CHMP recommends GSK’s Blenrep approval for multiple myeloma treatment
Pharmaceutical Technology
MAY 26, 2025
The European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of GSKs Blenrep.
Sat.May 24, 2025 - Fri.May 30, 2025
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New Summit data could slow US approval plans for PD-1/VEGF drug
Bio Pharma Dive
MAY 30, 2025
Ivonescimab helped cut the risk of lung tumor progression in half in a multi-country Phase 3 trial. But it hasn’t yet clearly extended survival, which will be necessary to support an FDA submission.
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Long-term remission of advanced liver cancer in 46% of patients achieved with combination therapy
Medical Xpress
MAY 25, 2025
An interdisciplinary research team has demonstrated a durable and lasting response to a novel treatmentcombined locoregional therapy and immunotherapy (LRT-IO)for advanced liver cancer patients. The study marks the first investigation into the long-term outcomes for patients with locally advanced liver cancer receiving this treatment. The researchers identified key factors associated with a complete response, and found that this pioneering approach is safe, effective and sustainable.
May 28, 2025: New NIH Collaboratory Learning Module Explores Challenges and Possibilities of Working With Electronic Health Record Data
Rethinking Clinical Trials
MAY 28, 2025
The NIH Pragmatic Trials Collaboratory has launched a new learning module, Healthcare Data Interoperability and Standardization for Research , exploring the complexities of collecting, storing, and transforming healthcare data in the electronic health record to achieve optimal patient and research outcomes. The learning module, which was developed by members of the NIH Collaboratory’s Electronic Health Records Core Working Group, comprises 2 new learning topic videos, “The Big Pictur
How to Turn “Check-the-Box” Compliance Trainings Into Real Learning
Speaker: Brian Richardson, Brian Richardson, Founder and CEO of Richardson Consulting Group
Let’s face it—most ethics and compliance training programs aren’t winning awards for engagement. But that doesn’t mean they can’t be effective, captivating, and maybe even enjoyable! Join learning design expert Brian Richardson for a dynamic session on how to breathe new life into your ethics and compliance training. We'll explore innovative strategies to bring traditionally dry topics to life, making them resonate with learners and drive tangible change.
Merck seeks China and US approval of TGCT drug after Phase III success
Pharmaceutical Technology
MAY 28, 2025
Merck KGaA is filing for global regulatory approvals of pimicotinibafter it met primary and secondary endpoints in a Phase III TGCT trial.
Cancer drugmaker iTeos to shut down
Bio Pharma Dive
MAY 28, 2025
Weeks after shelving a TIGIT drug prospect, the biotech is seeking to sell off its assets and intellectual property in a bid to "maximize" shareholder value.
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May 30, 2025: Randomizing in Clinical Care in the KP-VACCINATE Megatrial, in This Week’s PCT Grand Rounds
Rethinking Clinical Trials
MAY 30, 2025
In this Friday’s Rethinking Clinical Trials Grand Rounds, Ankeet Bhatt of the Kaiser Permanente Northern California Division of Research will present “Embedding Randomization Into Clinical Care in Learning Healthcare Systems: Insights From the KP-VACCINATE Megatrial.” The Grand Rounds session will be held on Friday, May 30, 2025, at 1:00 pm eastern.
HHS cancels $766m bird flu vaccine contract with Moderna
Pharmaceutical Technology
MAY 29, 2025
The HSS has terminated a contract previously awarded to Moderna to help advance a vaccine candidate targeting bird flu.
GSK-licensed antibiotic meets goal in late-stage study
Bio Pharma Dive
MAY 28, 2025
The British drugmaker may have succeeded in reviving an oral antibiotic previously rejected by the FDA when it was under development by Spero.
New blood test enables the rapid diagnosis of thousands of rare genetic diseases
Medical Xpress
MAY 25, 2025
A new, rapid testing method will greatly help the diagnosis of rare diseases in babies and children, according to research presented to the annual conference of the European Society of Human Genetics.
Clinical Research White Paper – Enhancing Transparency & Efficiency Throughout the Trial Lifecycle
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Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness
National Cancer Survivors Day 2025: An In-Depth Look at Cancer Survivorship
XTalks
MAY 28, 2025
On Sunday, June 1, 2025, communities will observe the 38th annual National Cancer Survivors Day a day to recognize the 18,060,100 cancer survivors in the US and the over 53.5 million cancer survivors worldwide in the last five years. This years official theme of National Cancer Survivors Day 2025, Celebrating Life, Raising Awareness and Inspiring Hope for the Future, acknowledges the ongoing challenges survivors face long after treatment ends.
Eli Lilly to expand pain pipeline with $1bn SiteOne buyout
Pharmaceutical Technology
MAY 27, 2025
The deal tees up a pain treatment market rivalry with Vertex Pharmaceuticals as the industry starts to move away from opioids.
Merck, Daiichi pull approval application for ADC in lung cancer
Bio Pharma Dive
MAY 29, 2025
A therapy at the center of their $22 billion alliance failed to extend survival in a type of lung tumor, leading the companies to abandon a U.S. submission.
You should wear sunscreen even if you have darker skin. Here's why
Medical Xpress
MAY 25, 2025
People with darker skin still need to wear sunscreenfor more reasons than one.
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!
Eli Lilly acquires SiteOne Therapeutics to advance treatment for chronic pain
Pharma Times
MAY 28, 2025
Global biopharma Eli Lilly will acquire SiteOne Therapeutics, a biotech dedicated to the development of non-opioid medicines to treat pain and other neuronal hyperexcitability disorders, to advance SiteOnes leading asset STC-004. Lilly will lead STC-004 through phase 2 trials and commercialisation for global markets.
Scynexis resumes dosing in Phase III MARIO study after lengthy delay
Pharmaceutical Technology
MAY 28, 2025
Scynexis has resumed dosing of its Brexafemme (ibrexafungerp) drug in a Phase III trial after a 19-month clinical hold by the FDA.
Muscle-sparing obesity drug safe for Phase 3 trial, Veru says
Bio Pharma Dive
MAY 28, 2025
The company is preparing a Phase 3 trial of enobosarm with a novel formulation that could extend its patent life.
ASCO 25: Can GLP-1 drugs reduce cancer risk?
pharmaphorum
MAY 26, 2025
A study has suggested the benefits of GLP-1 agonists could extend to a reduction in the risk of a slew of cancers associated with being overweight
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
Oxford Brain Diagnostics to launch groundbreaking dementia diagnosis technology
Pharma Times
MAY 26, 2025
Company secures regulatory approvals for commercial rollout in UK and US
FDA grants RMAT designation to AbelZeta’s CAR-T therapy
Pharmaceutical Technology
MAY 28, 2025
The US FDA has granted regenerative medicine advanced therapy (RMAT) designation to AbelZeta Pharmas C-CAR168.
Keros lays off nearly half its staff; Astellas buys into a China biotech’s ADC
Bio Pharma Dive
MAY 30, 2025
Keros will also stop work on a cardiovascular disease drug. Elsewhere, Stealth Biotherapeutics and Taysha Gene Therapies each think they've found a path to FDA approval.
ASCO 25: Jazz, PharmaMar reveal SCLC survival data
pharmaphorum
MAY 26, 2025
Jazz and PharmaMar have revealed the overall survival data with their small-cell lung cancer drug Zepzelca, described as a 'milestone' in the disease
Can Your Organization Spot a Conflict Before It’s a Crisis?
Speaker: Amie Phillips Pablo, VP, Corporate Compliance & Privacy Officer at Novo Nordisk
In today’s complex healthcare environment, navigating third-party relationships has become even more challenging—whether it’s vendor relationships, employee activities, or patient-facing interactions. Left unmanaged, these conflicts can compromise trust, regulatory compliance, and even organizational reputation. So, how can healthcare teams stay ahead?
NICE recommends sparsentan for IgA nephropathy
Pharma Times
MAY 26, 2025
First non-immunosuppressive dual-action therapy approved for eligible patients
CDC drops Covid-19 vaccine for healthy children and pregnant women
Pharmaceutical Technology
MAY 28, 2025
The US Centers for Disease Control and Prevention (CDC) is no longer recommending Covid-19 vaccines to healthy children and pregnant women.
FDA leaders seek industry input on ‘listening tour’
Bio Pharma Dive
MAY 28, 2025
Commissioner Martin Makary and two of his deputies aim to meet with drugmaker CEOs to discuss how the agency can “modernize” regulations.
The Commissioner’s Magical Mystery Tour: Many Questions About this Unique Opportunity
FDA Law Blog
MAY 27, 2025
By Dr. Naomi Lowy, Principal Drug Regulatory Expert FDA recently announced, CEO Forums: An FDA Listening Tour to Engage Pharma CEOs. These are scheduled to take place in several cities on both coasts in June and July (Link here). This tour to engage with pharmaceutical and biotech CEOs is unprecedented. According to the announcement, Commissioner Makary will be holding these along with Principal Deputy Commissioner Sara Brenner, M.D., M.P.H and Director of FDAs Center for Biologics Evaluation a
White Paper - A Roadmap to AI Data Readiness in R&D Labs
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Download this comprehensive guide to AI and ML in the R&D Laboratory Setting.
TQ Therapeutics acquires Juno GmbH to support decentralised cell therapy platform
Pharma Times
MAY 28, 2025
TQ Therapeutics (TQx) has acquired Juno Therapeutics GmbH, the German subsidiary of Juno Therapeutics, through a share purchase agreement. Juno GmbH was previously owned by Bristol Myers Squibb. Financial terms have not been disclosed.
GlycoEra secures $130m to progress IgG4-targeted protein degrader
Pharmaceutical Technology
MAY 28, 2025
GlycoEra has closed an oversubscribed Series B financing round, raising $130m, to support its lead IgG4-targeted protein degrader.
GLP-1 prescriptions for weight loss soar, despite obstacles
Bio Pharma Dive
MAY 28, 2025
The percentage of adults prescribed a GLP-1 drug like Wegovy or Zepbound jumped almost sevenfold over the past five years, according to a new report.
West Nile virus found in the UK for the first time: What you need to know
Medical Xpress
MAY 25, 2025
For the first time, traces of the West Nile virus have been found in mosquitoes in the UK, according to a report published this week by the UK Health Security Agency.
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