Pfizer names Patrizia Cavazzoni, former top FDA official, as chief medical officer
Bio Pharma Dive
FEBRUARY 24, 2025
Cavazzoni stepped down from her role as head of the FDA’s main drug review office in mid-January. She will succeed Aida Habtezion.
February, 2025
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February 12, 2025: Results of ACP PEACE, an NIH Collaboratory Trial, in This Week’s PCT Grand Rounds
Rethinking Clinical Trials
FEBRUARY 12, 2025
In this Friday’s PCT Grand Rounds, Angelo Volandes of Dartmouth Health and James Tulsky of Dana-Farber Cancer Institute will present “A Cluster Randomized, Stepped-Wedge Pragmatic Trial to Enhance Goals-of-Care Communication for Older Adults With Cancer (ACP-PEACE).” The Grand Rounds session will be held on Friday, February 14, 2025, at 1:00 pm eastern.
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Semaglutide shortage ends as FDA sets deadline for compounders
Pharmaceutical Technology
FEBRUARY 24, 2025
With Novo Nordisks blockbuster drugs Wegovy and Ozempic back in stock, copycat versions are no longer allowed for now.
An unexpected mechanism regulates the immune response during parasitic infections
Medical Xpress
FEBRUARY 7, 2025
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.
Running Decentralized Trials at Scale: Planning for Success
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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
The ICH E6(R3) Guideline: A Major Update to Good Clinical Practice
FDA Law Blog
FEBRUARY 27, 2025
By Julie Kim & Deborah L. Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3). No word yet on whether FDA will issue guidance endorsing the final ICH E6(R3).
Creative Biolabs Continues Partnering with Pharmaceutical Corporations to Drive Biopharmaceutical Innovation for 2025 and Beyond
Pharma Mirror
FEBRUARY 21, 2025
As a provider of custom services, Creative Biolabs aims to support the entire process of drug discovery and development for the global pharmaceutical industry using its cutting-edge technology and wide-ranging experiences. It is no secret that the complexities associated with biopharmaceuticals are ever increasing, particularly regarding the development of antibody therapeutics.
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February 24, 2025: Study Snapshots and Updated Ethics Documentation Available for 3 NIH HEAL Initiative–Supported Trials in Rural Populations
Rethinking Clinical Trials
FEBRUARY 24, 2025
Updated study snapshots and ethics and regulatory documentation are now available for the AIM-CP, ARBOR-Telehealth, and RAMP trials. The 3 NIH Collaboratory Trials, all supported through the NIH HEAL Initiative, or Helping to End Addiction Long-Term Initiative, reflect a special emphasis on developing strategies for the management of chronic pain in rural and remote populations. “There are many known disparities between urban and rural populations,” said Karen Kehl, a program directo
Biogen and Stoke Therapeutics to commercialise Dravet syndrome treatment
Pharmaceutical Technology
FEBRUARY 19, 2025
Biogen has entered a collaboration with Stoke Therapeutics to develop and commercialise zorevunersen to treat Dravet syndrome.
Brain cells mimic muscle signaling to enhance learning and memory
Medical Xpress
FEBRUARY 8, 2025
New research details the subcellular structures in neurons that enable signals to be transmitted from where they are received at specific sites on dendrites to the decision-making cell body located hundreds of micrometers away. The new research finds that the endoplasmic reticulum and the plasma membrane form contact sites where specialized molecules control the release of calcium, which regulates the signals sent along the dendrite to the soma.
Dangerous Kind of Fat Hidden in The Body Can Raise Your Risk of Death
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 4, 2025
(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).
2022 Research: The Rapid Rise of Ocean Freight Visibility
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Healthcare Layoffs 2025: A Roundup
XTalks
FEBRUARY 18, 2025
Healthcare organizations have long used workforce adjustments to respond to changing market dynamics, regulatory pressures and the need to refocus on core patient care. In this blog, we detail the healthcare layoffs in 2025, examining the underlying factors and potential ramifications for the industry. In 2024, major players like CVS Health and BioRad Laboratories made headlines by trimming their staff.
Drug compounders sue FDA over declaration ending Wegovy shortage
Bio Pharma Dive
FEBRUARY 25, 2025
Telehealth provider Hims & Hers said it will tell consumers they need to seek “alternative options on the commercial dosing,” but in earnings Monday still forecast higher revenue and profits in 2025.
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
FEBRUARY 4, 2025
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.
Amazon joins forces with Memorial Sloan Kettering for AI-powered drug discovery
Pharmaceutical Technology
FEBRUARY 19, 2025
MSK plans to speed up early-stage drug development by using AWS Drug Discovery Workbench to screen potential candidates.
An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
The Growing Importance of Specialty Generics in the Latin American Pharmaceutical Market
Drug Patent Watch
FEBRUARY 5, 2025
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?
Panel recommends developing comprehensive long-term strategic plan for mental healthcare and research
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 13, 2025
Identifying a significant gap in the Ministry’s actions in addressing the funding and resource challenges in the premier mental health institutions, the Department-Related Parliamentary Standing Committee on Health and Family Welfare has recommended various measures including development of a comprehensive long-term strategic plan for mental healthcare, research and infrastructure development.
Stealth virus: How Zika builds tunnels to covertly infect cells of the placenta
Medical Xpress
FEBRUARY 21, 2025
Infection with Zika virus in pregnancy can lead to neurological disorders, fetal abnormalities and fetal death. Until now, how the virus manages to cross the placenta, which nurtures the developing fetus and forms a strong barrier against microbes and chemicals that could harm the fetus, has not been clear. Researchers at Baylor College of Medicine with collaborators at Pennsylvania State University report in Nature Communications a strategy Zika virus uses to covertly spread in placental cells,
Bluebird, at risk of default, agrees to take-private deal
Bio Pharma Dive
FEBRUARY 21, 2025
The pioneering gene therapy developer will be acquired by investment firms Carlyle Group and SK Capital for a fraction of what it was once worth years ago.
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
FEBRUARY 6, 2025
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.
Inborn errors of metabolism elicit unique challenges for therapy development
Pharmaceutical Technology
FEBRUARY 28, 2025
As Rare Disease Day is commemorated on 28 February, experts discuss the barriers to gene therapy access for some rare diseases.
The Role of Quality Assurance in Generic Drugs
Drug Patent Watch
FEBRUARY 19, 2025
The Unsung Heroes of Generic Drugs: The Importance of Quality Assurance As we navigate the complex world of pharmaceuticals, it's easy to overlook the behind-the-scenes efforts that ensure the quality and safety of the medications we rely on. But today, I want to shine a spotlight on the often-overlooked heroes of the generic drug industry: Quality Assurance (QA) professionals.
A Type of Fiber Could Have Weight Loss Benefits Similar to Ozempic
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 5, 2025
(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.
'DeepFocus' offers minimally invasive brain stimulation through the nose
Medical Xpress
FEBRUARY 21, 2025
Researchers from Carnegie Mellon University and Allegheny Health Network have developed a new method for deep brain stimulation. The technique, called "DeepFocus," uses transcranial electrical stimulation (TES) on the scalp and transnasal electrical stimulation (TnES) to achieve more accurate electrical stimulation in the brain. The findings are published in the Journal of Neural Engineering.
AstraZeneca deepens China presence with FibroGen deal
Bio Pharma Dive
FEBRUARY 20, 2025
The $160 million acquisition of a FibroGen subsidiary expands AstraZeneca’s foothold in China while the company works through government investigations into its business practices there.
February 19, 2025: Texting for Behavior Change to Improve Chronic Care Management, in This Week’s PCT Grand Rounds
Rethinking Clinical Trials
FEBRUARY 19, 2025
In this Friday’s PCT Grand Rounds, Michael Ho and Sheana Bull will present “Texting for Behavior Change: Lessons Learned Across 2 Interventions to Improve Chronic Care Management.” The Grand Rounds session will be held on Friday, February 21, 2025, at 1:00 pm eastern. This Grand Rounds session will report the results of Chat 4 Heart Health, an NIH Collaboratory Trial.
Pharma and medtech industry reacts to FDA, CDC and NIH job cuts
Pharmaceutical Technology
FEBRUARY 20, 2025
The FDA, NIH and CDC has cut 5,200 probationary staff in a job cull across the HHS over the Valentine's Day weekend.
Texas Children’s Hospital and UT MD Anderson to Open Leading Pediatric Cancer Center
XTalks
FEBRUARY 25, 2025
Texas Childrens Hospital and The University of Texas MD Anderson Cancer Center have announced a collaboration dedicated to fighting childhood cancer. The first-of-its-kind joint venture, approved by both the Texas Childrens Board of Trustees and the UT System Board of Regents, marks a historic step toward building what leaders are calling the worlds preeminent pediatric cancer center.
Revealed: How Much Exercise You Need to ‘Offset’ a Day of Sitting
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 6, 2025
(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.
The link between headache disorders and suicide—a 25-year Danish cohort study
Medical Xpress
FEBRUARY 8, 2025
New evidence from a large population-based cohort analysis indicates an increased risk of both attempted and completed suicide among individuals diagnosed with headache disorders. Researchers at Aarhus University in Denmark found that individuals diagnosed with migraine, tension-type headache, posttraumatic headache, and trigeminal autonomic cephalalgia face an increased risk of suicide.
In FDA job cuts, experts see threat of far-reaching impact
Bio Pharma Dive
FEBRUARY 20, 2025
"Any place that gets cut, it's going to have an impact, because there's not any spare personnel at FDA,” said former agency commissioner Robert Califf.
What to Expect When you are Expecting…a Government Shutdown
FDA Law Blog
FEBRUARY 18, 2025
By Richard A. Lewis, , Principal Regulatory Device and Biologics Expert The FDA is currently funded through March 1st, 2025. Come Monday March 3rd, if Congress does not pass a budget or continuing resolution, the FDA will enter a shutdown and shutter many offices and programs while Congress works out their inter-party squabbles on national priorities.
FDA to review Sanofi and Regeneron’s Dupixent sBLA for bullous pemphigoid
Pharmaceutical Technology
FEBRUARY 18, 2025
As Sanofi and Regeneron await the FDA decision, a legal dispute between the partners over commercialisation details continues.
Regulatory considerations for biosimilar clinical efficacy trials
Drug Patent Watch
FEBRUARY 18, 2025
Unlocking the Potential of Biosimilars: Navigating Regulatory Considerations for Clinical Efficacy Trials As the pharmaceutical industry continues to evolve, biosimilars have emerged as a game-changer in the fight against high healthcare costs. These highly similar versions of biologic medications offer a more affordable alternative to their reference products, but their development requires careful consideration of regulatory requirements.
Radical Study Proposes a Single Cause to Explain Alzheimer’s Disease
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 11, 2025
(koto_feja/E+/Getty Images) A new model of Alzheimer’s disease has been proposed, which could speed up efforts to understand and cure the complex condition while bringing all manifestations of the condition under one unifying theory.
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