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 113
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Optimizing Data Collection in Post-Surgical Pain Studies & The Role of Clinical Assessments

Worldwide Clinical Trials

Authors: Rolana Avrumson, MS, VP Clinical Projects, Clinical Assessment Technologies; Barry Dussault Executive Director, Project Management, Franchise Area Lead, Pain Upwards of 58% of patients experience moderate to severe post-surgical pain, while some research places that figure even higher at a staggering 80%. These data highlight both the prevalence of post-surgical pain and the critical need for comprehensive, non-opioid treatments aimed at alleviating it.

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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.

Doctor 185
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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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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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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.

Vaccine 325

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Scientists Discover 2 Key Brain Systems Behind Psychosis

AuroBlog - Aurous Healthcare Clinical Trials blog

Researchers have identified dysfunctions in two specific brain systems in people who have psychosis – systems that help us filter attention to important internal and external information and predict or anticipate rewards.

Scientist 241
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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 162
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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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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 312
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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 237
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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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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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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 311
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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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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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MPE launches English Myeloma and AL Amyloidosis European Clinical Trial Navigator

Pharma Times

The tool will help people find out about clinical trials for myeloma, MGUS, SMM and AL amyloidosis

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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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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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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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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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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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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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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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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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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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Gilead writes $2.4B off Trodelvy as CEO underscores ‘time of focused execution’

Fierce Pharma

After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition. | After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on the antibody-drug conjugate Trodelvy. With a busy year ahead across therapeutic areas, CEO Dan O'Day emphasized a "time of focused execution.

Antibody 133
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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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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.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Scientists Identify a Link Between Sleep And Type 2 Diabetes Risk

AuroBlog - Aurous Healthcare Clinical Trials blog

Not getting enough sleep is a common affliction in the modern age. If you don’t always get as many hours of shut-eye as you’d like, perhaps you were concerned by news of a recent study that found people who sleep less than six hours a night are at higher risk of type 2 diabetes.

Scientist 170
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Orphan drug market to reach $270B by 2028, led by J&J, Vertex and Roche: Evaluate

Fierce Pharma

The orphan drug sector has long been clearing growth in the larger pharmaceutical market with booming sales. | The orphan drug sector has long been clearing growth in the larger pharmaceutical market with booming sales. But thanks to blockbuster meds across wider disease areas and other challenges, the lucrative market may soon slow down for the first time in years.

Marketing 132
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Datopotamab deruxtecan by Daiichi Sankyo for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer): Likelihood of Approval

Pharmaceutical Technology

Datopotamab deruxtecan is under clinical development by Daiichi Sankyo and currently in Phase I for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer).

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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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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.