Wed.Sep 22, 2021

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Chinese drugmaker Clover says vaccine prevents COVID-19 in large trial

Bio Pharma Dive

Positive results from Clover's Phase 3 study could mean another coronavirus vaccine option for the many countries still grappling with short supplies.

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Olympus Strengthens Surgical Portfolio with the Launch of POWERSEAL Advanced Bipolar Surgical Energy Devices

Pharma Mirror

TOKYO, Sept 21, 2021 – (ACN Newswire) – Olympus Corporation (Representative Executive Officer, President and CEO: Yasuo Takeuchi) announced the launch of the first devices in the new POWERSEAL™ family of advanced bipolar surgical energy products. The POWERSEAL 5mm Curved Jaw Tissue Sealer and Divider, Double-Action devices meet the highest standards of clinical performance for advanced bipolar surgical energy devices by delivering consistent sealing reliability in an ergonomic, multi

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'This is the time to double down': Top Vertex executives defend research plan as pressure builds

Bio Pharma Dive

A series of setbacks has led to criticism of the storied biotech's bid to diversify. But Vertex intends to stay the course, its CEO and top scientist say.

Scientist 308
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Galileo Research and InSilicoTrials partner up to reduce time and cost of drug development

Pharma Mirror

Milan, Italy, Innovation and cutting-edge technology to reduce Research and Development time and costs: InSilicoTrials, a company with broad expertise in Computational Modeling and Simulation, IT and cloud solutions for the healthcare sector, and Galileo Research established a partnership to apply in silico services for drug repurposing activities and provide mutual support in modeling and simulation activities.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Incyte eczema drug wins FDA OK, but with safety warning

Bio Pharma Dive

A topical cream formulation of the drug in Incyte's top-selling product could help the company expand. The black box warning, though, might limit use.

Drugs 273
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Naobios manufactures FluGen Inc’s M2SR influenza vaccine candidate for upcoming clinical trials

Pharma Mirror

Nantes, France, Naobios, a CDMO (Contract Development and Manufacturing Organization) providing bioprocess development and GMP production of clinical batches of viral vaccines BSL2/BSL3, oncolytic viruses and viral vectors, today announces the next phase in its partnership with FluGen, Inc., a clinical-stage vaccine company transforming vaccine efficacy in infectious respiratory diseases.

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Clinical investigation shows Herb-Pharma’s ViroStop spray effective in reducing impact of Covid-19

Pharma Mirror

A recent clinical study has shown that the ViroStop anti-viral spray from Swiss company, Herb-Pharma is effective in reducing the impact of Covid-19 for patients with mild to moderate symptoms. The key benefits were a 60% reduction in viral shedding after using the treatment and a reduction in the severity of clinical respiratory symptoms. The study supports the findings of earlier in-vitro tests where its mix of polyphenols inhibited the growth of the virus in cell cultures.

In-Vitro 100
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Study finds 10% of medicines in England are overprescribed

pharmaphorum

An alarming number of people in England are being prescribed medicines unnecessarily, which could harm their health, according to a UK government review. The study , led by the Chief Pharmaceutical Officer for England Dr Keith Ridge, estimates that 10% of items dispensed in primary care are inappropriate or could be better served with alternative treatments.

Medicine 122
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Incyte on a Roll with Two FDA Wins in Two Days

BioSpace

The approval is based on its Phase III REACH3 trial, which evaluated Jakafi versus the best available therapy for treating chronic GVHD after allogeneic stem cell transplantation.

Trials 89
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The benefits of being a family-run pharma company

pharmaphorum

The third generation of his family to hold a leadership role at Chiesi Group, Giacomo Chiesi reflects on the lessons he learned from his father and grandfather – and from his work as a former management consultant – about what it means to run a successful family business and its benefits. Family businesses across industries including the life sciences sector contribute significantly to the global economy – they represent about half of the world gross domestic product and global emplo

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Walmsley Targeted Again as Activists Renew Plea for New GSK CEO

BioSpace

GlaxoSmithKline Chief Executive Officer Emma Walmsley faces renewed calls for her ouster after Bluebell Capital Partners has taken a £10 million (about $13.7 million) stake in the company.

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Amnesty says COVID jab producers are causing human rights crisis

pharmaphorum

Amnesty International has slammed the six pharma companies behind the bulk of COVID-19 vaccine supplies of for not agreeing to waive their intellectual property rights and share the technology behind them. The charity says AstraZeneca, BioNTech, Johnson & Johnson, Moderna, Novavax, and Pfizer are fuelling an “unprecedented human rights crisis” as a result and their failure to act “paints a dismal picture of an industry that is woefully failing to respect human rights.”

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Umbilical Cord Protein Could Increase Stroke Survival and Recovery Rates

BioSpace

?Scientists found recently that a naturally occurring protein from human umbilical cord blood might be the key to increasing survival and recovery rates in stroke patients.

Protein 84
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FDA clears AI-powered prostate cancer detection software

pharmaphorum

Software that can help pathologists detect prostate cancer from slides of biopsies more effectively has been approved by the FDA. The software – called Paige Prostate – is the first artificial intelligence-based to be approved by the FDA for this purpose, according to the US regulator. It is used to screen for signs of cancer on biopsy slides that have been digitised using a scanner, identifying those with the highest risk so they can be reviewed further by a pathologist if not spotted on an ini

In-Vitro 105
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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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How to Effectively Lead a Project at Work

BioSpace

To lead a group or project well, the individual must start with competency and knowledge about project or group parameters and goals, and must also behave ethically while inspiring and coaching the group’s members.

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Connections, collaboration key to executing global trials: ICON

Outsourcing Pharma

A logistics leader from the CRO offers advice on navigating borders, cultures, regulatory issues and other important considerations on worldwide studies.

Trials 94
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AstraZeneca Dives into RNA Research with VaxEquity Collaboration

BioSpace

AstraZeneca aims to harness VaxEquity’s saRNA platform for use with its own therapeutic programs and intends to widely use it on up to 26 different drug targets.

RNA 87
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New UK partnership aims to help build startup companies focused on cancer

Pharma Times

Cancer Research UK has partnered with the University of Edinburgh's ‘venture builder incubator’

Research 104
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The New Age of Decentralized Clinical Trials

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.

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FDA Gives Narrow Authorization for Pfizer-BioNTech Booster

BioSpace

FDA authorizes Pfizer-BioNTech COVID-19 booster shots for individuals 65 and over, those at high risk for severe disease and front-line healthcare workers.

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Scientists show how mucus protein contributes to worsening COPD, asthma, lung conditions

Scienmag

CHAPEL HILL, NC – Mucus is an essential protective layer of gel-like liquid composed largely of proteins called mucins throughout our airways. One of them, called MUC5B, is crucial for the innate defense against the various things we inhale. But another mucin, called MUC5AC, generally increases disproportionately in response to cigarette smoke and allergens, adding […].

Protein 77
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Biogen Reps Blacklisted from DC Neurology Centers Due to Aduhelm

BioSpace

The Neurology Center posted a notice, saying, “At this time, the NCPA physicians will not be recommending this treatment for any of its patients.

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CHMP recommends Nucala for three new indications

Pharma Times

Positive opinions recommend approval for mAb in three additional eosinophil-driven diseases

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Accelerating Clinical Supply Through Integrated Drug Development

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.

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9 Tips for Navigating a Job Search as an Introvert

BioSpace

Here are tips for introverts who are trying to land their dream job.

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Healthcare Data Breach: What it Means for Companies and the Consumer?

Delveinsight

Data and analytics today are playing a major role in the organization’s growth. Stakeholders in a business environment such as companies, investors, and individuals deal with some or other kind of data in their day-to-day life. The data is key to the business prediction that helps to analyze consumer behavior. Companies stores a large amount of data related to their customers and analysis them accordingly to understand the market trends, to make future decisions, and setting strategies and commu

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Cassava’s Positive New Alzheimer’s Data Meets Lukewarm Reception

BioSpace

Cassava Sciences announced top-line results Wednesday from a 12-month interim analysis of its Alzheimer’s drug candidate simufilam.

Drugs 85
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Amgen to collab with Verastem on KRAS combination treatment

Pharma Times

Agreement will evaluate Verastem’s dual RAF/MEK inhibitor with Amgen’s KRAS G12C inhibitor

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How Machine Learning Drives Clinical Trial Efficiency

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.

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GenEdit Uncloaks to Solve Gene Editing “Delivery Problem”

BioSpace

Kunwoo Lee has uncloaked his solution to the gene-editing “delivery problem” with $26 million in Series A funds for his company, GenEdit.

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Boehringer buys Abexxa, bolstering its immuno-oncology pipeline

pharmaphorum

Boehringer Ingelheim says it has agreed to buy US biotech Abexxa Biologics, its second acquisition in the cancer immunotherapy area in the space of a year. Texas-based Abexxa has been on the Boehringer’s radar since it was set up, as it provided seed funding for the preclinical-stage company in 2016, buying into its approach of developing antibodies against targets inside cancer cells, rather than on the cell membrane.

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Global Roundup: Monument Therapeutics Takes New Approach to Treat Schizophrenia

BioSpace

Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.

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Government review highlights the impact of overprescribing medicines

Pharma Times

Review sets out practical and cultural changes to ensure patients get the most appropriate treatments

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.