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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Flagship and Quotient partner on cardiovascular and renal disease therapies

Drug Discovery World

Pfizer has expanded its strategic partnership with Flagship Pioneering, adding two new research programmes with Flagship-founded Quotient Therapeutics. Under the collaboration, the companies will analyse somatic mutations that occur in diseased patient tissue to inform the discovery and development of therapies for cardiovascular and renal diseases.

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

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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.

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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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More Trending

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National campaign launches to end prostate cancer postcode lottery

Pharma Times

Over 135,000 people have signed a petition to prioritise a national screening programme

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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.

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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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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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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

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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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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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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.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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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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CD44 Antigen drugs in development, 2024

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the CD44 Antigen pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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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.

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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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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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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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Claudin 18 drugs in development, 2024

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the Claudin 18 pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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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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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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AbbVie's Ubrelvy wards off migraines when used in reaction to early warning signs: study

Fierce Pharma

Despite competing against several drugs that have been approved to fend off migraine headaches, AbbVie’s Ubrelvy (ubrogepant) —which is approved only to treat them—has carved out a significant nich | Recent trial results indicate that AbbVie's migraine treatment Ubrelvy works as a preventative. In a study published this week in the journal Neurology, Ubrelvy was 73% more effective in preventing a migraine attack than placebo.

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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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Aromatase drugs in development, 2024

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the Aromatase pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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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.

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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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SCOTUS overturn of Chevron doctrine opens a Pandora's box for biopharma industry, expert says

Fierce Pharma

For the last 40 years, when federal legislation was ambiguous or left an administrative gap, courts were required to defer to the interpretation of federal agencies. | In June, when the Supreme Court voted 6-3 to overturn the Chevron doctrine, it brought significant impact for the healthcare industry and federal regulators like the FDA and the Centers for Medicare & Medicaid Services.

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MR dosage forms revolutionize patient compliance: Girish Nihalani

AuroBlog - Aurous Healthcare Clinical Trials blog

In the ever-evolving pharmaceutical landscape, modified release (MR) dosage forms have emerged as a groundbreaking innovation, providing solutions that significantly improve patient compliance by simplifying complex drug regimens.

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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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PBM executives threatened with fines for alleged perjury in House hearing

Bio Pharma Dive

Testimony from the heads of Express Scripts, Optum Rx and Caremark in July defending pharmacy benefit managers’ business practices could be coming back to bite them.

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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.