Thu.Nov 09, 2023

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Atara’s cell therapy approach to MS falls short in study

Bio Pharma Dive

Shares in the biotech tumbled by 75% as results from a Phase 2 trial showed more improvement in participants given a placebo.

Trials 290
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Cloud in pharma: Q&A with GlobalData thematic analyst

Pharmaceutical Technology

GlobalData analyst Jemima Walker discusses key topics around cloud computing for the pharmaceutical industry.

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FDA to Finally Outlaw Soda Ingredient Banned Around The World

AuroBlog - Aurous Healthcare Clinical Trials blog

An ingredient once commonly used in citrus-flavored sodas to keep the tangy taste mixed thoroughly through the beverage could finally be banned for good across the US.

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AstraZeneca stays in GLP-1 drug race with new deal

Bio Pharma Dive

AstraZeneca is paying $185 million upfront to gain access to an experimental GLP-1 drug from China-based biotech Eccogene.

Drugs 182
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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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NPP to tap international collaborations, enhancement of supply chain infrastructure to support pharma growth

AuroBlog - Aurous Healthcare Clinical Trials blog

In an effort to ensure a stable and cost-effective supply chain for active pharmaceutical ingredients (APIs) in the country, the Department of Pharmaceuticals (DoP) may look at tapping the potential of international collaborations for sourcing of raw materials and manufacturing of ingredients in the country.

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Takeda secures FDA approval for colon cancer drug

Bio Pharma Dive

The pharma paid $400 million to license the drug from Hutchmed earlier this year in an effort to bolster its oncology business.

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Childproof packaging: How things are changing for consumer drugs

Pharmaceutical Technology

New sustainable packaging technologies aimed at children and seniors need to be prioritised to avoid drug recalls.

Packaging 147
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A guide to clinical trial phases [infographic]

Antidote

Before any new treatment or therapy is able to be used by the patient population, it must go through the process of a clinical trial — this is the case for any new prescription drug, but also true for over-the-counter medications, medical devices, and more.

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Adicet pauses preclinical programme in CAR-T cell pipeline reprioritisation

Pharmaceutical Technology

Adicet has prioritised the development of ADI-270 in renal cell carcinoma while pausing the preclinical development of ADI-925.

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NIHR launches phase two of its Shape the Future campaign

Pharma Times

The campaign was first launched to coincide with the 75th anniversary of the NHS - News - PharmaTimes

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

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Lilly challenges Wegovy dominance in weight loss market with FDA approval

Pharmaceutical Technology

Zepbound (tirzepatide) has been approved by the FDA approval and is expected to be launched in the US by the end of 2023.

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Takeda scores second FDA approval this week with green light for rare blood clotting disorder drug Adzynma

Fierce Pharma

Thanks to a Takeda approval Thursday, patients now have a drug to tackle a rare inherited blood clotting disorder. | The FDA has given a green light to Takeda’s Adzynma, the first recombinant protein product as a preventative or on demand enzyme replacement therapy in adults and kids with congenital thrombotic thrombocytopenic purpura.

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Is patient recruitment out of control?

Pharmaceutical Technology

Every year, the patient recruitment landscape is getting larger and more multi-faceted. The good news is that sponsors now have a wide range of options at their fingertips; the challenge is that it’s becoming harder to oversee the flow of patients and understand what is and isn’t working – and therefore hard to make meaningful decisions that improve the trajectory of recruitment for your trial.

Trials 130
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Takeda bags FDA okay for Fruzaqla in colorectal cancer

pharmaphorum

Takeda bags FDA okay for Fruzaqla in colorectal cancer Phil.

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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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AAO 2023: Phase II ALTITUDE study provides promising results for ABBV-RGX-314

Pharmaceutical Technology

ALTITUDE provided results on the efficacy and safety of ABBV-RGX-314 to treat diabetic retinopathy over the course of 12 months.

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Medicine, Media, Metamorphosis: How M3 is championing medical communications for modern healthcare

pharmaphorum

Medicine, Media, Metamorphosis: How M3 is championing medical communications for modern healthcare Mike.

Medicine 111
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AstraZeneca targets obesity market with Eccogene partnership 

Pharmaceutical Technology

Eccogene will receive $185m upfront and up to $1.82bn in payments from AstraZeneca for the small molecule GLP-1 agonist.

Marketing 130
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Cancer drugs buttress AstraZeneca as questions swirl around new indications

Fierce Pharma

Cancer drugs buttress AstraZeneca as questions swirl around new indications aliu Thu, 11/09/2023 - 11:40

Drugs 110
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Avid partners with CIRM to offer CDMO services for CGT programmes

Pharmaceutical Technology

Avid Bioservices has entered into a partnership with CIRM to manufacture AAV and other cell and gene therapy (CGT) programmes.

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FH23: AI and humanity, a relationship for the future

pharmaphorum

FH23: AI and humanity, a relationship for the future Mike.

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FDA approves Takeda’s colorectal cancer drug Fruzaqla

Pharmaceutical Technology

Patients in the US who were previously treated for metastatic colorectal cancer are now cleared to use Takeda’s chemotherapy-free drug.

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Ten Ways to Think Differently About Small-to-Mid-Sized Pharma Launches

Intouch Solutions

Back in 2003, drugs from large pharma companies made up 36% of the late-stage R&D pipeline. By 2018, that share had fallen by about half. Meanwhile, the number of companies launching their first drug during the decade preceding 2018 more than tripled. These data are astonishing, given the perception that Big Pharma is the main driver of biopharma innovation.

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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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Teva Pharmaceutical posts increase in Q3 2023 net income to $80m 

Pharmaceutical Technology

Teva Pharmaceutical has posted net income attributable to the company of $80m for Q3 2023 as against $56m in Q3 2022.

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Navigating Challenges in Causality Assessment: Best Practices for Clinical Safety and Pharmacovigilance

Cloudbyz

Adverse events in clinical settings often pose a puzzle for pharmacovigilance professionals, demanding a careful examination of the complex multifactorial nature of these occurrences. The challenges in causality assessment are numerous, reflecting the intricate landscape of clinical safety pharmacovigilance. 1. Standardized Assessment Tools and Expert Review Committees: Adopting standardized causality assessment tools, such as the Naranjo algorithm or WHO causality assessment, and establishing e

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MHRA grants authorisation for Lilly’s weight loss drug Mounjaro

Pharmaceutical Technology

The UK MHRA has granted authorisation for Eli Lilly’s Mounjaro (tirzepatide) for weight loss and weight management.

Drugs 130
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EVERSANA INTOUCH Supports Light The Night

Intouch Solutions

A group of EVERSANA INTOUCHers recently volunteered at the Leukemia & Lymphoma Society’s (LLS) Light The Night walk in Mercer County, NJ. The purpose of Light The Night is to gather as a community to celebrate, honor, and remember those touched by blood cancers. Friends, families, schools, corporate teams, and sponsors joined together to bring light to the darkness of cancer.

Research 105
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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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Ascidian Therapeutics raises $40m to advance drug development

Pharmaceutical Technology

Ascidian Therapeutics has raised $40m Series A extension funding round to progress the development of its lead and pipeline programmes.

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AstraZeneca builds in obesity with $2bn+ Eccogene deal

pharmaphorum

AstraZeneca builds in obesity with $2bn+ Eccogene deal Phil.

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Takeda scores FDA green light for colorectal cancer drug Fruzaqla, 10 months after acquiring its rights in $1.1B deal with Hutchmed

Fierce Pharma

Takeda scores FDA green light for colorectal cancer drug Fruzaqla, 10 months after acquiring its rights in $1.

Drugs 98
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NHS will pilot blood tests for Alzheimer’s disease

pharmaphorum

NHS will pilot blood tests for Alzheimer’s disease Phil.

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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.