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.
Sat.Feb 15, 2025 - Fri.Feb 21, 2025
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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.
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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.
'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.
Bridging Innovation & Patient Care: The Growing Role of AI
Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
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.
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.
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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.
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.
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.
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,
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
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.
Ozempic, Wegovy shortage resolved; Pfizer CEO is PhRMA’s new chair
Bio Pharma Dive
FEBRUARY 21, 2025
The FDA determined that Novo Nordisk’s obesity and diabetes drugs are no longer in short supply. Elsewhere, Concentra made a competing bid for Acelyrin and Intra-Cellular sales rose.
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.
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.
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.
CDC vaccine meeting, set to be first since RFK Jr. sworn in, is postponed
Bio Pharma Dive
FEBRUARY 20, 2025
Originally scheduled for next week, the meeting of agency advisers will be delayed to give more time for public comment, according to an HHS spokesperson.
Pfizer shelves haemophilia gene therapy Beqvez amid low demand
Pharmaceutical Technology
FEBRUARY 21, 2025
Pfizer said resources will be directed to its other haemophilia gene therapy Hympavzi.
The CRA’s Role in Site-Sponsor Relationships
ACRP blog
FEBRUARY 19, 2025
A healthy relationship between sites and sponsors is critical to the success of clinical trials, including efficient and effective management, adaptability, innovation, problem-solving, and feedback mechanisms on the parts of those involved on both sides. Clinical research associate (CRA) competencies are key to creating and nurturing this relationship under all circumstances.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Aardvark Therapeutics IPO Sets Sights on Satiating Hyperphagia and Extreme Hunger
XTalks
FEBRUARY 21, 2025
Aardvark Therapeutics, Inc. has priced its initial public offering (IPO) at $16.00 per share, offering 5,888,000 shares and targeting approximately $94.2 million in gross proceeds. Trading on Nasdaq under the ticker AARD began on February 13, 2025. This capital will accelerate the companys clinical programs and support its pipeline of investigational drugs aimed at treatments for metabolic diseases like Prader-Willi syndrome (PWS).
Advamed CEO warns FDA job cuts put patients, industry at risk
Bio Pharma Dive
FEBRUARY 19, 2025
Scott Whitaker sent a letter to HHS calling for staff cuts at the FDA to be reversed, arguing patient care and U.S. leadership in medical devices are on the line.
Gilead’s lenacapavir moves closer to FDA approval for HIV PrEP use
Pharmaceutical Technology
FEBRUARY 18, 2025
The FDA has accepted Gileads new drug application with a decision expected by 19 June 2025.
FDA Audits and Inspections: Preparation and Approaches to Addressing Consequences
ACRP blog
FEBRUARY 18, 2025
Although relatively rare, clinical investigator inspections by the U.S. Food and Drug Administration (FDA) can have a significant business impact. Audits are conducted more frequently than regulatory inspections, which are estimated to take place at fewer than 3% of sites, but adequate responses in either case are essential to successful outcomes. Clinical research professionals who deal with complex study issues need to understand requirements, including key areas of Good Clinical Practice and
How Machine Learning Drives Clinical Trial Efficiency
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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.
Romvimza (Vimseltinib) for TGCT: FDA Approves Oral CSF1-Targeted Drug
XTalks
FEBRUARY 19, 2025
The FDA has approved Decipheras Romvimza (vimseltinib) for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) when surgery may lead to worsened joint function or severe complications. The approval was largely based on the results of the MOTION Phase III study. Dr. Hans Gelderblom, chair of Medical Oncology at Leiden University Medical Center, noted in the press release that the study data could establish Romvimza as a potential new standard of care for TGCT patients who are no
Recursion CEO launches pre-seed fund in response to NIH cuts
Bio Pharma Dive
FEBRUARY 19, 2025
Chris Gibson, Recursion’s head, cited the role small business grants played in helping his company grow its business.
GLP-1 receptor agonists could hold promise for opioid use disorder treatment
Pharmaceutical Technology
FEBRUARY 21, 2025
Glucagon-like peptide-1 receptor agonists (GLP-1RAs), originally developed for treating diabetes, work by stimulating insulin secretion and suppressing glucagon release, thereby helping regulate blood sugar.
FDA approves Deciphera’s Romvimza for rare tumour type
Pharma Times
FEBRUARY 20, 2025
Tenosynovial giant cell tumours can cause pain, stiffness, swelling and movement limitations
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.
Sanofi Wins FDA Nod for Merilog, First Rapid-Acting Insulin Biosimilar
XTalks
FEBRUARY 18, 2025
The FDA has approved Sanofis Merilog (insulin-aspart-szjj) as the first rapid-acting insulin biosimilar product for the treatment of diabetes. Merilog is a biosimilar to Novo Nordisks NovoLog, a widely used rapid-acting insulin aspart. Merilog is approved for use in adults and pediatric patients six years of age and older. The approval includes both a 3 mL single-patient-use prefilled pen and a 10 mL multiple-dose vial of the biosimilar.
Pfizer stops selling hemophilia gene therapy, citing weak demand
Bio Pharma Dive
FEBRUARY 21, 2025
Pfizer’s decision to halt further marketing of Beqvez is further sign of the sparse patient interest in gene therapies for the bleeding condition.
FDA authorises ImmunityBio’s BCG alternative to treat bladder cancer
Pharmaceutical Technology
FEBRUARY 20, 2025
ImmunityBio has gained the FDA authorisation for an EAP to supply an alternative source of BCG for treating bladder cancer.
FDA sets June date for Gilead's twice-yearly HIV PrEP
pharmaphorum
FEBRUARY 19, 2025
Gilead's already dominant position in HIV PrEP could be extended if the FDA approves a new twice-yearly injectable product later this year
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