Sat.Aug 24, 2024 - Fri.Aug 30, 2024

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Your Food Choices Can Fuel Anxiety And Depression. Here’s How.

AuroBlog - Aurous Healthcare Clinical Trials blog

(Thirdman/Pexels) The proverbial “sugar high” that follows the ingestion of a sweet treat is a familiar example of the potentially positive effects of food on mood.

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Pfizer launches digital healthcare platform to streamline access

Pharmaceutical Technology

Pfizer has launched a new digital platform, PfizerForAll, aimed at simplifying the process of accessing healthcare for millions of Americans.

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Tome Biosciences to lay off over 100 employees

Bio Pharma Dive

The buzzy startup, which had raised over $200 million in venture funding, is letting go of much of its workforce, according to a state regulatory notice.

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J&J's attempt to tweak 340B policy for Stelara, Xarelto denounced by HHS

Fierce Pharma

Even as Johnson & Johnson prepares to weather the impact of negotiated Medicare drug prices on two of its | The new rebate model would require eligible hospitals to submit rebate claims after paying full price for the drugs, as opposed to upfront discounts.

Drugs 119
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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MBX joins IPO queue with $100m Nasdaq filing

pharmaphorum

US biotech MBX Biosciences, files for an IPO, seeking around $100 million to take a hypoparathyroidism candidate into phase 3

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Regulatory Considerations for API Manufacturing in the EU: Ensuring Compliance and Supply Chain Resilience

Drug Patent Watch

The European Union (EU) has implemented a robust regulatory framework to ensure the quality and safety of active pharmaceutical ingredients (APIs) used in medicines. The EU’s Good Manufacturing Practice (GMP) guidelines provide the minimum standards for API manufacturing, and compliance with these guidelines is mandatory for all manufacturers and importers of APIs intended for the EU market.

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DEA To Announce Hearing on Proposed Marijuana Rescheduling

FDA Law Blog

By Larry K. Houck — Who says nothing happens in Washington, D.C., in August? The Drug Enforcement Administration (“DEA”) will announce Thursday in the Federal Register that it will hold a hearing on the proposed rescheduling of marijuana to schedule III at DEA Headquarters in Arlington, Virginia on December 2, 2024. DEA received over 43,500 public comments in response to the agency’s Notice of Proposed Rulemaking in the Federal Register on May 21, 2024.

Drugs 104
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HDA 2024 Traceability Seminar: An FDA Perspective on DSCSA

Pharmaceutical Commerce

The agency provides an update surrounding the Act’s implementation efforts.

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Cell and gene therapy investment, once booming, is now in a slump

Bio Pharma Dive

Far fewer venture funding rounds were closed by cell and gene therapy developers over the first six months of 2024 than in prior years. Experts say there are several factors.

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Singapore approves mpox vaccine as it adds border infection checks

Pharmaceutical Technology

Unlike its close neighbour Thailand, Singapore has not yet confirmed an mpox clade Ib case.

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

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Here Are All The Reasons Why You Should Enjoy Your Cup of Coffee

AuroBlog - Aurous Healthcare Clinical Trials blog

(iprogressman/Getty Images) Consuming too much caffeine is definitely bad for your health, and there may be good reasons why some people want to quit it altogether. But if you despair at the idea of giving up your morning coffee, fear not.

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August 29, 2024: HDRN Canada Pragmatic Trials Training Program Offers Open-Access Learning Modules

Rethinking Clinical Trials

A virtual, asynchronous learning program that offers open-access modules to anyone interested in learning about the complex art of pragmatic clinical trial design and implementation is now available. Every week, a new open-access module features essential resources and leading Canadian trialists discussing a key component of clinical trials. The 2-year, pan-Canadian program—HDRN Canada Pragmatic Trials Training Program—follows a structured curriculum that covers 12 key components of clinical tri

Trials 189
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Bayer partners with RNA drugmaker to develop new cancer therapies

Bio Pharma Dive

Under a collaboration with NextRNA Therapeutics, Bayer will access the biotech’s platform to target long, non-coding RNA interactions with small molecule drugs.

RNA 298
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Are PBMs to blame for high drug prices in the US?

Pharmaceutical Technology

US Congress labelled pharmacy benefit managers (PBMs) as ‘anticompetitive’; PBMs blame manufacturers for increasing pharmaceutical prices.

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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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Cutting Calories May Not Impact Your Exercise Performance After All

AuroBlog - Aurous Healthcare Clinical Trials blog

(Jordi Salas/Moment/Getty Images) A new mouse study challenges conventional wisdom that cutting down on calories can lead to a drop in exercise performance. Even when dieting, it seems mammalian bodies are able and willing to keep up previous activity levels.

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August 26, 2024: iPATH Trial Aims to Improve Diabetes Care in Community Health Centers

Rethinking Clinical Trials

The iPATH trial, one of the newest additions to our portfolio of NIH Collaboratory Trials , is testing the implementation of a practice transformation strategy for patients with type 2 diabetes in federally qualified health centers (FQHCs) in California, Massachusetts, Ohio, and Puerto Rico. We asked the principal investigator for iPATH, Sara Singer of Stanford University, to tell us more about her innovative study.

Trials 162
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Lilly rolls out Zepbound vials at a discount price

Bio Pharma Dive

The launch of a single-use vial form of the popular weight loss medicine could help Lilly improve supply and compete with telehealth companies offering compounded versions.

Medicine 298
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Shortages improve for Lilly’s GLP-1 weight loss drugs, bumping sales forecast by $3bn

Pharmaceutical Technology

Eli Lilly and Novo Nordisk have announced that the supply of their GLP-1 weight loss drugs has improved with increased availability of Zepbound, Mounjaro, Wegovy, and Trulicity.

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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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Eating Seaweed May Help Prevent Parkinson’s, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

(Douglas Klug/Getty Images) Eating the seaweed Ecklonia cava may be able to slow down or prevent Parkinson’s disease, according to a 2024 study. Researchers found that antioxidants in the seaweed – which is often used in soups and salads in Asian cuisine – may protect our neurons from free radicals to prevent this debilitating disease.

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Eli Lilly rolls out direct patient access to weight loss star Zepbound—at a deep discount

Fierce Pharma

Eli Lilly has come up with a new way of supplying its popular weight-loss drug Zepbound that the company hopes could expand access while addressing other issues such as high prices and off-label co | Eli Lilly is offering its popular weight-loss drug Zepbound directly to consumers at a discount through its own online pharmacy. The company hopes the move could expand access while addressing other issues such as high prices and off-label cosmetic usage.

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Pfizer launches DTC service for migraine, COVID drugs

Bio Pharma Dive

The platform is similar in concept to a service launched this year by Eli Lilly, and aims to give consumers easier access to Pfizer’s migraine, COVID-19 and flu treatments.

Drugs 285
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MSD snags European approval for pulmonary arterial hypertension therapy

Pharmaceutical Technology

Winrevair is the first approved actin signaling pathway-targeting therapy for the treatment of the rare blood vessel disorder.

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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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FABA’s life sciences innovation cluster works on global partnerships to propel novel biologics & diagnostics

AuroBlog - Aurous Healthcare Clinical Trials blog

Federation of Asian Biotech Associations’ (FABA) Life Sciences Innovation Cluster is now working to strengthen the global partnerships to propel an ecosystem for novel biologics and diagnostics.

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Optimizing Patient-Driven Site Engagement in Rare Disease Clinical Trials

Worldwide Clinical Trials

By: Nathan Chadwick, Therapeutic Strategy Lead, Rare Disease Over the last few years in clinical trials, particularly within the rare disease community, a notable shift is underway, where patients and caregivers are taking the lead in reaching out to clinical trial sites rather than the other way around. This departure from traditional recruitment methods, where sites would typically initiate contact with patients, presents both opportunities and challenges, marking a pivotal moment in how we ap

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Neurocrine’s mixed schizophrenia data disappoint Wall Street

Bio Pharma Dive

Despite “positive” results, shares of the biotech slid by 20%. Analysts cautioned that Neurocrine shouldn’t get “the benefit of the doubt” with its data.

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J&J targets generalised myasthenia gravis landscape with nipocalimab

Pharmaceutical Technology

J&J’s BLA was supported by data from the Phase III VIVACITY study, demonstrating the safety and efficacy of biweekly nipocalimab.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Jan Vishwas Act amendment on Pharmacy Act to be in force from December 31

AuroBlog - Aurous Healthcare Clinical Trials blog

The amended provisions under the Jan Vishwas (Amendment of Provisions) Act, 2023, notified by the Central Government last year for removal of stringent punishments such as imprisonment from some of the Sections of The Pharmacy Act, 1948, will come into force from December 31, 2024.

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Merck’s Keytruda flunks pivotal studies in early-stage lung and skin cancers

Fierce Pharma

A Merck & Co. effort to move its PD-1 behemoth Keytruda into early treatment of lung cancer has reached a dead end, along with another bid to expand into a type of early-stage skin cancer. | A Merck & Co. effort to move its PD-1 behemoth Keytruda into early treatment of lung cancer has reached a dead end, along with another bid to expand into a type of early-stage skin cancer.

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Keytruda fails lung and skin cancer trials, limiting further expansion

Bio Pharma Dive

The trial setbacks for Merck’s best-selling drug, which faces patent expiration in 2028, are a blow to the company’s plans for further indication expansion.

Trials 279
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ESC 2024: Latest FLOW trial analysis highlights how Ozempic can benefit CKD patients

Pharmaceutical Technology

If approved, Novo Nordisk's Ozempic will become the first GLP-1 therapy option for patients with type 2 diabetes and chronic kidney disease.

Trials 130
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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.