

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Amgen Drug for Aggressive Type of Lung Cancer Wins Accelerated FDA Approval

MedCity News

Amgen’s Imdelltra has FDA approval in extensive-stage small cell lung cancer, making it the first bispecific T cell engager approved for treating this type of cancer. Analysts project the new Amgen drug will become a blockbuster seller. The post Amgen Drug for Aggressive Type of Lung Cancer Wins Accelerated FDA Approval appeared first on MedCity News.

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ATS: Amgen, AZ say data backs Tezspire’s role in COPD

pharmaphorum

Amgen and AstraZeneca have said their severe asthma therapy Tezspire could have a role to play in chronic obstructive pulmonary disease (COPD) – a key target indication for the drug – despite missing its primary objective in a clinical trial.

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Sanders issues warning to Novo Nordisk amid GLP-1 drug price investigation

Pharmaceutical Technology

The US Senator took another swipe at the US prices of Novo Nordisk’s blockbuster GLP-1 receptor agonist drugs Ozempic and Wegovy.

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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.

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Pharma Pulse 5/17/24: Apple Watch's Afib App certified by FDA, Learning Telehealth Platforms Benefits Pharmacy Students & more

Pharmaceutical Commerce

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

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As Stelara nears patent cliff, J&J fortifies Tremfya for upcoming ulcerative colitis showdown

Fierce Pharma

The biologics market for inflammatory bowel disease is continually getting more competitive, and now Johnson & Johnson’s Tremfya is the latest medicine angling to make a mark in the space. | The biologics market for inflammatory bowel disease is continually getting more competitive, and now Johnson & Johnson’s Tremfya is the latest medicine angling to make a mark in the space.

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5 Things to Know About How NIH’s SEED Can Help Life Science Startups Grow

MedCity News

The NIH’s SEED office formed to help startups leverage government’s funding programs. Chris Sasiela, director of the SEED office, discussed these programs during the MedCity News INVEST Conference in Chicago. The post 5 Things to Know About How NIH’s SEED Can Help Life Science Startups Grow appeared first on MedCity News.

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EU rules PTC’s Duchenne drug can stay on the market

pharmaphorum

Going against the advice of the CHMP, the EU has said that PTC Therapeutics’ Translarna therapy for Duchenne muscular dystrophy should stay on the market

Marketing 101
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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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Roche’s PI3K inhibitor secures breakthrough status in breast cancer

Pharmaceutical Technology

Roche announced an FDA breakthrough therapy designation for its inavolisib/Ibrance combination therapy.

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3 up-and-coming US biotech hotspots

PharmaVoice

These three U.S. cities are putting themselves on the biotech map as unsung hubs of the industry.

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Lab at center of Zantac saga claims GSK hid drug’s risks for decades

Fierce Pharma

Even as GSK defends itself against thousands of personal injury lawsuits relating to its sale of heartburn pill Zantac, a whistleblower lawsuit from the laboratory that first raised alarm bell | A newly unsealed complaint from the laboratory that first revealed Zantac's links to a carcinogenic impurity lays out a web of allegations about GSK's efforts to bring the drug to market in the 1980s and its attempts to hide the risks since then.

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4 Things Digital Health Investors Need To Get Off Their Chest

MedCity News

During a panel at MedCity News’ INVEST conference, venture capitalists shared some of their takes on today’s healthcare funding landscape — including their thoughts on AI and the industry’s slower investment pace. The post 4 Things Digital Health Investors Need To Get Off Their Chest appeared first on MedCity News.

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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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Lung disease imaging AI from Brainomix gets FDA nod

pharmaphorum

Brainomix gets FDA approval for e-Lung, an AI tool that assists in the diagnosis and assessment of patients with interstitial lung diseases (ILDs) from medical images.

FDA 109
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Docetaxel albumin bound by CSPC Pharmaceutical Group for Hypopharyngeal Cancer: Likelihood of Approval

Pharmaceutical Technology

Docetaxel albumin bound is under clinical development by CSPC Pharmaceutical Group and currently in Phase II for Hypopharyngeal Cancer.

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European authorities recognised for leading medicine regulatory oversight

European Pharmaceutical Review

A total of 33 regulatory authorities have been granted designation as World Health Organization ( WHO ) Listed Authorities under the WLA framework. The agencies holding this status have been approved and validated as compliant and committed to upholding the “highest level of regulatory standards and practices for quality, safety and efficacy of medicines and vaccines ”.

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FDA snubs another China-made PD-1 with rejection of Elevar, Hengrui's liver cancer combo

Fierce Pharma

China-made PD-1 inhibitors just can’t get a clean pass through the FDA. | China-made PD-1 inhibitors continue to struggle at the FDA. This week, the U.S. agency rejected Elevar Therapeutics and Jiangsu Hengrui Pharma's PD-1 combination in liver cancer.

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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.