Sat.Nov 02, 2024 - Fri.Nov 08, 2024

article thumbnail

Top 20 biopharmas’ market cap rises 2% in Q3 2024 amid flurry of drug approvals

Pharmaceutical Technology

The top 20 biopharmaceutical companies demonstrated signs of recovery during the third quarter (Q3) of 2024 as investor optimism improved following the interest rate cuts by the US Federal Reserve in September 2024.

Marketing 263
article thumbnail

Q&A with Worldwide’s Rare Disease Experts: The Latest Innovations and Hopes for 2025

Worldwide Clinical Trials

In preparation for World Orphan Drug Congress Europe, we interviewed Nathan Chadwick, Senior Director, Therapeutic Strategy Lead, Rare Disease, and Derek Ansel, MS, LCGC, Vice President, Therapeutic Strategy Lead, Rare Disease, to hear their insights into the current progress in rare disease research and their hopes for 2025. What was the biggest development in rare disease in 2024, and how has that impacted clinical research or patient outcomes?

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

AZ shares weaken as China investigation rumours swirl

pharmaphorum

AstraZeneca's shares have fallen more than 8% on speculation about an anti-corruption probe in China, its second-largest market, wiping around $14 billion off its value.The sell-off appears to have been prompted by an article in Chinese financial media outlet Yicai which suggested that "dozens of senior executives" at AZ's Chinese subsidiary have been implicated in an ongoing insurance fraud case.

Marketing 115
article thumbnail

Sickle cell patient dies in Beam study of base editing therapy

Bio Pharma Dive

The death, which investigators linked to a preparatory chemo treatment rather than Beam's medicine, highlights the risks of using decades-old transplant drugs alongside cutting-edge CRISPR medicines.

Medicine 300
article thumbnail

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 trainings aren’t winning awards for engagement. But that doesn’t mean they can’t be effective, relevant, and maybe even enjoyable! Join expert Brian Richardson for a dynamic session on how to breathe new life into your ethics and compliance training programs. You’ll discover creative strategies to turn traditionally dry topics into meaningful learning experiences that resonate and drive real change.

article thumbnail

Streamlining eCOA: From complex setup to simplified solutions

Outsourcing Pharma

As clinical trials evolve, electronic Clinical Outcome Assessments (eCOA) remain central to data quality but often lag in adoption due to complex setup and deployment challenges.

article thumbnail

November 5, 2024: Study Snapshot and Updated Ethics Documentation Available for MOMs Chat and Care Study

Rethinking Clinical Trials

A new study snapshot and updated ethics and regulatory documentation are now available for the MOMs Chat and Care Study. One year into the study, the research team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. The MOMs Chat and Care Study , and NIH Collaboratory Trial, is testing the effectiveness of an integrated care model approach at 2 levels of intensity designed to facilitate timely, appropriate care for Black birthing people to reduce t

Nurses 162

More Trending

article thumbnail

An RNAi renaissance is creating a new generation of startups

Bio Pharma Dive

Pioneers like Alnylam Pharmaceuticals have led the RNA interference field for years. Now, a crop of young biotechs is building on that foundation by taking the drugmaking technology in new directions.

RNA 348
article thumbnail

Ultra-processed food is causing a boom for obesity drug Ozempic

Pharmaceutical Technology

The seemingly inexorable rise in global obesity is being reflected in the sales of diabetes and weight-loss drugs, including Ozempic.

Drugs 264
article thumbnail

November 6, 2024: Effects of Income Support on Health and Healthcare Use, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Sumit Agarwal of the University of Michigan will present “The Effect of Cash Benefits on Health Care Utilization and Health: A Randomized Study of an Income Support.” The Grand Rounds session will be held on Friday, November 8, 2024, at 1:00 pm eastern. Agarwal is an assistant professor of internal medicine and health management and policy at the University of Michigan.

article thumbnail

Journey Medical’s Emrosi Wins FDA Approval for Rosacea, Could Rival Galderma’s Oracea

XTalks

Journey Medical Corporation, a leading biopharmaceutical company dedicated to the development and commercialization of innovative dermatology treatments, has announced that the US Food and Drug Administration (FDA) has approved Emrosi (minocycline hydrochloride extended release capsules, 40 mg), formerly referred to as DFD-29, for the treatment of rosacea.

article thumbnail

Clinical Research White Paper – Enhancing Transparency & Efficiency Throughout the Trial Lifecycle

Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness

article thumbnail

Cancer cell therapy from Arcellx, Gilead shows promise in early data

Bio Pharma Dive

The companies’ CAR-T seemed to cause fewer movement disorders in a multiple myeloma trial than J&J's Carvykti has in other tests, although Wall Street analysts were divided on how the two drugs compare.

Trials 301
article thumbnail

AstraZeneca and Amgen’s Tezspire succeeds in Phase III nasal polyps trial

Pharmaceutical Technology

A Phase III trial with the companies’ monoclonal antibody in patients with chronic rhinosinusitis with nasal polyps met its primary endpoint.

Trials 264
article thumbnail

November 4, 2024: Update to Living Textbook Offers Tips for Developing a Compelling PCORI Grant Application

Rethinking Clinical Trials

The NIH and the Patient-Centered Outcomes Research Institute (PCORI) are major funders of pragmatic clinical trials embedded in healthcare systems. An existing chapter of the Living Textbook of Pragmatic Clinical Trials provided guidance on how to Develop a Compelling Grant Application for the NIH. The updated chapter now includes information about how to develop a grant application for PCORI.

article thumbnail

World Diabetes Day 2024: Advanced Care for Diabetes Management

XTalks

As we approach World Diabetes Day on November 14, this year’s theme , “Diabetes and Well-being,” underscores the need to support both physical and mental health in diabetes care. With over 537 million people affected globally, diabetes complications like cardiovascular disease, kidney failure and neuropathy are on the rise. Early diagnosis and proactive management are essential to reducing these risks.

Insulin 108
article thumbnail

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!

article thumbnail

Sarepta scraps a Duchenne drug as gene therapy sales rise

Bio Pharma Dive

Elevidys sales have increased since the FDA made a controversial choice to expand the therapy's use. Now, Sarepta is abandoning a successor to its drug Exondys 51, citing an “evolving" treatment landscape.

Sales 284
article thumbnail

EMA approves Sanofi/Regeneron’s Dupixent for young EoE patients

Pharmaceutical Technology

The EMA has granted approval for Sanofi/Regeneron’s Dupixent (dupilumab) to treat EoE in children as young as one.

264
264
article thumbnail

Novo sheds kidney drug licensed for $1.3bn a year ago

pharmaphorum

Novo Nordisk has abandoned a drug it licensed from KBP Biosciences last year in a deal valued at up to $1.3 billion after it missed the mark in a chronic kidney disease (CKD) trial.The Danish group bought rights to ocedurenone, an oral non-steroidal mineralocorticoid receptor antagonist (nsMRA), from the Singapore biotech in October 2023 as a companion to its GLP-1-based therapies for reducing cardiovascular risk and kidney disease in people with diabetes and obesity.

Licensing 105
article thumbnail

Top 10 Healthcare Innovations of 2024, Per TIME’s Best Inventions List

XTalks

This blog is the fourth in our series exploring TIME’s “Best Inventions of 2024” list, following our deep dives into some of the most transformative medical devices , pharma and food innovations. Today, we spotlight healthcare inventions transforming clinical and at-home care, selected by TIME for their potential to tackle major healthcare challenges and elevate patient care.

Doctors 104
article thumbnail

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

article thumbnail

Empowering versatile applications of digital PCR with standardized, validated assays

Bio Pharma Dive

Bio-Rad’s extensive ddPCR assay offerings help researchers leverage the full power of digital PCR.

Research 237
article thumbnail

Pharma cold chains: Major trends shaping the next decade

Pharmaceutical Technology

Analysis of future trends highlights that the cold chain logistics sector is at a critical juncture, with tech advancements driving change.

246
246
article thumbnail

Strategies for effective biosimilar risk management plans

Drug Patent Watch

The development and approval of biosimilars have become increasingly important in the biopharmaceutical industry, offering cost-effective alternatives to original biological medicines. However, biosimilars pose unique challenges in terms of risk management due to their complex nature and potential for immunogenicity.

article thumbnail

From neurosurgery to focused ultrasound: Not if, but when

pharmaphorum

Therapeutic or focused ultrasound began being applied to neurologic conditions less than a decade ago, but its potential in a wide spectrum of brain applications is high. In today’s podcast, web editor Nicole Raleigh speaks with Dr Neal Kassell, chair and founder of the Focused Ultrasound Foundation and previously a neurosurgeon, who created the Foundation in 2006 to improve the lives of millions of people with serious medical disorders by accelerating the development and adoption of focused ult

article thumbnail

Can Your Organization Spot a Conflict Before It’s a Crisis?

Speaker: Amie Phillips Pablo, VP, Corporate Compliance & Privacy Officer at Novo Nordisk

article thumbnail

Centers of excellence or product-centric BizDevOps managed services?

Bio Pharma Dive

As novel therapeutics become more complex — and costly — to bring to market, drug developers are looking to unified clinical development platforms to streamline operations.

article thumbnail

Minister for Science champions partnerships with private clinical sector in UK

Pharmaceutical Technology

Lord Vallance stated the government sees investment, innovation, and public-private partnership as crucial to UK healthcare.

246
246
article thumbnail

J&J angles Darzalex for first move into early-stage myeloma with trial win, FDA filing

Fierce Pharma

After a positive phase 3 trial, Johnson & Johnson hopes its Darzalex could become the first treatment option for patients with smoldering multiple myeloma, an early-stage form of the blood diso | After a positive phase 3 trial, Johnson & Johnson hopes its Darzalex could become the first treatment option for patients with smoldering multiple myeloma, an early-stage form of the blood disorder.

Trials 92
article thumbnail

Journey slips on FDA approval of rosacea therapy

pharmaphorum

Journey Medical has claimed FDA approval for its Emrosi therapy for rosacea, which it thinks could become a "standard of care" drug for the common skin disorder.The new capsule formulation of the antibiotic minocycline hydrochloride has been cleared by the US regulator to treat the inflammatory lesions caused by rosacea – which causes flushing or long-term redness and pustules on the face – in adults.

article thumbnail

White Paper - A Roadmap to AI Data Readiness in R&D Labs

Download this comprehensive guide to AI and ML in the R&D Laboratory Setting.

article thumbnail

Viking data provide latest test of oral obesity drug potential

Bio Pharma Dive

Wall Street analysts were impressed by data showing competitive rates of weight loss for Viking’s therapy, but shares in the company still slipped.

Drugs 184
article thumbnail

DBV Technologies’ stock slides as financial woes worsens

Pharmaceutical Technology

The company reported that it does not have sufficient cash reserves to operate for the next 12 months, can only fund operations into Q1 2025.

245
245
article thumbnail

How to Develop a Risk Management Plan for Generic Drugs

Drug Patent Watch

Developing a Risk Management Plan (RMP) for generic drugs is a crucial step in ensuring the safety and efficacy of these medications. An RMP provides detailed information on a medicine’s safety profile, measures to prevent or minimize risks, and plans for ongoing safety monitoring and evaluation.

article thumbnail

New study to assess mpox vaccine in pregnant women and infants

Pharma Times

Trial to evaluate safety and efficacy of MVA-BN vaccine

Vaccine 152
article thumbnail

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