XTalks

NOVEMBER 2, 2023

The clinical research landscape is witnessing a significant transformation. With rapid technological advancements, evolving regulatory environments and a growing need for collaborative knowledge exchange, it’s imperative for professionals within this space to stay abreast of the latest trends and insights. Xtalks has taken a monumental step to cater to this need by unveiling its pioneering publication, the Xtalks Clinical Edge magazine.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Bio Pharma Dive

NOVEMBER 2, 2023

The rival companies reported strong quarterly sales growth for their latest products, which could face off as weight loss treatments next year.

Sales 287

Sales Drugs Production 287

Pharmaceutical Technology

NOVEMBER 2, 2023

Memo’s fast track-designated candidate is currently in a Phase II trial for BKV infection, with a data readout expected in 2024.

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Trials 278

Bio Pharma Dive

NOVEMBER 2, 2023

The gene therapy company will move headquarters and reduce its workforce by 40%, while seeking partners for its Fabry and cell therapy research.

Gene Therapy 273

Gene Therapy Gene Research 273

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Clinical Supply

Pharmaceutical Technology

NOVEMBER 2, 2023

Generate:Biomedicines has entered a strategic collaboration with Roswell Park to accelerate the development of new oncology therapies

Development 243

Development 243

Bio Pharma Dive

NOVEMBER 2, 2023

The rare disease drug developer is turning to former Genentech head Alexander Hardy as the launch of its Roctavian gene therapy stumbles.

Gene Therapy 264

Gene Therapy Gene Development Drugs 264

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 2, 2023

If you have hay fever, you’ve probably been sneezing a lot lately. Sneezing is universal but also quite unique to each of us. It is a protective reflex action outside our conscious control, to remove irritants from inside our nose.

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Clinical Trials Clinical Trials Clinical Research Trials 185

Bio Pharma Dive

NOVEMBER 2, 2023

Stock selloffs across the medical device sector have erased hundreds of billions of dollars in market value. But medtech executives argue GLP-1 drug demand will complement, not cannibalize, their sales.

Drugs 156

Drugs Sales Marketing 156

Pharmaceutical Technology

NOVEMBER 2, 2023

While things may have slowed down a little since the rapid approvals of the COVID-19 vaccines, the excitement around RNA-LNP is still going strong. We spoke to nanomedicine experts at Precision NanoSystems to understand the process development and manufacturing challenges that lie ahead of companies approaching the clinical phase, and how the right partnerships can work wonders.

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RNA Manufacturing Vaccination Vaccine 130

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 2, 2023

India is strengthening its scope in contract manufacturing as the global customers commend the strengths and dependability of its pharma and biotech sectors.

Contract Manufacturing 151

Contract Manufacturing Manufacturing Pharmacy Clinical Trials 151

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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

NOVEMBER 2, 2023

The companies will jointly develop up to five antibody-drug conjugates for treating cancer, with a focus on SMARCA degraders.

Antibody 162

Antibody Development Drugs 162

Rethinking Clinical Trials

NOVEMBER 2, 2023

The NIH Pragmatic Trials Collaboratory has launched an enhanced training section of rethinkingclinicialtrials.org that includes a new series of video learning modules and reorganized and refreshed pragmatic clinical trials training resources. The new training section features a series of 8 self-paced, guided video modules on topics that cover every phase of a pragmatic clinical trial.

Trials 100

Trials Clinical Trials Clinical Trials Research 100

Pharmaceutical Technology

NOVEMBER 2, 2023

Revenues saw a decline of 32% to $3.4bn from $5bn in the same quarter of the previous year, but the company is projecting a profit in 2024.

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Fierce Pharma

NOVEMBER 2, 2023

The days of booming COVID-19 vaccine sales, which sent Moderna into the ranks of pharma's top companies, have | The company is focusing on scaling back its manufacturing efforts to cope with the lack of COVID-19 vaccine demand.

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Sales Manufacturing Vaccination Vaccine 123

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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

NOVEMBER 2, 2023

As per the latest restructuring plan, Sangamo will advance its programs using AAV capsid delivery, Nav1.7 program, and Prion therapies.

Production 130

Production 130

Outsourcing Pharma

NOVEMBER 2, 2023

The US Food and Drug Administration (FDA) has approved a potassium-competitive acid blocker (PCAB) as a new treatment for the healing of all grades of erosive esophagitis.

Drugs 105

Drugs Clinical Development Development 105

Pharmaceutical Technology

NOVEMBER 2, 2023

Aldeyra Therapeutics and AbbVie have signed an agreement for the development, manufacture and commercialisation of reproxalap.

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Development Manufacturing 130

Pharma Times

NOVEMBER 2, 2023

The NHS has already delivered over 20 million winter vaccines this year - News - PharmaTimes

Vaccination 132

Vaccination Vaccine 132

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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

NOVEMBER 2, 2023

The company terminated the RT-101 programme while pausing the development of the RT-105 and RT-110 compounds.

Drugs 130

Drugs Development 130

ProRelix Research

NOVEMBER 2, 2023

Although clinical trials provide useful information regarding the efficacy and safety of new drugs, biological products, and medical devices, the information captured through them is not all-encompassing. Limited patient populations, […] The post Post-Marketing Surveillance Strategies appeared first on ProRelix Research.

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Marketing Clinical Trials Clinical Trials Production 98

Pharmaceutical Technology

NOVEMBER 2, 2023

GSK has reported a total operating profit of £1.

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BioSpace

NOVEMBER 2, 2023

Novo Nordisk’s Wegovy and Eli Lilly’s Mounjaro drove blockbuster sales in the third quarter and the sky’s the limit for the duopoly. The only limiting factor is that the frenzied demand for their drugs is outpacing supply.

Drugs 95

Drugs Sales 95

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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

Fierce Pharma

NOVEMBER 2, 2023

Supply problems for Eli Lilly’s diabetes med Mounjaro were no secret. But strong demand continues to push sales of the GLP-1/GIP agonist to new highs ahead of an FDA decision on weight loss. | As strong demand continues to push Mounjaro sales to new highs, Eli Lilly CEO David Ricks said the company is "not done with" manufacturing expansions.

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Manufacturing Sales 94

Pharma Times

NOVEMBER 2, 2023

The new AI model could potentially be applied to other cancers - News - PharmaTimes

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Fierce Pharma

NOVEMBER 2, 2023

The third quarter marked a momentous one for Sarepta Therapeutics, bringing the long-anticipated launch of its Duchenne muscular dystrophy (DMD) gene therapy Elevidys. | Even before a potential label expansion, the gene therapy Elevidys has raked in around $69 million since its launch. Earlier this week, the company said that a pivotal trial on the medicine failed to reach its primary endpoint.

Gene Therapy 94

Gene Therapy Gene Sales Medicine 94

BioSpace

NOVEMBER 2, 2023

In a late-stage study, most Huntington’s disease patients reported that their symptoms of chorea were “much improved” or “very much improved” following treatment with Neurocrine Biosciences’ VMAT2 inhibitor Ingrezza.

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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

Fierce Pharma

NOVEMBER 2, 2023

Ever since Novo Nordisk won FDA approval for its GLP-1 weight-loss med Wegovy more than 2 years ago, analysts and investors have been keeping a close eye on the blockbuster drug launch. | Ever since Novo Nordisk won FDA approval for its GLP-1 weight-loss med Wegovy more than 2 years ago, analysts and investors have been keeping a close eye on the blockbuster drug launch.

FDA Approval 87

FDA Approval Sales Manufacturing Drugs 87

BioSpace

NOVEMBER 2, 2023

The New York-based genetic medicine company, which expects gross proceeds of approximately $100 million, joins a small group of biotechs that have launched initial public offerings this year.

Genetics 88

Genetics Medicine 88

JAMA Internal Medicine

NOVEMBER 2, 2023

This randomized clinical trial evaluates the effect of implementing a novel multicomponent intervention designed to target several barriers that prevent eligible patients from completing key steps toward receiving a kidney transplant.

Clinical Trials 93

Clinical Trials Clinical Trials Trials 93

Fierce Pharma

NOVEMBER 2, 2023

In a span of three days, Phathom Pharmaceuticals has scored two green lights from the FDA for its first-in-class heartburn drug Voquezna (vonoprazan). | In a span of three days, Phathom Pharmaceuticals has scored two green lights from the FDA for its first-in-class heartburn drug Voquezna. The first came on Monday when the regulator signed off on Phathom’s reformulation of Voquezna to treat Helicobacter pylori infection.

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FDA Approval Regulation Drugs 87

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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