BioSpace

AUGUST 29, 2021

A new variant, C.1.2. is causing public health experts worldwide to keep an eye out for its presence as it seems to be more infectious and even more resistant to vaccines than other variants.

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Vaccination Vaccine 144

BioPharma Reporter

AUGUST 29, 2021

BioNTech is looking at establishing vaccine manufacturing capabilities in Rwanda and Senegal to support long-term vaccine supply in Africa.

Manufacturing 88

Manufacturing Vaccination Vaccine Development 88

BioSpace

AUGUST 29, 2021

?Laronde has managed to secure as much as $440 million from a Series B financing round to support as many as 100 Endless RNA (eRNA) products and drug programs over the next decade.

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RNA Production Drugs 94

BioPharma Reporter

AUGUST 29, 2021

An Australian biotech incubator has been founded to help turn promising research into new therapies.

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Research Development 103

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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

AUGUST 29, 2021

The SPAC craze continues as San Diego-based Revelation Biosciences announced its merger with Petra Acquisition that will result in the company’s listing on the Nasdaq exchange.

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JAMA Internal Medicine

AUGUST 29, 2021

This cohort study examines outcomes associated with chronic kidney disease as defined by a fixed vs an age-adapted estimated glomerular filtration rate threshold.

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FDA Law Blog

AUGUST 29, 2021

By Anne K. Walsh & JP Ellison — Companies often use rebranding to reposition and refocus their business. Sometimes they do it with great fanfare; sometimes it is done quietly and incrementally. The federal government does its own version of rebranding with each change in administration. Just before the July 4 holiday weekend, DOJ quietly rebranded the role of guidance documents, reversing two distinct but related policies regarding such documents.

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Branding Regulation Containment Development 52

BioSpace

AUGUST 29, 2021

Shares of Bone Therapeutics are down more than 34% on the Euronext stock exchange after the company announced its Phase III osteoarthritis study failed to meet primary and critical secondary endpoints.

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Clinical Trial Gurus

AUGUST 29, 2021

International Medical Graduates (IMGs) and PhD holders may not even realize it but many clinical research sites, especially those in the central nervous system arena, would benefit tremendously from having more psychometric raters at their sites. This underutilized strategy has worked wonders for many advanced degree holders in clinical research.

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Clinical Research Research 52

BioSpace

AUGUST 29, 2021

Regeneron and Sanofi broke ground with the 2017 approval of the first biologic drug for atopic dermatitis, the most common form of eczema driven by allergic reactions.

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Marketing Drugs 96

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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

BioTech 365

AUGUST 29, 2021

DGAP-News: BRAIN Biotech AG / Key word(s): 9 Month figures/Quarterly / Interim Statement 30.08.2021 / 07:30 The issuer is solely responsible for the content of this announcement.

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BioSpace

AUGUST 29, 2021

Two former executives of JHL Biotech were indicted on charges of orchestrating the theft of trade secrets, wire fraud exceeding $101 million, and money laundering.

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BioTech 365

AUGUST 29, 2021

Bone Therapeutics announces topline results from Phase III knee osteoarthritis study with its enhanced viscosupplement JTA-004 Bone Therapeutics announces topline results from Phase III knee osteoarthritis study with its enhanced viscosupplement JTA-004 REGULATED INFORMATION No statistically significant difference in knee … Continue reading →

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Regulation 40

BioSpace

AUGUST 29, 2021

The research underlines the progress being made in messenger RNA approaches, as spotlighted by the success of the mRNA vaccines against COVID-19.

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RNA Vaccination Vaccine Research 88

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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

BioTech 365

AUGUST 29, 2021

Press release Biocartis Group NV: Disclosure of a transparency notification Press release Biocartis Group NV: Disclosure of a transparency notification PRESS RELEASE: REGULATED INFORMATION 30 August 2021, 07:00 CEST Disclosure of a transparency notification Mechelen, Belgium, 30 August 2021 – Biocartis … Continue reading →

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Regulation 40

BioSpace

AUGUST 29, 2021

It was a busy week for clinical trial news. Here’s a look.

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Clinical Trials Clinical Trials Trials 98

BioTech 365

AUGUST 29, 2021

Dupixent® (dupilumab) pivotal trial meets all primary and secondary endpoints becoming first biologic medicine to significantly reduce signs and symptoms of moderate-to-severe atopic dermatitis in children as young as 6 months Dupixent® (dupilumab) pivotal trial meets all primary and secondary … Continue reading →

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Medicine Trials 40

BioSpace

AUGUST 29, 2021

The state-of-the-art 146,000 square foot facility will make it easier for Umoja to eliminate crucial CAR-T production barriers.

Manufacturing 66

Manufacturing Production 66

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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

BioTech 365

AUGUST 29, 2021

New Data Demonstrate the Benefits of Early Use of UPTRAVI® (selexipag) in Delaying Disease Progression in a Broad Population of Patients with Pulmonary Arterial Hypertension (PAH) New Data Demonstrate the Benefits of Early Use of UPTRAVI® (selexipag) in Delaying Disease … Continue reading →

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JAMA Internal Medicine

AUGUST 29, 2021

Less is More

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BioTech 365

AUGUST 29, 2021

European observational study SANTORINI shows LDL-C levels remain higher than recommended goals and combination therapies are under-utilised in patients at very high or high cardiovascular risk European observational study SANTORINI shows LDL-C levels remain higher than recommended goals and combination … Continue reading →

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Drug Patent Watch

AUGUST 29, 2021

This chart shows the drugs with the most patents in Iceland. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Iceland? appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs 52

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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

BioTech 365

AUGUST 29, 2021

Lysogene Announces First Patient in the United States Dosed with LYS-GM101 Investigational Gene Therapy for the Treatment of GM1 Gangliosidosis Lysogene Announces First Patient in the United States Dosed with LYS-GM101 Investigational Gene Therapy for the Treatment of GM1 Gangliosidosis … Continue reading →

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Gene Therapy Gene 40

BioTech 365

AUGUST 29, 2021

Teladoc Health Is Providing Free Virtual Health Care Services to Those Impacted by Hurricane Ida Teladoc Health Is Providing Free Virtual Health Care Services to Those Impacted by Hurricane Ida PURCHASE, NY, Aug.

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BioTech 365

AUGUST 29, 2021

Innate Pharma to Participate in Upcoming Investor Conferences Innate Pharma to Participate in Upcoming Investor Conferences MARSEILLE, France, Aug.

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BioTech 365

AUGUST 29, 2021

Distribution of Etesevimab/JS016 in the US Reopened Distribution of Etesevimab/JS016 in the US Reopened SHANGHAI, China, Aug.

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Development 40

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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