Thu.Oct 26, 2023

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Vertex gearing up for launch as sickle cell therapy review advances

Bio Pharma Dive

Executives at the biotech say they’re trying to get ahead of the payer and production challenges that will face their gene editing treatment exa-cel, which is now under FDA review.

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How gene therapies can transform sickle cell disease treatment

Pharmaceutical Technology

The potential for using gene therapies to treat sickle cell disease is high, but their durability and high price point invite scrutiny.

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Pfizer, BioNTech say combo flu, COVID shot met goal in study

Bio Pharma Dive

The partners announced the trial had succeeded weeks after Moderna disclosed positive results from a study of its similar combination vaccine.

Vaccine 286
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European Commission bolsters defences against critical medicine shortages

Pharmaceutical Technology

The EC announced new initiatives to tackle critical medicine shortages in winter, introducing more flexibility to strengthen supplies.

Medicine 246
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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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New Link Between Fungal Organisms And Severe COVID Discovered

AuroBlog - Aurous Healthcare Clinical Trials blog

Many tiny organisms including bacteria, fungi and viruses normally live on our bodies, and even inside us. These are called the microbiome. The large number of these organisms living in the gastrointestinal tract are collectively known as the gut microbiome.

Bacteria 245
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Pfizer and BioNTech post early win for combination Covid-19/flu vaccine 

Pharmaceutical Technology

A pivotal Phase III trial will be initiated in the coming months to further evaluate the lead formulations of the combination vaccine.

Vaccine 241

More Trending

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ICMR invites proposals to establish Ayush-ICMR Advanced Centre for Integrative Health Research at AIIMS

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Council of Medical Research (ICMR) has invited proposals to establish Ayush-ICMR Advanced Centre for Integrative Health Research (AI-ACIHR) at the All India Institute of Medical Sciences (AIIMS) under Extramural Programme. This is following a Memorandum of Agreement (MoA) signed between the Union Ministry of Ayush and the ICMR at an inter-ministerial level.

Research 189
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Triveni emerges from biotech merger with $92M for immune disease drugs

Bio Pharma Dive

Backed by like Atlas, Cormorant and OrbiMed, Triveni is developing an antibody drug for eczema and asthma that takes aim at a different kind of target.

Drugs 195
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NHS virtual wards to treat heart failure patients at home

Pharma Times

Thousands of patients with heart failure are set to benefit from the expansion - News - PharmaTimes

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Bristol Myers says new drugs sales will grow more slowly

Bio Pharma Dive

Company shares fell Thursday as the company adjusted its medium-term guidance for sales of new products like Reblozyl, Camzyos and Abecma.

Sales 182
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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MSD terminates Phase II trials for Alzheimer’s drug due to liver toxicity

Pharmaceutical Technology

MK-1942 was in two Phase II trials for the treatment of Alzheimer’s disease and major depressive disorder.

Trials 147
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Novartis claims ex-staffer jumped to Takeda with 'thousands' of sensitive files

Fierce Pharma

Novartis believes a former employee of its Egyptian affiliate made off with thousands of files before jumping ship to Takeda. | Novartis believes a former employee of its Egyptian affiliate made off with thousands of files before jumping ship to Takeda. Now, the Swiss pharma giant wants a peek at Takeda’s business records to find out whether its confidential information has been used improperly.

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Triventi secures $92m to advance clinical development of antibody therapy

Pharmaceutical Technology

The Series A funds will go towards the clinical development of TRIV-509, with plans for a proof-of-concept atopic dermatitis study.

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Bayer and PCF launch darolutamide challenge awards for prostate cancer

Pharma Times

The two projects will be awarded $1m each to support their clinical investigations - News - PharmaTimes

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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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Sanguinate by Prolong Pharmaceuticals for Sickle Cell Disease With Vaso-Occlusive Crisis: Likelihood of Approval

Pharmaceutical Technology

Sanguinate is under clinical development by Prolong Pharmaceuticals and currently in Phase II for Sickle Cell Disease With Vaso-Occlusive Crisis.

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Eisai, Biogen's injectable Leqembi clears toxic protein in Alzheimer's disease. What about safety?

Fierce Pharma

With concerns growing over the burden Leqembi could impose on healthcare infrastructure, Eisai and Biogen have trotted out data for an under-the-skin version of the Alzheimer’s disease drug that ma | Eisai and Biogen have trotted out data for a subcutaneous version of the Alzheimer’s disease drug Leqembi. The self-injected version showed an encouraging efficacy result but a seemingly increased risk of ARIA, which analysts said shouldn't be too much of a concern.

Protein 126
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NKTR-255 by Nektar Therapeutics for Diffuse Large B-Cell Lymphoma: Likelihood of Approval

Pharmaceutical Technology

NKTR-255 is under clinical development by Nektar Therapeutics and currently in Phase III for Diffuse Large B-Cell Lymphoma.

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COVID, flu combo jab from Pfizer/BioNTech heads for phase 3

pharmaphorum

COVID, flu combo jab from Pfizer/BioNTech heads for phase 3 Phil.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Bio-Thera’s Milestone: FDA Approves Tofidence, a Biosimilar Referencing Actemra

Pharmaceutical Technology

The FDA has approved Tofidence as the first biosimilar referencing the IL-6 receptor antagonist tocilizumab for rheumatoid arthritis

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The longitudinal history of medicines innovation: Part One

pharmaphorum

The longitudinal history of medicines innovation: Part One Mike.

Medicine 115
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Flashpoint secures funds to develop nanotechnology-enabled therapies

Pharmaceutical Technology

Flashpoint Therapeutics has secured $10m in a seed funding round to develop nanotechnology-enabled medicines.

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Merck raises revenue guidance thanks to a surprising bump from COVID-19 pill Lagevrio

Fierce Pharma

It’s been grounded in Europe and reduced to irrelevancy in the U.S., but Merck’s COVID-19 pill Lagevrio somehow remains a force. | It’s been grounded in Europe and reduced to irrelevancy in the U.S., but Merck’s COVID-19 pill Lagevrio somehow remains a force. The antiviral treatment racked up sales of $640 million in the third quarter, shocking analysts who figured it would generate $120 million.

Sales 115
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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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US recommends Bavarian Nordic’s mpox vaccine for routine use 

Pharmaceutical Technology

The ACIP of the US Centers for Disease Control and Prevention recommended routine use of Bavarian Nordic’s mpox vaccine, Jynneos, in adults.

Vaccine 130
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NICE backs pump-based Parkinson’s drug from AbbVie

pharmaphorum

NICE backs pump-based Parkinson’s drug from AbbVie Phil.

Drugs 115
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GSK’s RSV vaccine Arexvy effective in adults aged 50-59 years

Pharmaceutical Technology

GSK plans to submit the data to regulatory agencies to support label expansion for Arexvy in the younger adult patient population in 2024.

Vaccine 130
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Grand Rounds October 20, 2023: A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists (Rachael L. Fleurence, PhD, MSc; Joshua M. Sharfstein, MD)

Rethinking Clinical Trials

      Speakers Rachael L. Fleurence, PhD, MSc Senior Advisor National Institutes of Health Joshua M. Sharfstein, MD Vice Dean for Public Health Practice and Community Engagement Director, Bloomberg American Health Initiative Professor of the Practice in Health Policy and Management Slides Keywords Hepatitis C, NIH, PCORnet Key Points The advances in Hepatitis C drugs is one of the greatest successes in clinical research in the last 20 years, yet Hepatitis C is a public health crisis in th

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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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Zenith and Cencora partner to expedite ZEN-3694 programme

Pharmaceutical Technology

Zenith Epigenetics and Cencora have signed an agreement for expediting the commercialisation of the former’s ZEN-3694 programme.

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Bristol Myers' incoming CEO plots turnaround for struggling new launches

Fierce Pharma

On outgoing chief executive Giovanni Caforio’s last earnings call, Bristol Myers Squibb had some tough questions to answer about a roster of underperforming new products. | On outgoing chief executive Giovanni Caforio’s last earnings call, Bristol Myers Squibb had some tough questions to answer about a roster of underperforming new products. But according to CEO-elect Chris Boerner, it’s a question of “when, not if” those drugs rise to meet expectations.

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Appili receives funds for biodefence vaccine development

Pharmaceutical Technology

Appili Therapeutics has received additional funding of $6.6m from the US Air Force Academy to develop ATI-1701.

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How to leverage real-world data for better patient care

pharmaphorum

How to leverage real-world data for better patient care Mike.

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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.