Trending Articles

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After rejections, AbbVie secures approval for Parkinson’s drug

Bio Pharma Dive

Vyalev’s clearance is the second victory for AbbVie in Parkinson’s this year, following an April readout for a drug acquired through its Cerevel buyout.

Drugs 271
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October 17, 2024: GGC4H Pilot Finds Spanish-Language Intervention Feasible and Acceptable in Pediatric Primary Care

Rethinking Clinical Trials

Dr. Margaret Kuklinski and Dr. Stacy Sterling In a pilot study for the GGC4H trial, researchers found that a virtual version of the Guiando Buenas Decisiones program delivered in the context of pediatric primary care was feasible, acceptable, and appealing to pediatricians and parents. The program is a Spanish-language version of the Guiding Good Choices intervention being implemented in the GGC4H trial.

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Cell and gene therapy approvals drive paradigm change in manufacturing

Pharmaceutical Technology

Trends in gene therapy approvals in recent years are rapidly shaping the future of manufacturing capabilities in the pharmaceutical industry.

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October 16, 2024: Testing of Behavior Change Interventions, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Alexander Fanaroff In this Friday’s PCT Grand Rounds, Alexander Fanaroff of the University of Pennsylvania will present “Rigorous Testing of Behavior Change Interventions: Lessons From the BE ACTIVE Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, October 18, 2024, at 1:00 pm eastern. Fanaroff is an assistant professor of medicine at the University of Pennsylvania.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Imitation Ozempic Is Flooding The Market: Here’s What You Need to Know

AuroBlog - Aurous Healthcare Clinical Trials blog

(Abdullah Durmaz/Getty Images) In just a few years, brand-name injectable drugs such as Ozempic, Wegovy, Mounjaro and Zepbound have rocketed to fame as billion-dollar annual sellers for weight loss as well as to control blood sugar levels and reduce the risk of heart disease.

Marketing 146
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Innovation in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes

Worldwide Clinical Trials

Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. From the unpredictability of lupus flare-ups to the silent progression of osteoporosis, patients face daily struggles that can significantly impact their quality of life. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.

Research 130

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Healing begins with research: Promising development program on stem cells in rare diseases

Pharmaceutical Technology

RHEACELL has been researching ABCB5-positive stem cell therapies for patients with severe immune and inflammation-related diseases for which there are currently no adequate treatment options. Positive feedback from the regulatory authorities on the study program now gives reason to hope that those affected will be able to benefit from this new approach to regenerative medicine in the near future.

Research 234
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Does Stress Really Turn Your Hair Gray?

AuroBlog - Aurous Healthcare Clinical Trials blog

(juanma hache/Getty Images) When we start to go gray depends a lot on genetics. Your first gray hairs usually appear anywhere between your twenties and fifties. For men, gray hairs normally start at the temples and sideburns. Women tend to start graying on the hairline, especially at the front.

Genetics 130
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Innovating in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes

Worldwide Clinical Trials

Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. From the unpredictability of lupus flare-ups to the silent progression of osteoporosis, patients face daily struggles that can significantly impact their quality of life. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.

Research 130
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Sanofi may have found a buyer for its consumer health business

Bio Pharma Dive

The French pharmaceutical giant said it’s in negotiations to sell a controlling stake of Opella to the private equity firm CD&R, in a deal that reportedly could be worth more than $16 billion.

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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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Sanofi in talks to sell stake in consumer healthcare unit to CD&R

Pharmaceutical Technology

Sanofi has announced negotiations with Clayton Dubilier & Rice (CD&R), regarding the potential sale of a 50% controlling stake in Opella.

Sales 246
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October 15, 2024: Case Study Describes a Reassessment of Sample Size in an Ongoing Cluster Randomized Trial

Rethinking Clinical Trials

A new case study from the NIH Pragmatic Trials Collaboratory highlights an interim reassessment of sample size during an ongoing cluster randomized trial. The case study was published this week in the Living Textbook of Pragmatic Clinical Trials. Researchers in cluster randomized trials must account for potential correlation between clusters in the design and analysis of their trial by estimating the intraclass correlation when calculating the target sample size.

Trials 162
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Can a Supplement Really Help Control Your Pesky Eye Floaters?

AuroBlog - Aurous Healthcare Clinical Trials blog

(Filipp Romanovski/Unsplash) If you look up at the sky on a clear day, you might notice little cobweb-like structures drifting across your field of vision.

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Lilly pledges £279m to UK for biotech hub and obesity plan

pharmaphorum

Eli Lilly may invest $364m in the UK and work with the government to tackle serious public health challenges including obesity.

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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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Ex-Pfizer execs ‘threatened’ for supporting plans to shake up company, Starboard says

Bio Pharma Dive

In a letter to Pfizer’s board, the activist investor claimed former CEO Ian Read and CFO Frank D’Amelio were pressured to abandon a Starboard-led attempt to change the company’s direction.

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GITEX GLOBAL 2024: Huawei launches a series of industrial digital and intelligent transformation solutions, and flagship products

Pharmaceutical Technology

Huawei hosted GITEX's Industrial Digital and Intelligent Transformation Summit and launched joint solutions with partners for ten industries.

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In win for compounders, FDA will review its decision to put Eli Lilly's tirzepatide on shortage list

Fierce Pharma

Four days after a compounding industry group filed a lawsuit against the FDA | Four days after a compounding industry group filed a lawsuit against the FDA for removing Eli Lilly’s tirzepatide products from its shortage list, the U.S. regulator is taking a second look at its decision.

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Isometric Exercise: Why This Workout Regime Is So Good For You

AuroBlog - Aurous Healthcare Clinical Trials blog

(Valerii Apetroaiei/Getty Images) Exercise is great for improving heart health. But the thought of hitting the gym or going for a jog might put some people off from doing it. And, if you have a heart condition already, such dynamic exercises may not be safe to do.

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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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Lundbeck drops in on epilepsy drug with $2.6bn Longboard bid

pharmaphorum

Neuroscience specialist Lundbeck has agreed to buy Longboard Pharmaceuticals for $2.6 billion, expanding its pipeline with an epilepsy drug tipped as a future blockbuster.The Danish drugmaker has offered $60 per share for California biotech Longboard, with the main asset in the deal bexicaserin, an oral, centrally acting serotonin 5-HT 2C receptor super-agonist in late-stage testing for seizures associated with rare forms of epilepsy.

Drugs 104
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Pfizer drug for hemophilia approved by FDA

Bio Pharma Dive

The approval of Hympavzi Friday was a dose of good news for Pfizer, which is dealing with research setbacks and a challenge from an activist investor.

Drugs 261
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Lundbeck to acquire Longboard Pharmaceuticals for $2.6bn

Pharmaceutical Technology

Lundbeck is to acquire Longboard for $2.6bn equity value in a move set to enhance its capabilities within neuro-rare conditions.

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GSK takes mRNA patent fight to Moderna, suing over vaccines for COVID and RSV

Fierce Pharma

Nearly six months after lodging a similar complaint against Pfizer and BioNTech over the partners’ COVID shot Comirnaty, GSK is targeting Moderna in a pair of lawsuits alleging the Massachusetts-ba | GSK is targeting Moderna in a pair of lawsuits claiming the mRNA specialist violated multiple patents with its vaccines Spikevax and mRESVIA. In the complaints, GSK says it hopes to recover a “reasonable royalty” tied to Moderna’s vaccine sales, plus damages.

Vaccine 122
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2022 Research: The Rapid Rise of Ocean Freight Visibility

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.

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No new traditional retail shop opened in TN during the last five years due to mushrooming of chain pharmacies

AuroBlog - Aurous Healthcare Clinical Trials blog

Concerned over the pathetic condition of the traditional medicine retailers in Tamil Nadu, the veteran pharma trader and former president of the Tamil Nadu Chemists and Druggists Association (TN CDA), Mannargudi Ramachandran, has commented that no new registered pharmacist in the state is coming forward to open individual pharmacy shops because of mushrooming of corporate […]

Pharmacy 140
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SPECTRALIS Flex Module Add-On Gets FDA Clearance, Aims to Improve Access to Ophthalmic Imaging

XTalks

The US Food and Drug Administration (FDA) has granted clearance to imaging and healthcare IT company Heidelberg Engineering’s Flex Module, a multimodal, diagnostic imaging-only platform designed for imaging the posterior segment of pediatric and adult patients in a supine (face up) position. Being able to image macular and optic nerve pathologies in the supine position ensures that vulnerable individuals can receive timely and sight-saving diagnoses and treatments.

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Wave sees RNA editing validation in early trial results

Bio Pharma Dive

The results provide the first clinical evidence of RNA editing, a burgeoning field that's drawn interest from biotechs and pharmaceutical companies alike.

RNA 196
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Glaukos eyes FDA approval for ocular therapy after Phase III win

Pharmaceutical Technology

The company’s keratoconus medication, Epioxa, was effective in a Phase III trial, with plans to file for submission with the US Food and Drug Administration (FDA).

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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On road to crowded Crohn's disease market, Lilly's Omvoh bests J&J's Stelara in head-to-head study

Fierce Pharma

On a mission to collect a key Crohn’s disease approval and build out its inflammatory bowel disease (IBD) profile, Eli Lilly has notched a trial win over a major rival in a head-to-head study.&nbsp | Eli Lilly's drug outperformed Johnson & Johnson's established Stelara in a phase 3 study that looked at histologic disease responses over 52 weeks.

Marketing 122
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GSK turns its guns on Moderna in mRNA jab patent dispute

pharmaphorum

GSK has filed lawsuits against Moderna, claiming infringement of patents covering mRNA vaccines for COVID-19 and RSV

Vaccine 116
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Women in STEM: Gitte Barknowitz’s journey to leading global initiatives

BioPharma Reporter

From exploring the wonders of plants as a curious teen to leading global initiatives at SCIEX, Gitte Barknowitz has carved out an exciting and unconventional career in science.

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Sage to cut one-third of workforce, streamline drug pipeline

Bio Pharma Dive

The restructuring, which follows clinical setbacks in Alzheimer’s, Parkinson’s and tremor, will also involve the departure of five senior executives.

Drugs 167
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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.