Sat.Sep 02, 2023 - Fri.Sep 08, 2023

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Biogen, continuing executive revamp, finds a new research head

Bio Pharma Dive

Jane Grogan, an industry veteran who worked at Genentech for over 15 years, will take over the role starting Oct. 2. She’ll fill a seat that's lacked a permanent replacement since the departure of Al Sandrock.

Research 299
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Nestlé divests peanut allergy treatment Palforzia to Stallergenes Greer

Pharmaceutical Technology

Nestlé has sold its peanut allergy drug Palforzia to Swiss biopharma Stallergenes Greer harma, concluding a year-long strategic review.

Allergies 299
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September 5, 2023: NIH Pragmatic Trials Collaboratory Announces Grand Rounds Series on Design and Analysis of Pragmatic Clinical Trials

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory is launching a special Grand Rounds series to share advances in the design and analysis of pragmatic clinical trials. Join us on the first Friday of each month, October through January, to hear the latest best practices and explore emerging questions with experts from the program’s Biostatistics and Study Design Core.

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Repurposing the anthelmintic drug Niclosamide

Pharma Mirror

Niclosamide is an anthelmintic medication that has been used for decades to treat various types of parasitic infections in humans and animals. Niclosamide works by disrupting the energy metabolism of the parasitic worms, specifically by interfering with their ability to generate adenosine triphosphate (ATP), which is essential for their survival. This disruption ultimately leads to the death of the parasites.

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

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Nestle gives up on peanut allergy treatment after sluggish sales

Bio Pharma Dive

The FDA-approved therapy, called Palforzia, was little used, leading Nestle to abandon a business it had secured in a $2.6 billion deal three years ago.

Allergies 321
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Eloxx moves ahead with plans with gene therapy for rare kidney disorder

Pharmaceutical Technology

Eloxx has submitted an IND for a pivotal trial to study its Alport syndrome therapy ELX-02 following a positive Phase II data readout.

More Trending

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Patient-Centric Marketing in the Life Science Industry: Putting the Focus on Patient Needs

Pharma Mirror

by Nataliya Andreychuk, Co-founder and CEO of Viseven Many pharma brands still shy away from marketing directly to patients, depending on conversion through healthcare providers (HCPs). And it is not hard to see why. Compliance with complex laws and regulations, like Direct-to-Consumer Advertising (DTCA) Rules or the Health Insurance Portability and Accountability Act (HIPAA), can be quite daunting.

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Otsuka taps Shape in deal to design eye gene therapies

Bio Pharma Dive

Shape uses machine learning and high throughput screening to identify new AAV capsids in ways the company’s CEO compares to the generative AI tools Midjourney and DALLE-2.

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Veracyte and Gustave Roussy announce partnership for cancer therapies

Pharmaceutical Technology

Veracyte has announced a partnership with Gustave Roussy to support biopharmaceutical companies in expediting the development

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Novo, Lilly set to dominate $71B GLP-1 drug market by 2032: J.P. Morgan

Fierce Pharma

Demand is so strong for Novo Nordisk’s obesity drugs that the only limitation on sales—in the short term—seems to be the company’s ability to produce them. | Promising heart data for Novo Nordisk's Wegovy are a "paradigm shift," according to J.P. Morgan, which has doubled its market projection for GLP-1 diabetes and obesity treatments to $71 billion for 2032.

Marketing 138
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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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Brainomix’s e-Lung enters TIPAL trial

Pharma Times

The company will use its AI technology during a sub-study to analyse the effect of lansoprazole - News - PharmaTimes

Trials 151
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AstraZeneca, seeking new drug targets, taps a genomics biotech and its AI technology

Bio Pharma Dive

Worth up to $840 million, the collaboration will give Alexion access to Verge Genomics’ platform, which uses human tissue data to find drug targets for diseases that degrade the nerve system.

Genome 286
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Digital dilemma in UK’s life sciences job market

Pharmaceutical Technology

In this issue: Digital jobs in UK life sciences, generative AI changes drug discovery, and how robotics is impacting gene therapy manufacturing.

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Patent cliffs, divestitures and maturing biotechs all point to more pharma M&A: analysts

Fierce Pharma

Biopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. | Biopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. Analysts anticipate that the trend will continue in 2023 and into 2024 as companies attempt to beef up their portfolios.

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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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AMO Pharma reveals data from myotonic dystrophy study

Pharma Times

Clinically significant results have emerged from trial evaluating the company’s AMO-02 candidate - News - PharmaTimes

Trials 143
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In advocates’ push for superbug funding, ‘$6 billion is nothing’

Bio Pharma Dive

The PASTEUR Act could be heading for another legislative blow, but advocates say they see a future for the mechanism to fund research into antimicrobial resistance.

Research 286
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MHRA grants approval for Pfizer-BioNTech’s adapted vaccine for Covid-19

Pharmaceutical Technology

The UK MHRA has granted approval for Pfizer and BioNTech’s adapted Covid-19 vaccine (Comirnaty) targeting the Omicron XBB 1.5 subvariant.

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J&J's patient assistance program suffers data breach, IBM says

Fierce Pharma

IBM disclosed "unauthorized access" to J&J’s Janssen CarePath patient assistance program, which helped over 1 million U.S. patients last year.

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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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Ariceum doses first patient with satoreotide

Pharma Times

The treatment targets extensive stage small cell lung cancer and aims to boost therapeutic impact - News - PharmaTimes

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Kriya, flush with funding, buys a gene therapy for NASH

Bio Pharma Dive

Fresh off a Series C fundraise, Kriya has acquired the privately held Tramotane Therapeutics and its preclinical candidate for the widely prevalent liver disease.

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EC expands indication approval for Merck’s Ebola vaccine

Pharmaceutical Technology

The European Commission granted expanded indication approval for Merck’s Ebola vaccine, Ervebo, to include children aged one year or above.

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Biopharma’s rapid transition to omnichannel marketing

pharmaphorum

In today’s episode, sponsored by Veeva, we’ll hear a roundtable discussion on this fascinating topic featuring Victoria Serra Gittermann, European customer experience lead at Veeva Systems and Sebastian Noel, Veeva’s director of multichannel strategy – moderating a discussion with two executives with first-hand experience leading this change: Andy Eeckhout, global head of CRM and digital solutions at Advanz Pharma and Mokhtar Elsayed, head of global go to market commercial transformation at Sano

Marketing 122
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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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Novartis files suit against IRA after blockbuster Entresto makes CMS' price negotiations list

Fierce Pharma

Add Novartis to the list of biopharma giants that have filed lawsuits against the U.S. government as a reaction to the Inflation Reduction Act (IRA). | Add Novartis to the list of biopharma giants that have filed lawsuits against the U.S. government as a reaction to the Inflation Reduction Act. The case was filed Friday in New Jersey federal court, three days after the CMS revealed that Novartis’ heart failure treatment Entresto was among 10 drugs subject to price negotiations in 2026.

Drugs 118
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Beam begins US testing of first-of-its-kind ‘base editing’ cancer drug

Bio Pharma Dive

The announcement marks progress for Beam after trial delays, and is the first time in the U.S. that a patient has received a base editing treatment.

Drugs 300
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NICE recommends Lilly’s tirzepatide to treat T2D

Pharmaceutical Technology

The UK NICE has recommended Eli Lilly’s tirzepatide for the treatment of adult patients with inadequately controlled type 2 diabetes.

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Exploring Next Generation Chemotherapy Drugs with Processa Pharma’s Dr. David Young – Xtalks Life Science Podcast Ep. 126

XTalks

This episode features an interview with Dr. David Young, founder and President R&D at Processa Pharmaceuticals, a clinical-stage pharmaceutical company developing personalized approaches to cancer treatments with a focus on next generation chemotherapy drugs with improved safety and efficacy. Processa recently released an update on its clinical cancer program, which Dr.

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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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BlueWhale Bio surfaces with $18M on mission to overhaul cell therapy production

Fierce Pharma

University of Pennsylvania spinout BlueWhale Bio has surfaced on a mission to smash bottlenecks in cell and gene therapy manufacturing. | Cell therapy manufacturer BlueWhale Bio uncloaked Thursday with news it has raised $18 million in seed financing. The funding round was led by Danaher Corporation.

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Do not miss the return to growth

Bio Pharma Dive

The signals of a return to growth are emerging. As commercial leaders gear up for 2024 planning, they must prepare to fight for resources in a budget constrained environment.

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UK rejoins EU’s Horizon Europe science programme

Pharmaceutical Technology

The country returns to the EU’s research programme after a Brexit-related absence and questions surrounding its re-entry prospects.

Research 246
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Bristol Myers Squibb’s Camzyos gets NICE recommendation

Pharma Times

Therapy is used among adult patients with symptomatic obstructive hypertrophic cardiomyopathy - News - PharmaTimes

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.