Mon.Oct 23, 2023

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Verve gets FDA green light to run base editing study in US

Bio Pharma Dive

The trial, which is ongoing in the U.K. and New Zealand, has been on hold in the U.S. since late last year as the FDA sought more details on Verve’s in vivo treatment for heart disease.

In-Vivo 344
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ESMO 2023: MSD’s Welireg leads HIF-2? inhibitors in RCC despite unclear OS

Pharmaceutical Technology

At ESMO 2023, interim results from the Phase III LITESPARK-005 trial evaluating MSD’s Welireg (belzutifan) as a treatment for patients with previously treated advanced clear cell renal cell carcinoma (RCC) were presented.

Trials 189
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Pfizer wins FDA approval of new meningococcal vaccine

Bio Pharma Dive

The clearance of the pentavalent shot Penbraya adds to Pfizer’s infectious disease portfolio as it adjusts to slumping COVID-19 vaccine sales.

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What is quantum computing and what does it mean for business?

Pharmaceutical Technology

What is quantum computing and what does it mean for business. Quantum computing has emerged from a hype cycle with continued investment.

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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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Seagen trial data impresses at ESMO, lifting Merck, Pfizer in the process

Bio Pharma Dive

A combination of Seagen and Astellas’ antibody-drug conjugate Padcev with Merck’s Keytruda dramatically improved survival in first-line bladder cancer.

Antibody 293
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AstraZeneca granted licence for Nanoform’s AI technology

Pharma Times

STARMAP will accelerate the selection of AZ’s best molecule candidates - News - PharmaTimes

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More Trending

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ESMO 2023: Mirati’s Krazati and immuno-oncology combo to shape first-line NSCLC

Pharmaceutical Technology

The combination’s ORR had a noticeable improvement over the data demonstrated by Keytruda in the first-line metastatic NSCLC setting.

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5 things to look for in a marketing analytics partner

Bio Pharma Dive

Effective marketing measurement requires objectivity, connected data, transparency, a track record of innovation and a proven ability to execute.

Marketing 279
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Signal: Roche to buy ulcerative colitis drug from Roivant for $7.1bn

Pharmaceutical Technology

Less than a year after Roivant purchased the IBD drug from Pfizer, it is selling it on for massive profit.

Drugs 147
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Roche to gain gut disease drug in $7.1B deal for Roivant subsidiary

Bio Pharma Dive

The Swiss pharmaceutical company has agreed to buy Televant, a company set up by Roivant and Pfizer to develop a promising inflammatory bowel disease treatment.

Drugs 173
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Businesses largely ignorant to GenAI security threats, suggests research

Pharmaceutical Technology

Businesses are commonly unaware of the threats generative AI poses to cybersecurity and data privacy, new research has suggested.

Research 147
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J&J medtech head Ashley McEvoy to step down

Bio Pharma Dive

McEvoy is leaving the company after 27 years to pursue other opportunities. Tim Schmid will now lead the MedTech business.

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AstraZeneca granted license for Nanoform’s AI technology

Pharma Times

STARMAP will accelerate the selection of AZ’s best molecule candidates - News - PharmaTimes

Licensing 143
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Why the evolution of patient advocacy organizations means better data for your rare disease trial

Bio Pharma Dive

Rare disease drug development is a unique and challenging field that demands strategic development expertise and uniting of the various stakeholders working toward the same goal.

Trials 162
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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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FlyPharma Conference Europe 2023 shares industry collaboration initiatives and explores the future of pharma logistics

Pharma Times

On 10 to 11 October 2023, the seventh FlyPharma Conference Europe successfully concluded in Vienna, Austria - News - PharmaTimes

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AmerisourceBergen is improving access to H2O Therapeutics’s Parky DTx App

Pharmaceutical Technology

H2O Therapeutics’s Parky app is a symptom tracker app designed to quantify the kinematics of movement disorder symptoms in PD patients.

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Embracing generative AI will enhance, not replace, the humanity in commercial models

pharmaphorum

Embracing generative AI will enhance, not replace, the humanity in commercial models Mike.

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Delbag and Nordic Air are now Hengst Filtration

Pharmaceutical Technology

Hengst consolidates expertise in industrial air filtration bringing DELBAG and Nordic Air Filtration under the umbrella brand Hengst Filtration.

Branding 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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With FDA rejection to treat hives disorder, Sanofi and Regeneron's Dupixent suffers rare setback

Fierce Pharma

Regeneron and Sanofi are anxious to bring Dupixent as an answer for chronic spontaneous urticaria (CSU), a severe inflammatory condition that causes hives and deep swelling on or under the skin.

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Liver specialist Aligos scores $92m in private placement funding

Pharmaceutical Technology

As it builds momentum towards a Phase IIa study for its NASH drug, Aligos aims to be a THR-β agonist market contender.

Marketing 130
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Understanding the complex rare disease and specialty pharmaceutical landscape

pharmaphorum

Understanding the complex rare disease and specialty pharmaceutical landscape Mike.

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Voxzogo given green-light to treat children under five by US FDA

Pharmaceutical Technology

BioMarin has seen the label for its achondroplasia drug expand following two clinical trials that saw positive growth in children living with the condition.

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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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ESMO: Trials end 20-year hiatus in cervical cancer therapy

pharmaphorum

ESMO: Trials end 20-year hiatus in cervical cancer therapy Phil.

Trials 111
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FDA approves Celltrion’s subcutaneous Remicade biosimilar for IBD

Pharmaceutical Technology

The Remicade biosimilar is forecasted to have sales of $2.3bn by 2029 as a subcutaneous form is approved for the US market.

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Rumour confirmed as Roche buys Telavant for $7.1bn

pharmaphorum

Rumour confirmed as Roche buys Telavant for $7.1bn Phil.

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FDA clears Pfizer’s meningococcal disease vaccine

Pharmaceutical Technology

Penbraya reduces the total number of doses needed for adolescents to be fully vaccinated against the leading serogroups that cause meningococcal disease.

Vaccine 130
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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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EU authorities fine Boehringer, others for operating drug-ingredient 'cartel'

Fierce Pharma

Five pharmaceutical companies, including the global player Boehringer Ingelheim, have landed in hot water for running a "cartel" to dominate the market for a specific drug ingredient in Europe. | Authorities said the companies agreed to set minimum prices, allocated business and more. Boehringer Ingelheim was hit with the largest fine among the group.

Drugs 111
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Manufacturing issues delay lebrikizumab’s entry to the atopic dermatitis market

Pharmaceutical Technology

On 2 October, Eli Lilly announced that the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) regarding the biologic license application (BLA) for its anti-interleukin (IL)-13 biologic lebrikizumab for the treatment of adults and adolescents (12 and older) with moderate-to-severe atopic dermatitis (AD).

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ESMO: Immunotherapy combos extend lives in bladder cancer

pharmaphorum

ESMO: Immunotherapy combos extend lives in bladder cancer Phil.

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With $385M settlement, Indivior closes out long-running Suboxone antitrust case

Fierce Pharma

With a $385 million settlement, Suboxone maker Indivior is moving to wrap up years of antitrust litigation tied to its opioid addiction treatment. | The deal follows previous settlements worth $102 million and $30 million with two other claimant groups.

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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.