Wed.Jan 03, 2024

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January 3, 2024: Special Biostatistics Series Concludes With Missing Data in Cluster Randomized Trials

Rethinking Clinical Trials

In this Friday's PCT Grand Rounds, Rui Wang of Harvard Medical School will offer the final session in our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with "Methods for Handling Missing Data in Cluster Randomized Trials." The session will be held on Friday, January 5, at 1:00 pm eastern. Wang is an associate professor of population medicine and the director of the Division of Biostatistics in the Department of Population Medicine at Harvard Medical School and

Trials 298
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Expert analysis: the latest in HIV research and clinical trials 

Pharmaceutical Technology

A new report from Novotech delves into the multifaceted landscape of HIV, focusing on its impact, treatment, and global initiatives.

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Goldman Sachs gets into biotech investing with new venture fund

Bio Pharma Dive

The $650 million fund exceeded Goldman’s target and comes amid cautious optimism that biotech could rebound from a lengthy downturn.

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Novartis allies with Voyager to develop gene therapies in $1.3bn deal

Pharmaceutical Technology

Novartis will pay Voyager $100m upfront and up to $1.2bn in milestone-based payments and royalties on net sales.

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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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A Nutritionist Reveals The Secret to Making Friends With Salad

AuroBlog - Aurous Healthcare Clinical Trials blog

Do you hate salad? It’s OK if you do, there are plenty of foods in the world, and lots of different ways to prepare them.

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Boehringer reinforces interest in NASH with new $2bn deal  

Pharmaceutical Technology

This collaboration comes six years after the German company Boehringer signed two agreements to develop treatments for NASH.

More Trending

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Navigating regulatory affairs in biopharma industry requires skilled talent pool: Expert

AuroBlog - Aurous Healthcare Clinical Trials blog

Navigating regulatory affairs in the biopharma industry requires a skilled talent pool, according to Benjamin James, HR Leader, Asia-Pacific, Cytiva Lifesciences – a global life sciences (biopharma) company. He cited Cytiva’s Global Biopharma Resilience Index (GBRI), which reveals a decline in overall talent pool resilience, with the score dropping from 6.27 in 2021 to 5.

HR 168
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Inside the world of priority review vouchers where ‘time is money’ – Part I

Pharmaceutical Technology

The first of a two-part series on therapies that receive an FDA priority review designation dives into how these vouchers incentivise innovation for low-commercial value-diseases.

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JPM24, Day 2: BioNTech warns of COVID vaccine sales decline; Alnylam looks to become 'top-tier' biopharma player

Fierce Pharma

As the J.P. | As the J.P. Morgan Healthcare Conference rolled on in San Francisco, BioNTech, Alnylam and many other companies updated investors on their strategies heading into 2024.

Sales 138
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AnX Robotica receives FDA clearance for small bowel capsule endoscopy technology

Pharma Times

NaviCam ProScan is the first AI-assisted reading tool for gastrointestinal bleeding

Drugs 138
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Signal: FTC granted injunction to pause IQVIA’s acquisition of Propel Media

Pharmaceutical Technology

A US court has granted the FTC's request to halt the acquisition due to concerns that it will promote anticompetitive practices.

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Novo Nordisk to open new AI hub in UK for drug discovery

Pharma Times

The new hub will be located in the King’s Cross Knowledge Quarter, London

Drugs 135
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Diakonos’ brain tumour vaccine wins FDA’s orphan drug designation

Pharmaceutical Technology

The immuno-oncology company has also completed enrolment in a Phase I trial investigating its dendritic cell vaccine DOC1021.

Vaccine 130
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Novo Nordisk, Eli Lilly's obesity drugs will lead in new drug sales in 2024: Evaluate

Fierce Pharma

Booming demand for blood sugar-modulating diabetes and obesity drugs became the top trend in the biopharma industry in 2023, with two companies—Novo Nordisk and Eli Lilly—overwhelming the market wi | Booming demand for blood sugar-modulating diabetes and obesity drugs became the top trend in the biopharma industry in 2023, with two companies—Novo Nordisk and Eli Lilly—overwhelming the market with their dominance.

Sales 128
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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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Oragenics acquires neurological assets from Odyssey Health

Pharmaceutical Technology

Oragenics has concluded the announced acquisition of assets focusing on neurological drug therapies and technologies from Odyssey Health.

Drugs 130
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JPM24, Day 3: Alkermes enters new phase after busy year

Fierce Pharma

As the J.P. Morgan Healthcare Conference moves into its third day, we're covering the latest developments here. | On Wednesday at the the J.P. Morgan Healthcare Conference, attendees will get a chance to hear from AbbVie, Amarin and several other pharmaceutical companies.

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UK MHRA introduces new procedure for medicine approvals

Pharmaceutical Technology

The UK MHRA has introduced the International Recognition procedure (IRP), a new pathway for medicine approvals.

Medicine 130
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With trial win for oral thalassemia drug, Agios charts broader path than gene therapy rivals

Fierce Pharma

Gene therapies have been approved for certain patients with beta thalassemia. After a successful phase 3 readout, Agios hopes it can reach a unique subgroup and eventually all patients. | Gene therapies have been approved for certain patients with beta thalassemia. After a successful phase 3 readout, Agios hopes it can reach a unique subgroup and eventually all patients.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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MediLink and Roche partner on cancer drug development

Pharmaceutical Technology

MediLink Therapeutics has signed a global partnership and licence deal with Roche to develop YL211 for solid tumours.

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JPM24, Day 1: Moderna touts $6.7B in '23 sales; Bluebird has cash on hand to last until early 2025

Fierce Pharma

As the J.P. Morgan Healthcare Conference kicked off in San Francisco, EY released its annual report on the industry's dealmaking firepower. | As the J.P. Morgan Healthcare Conference kicked off in San Francisco, EY released its annual report on the industry's dealmaking firepower. Plus, Moderna, bluebird and other companies updated investors on their businesses heading into 2024.

Sales 124
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EMA validates BMS’s repotrectinib application to treat cancer

Pharmaceutical Technology

The EMA has validated the marketing authorisation application of Bristol Myers Squibb (BMS) for repotrectinib to treat solid tumours.

Marketing 130
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MHRA’s post-Brexit mutual recognition framework goes live

pharmaphorum

The UK medicines regulator has launched its mutual recognition framework for authorising medicines in a move that it says will help to bring new drugs to patients in the UK more quickly.

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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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Enhancement, Efficiency, Equity, and Engagement: Four Trends Shaping Clinical Trials in 2024

ACRP blog

Historically, patient recruitment and retention have been pressing issues within the clinical trial space. Eighty-five percent of trials fail to recruit enough patients, while 80% are delayed due to other factors like participant dropouts. These high rates are influenced by financial, emotional, and logistical barriers to participation, such as geographic location and travel-related costs, which prevent patients from enrolling in trials and accessing life-changing medicine.

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The race for obesity drug assets heats up

pharmaphorum

The race for obesity drug assets is becoming more intense as pharmaceutical companies strive to develop effective treatments for weight loss. This article explores the efficacy, potential sales, and market trends in the field of obesity drugs.

Drugs 119
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GSK amends commercial deal with Scynexis as antifungal recall drags into 2024

Fierce Pharma

When GSK laid out $90 million upfront to acquire rights to Scynexis’ antifungal Brexafemme last spring, the British pharma threw a lifeline to a company whose blockbuster launch ambitions had hit t | GSK has downgraded a licensing deal for Scynexis' antifungal ibrexafungerp following an ongoing recall of the drug's approved form, Brexafemme.

Licensing 113
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UK should remove blocks on phage research as AMR fears rise

pharmaphorum

UK report calls for the mothballed Rosalind Franklin Lab to be repurposed as a manufacturing unit to support clinical trials of bacteriophages as new antimicrobial agents

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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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Wainua (Eplontersen) Now FDA-Approved for Rare Disease ATTRv-PN

XTalks

Leading global biopharma company AstraZeneca along with Ionis Pharmaceuticals, a pioneer in RNA-targeted therapy, received approval from the US Food and Drug Administration (FDA) for their innovative drug Wainua (eplontersen) for treating polyneuropathy associated with hereditary transthyretin-mediated amyloidosis in adults, commonly known as hATTR-PN or ATTRv-PN.

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Women in Science: Gilda D'Incerti on being fired doing her a favour and big business success

BioPharma Reporter

Gilda DâIncerti is CEO and founder of PQE Group, a life science consulting company, and she likes her company to work like a small English village where everyone knows each other.

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New Food Products Hitting the Shelves in 2024

XTalks

As we step into 2024, the food industry is buzzing with the introduction of innovative new food products. From air fryer-ready chicken wings to cauliflower-based puffs, let’s dive into the list of exciting new offerings that are set to hit the shelves this year. 1. Perdue’s Revolution in Wings: Air Fryer Ready Crispy Wings Perdue Farms introduced a game-changer in the world of chicken wings: Perdue Air Fryer Ready Crispy Wings.

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Interview: Inborn errors of immunity and the newer therapies becoming available

BioPharma Reporter

Heather Stefanski joined NMDP/Be The Match in May, 2021 as vice president, medical services.

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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.