Sat.Feb 01, 2025 - Fri.Feb 07, 2025

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Is 2025 the Chinese Year of BioPharma?

Bio Pharma Dive

China is now a dealmaking hot spot for firms seeking next-generation innovation. What will 2025 hold?

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An unexpected mechanism regulates the immune response during parasitic infections

Medical Xpress

Researchers at the University of Lige (Belgium) have uncovered a previously unknown mechanism that regulates the immune response against parasites. During a parasitic infection, specific immune cells, known as virtual memory T cells, become activated and express a surface molecule called CD22, which prevents an excessive immune reaction. This discovery could help in better-controlling inflammation and improving immune responses to infections.

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Bain Capital buys Mitsubishi Tanabe Pharma for $3.3bn

Pharmaceutical Technology

Bain Capital said its decision to buy Mitsubishi Tanabe is due to the strong growth potential of Japans healthcare industry.

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February 4, 2025: Workshop Summary Now Available for ‘Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues’

Rethinking Clinical Trials

A workshop summary, videocast recordings, and other materials are now available from the NIH Pragmatic Trials Collaboratory’s 2024 virtual workshop, “Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues. “ The 2-day workshop, hosted by the NIH, featured a keynote address by Monica Bertagnolli exploring how to identify high-priority healthcare issues that require the effort, time, and funding of a clinical trial.

Research 130
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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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Shares of psychedelics biotech nearly double on depression data

Bio Pharma Dive

The small, Ireland-based company GH Research said its inhaled version of mebufotenin — a molecular cousin to psilocybin — was fast and effective in a treatment-resistant depression trial.

Trials 292
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Dangerous Kind of Fat Hidden in The Body Can Raise Your Risk of Death

AuroBlog - Aurous Healthcare Clinical Trials blog

(Peathegee Inc/Getty Images) Humans with relatively more fat hidden in and around their muscles face a higher risk of death or hospitalization from heart disease, according to new research an association that persists regardless of body mass index (BMI).

Research 244

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Grand Rounds January 31, 2025: Advancing Rural Back Pain Outcomes Using Rehabilitation Telehealth (ARBOR-Telehealth): Early Progress and Lessons Learned (Richard L. Skolasky, ScD; Kevin H. McLaughlin, DPT)

Rethinking Clinical Trials

Speakers Richard L. Skolasky, ScD Professor, Johns Hopkins School of Medicine Department of Orthopaedic Surgery Kevin H. McLaughlin, DPT Assistant Professor, Johns Hopkins School of Medicine Department of Physical Medicine and Rehabilitation Slides Keywords Back Pain; Rural Health; Telehealth Key Points Low back pain (LBP) is the most common cause of disability globally and in the U.S.

Medicine 100
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Vertex challenger Sionna prices $191M IPO

Bio Pharma Dive

The biotech is evaluating several cystic fibrosis medicines that could either work alongside Vertex’s top-selling Trikafta or be used in new, multi-drug combinations.

Medicine 284
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The Growing Importance of Specialty Generics in the Latin American Pharmaceutical Market

Drug Patent Watch

The Latin American Pharmaceutical Market: Why Specialty Generics Are Poised for Growth As the pharmaceutical industry continues to evolve, one trend is becoming increasingly clear: the demand for specialty generics is on the rise, particularly in the Latin American market. But what exactly are specialty generics, and why are they gaining traction in this region?

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Thermo Fisher continues viral vector withdrawal; lays off 300 employees

Pharmaceutical Technology

The cuts at two Massachusetts plants follow further site closures and layoffs across the company over the past few years.

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

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A Type of Fiber Could Have Weight Loss Benefits Similar to Ozempic

AuroBlog - Aurous Healthcare Clinical Trials blog

(courtneyk/Getty Images) Research on the gut microbiome has triggered a ‘revolution‘ in nutritional science, and in the last few years, dietary fiber has become the “new protein” added to foods in abundance to feed our gut and boost our health. A recent study on mice, however, suggests not all fiber supplements are equally beneficial.

Protein 231
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Pfizer drug acquired in $11B buyout confirms benefit in colon cancer

Bio Pharma Dive

The results could sway U.S. regulators to convert Braftovi’s accelerated clearance in colorectal tumors into a full approval — boosting an oncology portfolio Pfizer is looking to for revenue growth.

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Study finds stem-like T cells key to lasting immune response in cancer, chronic diseases

Medical Xpress

Prolonged illnesses like cancer and chronic infections often leave the immune system in a state of exhaustion, where its frontline defendersT cellslose their ability to function effectively. Research, led by the Peter Doherty Institute for Infection and Immunity (Doherty Institute) and the Peter MacCallum Cancer Center (Peter Mac), have identified a rare type of immune cells, called stem-like T cells, that holds the key to maintaining powerful, long-term immune responses.

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Sanofi increases ownership stake partaking in pharma buyback trend

Pharmaceutical Technology

Sanofi has agreed to purchase its own shares worth 2bn ($2.08bn), part of a $5.1bn share buyback initiative in 2025.

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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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Revealed: How Much Exercise You Need to ‘Offset’ a Day of Sitting

AuroBlog - Aurous Healthcare Clinical Trials blog

(Jack Atkinson/Unsplash) We know that spending lots of time sitting down isn’t good for us, but just how much exercise is needed to counteract the negative health effects of sitting down all day? Research suggests about 30-40 minutes per day of building up a sweat should do it.

Research 228
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Bristol Myers gives first peek at closely watched launch of schizophrenia drug

Bio Pharma Dive

Cobenfy, the main asset acquired through Bristol Myers’ $14 billion purchase of Karuna, had $10 million in sales in the fourth quarter and is around 1,000 prescriptions weekly by late January.

Sales 251
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Optimizing Research Productivity Using Data-Driven Protocol Feasibility

ACRP blog

As many as 20% to 50% of clinical trials do not accrue participants at the site level, leading to wasted time and financial resources. This waste can be minimized by early selection of trials most likely to succeed. The protocol feasibility review process informs this selection by offering a way to evaluate logistical elements of a clinical trial before the activation process is started.

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MHRA seeks input on new regulatory guidance for cancer vaccines

Pharmaceutical Technology

The proposed guidance aims to provide a framework for the approval of personalised mRNA-based cancer vaccines.

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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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Obesity-Focused Metsera Launches IPO Amid Much Anticipation

XTalks

Metsera, Inc., a clinical-stage biotech company focused on developing next-gen injectable and oral nutrient-stimulated hormone (NuSH) analog peptides for the treatment of obesity, overweight and related conditions, has priced its initial public offering (IPO) at $18.00 per share, raising $275 million in gross proceeds. Current Share Price: The offering, which includes 15,277,778 shares of common stock, is set to close on February 3, 2025, after beginning trading on the Nasdaq under the ticker sy

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Drugmakers prep for bird flu outbreak, despite continued low risk

Bio Pharma Dive

While the virus hasn’t made a sustained leap into humans, vaccines and treatments are being developed ahead of an outbreak.

Vaccine 241
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Reducing Study Start-Up Times: Quality Improvement Practices at a Site Management Organization

ACRP blog

Taking an average of around eight months, study start-up can be subject to a wide variety of delays that impact study costs and timelines. In effort to reduce this average, HCA Healthcare Research Institute, a site management organization with around 40 sites and 275 open trials, has a centralized approach to reducing start-up timelines. We pride ourselves on being a watchdog, for example, by making sure that operational elements of the protocol do not over-burden study participants and lead to

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Treating alcohol addiction: filling the medication gap

Pharmaceutical Technology

With Dry January firmly behind us, many adults are prompted to reassess their relationship with alcohol. Alcohol Change, the UK charity behind the popular Dry January initiative, found that 30% of men and 26% of women in the UK wished to reduce the amount of alcohol they drank in 2024.

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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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Nobi Raises $37M in Series B Funding for AI-Driven Fall Detection Technology

XTalks

Belgian AgeTech innovator Nobi has successfully secured 35 million ($37 million) in an oversubscribed Series B funding round to advance its AI-powered smart light designed for fall detection and prevention among the elderly. The financing round was co-led by Angelini Ventures and Nexus NeuroTech Ventures, with participation from Japanese investor 15th Rock and existing investors, including EQT Health Economics, EQT Dementia Fund, Belgian investment company PMV and Nobis co-founders Roeland Pelgr

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Tariffs raise concern among generic drugmakers, as advocacy groups seek exemptions

Bio Pharma Dive

“There is not a single member of AAM who has not raised concerns about the tariff situation,” said the CEO of the generic drug lobby Association for Accessible Medicines.

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Scientists discover mitochondria's role in shaping memory circuits

Medical Xpress

Virginia Tech neuroscientists have uncovered a mitochondrial process that supports the brain cells critical for learning, memory, and social recognition.

Scientist 142
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Radiopharmaceutical deals drive sector growth despite supply crisis

Pharmaceutical Technology

Developers celebrate gains for advances with radiopharmaceuticals while regulators and isotope suppliers work to keep up.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Maze Therapeutics Introduces IPO with Two CKD Candidates in Clinical Trials

XTalks

Maze Therapeutics, a clinical-stage biopharmaceutical company, has raised $140 million in its upsized initial public offering (IPO), pricing shares at $16 each. The company plans to use these funds to advance its groundbreaking research in small molecule precision medicines, targeting renal, cardiovascular and metabolic diseases, including obesity. Current Share Price: The announcement follows a $115 million Series D financing in December 2024, co-led by Frazier Life Sciences and Deep Track Capi

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GSK, Pfizer sales of RSV shots slow as vaccination rates ebb

Bio Pharma Dive

Revenue for Arexvy and Abrysvo fell sharply year over year in the fourth quarter due to narrower U.S. guidelines for their use.

Sales 220
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Experts Share Ways to Streamline Informed Consent Process in Clinical Trial Startup

Advarra

At a busy research site, a clinical trial is ready to launch but its stuck in limbo over a single paragraph in the informed consent form (ICF). The issue? Language relating to the potential cost of participation. One sites language on what they will pay for differs from anothers, and the contradictory wording needs to be reviewed and agreed to by the sponsor before the IRB can proceed.

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Relmada acquires Tourette’s therapy rights from Asarina

Pharmaceutical Technology

Relmada has acquired complete ownership rights to Sepranolone, developed for Tourette syndrome (TS) from Asarina Pharma.

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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.