Sat.Apr 20, 2024 - Fri.Apr 26, 2024

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Early Data Indicate Cell Therapies Could ‘Reset the Clock’ in Parkinson’s

BioSpace

A one-time treatment for Parkinson’s disease could be a ‘market changer,’ experts told BioSpace, adding that cell therapies could limit the adverse effects seen with current drugs.

Marketing 122
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Moderna banks on OpenAI to accelerate mRNA research 

pharmaphorum

In an ambitious move, Moderna has teamed up with OpenAI, the artificial intelligence company behind ChatGPT, to further integrate generative AI (GenAI) across its mRNA drug development and manufacturing operations.

Research 111
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Doctor Reveals What Happens When You Stop Taking Ozempic

AuroBlog - Aurous Healthcare Clinical Trials blog

Drugs like Ozempic are very effective at helping most people who take them lose weight. Semaglutide (sold as Wegovy and Ozempic) and tirzepatide (sold as Zepbound and Mounjaro) are the most well known in the class of drugs that mimic hormones to reduce feelings of hunger.

Doctors 150
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Food Additive Ban? States Uphold Science Over Fear

XTalks

Several states are actively rejecting proposals to ban certain US Food and Drug Administration (FDA)-approved food additives, prioritizing scientific evidence over misinformation and fear. Leaders in Indiana, Kentucky, Maryland, South Dakota, Washington and West Virginia have made clear decisions based on the facts at hand, supported by the National Confectioners Association (NCA) and other expert voices.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Pfizer and BioNTech commence legal action against Moderna in UK court

Pharmaceutical Technology

Pfizer and its Germany partner BioNTech have urged London’s High Court to invalidate competitor Moderna's patents over technology instrumental in the Covid-19 vaccines development as the latest phase of a global legal fight that started yesterday (23 April), reported Reuters.

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Pfizer hemophilia gene therapy arrives in US to uncertain future

Bio Pharma Dive

The Food and Drug Administration approval of Beqvez comes as other gene therapies for the bleeding condition that were approved earlier struggle to gain traction.

More Trending

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April 23, 2024: Younger, Uninsured Patients Among Those at Greatest Risk for Missing Follow-up Assessments in Trauma Research

Rethinking Clinical Trials

In an analysis of data from the TSOS study, younger patients and patients who were publicly insured or uninsured were among several subgroups of patients who were at significant risk of missing follow-up outcome assessments. The report was published this week in Injury. Successful studies of interventions for patients with posttraumatic stress disorder (PTSD) require engaging with injured patients in long-term follow-up.

Research 152
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Health Canada approves Merck’s KEYTRUDA for gastric cancer treatment

Pharmaceutical Technology

Health Canada has approved Merck’s KEYTRUDA (pembrolizumab), an anti-programmed cell death protein 1 (PD-1) therapy for use in combination with fluoropyrimidine- and platinum-containing-chemotherapy as a first-line treatment for adult gastric cancer patients.

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Bristol Myers to cut 6% of workforce, trim drug pipeline

Bio Pharma Dive

The layoffs will impact some 2,200 employees, the company said, as it repositions its business ahead of looming patent expirations for top-selling products.

Drugs 290
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For The First Time, Scientists Showed Structural, Brain-Wide Changes During Menstruation

AuroBlog - Aurous Healthcare Clinical Trials blog

The constant ebb and flow of hormones that guide the menstrual cycle don’t just affect reproductive anatomy. They also reshape the brain, and a study has given us insight into how this happens.

Scientist 188
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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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Could placenta-derived cells revolutionize age-related disease treatment?

BioPharma Reporter

Celularity, a biotech company specializing in placental-derived allogeneic cell therapies, will be showcasing data at the upcoming ASGCT Annual Meeting, showcasing the potential of their off-the-shelf natural killer (NK) cells to combat age-related diseases.

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EC approves Pfizer’s Emblaveo for multidrug-resistant infections

Pharmaceutical Technology

The European Commission (EC) has granted marketing authorisation for Pfizer’s EMBLAVEO (aztreonam-avibactam), aimed at treating adults with multidrug-resistant infections where treatment options are limited.

Marketing 253
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Regeneron expands in gene editing with Mammoth deal

Bio Pharma Dive

“With each passing year, we're more committed to becoming a serious player in the genetic medicine space,” a Regeneron executive said.

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NABH unveils plan for 2nd Edition of Accreditation Standards for Allopathic Clinics

AuroBlog - Aurous Healthcare Clinical Trials blog

In a significant development for healthcare quality assurance in India, the National Accreditation Board for Hospitals & Healthcare Providers (NABH) has announced the implementation plan for the 2nd Edition of NABH Accreditation Standards for Allopathic Clinics.

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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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Novartis nominates former Bristol Myers CEO Giovanni Caforio as its new chair. Will M&A deals follow?

Fierce Pharma

Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. | Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. The recent Big Pharma CEO, known for steering the $74 billion acquisition of Celgene, has been proposed as the new chair at Novartis for 2025.

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Avidity Biosciences gets grant for polynucleic acid conjugate for treating FSHD through rna interference

Pharmaceutical Technology

Discover how Avidity Biosciences' patented polynucleic acid molecule conjugate targets the DUX4 gene to combat FSHD. Learn more about this groundbreaking approach in gene therapy.

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Lilly to buy injectable drug plant in manufacturing ramp-up

Bio Pharma Dive

The acquisition of a Nexus Pharmaceuticals facility in Wisconsin could help Lilly better meet demand for injectable medicines, like those it makes for diabetes and obesity.

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SCDA urges FSSAI to act on Nestle India for allegedly adding high level sugar in baby foods

AuroBlog - Aurous Healthcare Clinical Trials blog

Delhi-based South Chemists & Distributors Association (SCDA), which represents chemists and pharmaceutical distributors working in Delhi, has requested the Food Safety and Standards Authority of India (FSSAI) to take action against multinational corporation Nestle India for allegedly adding high sugar content in baby foods, affecting the health of children.

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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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Spotlight on kidney disease: Driving change for patients

pharmaphorum

Explore the latest advancements and initiatives in kidney disease research, driving change for patients with kidney conditions. Learn more about the current research landscape and potential breakthroughs in treatment from Kidney Research UK.

Research 126
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BioMarin Pharmaceutical gets grant for treatment of adolescent PKU patients using AVPAL variant

Pharmaceutical Technology

Discover how BioMarin Pharmaceutical's patent for PAL variants offers a groundbreaking method to treat PKU in adolescents. Administering AvPAL variants weekly over 50 weeks effectively reduces blood phenylalanine levels.

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Bristol Myers taps startup to boost CAR-T production

Bio Pharma Dive

A partnership with Cellares, worth up to $380 million, is meant to help Bristol Myers speed and scale manufacture of the complex cellular treatments.

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NeuroSmart Portable MER system paves way for improved treatments in Parkinson’s disease

AuroBlog - Aurous Healthcare Clinical Trials blog

Positive outcomes with brain pacemakers & NeuroSmart Portable MER (micro-electrode recording) system have paved the way for improved treatments in Parkinson’s disease.

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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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How do we unlock the potential of digital health?

pharmaphorum

Unlock the power of digital health through AI and clinical advancements. Learn how these technologies are shaping the future of healthcare and how to harness their potential.

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Cidara buys back rights to flu therapy from J&J for $85m

Pharmaceutical Technology

Marking another chapter in the long-running saga, J&J has deprioritised the CD388 influenza programme allowing Cidara to buy it back.

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Moderna turns to AI to change how its employees work

Bio Pharma Dive

An expanded partnership with OpenAI is helping Moderna embed custom-built AI chatbots in a wide range of research and business processes.

Research 291
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Pfizer Secures FDA Approval for Hemophilia B Gene Therapy, Launches Warranty

BioSpace

Pfizer will go toe-to-toe with CSL Behring following the FDA’s Friday approval of its hemophilia B gene therapy Beqvez and will launch a warranty program based on the durability of response.

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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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FDA clears ImmunityBio’s bladder cancer drug at 2nd attempt

pharmaphorum

After rejecting ImmunityBio’s Anktiva last year, the FDA has now cleared the drug as a treatment for bladder cancer, making it the biotech's first commercial-stage product

Drugs 122
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GS-6212 by Gilead Sciences for Human Immunodeficiency Virus (HIV) Infections (AIDS): Likelihood of Approval

Pharmaceutical Technology

GS-6212 is under clinical development by Gilead Sciences and currently in Phase I for Human Immunodeficiency Virus (HIV) Infections (AIDS).

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BioMarin drops drug programs in pipeline cull

Bio Pharma Dive

The cuts of four pipeline prospects come as BioMarin resets its priorities following the slow launch of its hemophilia gene therapy Roctavian.

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FDA Rejects Abeona’s Epidermolysis Bullosa Cell Therapy, Asks for CMC Data

BioSpace

The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.