Drug Discovery World

MAY 21, 2024

Ben Holland , CTO and Co-Founder of Antiverse discusses how artificial intelligence and machine learning are benefitting antibody discovery and design. Modern experimental procedures, such as immunisation, B-cell screening, and synthetic library generation, have been pivotal in developing approximately 80 FDA-approved antibody therapeutics. This remarkable progress in antibody modalities for disease treatment is a testament to the effectiveness of these methods, and they remain key for many use

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Antibody Development FDA Approval Contract Manufacturing 59

Bio Pharma Dive

MAY 21, 2024

The U.K. pharma expects to launch 20 new drugs by then, among them complex medicines for cancer as well as treatments for weight loss.

Medicine 298

Medicine Drugs 298

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 21, 2024

The idea that the heart contains the very ‘essence’ of a person might be more than just a spiritual concept. Ever since the first human heart transplants back in 1967, patients have reported, often reluctantly, some eerie and inexplicable changes to their personalities.

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Containment Clinical Trials Clinical Trials Clinical Research 190

Bio Pharma Dive

MAY 21, 2024

Since pivoting from oncology, the startup has raised close to $300 million and advanced an ulcerative colitis drug into mid-stage testing.

Drugs 278

Drugs Research 278

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Clinical Supply

Pharmaceutical Technology

MAY 21, 2024

Roche announced an FDA breakthrough therapy designation for its inavolisib/Ibrance combination therapy.

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Bio Pharma Dive

MAY 21, 2024

The U.K. drugmaker aims to catch up in developing new tumor-fighting technologies — areas where it has lagged behind leaders like Novartis and J&J.

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Sales Drugs Development 257

Bio Pharma Dive

MAY 21, 2024

CEO Cyrus Mozayeni said the company is taking a different approach than other developers of antibody-drug conjugates, though it’s keeping details close.

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Antibody Development Drugs 183

Pharmaceutical Technology

MAY 21, 2024

AstraZeneca is set to invest $1.5bn in a new manufacturing facility in Singapore dedicated to the production of antibody drug conjugates.

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Production Antibody Manufacturing Drugs 130

Bio Pharma Dive

MAY 21, 2024

The collaboration, which gives Lilly access to Aktis’ technology in return for $60 million, adds to a flurry of dealmaking in the radiopharma field.

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Pharmaceutical Technology

MAY 21, 2024

The US FDA has approved Yesafili and Opuviz, two interchangeable biosimilars to Eylea, for macular degeneration and other eye conditions.

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

BioSpace

MAY 21, 2024

Despite weathering a difficult year, biopharma continues to see massive pay gaps between CEOs and their median employees, with top executives often earning hundreds of times more.

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Pharmaceutical Technology

MAY 21, 2024

AmplifyBio and Xcell Biosciences have announced a strategic collaboration to manufacture engineered T-cell receptor (TCR) therapies.

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Manufacturing Engineer 130

BioSpace

MAY 21, 2024

Days after backing out of two Ionis-partnered neuro programs, Biogen has inked a potential $1.8 billion buy of Human Immunology Biosciences and boosting its late-stage immunology pipeline.

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Pharmaceutical Technology

MAY 21, 2024

Glenmark has entered into an exclusive agreement with BeiGene to market and distribute two Beigene oncology medicines in India.

Medicine 130

Medicine Marketing 130

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Clinical Supply

Rethinking Clinical Trials

MAY 21, 2024

May 19, 2024: The NIH Pragmatic Trials Collaboratory hosted a Pre-Conference Workshop at the 2022 Health Care Systems Research Network (HCSRN) Annual Conference. This training workshop introduces concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs), and provides firsthand ePCT experiences and case studies from the NIH Pragmatic Trials Collaboratory Trials.

Clinical Trials 100

Clinical Trials Clinical Trials Trials Research 100

Pharmaceutical Technology

MAY 21, 2024

The UK-based company plans to use the proceeds for financing the proof-of-concept clinical trials for its ADC pipeline.

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Clinical Trials Clinical Trials Trials 130

BioSpace

MAY 21, 2024

Patent cliffs and other factors may lead other large drugmakers to embrace similar cost-cutting measures, experts tell BioSpace.

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Pharmaceutical Technology

MAY 21, 2024

Larimar will continue the open label extension study in Friedreich’s ataxia with results expected in Q4 this year.

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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.

Clinical Trials

pharmaphorum

MAY 21, 2024

FDA is asking artificial intelligence teams to develop a digital endpoint tool to study freezing of gait, a symptom of Parkinson’s that can have a serious impact on patients.

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Development 119

Fierce Pharma

MAY 21, 2024

A decade ago, with AstraZeneca in decline and some investors urging the drugmaker to sell out to Pfizer, new CEO Pascal Soriot presented an audacious plan to hike revenue to $45 billion by 2023. | After AstraZeneca achieved Pascal Soriot's ambitious $45-billion-by-2023 revenue goal, the CEO is thinking big again. On Tuesday morning, AZ unveiled its new plan to swell its revenue to $80 billion by 2030.

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BioSpace

MAY 21, 2024

As part of an ongoing Senate investigation into pharma companies’ tax rates, Sen. Ron Wyden (D-Ore.) has asked Pfizer CEO Albert Bourla to explain irregularities in its reported revenues, losses and taxes paid.

Pharma Companies 115

Pharma Companies 115

pharmaphorum

MAY 21, 2024

In today’s podcast, web editor Nicole Raleigh speaks with PASQAL’S technical business developer Europe, Krisztian Benyo, PhD, about the pharma applications and commercialisation of quantum science.

Business Development 114

Business Development Development 114

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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

Clinical Research

BioSpace

MAY 21, 2024

Otsuka Pharmaceuticals announced Wednesday it is ending development of drug candidate AVP-786 after failing to improve agitation associated with dementia due to Alzheimer’s disease.

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Drugs Development 103

pharmaphorum

MAY 21, 2024

AstraZeneca CEO Pascal Soriot says group revenues can reach $80bn by 2030, fuelled by a pipeline that features 'many' potential $5bn-plus candidates.

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Drug Patent Watch

MAY 21, 2024

Annual Drug Patent Expirations for BELSOMRA Belsomra is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier.

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Drugs Marketing 105

pharmaphorum

MAY 21, 2024

Despite the rate of bipolar disorder being the same among Black Americans as other Americans, there exists a significant disparity in diagnosis and subsequent treatment. Many Black Americans with bipolar disorder remain undiagnosed and untreated.

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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.

Clinical Trials

BioSpace

MAY 21, 2024

The PR departments of Chinese CDMOs affected by the BIOSECURE Act and their U.S. partners must step up to ensure proposed legislation doesn’t squash innovation.

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pharmaphorum

MAY 21, 2024

Discover how the Quillaja saponaria tree is revolutionising vaccine development as a sustainable, natural adjuvant. Learn about BSI's innovative work harnessing the power of this remarkable plant.

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Vaccination Vaccine Development 101

Outsourcing Pharma

MAY 21, 2024

A âtransformationalâ treatment for people with severe alcohol-associated hepatitis (AH) has today (May 21) been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA).

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Drugs Clinical Development Development 96

pharmaphorum

MAY 21, 2024

Going against the advice of the CHMP, the EU has said that PTC Therapeutics’ Translarna therapy for Duchenne muscular dystrophy should stay on the market

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Marketing Drugs 106

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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.

Clinical Supply