Bio Pharma Dive

JUNE 17, 2021

Capitalizing on investor interest in gene editing, the high-profile startup has secured one of the richest biotech initial public offerings priced this year.

Gene Editing 294

Gene Editing Gene 294

World of DTC Marketing

JUNE 17, 2021

SKIMMERS SUMMARY: Health experts, including those on an external advisory committee to the FDA, are skeptical that Biogen’s drug will even successfully slow the progression of Alzheimer’s after late-stage clinical trials yielded mixed results and are angry the FDA approved the product. The FDA’s recent approval of aducanumab (Aduhelm) shows just how badly the agency has failed the public.

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FDA Approval Drugs Clinical Trials Clinical Trials 164

Bio Pharma Dive

JUNE 17, 2021

The German biotech’s shot appeared less effective than other mRNA vaccines at preventing COVID-19. But it's unclear whether differences between the shots, or exposure to more elusive variants in testing, are the cause.

Vaccination 257

Vaccination Vaccine 257

pharmaphorum

JUNE 17, 2021

While the heroic abilities of the NHS have been on display throughout the COVID-19 pandemic, the last year has also exposed the longstanding limitations and frailties of our underfunded healthcare system, says Maya Ward. With an estimated 100,000 unfilled posts and staff turnover expected to increase due to emotional exhaustion, the health service’s workforce stands to be further stretched by an ageing population.

Pharmacy 113

Pharmacy Doctors Doctor Marketing 113

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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

Bio Pharma Dive

JUNE 17, 2021

Days after Aduhelm's approval, Biogen said an experimental drug that works in a different way didn't help patients, leading the company to stop research.

Drugs 260

Drugs Trials Research 260

Drug Patent Watch

JUNE 17, 2021

Annual Drug Patent Expirations for SOLOSEC Solosec is a drug marketed by Lupin and is included in one NDA. It is available from one supplier. There are four patents protecting…. The post New patent for LUPIN drug SOLOSEC appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 98

BioPharma Reporter

JUNE 17, 2021

Sorrento Technologies, a biotech firm developing novel treatments for COVID-19 and aggressive cancers such as melanoma, has received FDA clearance to start a research collaboration together with Mayo Clinic.

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Drug Delivery Development Drugs Research 98

pharmaphorum

JUNE 17, 2021

Biogen has four other Alzheimer’s candidates in its clinical pipeline behind recently-approved Aduhelm, but one of them – anti-tau antibody gosuranemab – has just been canned. The decision comes on the back of the phase 2 TANGO study of gosuranemab (also known as BIIB092), which showed that the antibody was unable to show a benefit on cognition symptoms in patients with mild Alzheimer’s, despite being effective at clearing tau out of cerebrospinal fluid.

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Antibody Protein Licensing Licensing 98

BioSpace

JUNE 17, 2021

In the report to the Committee on the Judiciary in the U.S. Senate, the GAO says drug makers have spent nearly $8.2 billion on DTC drug ads in three therapeutic areas from 2016 to 2018.

Drugs 98

Drugs 98

Scienmag

JUNE 17, 2021

Credit: Yali Zhang, Monell Chemical Senses Center PHILADELPHIA – Sour taste does not have the nearly universal appeal that sweet taste does. Slightly sour foods or drinks such as yogurt and lemon juice are yummy to many, but such highly sour foods as spoiled milk are yucky, even dangerous. Like humans, many other animals, including […].

Medicine 98

Medicine 98

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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

Triage Cancer

JUNE 17, 2021

by Katie Budris. Cancer has long impacted the women in my family, starting with my grandmother, then my mother, and now me. When I was 10, my grandmother moved in with us along with a live-in nurse to help my mother care for her until cancer and old age took her life. When I was 12, my mother was diagnosed with lymphoma, and after a very short remission and several rounds of experimental treatment, she passed.

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Nurses Doctors Doctor 93

Scienmag

JUNE 17, 2021

Credit: David Gallan When animals are hot, they eat less. This potentially fatal phenomenon has been largely overlooked in wild animals, explain researchers from The Australian National University (ANU). According to lead author Dr Kara Youngentob, it means climate change could be contributing to more deaths among Australia’s iconic marsupials, like the greater glider, than […].

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Research 97

Outsourcing Pharma

JUNE 17, 2021

Elligo Health Research is joining forces with Laguna Clinical research Associates to expand access to clinical care to a broader range of patient populations.

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Research Clinical Research Clinical Development Development 98

Scienmag

JUNE 17, 2021

Researchers at Osaka University identify a new noninvasive biomarker that can be used in the diagnosis of nonalcoholic fatty liver disease Credit: Osaka University Osaka, Japan – Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease worldwide and can progress to liver cirrhosis, liver failure or cancer. Currently, nonalcoholic steatohepatitis (NASH) diagnosis requires […].

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Research Gene Medicine 97

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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

NY Times

JUNE 17, 2021

A new $3.2 billion program will support the development of antiviral pills, which could start arriving by the end of this year.

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Development Clinical Trials Clinical Trials Drugs 105

Scienmag

JUNE 17, 2021

Credit: IBEC/IDIBAPS The brain presents different states depending on the communication between billions of neurons, and this network is the basis of all our perceptions, memories, and behaviours. It is often considered a “black box”, with difficult access for clinicians and researchers, as few limited tools are available to perform accurate and spaciotemporal studies on […].

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Research Engineer Medicine 91

BioSpace

JUNE 17, 2021

Three other drug contenders that work similarly to Biogen’s drug are currently in clinical trials and expecting data relatively soon.

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Drugs Clinical Trials Clinical Trials Trials 98

Scienmag

JUNE 17, 2021

Credit: Victoria Chen/Alwin Daus/Pop Lab Ultrathin, flexible computer circuits have been an engineering goal for years, but technical hurdles have prevented the degree of miniaturization necessary to achieve high performance. Now, researchers at Stanford University have invented a manufacturing technique that yields flexible, atomically thin transistors less than 100 nanometers in length – several times […].

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Manufacturing Engineer Research 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

Pharma Times

JUNE 17, 2021

Company attributed 47% vaccine efficacy to ‘unprecedented’ amount of circulating variants

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Vaccination Vaccine 103

Scienmag

JUNE 17, 2021

Long-term study finds natural regeneration could make significant contribution to tree planting targets — with jays playing a leading role Credit: UKCEH A long-term passive rewilding study has shown that natural woodland regeneration could make a significant contribution to meeting the UK’s ambitious tree planting targets – potentially at no cost and within relatively short […].

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BioSpace

JUNE 17, 2021

In its announcement, the company did not specify why Kawas’ doctoral research was under investigation, only saying it did not intend to comment on the issue until it had been resolved.

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Doctors Doctor Research 80

Scienmag

JUNE 17, 2021

Inhibiting necroptosis, a form of cell death, in the lung tissue of COPD patients significantly reduced chronic airway inflammation and lung damage Credit: Toby Burrows/UTS Research shows that inhibiting necroptosis, a form of cell death, could be a novel therapeutic approach for treating chronic obstructive pulmonary disease (COPD), an inflammatory lung condition, also known as […].

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Research Medicine 89

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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

JUNE 17, 2021

New data shows Zolgensma, Novartis’ gene therapy for spinal muscular atrophy, has the potential to be used presymptomatically in juveniles.

Gene Therapy 92

Gene Therapy Gene 92

Scienmag

JUNE 17, 2021

Research team from the Universities of Kassel, Göttingen and Kurdistan investigate this form of local nature conservation Credit: Zahed Shakeri How much do traditional practices contribute to the protection of local biodiversity? Why and how are sacred groves locally valued and protected, and how can this be promoted and harnessed for environmental protection?

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Research Medicine 86

BioSpace

JUNE 17, 2021

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.

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Research 97

Scienmag

JUNE 17, 2021

Study provides mechanistic link between red meat consumption and colorectal cancer development Bottom Line: Genetic mutations indicative of DNA damage were associated with high red meat consumption and increased cancer-related mortality in patients with colorectal cancer. Journal in Which the Study was Published: Cancer Discovery, a journal of the American Association for Cancer Research Author: […].

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DNA Genetics Development Research 73

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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

JUNE 17, 2021

Here are some strategies to keep in mind to manage your time well and get work done efficiently.

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Scienmag

JUNE 17, 2021

Finding may have implications for the diagnosis of child abuse, non-accidental trauma (Boston)–An intrauterine fracture is a rare finding during routine prenatal imaging. This condition can be due to maternal trauma, genetic disorders of the skeleton, as well as other predisposing maternal metabolic and vascular disorders. Genetic disorders that have previously been reported to cause […].

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Gene Genetics Research Medicine 72

BioSpace

JUNE 17, 2021

Biogen’s quest to develop additional medicines for Alzheimer’s disease beyond its newly-approved aducanumab has hit a clinical snag after gosuranemab failed.

Medicine 69

Medicine Development 69

Scienmag

JUNE 17, 2021

Tools for clinicians in point-of-care use UTICA, NY — More than 2 million coronary artery stents are implanted each year to help protect or restore normal blood flow to the heart, to treat patients suffering from angina or a heart attack due to coronary artery disease (CAD). While stents are highly effective and safe devices, […].

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Research Development Clinical Trials Clinical Trials 72

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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