Mon.Jul 03, 2023

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Eli Lilly’s retatrutide sets new record for weight loss in obesity space

Pharmaceutical Technology

Pipeline developments within the obesity space have recently garnered interest following recent results published on Eli Lilly’s retatrutide.

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What US trial sponsors should know about the GDPR

Bio Pharma Dive

What is the GDPR and why does it matter to your life sciences company. iliomad Health Data can help you maintain GDPR compliance.

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Generative AI – beyond the hype

Pharmaceutical Technology

2023 started with a buzz around ChatGPT, and more generally around the immense potential that generative AI (GenAI) holds.

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July 3, 2023: Report Shares Strategies for Addressing Bias and Lack of Generalizability of EHR Data

Rethinking Clinical Trials

Pragmatic research is vulnerable to biases due to differences in data capture and access to care for different subsets of the population, which, if left unaddressed, can propagate inequities in health and the healthcare system. In a new article published online ahead of print in JAMIA , the NIH Pragmatic Trials Collaboratory’s Demonstration Project teams reflect on the health equity challenges encountered by their trials and share the specific strategies they used to mitigate sources of po

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Chinese NMPA approves Innovent and IASO Bio’s myeloma therapy

Pharmaceutical Technology

China has granted approval for Innovent Biologics and IASO Bio Fucaso for treating relapsed or refractory multiple myeloma (RRMM) in adults.

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Meet Dr. Linda Traylor, VP of Medical Excellence with Acceleration Point

Bio Pharma Dive

As the new vice president of medical excellence with global consulting and software firm Acceleration Point, she’s excited to focus on the role of technology in advancing her industry.

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More Trending

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DigitalHealth.London’s Accelerator programme selects Aide

Pharma Times

Project aims to boost the adoption of technology across London’s NHS and help patients manage conditions - News - PharmaTimes

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Camena bags $10m in funding from Mercia

Pharmaceutical Technology

The bioscience company has received $10m Series A financing from asset manager Mercia.

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UK science minister celebrates decade of growth at Discovery Park

Outsourcing Pharma

George Freeman MP, minister of state at the new Department for Science, Innovation and Technology, has praised a decade of growth at Discovery Park, the leading science and innovation campus in Sandwich, Kent.

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Baudax Bio acquires biotechnology firm TeraImmune

Pharmaceutical Technology

Baudax Bio has acquired all outstanding equity interests of biotechnology firm TeraImmune in a stock-for-stock deal.

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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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RAIR Health signs data agreement with Royal Cornwall Hospitals NHS Trust

Outsourcing Pharma

RAIR Health, an applied data and AI company focused on the extraction of clinical insights from real world data, has signed a non-exclusive data license agreement with Royal Cornwall Hospitals NHS Trust (RCH) focussed on the field of ophthalmology.

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Chime Biologics, Leads and Beigene enter antibody development deal

Pharmaceutical Technology

Chime Biologics, Leads Biolabs and BeiGene have entered a strategic partnership to expedite the development of a monoclonal antibody, LBL-007.

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Donaldson acquires Univercells Technologies for €136 million

BioPharma Reporter

Donaldson, a provider of filtration products and solutions, has acquired Univercells Technologies, a producer of biomanufacturing solutions for cell and gene therapy research, development, and commercial manufacturing, to broaden its life sciences reach.

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Zealand Pharma submits NDA for hyperinsulinism drug dasiglucagon

Pharmaceutical Technology

The NDA includes pivotal data from Phase III trials and a long-term extension, with one trial missing its primary endpoint.

Drugs 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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Investigators and site coordinators 'don't want to hunt and peck through information - they need a one-click solution' says OpenClinca CEO

Outsourcing Pharma

Kicking off a series of DIA Global interviews in Boston, OSP had the pleasure of speaking to Cal Collins, co-founder and CEO of OpenClinica - a company that wants to empower data managers, clinical researchers, and study participants.

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Cyltezo Pen: first interchangeable biosimilar to Humira rolls out across US

Pharmaceutical Technology

The Humira biosimilar from Boehringer Ingelheim launches amidst a loss of exclusivity for AbbieVie’s blockbuster drug.

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BMS’ Sotyktu gets NICE green light for NHS use

Pharma Times

The therapy becomes an option for moderate-to-severe plaque psoriasis in certain adults - News - PharmaTimes

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The VPAS fallout continues – Celltrion pulls high-profile biosimilar from UK market

Pharmaceutical Technology

In late June 2023, Celltrion (South Korea) withdrew its key anti-cancer biosimilar, Herzuma, from the UK market.

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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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Clinical Site Monitoring Visit Letters: Templates Guide

Cloudbyz

Sponsors or Contract Research Organizations (CROs) conduct several types of site visits at various stages of a clinical trial to ensure the quality and integrity of the data collected, compliance with protocols and regulatory requirements, and safety of the trial participants. These visits are an essential part of clinical trial management and oversight.

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AstraZeneca’s liver cancer treatment shows ‘continued survival benefit’ in phase 3 trial

BioPharma Reporter

AstraZeneca has shared updated results from a recent phase 3 clinical trial of its Imfinzi (durvalumab) plus Imjudo (tremelimumab) treatment plan in certain patients with hepatocellular carcinoma (HCC), the most common type of liver cancer.

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Australia first to prescribe MDMA and psilocybin for depression, PTSD

pharmaphorum

Australia first to prescribe MDMA and psilocybin for depression, PTSD Nicole.

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New tentative approval for Mylan Labs drug posaconazole

Drug Patent Watch

[![posaconazole structure]([link] Posaconazole is the generic ingredient in three branded drugs marketed by Msd Merck Co, Merck Sharp Dohme, Par Sterile Products, Schering, Hikma, Actavis Labs Fl Inc, Aet Pharma,… The post New tentative approval for Mylan Labs drug posaconazole appeared first on DrugPatentWatch - Make Better Decisions.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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AZ, Daiichi’s TROP2 drug hits the mark in lung cancer

pharmaphorum

AZ, Daiichi’s TROP2 drug hits the mark in lung cancer Phil.

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Drug Patent Expirations for the Week of July 2, 2023

Drug Patent Watch

LEVITRA (vardenafil hydrochloride) Bayer hlthcare Patent: 8,841,446 Expiration: Jul 3, 2023 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com… The post Drug Patent Expirations for the Week of July 2, 2023 appeared first on DrugPatentWatch - Make Better Decisions.

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Don't hold back lab digital transformation

pharmaphorum

Don't hold back lab digital transformation Mike.

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New patent for Corium drug ADLARITY

Drug Patent Watch

Annual Drug Patent Expirations for ADLARITY Adlarity is a drug marketed by Corium and is included in one NDA. It is available from one supplier. There are seven patents protecting… The post New patent for Corium drug ADLARITY appeared first on DrugPatentWatch - Make Better Decisions.

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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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Launching a life sciences company: How to stand out from the crowd

Drug Discovery World

It’s not easy being the new kid on the block. DDW’s Diana Spencer speaks to the CEOs of two drug discovery start-ups to find out how they have overcome the challenges of launching a new company in a competitive market. It’s a challenging time to launch a new company in the life sciences sector. High interest rates and other economic challenges, along with low investment, have made it very difficult for companies to raise funding.

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New patent for Astellas drug CRESEMBA

Drug Patent Watch

Annual Drug Patent Expirations for CRESEMBA Cresemba is a drug marketed by Astellas and is included in two NDAs. It is available from one supplier. There are four patents protecting… The post New patent for Astellas drug CRESEMBA appeared first on DrugPatentWatch - Make Better Decisions.

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Janssen reveals positive trial data for nipocalimab

Drug Discovery World

Janssen has announced positive results from the proof-of-concept Phase II UNITY trial for the treatment of pregnant individuals at high risk of early-onset severe (EOS) haemolytic disease of the foetus and newborn (HDFN). A statistically significant (54%) proportion of participants who received nipocalimab achieved the primary endpoint of a live birth at or after gestational age of 32 weeks without intrauterine transfusions (IUTs).

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PrecisionLife partners with University of Oxford to discover new endometriosis treatments

BioPharma Reporter

PrecisionLife, a techbio company driving precision medicine in complex chronic diseases, has announced a data access agreement with the University of Oxford to spearhead new treatments for endometriosis.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.