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

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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
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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?

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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 114
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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 305
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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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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.

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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

More Trending

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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
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Daiichi Sankyo links up with Korea's Alteogen on subcutaneous Enhertu in $300M licensing deal

Fierce Pharma

A subcutaneous version of Daiichi Sankyo’s AstraZeneca-partnered blockbuster antibody-drug conjugate (ADC) Enhertu could be in the works from Korea’s Alteogen following a licensing deal worth up to | Alteogen will use its human hyaluronidase hybridization platform to develop a subcutaneous formulation of the blockbuster antibody-drug conjugate.

Licensing 141
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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
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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.

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

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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 306
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AZ confirms China president has been detained

pharmaphorum

AstraZeneca has revealed that its top executive in China, Leon Wang, has been detained by Chinese authorities

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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.

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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.

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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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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 290
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LumiThera’s Valeda Photobiomodulation System Gets FDA Authorization for Dry AMD

XTalks

LumiThera Inc. , a vision tech company focused on developing photobiomodulation (PBM) therapies for ocular diseases and disorders, has received US Food and Drug Administration (FDA) authorization for its Valeda Light Delivery System for patients with dry age-related macular degeneration (AMD), one of the most common causes of vision impairment in the aging population.

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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.

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Novavax coughs up $123.8M to settle COVID vaccine supply dispute with UK

Fierce Pharma

Novavax has inked another settlement for a past COVID-19 vaccine supply deal. | Novavax has inked another settlement for a past COVID-19 vaccine supply deal. The Maryland biotech has agreed to pay $123.8 million to end a COVID vaccine supply pact with the U.K.

Vaccine 126
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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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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
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Eisai dials back forecasts for Alzheimer's drug Leqembi

pharmaphorum

Eisai has scaled down its sales expectations for Alzheimer's disease drug Leqembi after sluggish sales growth in the first half of the current fiscal year.

Drugs 124
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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.

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New study to assess mpox vaccine in pregnant women and infants

Pharma Times

Trial to evaluate safety and efficacy of MVA-BN vaccine

Vaccine 122
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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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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.

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Intra-Cellular's unstoppable Caplyta nails another trial, this time for relapse prevention in schizophrenia

Fierce Pharma

Intra-Cellular Therapies’ atypical antipsychotic medication Caplyta has been on a roll, delivering fast commercial growth and coming up triumphant in yet another late-stage trial. | Intra-Cellular Therapies’ atypical antipsychotic medication Caplyta has been on a roll, delivering fast commercial growth and coming up triumphant in yet another late-stage trial.

Trials 122
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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.

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NICE backs first ophthalmic bevacizumab for NHS use

pharmaphorum

Outlook Therapeutics' Lytenava is the first ophthalmic formulation of bevacizumab to be cleared for use by NICE for use in the NHS for wet AMD

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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 189
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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.

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Northwestern and Case Western Reserve universities develop Huntington’s therapy

Pharmaceutical Technology

Researchers from Northwestern and Case Western Reserve universities have developed a polymer therapeutic to treat Huntington's disease.

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Daiichi Sankyo partners Alteogen on subcutaneous Enhertu

pharmaphorum

Daiichi Sankyo signs a $300m deal with Alteogen to develop a subcutaneous version of anti-HER2 cancer drug Enhertu.

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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.