pharmaphorum

SEPTEMBER 12, 2021

Deployment of digital health technologies during the pandemic improved patient satisfaction, expanded the delivery of care and augmented training of staff at a leading neurosurgery provider in the US, according to a new study. Faced with the disruption caused by the COVID-19 crisis, Cleveland Clinic centres implemented a number telehealth and audio-visual technologies to compensate for the difficulties in having face-to-face interactions with patients.

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Regulation Licensing Licensing Research 133

BioSpace

SEPTEMBER 12, 2021

Everest will pay Providence $50 million in cash upfront for access to its COVID-19 vaccine and other mRNA vaccine candidates targeting specific variants in earlier stages of development.

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Vaccination Vaccine Development 82

Scienmag

SEPTEMBER 12, 2021

A change in diet is proving to be a key tool in the reversal of Type 2 diabetes. Credit: UBC Okanagan A change in diet is proving to be a key tool in the reversal of Type 2 diabetes. A team of researchers from the University of British Columbia and England’s Teesside University have published […].

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Research 78

BioSpace

SEPTEMBER 12, 2021

A recent study suggests that about one-third of cancer indications with Accelerated Approval pathways are still on product labels without follow-up studies confirming their benefits.

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Production 78

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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

JAMA Internal Medicine

SEPTEMBER 12, 2021

This cross-sectional study examines the association between the number of days worked clinically per year by physicians and patient mortality.

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BioSpace

SEPTEMBER 12, 2021

September is turning out to be a busy month for the U.S. Food and Drug Administration. Here’s a look at this week’s schedule for PDUFA dates.

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Drugs 90

BioSpace

SEPTEMBER 12, 2021

AzurRx will change its name to First Wave BioPharma, Inc., and the company’s shares will trade on the Nasdaq under the ticker symbol “FWBI.

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Marketing 92

Scienmag

SEPTEMBER 12, 2021

Pre-COVID-19 pandemic, University of Ottawa biology student Megan Reich enjoyed the road trip of a lifetime, crisscrossing the east coast of the United States in search of a specific thrill: Milkweed. Credit: Megan Reich, University of Ottawa Pre-COVID-19 pandemic, University of Ottawa biology student Megan Reich enjoyed the road trip of a lifetime, crisscrossing the […].

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BioSpace

SEPTEMBER 12, 2021

South San Francisco-based Walking Fish started the week off strong by announcing its closing of a $50 million Series A financing round on Monday.

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FDA Law Blog

SEPTEMBER 12, 2021

By Serra J. Schlanger — Earlier this year, North Dakota enacted a prescription drug price transparency reporting law, HB 1032 , that became effective on August 1, 2021. (See our summary here.) This new law requires prescription drug manufacturers to report the current wholesale acquisition cost (WAC) information for drugs sold in or into the state on a quarterly basis.

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Drugs Manufacturing Marketing 52

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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

SEPTEMBER 12, 2021

AI can enable the analysis of massive databases, accelerate research and development, save costs and promote effective decision making.

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Development Drugs Research 80

Scienmag

SEPTEMBER 12, 2021

Lugano, Switzerland, 13 September 2021 – The announcement of a cancer diagnosis abruptly and durably alters the course of daily life – not just for the person receiving it, but also for their family. New research (1) [to be] presented at the ESMO Congress 2021 suggests that adequate communication and support for children of cancer patients still represents a significant unmet need that parents require help to fulfil.

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Research 52

BioSpace

SEPTEMBER 12, 2021

It was a very busy week for clinical trial announcements, although there were only three that were COVID-19-related. Here’s a look.

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Clinical Trials Clinical Trials Trials 94

BioTech 365

SEPTEMBER 12, 2021

Valneva Receives Notice of Termination of COVID-19 Vaccine Supply Agreement by UK Government Valneva Receives Notice of Termination of COVID-19 Vaccine Supply Agreement by UK Government Saint-Herblain (France), September 13, 2021 – Valneva SE, a specialty vaccine company, today announced … Continue reading →

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Vaccination Vaccine 40

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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

BioSpace

SEPTEMBER 12, 2021

?The drug, called RGX-314, is a possible one-time treatment for wet AMD, diabetic retinopathy, and other chronic retinal diseases.

Drugs 84

Drugs 84

BioTech 365

SEPTEMBER 12, 2021

RELIEF THERAPEUTICS Holding AG / Key word(s): Study 13-Sep-2021 / 07:00 CET/CEST Release of an ad hoc announcement pursuant to Art. 53 LR The issuer is solely responsible for the content of this announcement.

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Drugs 40

BioSpace

SEPTEMBER 12, 2021

Dr. Scott Gottlieb estimated that a vaccine for the 5-11-year-old age group could be available by Halloween – in a best-case scenario.

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Vaccination Vaccine 75

BioTech 365

SEPTEMBER 12, 2021

Sensome Begins Human Trial for Its AI-Powered Stroke Guidewire Sensome Begins Human Trial for Its AI-Powered Stroke Guidewire PARIS–(BUSINESS WIRE)–#ai–Sensome, the company pioneering the connected medical device revolution with the world’s smallest biological tissue sensor, announced today that Gold Coast … Continue reading →

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Trials 52

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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

BioSpace

SEPTEMBER 12, 2021

Experts are predicting a record-breaking rush of IPOs this fall as companies flood to the Nasdaq.

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Life Science 87

BioTech 365

SEPTEMBER 12, 2021

Recent Fluvoxamine COVID benefits discovered using Cytel-designed platform trial Recent Fluvoxamine COVID benefits discovered using Cytel-designed platform trial Using Cytel’s expertise, the TOGETHER Trial simultaneously tests multiple repurposed therapies WALTHAM, Mass.

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Trials Drugs 52

BioSpace

SEPTEMBER 12, 2021

?The Phase II study showed enhanced immune memory response to the virus in 96% of vaccinated subjects, all of whom were exposed to an environment dominated by the delta variant.

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Vaccination Vaccine 61

BioTech 365

SEPTEMBER 12, 2021

BeiGene to Present Latest Findings in Robust Lung Cancer Portfolio at ESMO Congress 2021 BeiGene to Present Latest Findings in Robust Lung Cancer Portfolio at ESMO Congress 2021 CAMBRIDGE, Mass. & BEIJING–(BUSINESS WIRE)–$BGNE #BTKi—BeiGene, Ltd.

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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

BioSpace

SEPTEMBER 12, 2021

BeiGene plans to describe the power of its lung cancer portfolio at the European Society for Medical Oncology Congress 2021. The conference will run from September 16-21.

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BioTech 365

SEPTEMBER 12, 2021

EMD Serono to Present Latest Highlights From Oncology Portfolio at WCLC and ESMO 2021 EMD Serono to Present Latest Highlights From Oncology Portfolio at WCLC and ESMO 2021 27 abstracts showcase the Company’s innovation in the areas of immuno-oncology, oncogenic … Continue reading →

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BioSpace

SEPTEMBER 12, 2021

Frederick Frank, an innovator of biotech investment who played a key role in Roche’s acquisition of Genentech and the merger that formed Bristol-Myers Squibb, has died.

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BioTech 365

SEPTEMBER 12, 2021

Merck to Present Latest Highlights From Oncology Portfolio at WCLC and ESMO 2021 Merck to Present Latest Highlights From Oncology Portfolio at WCLC and ESMO 2021 27 abstracts showcase the Company’s innovation in the areas of immuno-oncology, oncogenic pathways, and … Continue reading →

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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

SEPTEMBER 12, 2021

In a recent multinational survey, healthcare providers expressed the belief that immunotherapy will improve outcomes for patients with earlier-stage cancers.

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BioTech 365

SEPTEMBER 12, 2021

Zymeworks Announces Abstract for Zanidatamab in First-line HER2-Expressing Gastroesophageal Cancers (GEA) at the European Society for Medical Oncology (ESMO) Annual Congress Zymeworks Announces Abstract for Zanidatamab in First-line HER2-Expressing Gastroesophageal Cancers (GEA) at the European Society for Medical Oncology (ESMO) … Continue reading →

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BioSpace

SEPTEMBER 12, 2021

SENS Research Foundation released findings that confirmed the charges of inappropriate behavior raised by two former female employees against Aubrey de Grey.

Research 52

Research 52

BioTech 365

SEPTEMBER 12, 2021

BioXcel Therapeutics to Present Updates from Ongoing Trial of BXCL701 in Aggressive Forms of Prostate Cancer at 2021 ESMO Congress BioXcel Therapeutics to Present Updates from Ongoing Trial of BXCL701 in Aggressive Forms of Prostate Cancer at 2021 ESMO Congress … Continue reading →

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Trials 40

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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

Clinical Trials