Bio Pharma Dive

JULY 11, 2023

While the shot is approved in the EU, Takeda wasn’t able to address data collection issues raised by the US regulator in its current review cycle.

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FDA Approval Vaccination Vaccine Regulation 246

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 11, 2023

Being surrounded by people who don’t see the world quite like you do increases your risk of feeling lonely, even if you’re friends with them. Neuroimaging tests on 66 young adults discovered significant contrasts in the way lonely people’s brains process information compared to their peers.

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Research Clinical Trials Clinical Trials Clinical Research 190

Bio Pharma Dive

JULY 11, 2023

The companies’ decision to end their partnership on a TIGIT-blocking drug raises new doubts over a mechanism of action that has already produced setbacks for Roche and Merck.

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Drugs 194

Pharmaceutical Technology

JULY 11, 2023

Iovance Biotherapeutics completes a preliminary analysis after the US' FDA found the trial design acceptable for accelerated approval.

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Trials 189

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Clinical Supply

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 11, 2023

The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June.

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Pharma Companies Licensing Licensing Sales 138

Pharmaceutical Technology

JULY 11, 2023

Study shows patients taking abatacept, cenicriviroc, or Remicade in addition to SOC do not recover quicker compared to placebo.

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Drugs 186

Fierce Pharma

JULY 11, 2023

Caught in a litigation crossfire, Moderna has reportedly opened two new fronts in its COVID-19 vaccine patent war with Pfizer and BioNTech. | Moderna has lodged two new lawsuits at the High Court in Dublin, Ireland, and the Brussels Commercial Court in Belgium, Juve Patent first reported. This adds to a complex web of ongoing mRNA patent litigation.

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Vaccination Vaccine 138

Bio Pharma Dive

JULY 11, 2023

Keisuke Naito, the son of Eisai’s CEO, will replace Cheung as the company’s global Alzheimer’s disease head. The change in leadership comes days after Eisai won full U.S. approval of its drug Leqembi.

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Drugs 107

Rethinking Clinical Trials

JULY 11, 2023

The NIH Collaboratory is excited to announce the addition of LE8 Bot + BackUp (or Using Artificially Intelligent Text Messaging Technology to Improve American Heart Association's Life's Essential 8 Health Behaviors) to its portfolio of innovative Demonstration Projects. The American Heart Association (AHA) identifies Life's Essential (LE8) lifestyle factors as blood glucose, cholesterol, blood pressure, physical activity, weight, diet, smoking, and sleep.

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Trials Clinical Trials Clinical Trials Medicine 100

Bio Pharma Dive

JULY 11, 2023

RA Capital led a Series B financing round that drew participation from more than a dozen blue-chip venture backers, including new investors Goldman Sachs and Vertex Ventures.

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Research Drugs 107

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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

Pharmaceutical Technology

JULY 11, 2023

Astellas Pharma has entered into an agreement to license 4DMT's R100 vector for a genetic target associated with rare ophthalmic ailments.

Licensing 100

Licensing Licensing Genetics 100

Bio Pharma Dive

JULY 11, 2023

The pharma, which had largely exited the field several years ago, will pay nearly $100 million combined to the two biotechs for rights to several experimental candidates.

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Licensing Licensing Drugs 107

Pharmaceutical Technology

JULY 11, 2023

Fulcrum Therapeutics has signed a licence agreement with CAMP4 Therapeutics to develop new therapies to treat Diamond-Blackfan anaemia.

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Development 100

Pharmaceutical Commerce

JULY 11, 2023

The National Alliance of Healthcare Purchaser Coalitions releases resources for employers/health plan purchasers to offer insights on PBMs role in high prescription drug costs.

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Drugs 98

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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

Pharmaceutical Technology

JULY 11, 2023

BeiGene has signed an agreement with DualityBio for the acquisition of an exclusive licence for an ADC therapy to treat solid tumours.

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FDA Law Blog

JULY 11, 2023

By Sara W. Koblitz — One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. As we have explained before , that distinction is critical to assigning a particular product to the appropriate regulatory scheme. While it is exceedingly obvious that some products, like eyeshadow for example, are cosmetics, or a pacemaker is a device, it can get thorny where the disti

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Protein Production Regulation Cosmetics 95

Pharmaceutical Technology

JULY 11, 2023

Elsie has signed a research collaboration agreement with GSK to accelerate the development of its oligonucleotide discovery platform.

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Development Research 100

BioSpace

JULY 11, 2023

With funding and business-friendly incentives more challenging to come by in constricting Western economies, some life sciences companies partner with Middle Eastern governments, which are rolling out the red carpet.

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Life Science Marketing 90

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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

Pharmaceutical Technology

JULY 11, 2023

The European Commission has granted conditional marketing authorisation for Columvi to treat relapsed or refractory DLBCL in Europe.

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Marketing 100

BioSpace

JULY 11, 2023

Severe respiratory problems killed seven patients and affected five others, though the company said that most of these were likely unrelated to the drug.

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Trials Drugs 84

Pharmaceutical Technology

JULY 11, 2023

Pluri signed a 3-year contract to develop cell therapy to treat acute radiation syndrome in collaboration with the US Army.

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Development 100

Drug Discovery World

JULY 11, 2023

Evotec and Bristol Myers Squibb (BMS) have entered into an exclusive global licence agreement, extending their neuroscience partnership. The agreement covers selected late-stage discovery programmes that were developed and progressed within the collaboration between the two companies. Evotec and BMS originally entered their neurodegeneration partnership in 2016.

Drugs 75

Drugs Licensing Licensing Sales 75

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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

Pharmaceutical Technology

JULY 11, 2023

Preclinical work is currently underway for all three candidates, with the first two trials set to start by mid-2024.

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Drug Delivery Systems Drug Delivery Trials Drugs 100

Outsourcing Pharma

JULY 11, 2023

A licensing agreement between Evotec SE and Bristol Myers Squibb Company (BMS) that will âbolster a pipeline of programmes targeting several neurodegenerative conditionsâ was announced today (July 11).

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Licensing Licensing Regulation Marketing 75

BioPharma Reporter

JULY 11, 2023

UK immersive technology company FourPlus, along with collaborators Holosphere and the Cell and Gene Therapy Catapult, have been awarded funding from Innovate UK to create and test a mixed-reality training platform for pharmaceutical and healthcare companies.

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Gene Therapy Gene 75

Outsourcing Pharma

JULY 11, 2023

Jason Dong, co-CEO-founder of Mural Health, wants to make sure patients taking part in trials are not out of pocket. He joined OSP while at DIA Global to discuss how his business came about and why it is so important.

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Clinical Trials Clinical Trials Trials 74

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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

Pharma Times

JULY 11, 2023

Therapy treats patients with chronic graft-versus-host disease who have already received other treatments - News - PharmaTimes

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BioPharma Reporter

JULY 11, 2023

A new genetic sequencing technology from Element Biosciences has helped researchers from the Translational Genomics Research Institute (TGen), part of the City of Hope, identify the likely genetic causes of disorders in six of nine children from Sonora, Mexico.

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Gene Sequencing Gene Genetics Genome 72

Fierce Pharma

JULY 11, 2023

After one combination’s failure, Bristol Myers Squibb is celebrating a new triumph in bladder cancer. But a showdown with the two “Merck” companies likely lies ahead. | After one combination’s failure, Bristol Myers Squibb is celebrating a new triumph in bladder cancer. But a showdown with the two “Merck” companies likely lies ahead.

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BioSpace

JULY 11, 2023

Early-stage data shows that Viridian’s thyroid eye disease candidate induces clinically meaningful improvements in eye protrusion after six weeks of treatment.

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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.

Clinical Supply