Fri.Nov 26, 2021

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New Merck study results raise questions about its COVID-19 pill

Bio Pharma Dive

Final trial data for molnupiravir were less convincing than what Merck previously reported and could alter how the FDA views the drug, which will be evaluated at a meeting Tuesday.

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Pharmaceuticals and the environment: how can the industry put its best foot forward?

Pharma Mirror

In recent years, it has become more and more important to both consumers and investors that they support organisations which display a high level of social and environmental responsibility. This means that it’s no longer enough for businesses to manage their bottom lines and maintain profitability, they must also be conscious of the impact they have on the world around them.

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EMA approves Pfizer-BioNTech COVID-19 vaccine for young children

Pharma Times

The Food and Drug Administration (FDA) granted approval for emergency use of the Comirnaty vaccine in children in October 2021.

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General Mills Releases Eight New Cereals as Its Retail Prices Rise

XTalks

Eight new cereals will be joining General Mills’ robust cereal lineup later this year and early next year. To the delight of cereal fans, the new offerings range from brand new flavors to twists on existing brands. While its classic flavors will always be choice favorites, General Mills does not shy away from new offerings to incentivize cereal lovers.

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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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Turkey’s home-grown COVID vaccine project nears fruition

pharmaphorum

Turkey could have its own COVID-19 vaccine Turkovac available for use by the end of the year, according to the country’s Health Minister Fahrettin Koca. An emergency use authorisation (EUA) application for the inactivated SARS-CoV-2 vaccine has been submitted to the Turkish Medicines and Medical Devices Agency (TITCK) on the back of preliminary data from ongoing phase 3 trials.

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New patent for Allergan Holdings drug VIBERZI

Drug Patent Watch

Annual Drug Patent Expirations for VIBERZI Viberzi is a drug marketed by Allergan Holdings and is included in one NDA. It is available from one supplier. There are sixteen patents…. The post New patent for Allergan Holdings drug VIBERZI appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 98

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Fall in efficacy of Merck’s molnupiravir puts Pfizer in driver’s seat

pharmaphorum

Merck & Co has reported new data with its oral antiviral molnupiravir that suggests it is not as effective against COVID-19 as originally hoped. An updated readout from the MOVE-OUT study of molnupiravir shows that the original 48% reduction in the risk of hospitalisation or death in people with mild or moderate COVID-19 at high risk of progression has now been trimmed to 30% with longer follow-up.

HR 91
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A tough attachment between rotator cuff, bone achieved through unique fibrous architecture

Scienmag

Engineers often use nature to inspire new materials and designs. A discovery by a multi-institutional team of researchers and engineers about how tendon and bone attach in the shoulder joint has uncovered previously unsuspected engineering strategies for attaching dissimilar materials. The discovery also sheds new light on how the rotator cuff functions and on why […].

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COVID-19 vaccines safe for pregnant women

Pharma Times

Data from the UK’s Health Security Agency (UKHSA) has revealed that COVID-19 vaccines are safe in pregnancy.

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In the quantum realm, not even time flows as you might expect

Scienmag

A team of physicists at the Universities of Bristol, Vienna, the Balearic Islands and the Institute for Quantum Optics and Quantum Information (IQOQI-Vienna) has shown how quantum systems can simultaneously evolve along two opposite time arrows – both forward and backward in time. Credit: © Aloop Visual & Science, University of Vienna, Institute for Quantum […].

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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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What Is PCD Pharma Franchise Monopoly Basis?

Fossil Remedies

Monopoly PCD Pharma franchise model is a specialized business model where the company provides franchises on a monopoly basis all over the country for marketing and distribution of products. Why does this business model hold a unique place in the business space? In fact, it is the most prevalent model. The reason is it I profitable and appealing. All leading and successful companies give it precedence.

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PMEA 2021: A Celebration of Excellence in Patient Engagement

Pharma Times

After hosting a virtual ceremony in 2020, this year’s awards returned to the Royal Lancaster London hotel

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Jaws of defeat: Anglers’ emotions toward shark depredation is key to conservation

Scienmag

AMHERST, Mass. – In a broad-scale study recently published in Fisheries Research, researchers from the University of Massachusetts Amherst quantified the emotional and behavioral responses to shark depredation in recreational fisheries. The study found that anglers, and especially recreational fishing guides, who experienced depredation were more likely to have a negative response towards sharks and […].

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Health Innovators: Healthware Group’s Roberto Ascione

pharmaphorum

pharmaphorum’s founder, Dr Paul Tunnah, continues his Health Innovators video series, in discussion with digital health visionary Roberto Ascione, from Healthware Group. In the first ‘in person’ video interview in the series, Paul speaks with Roberto live from the Frontiers Health conference in Milan, where he was again chairing the event and announcing the release of his new book, ‘The Future of Health’.

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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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COVID-19 : Measuring viral RNA to predict which patients will die

Scienmag

Credit: CHUM The amount of a SARS-CoV-2 genetic material—viral RNA—in the blood is a reliable indicator in detecting which patients will die of the disease, a team led by Université de Montréal medical professor Dr.?Daniel Kaufmann has found. The finding is published today in Science Advances. Kaufmann and his team did the work at […].

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China’s insulin plans will hit 2022 revenues, says Novo Nordisk

pharmaphorum

Novo Nordisk has said that the introduction of value-based procurement (VBP) for insulin products by the Chinese government will have an impact on its revenues next year. This year, China has started to include insulin in its centralised procurement programme, first introduced in 2018, forcing producers to enter into a tender process to get their products included in a national formulary.

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How can our brain still perceive familiar objects even when they become indistinct?

Scienmag

The appearance of objects can often change. For example, in dim evenings or fog, the contrast of the objects decreases, making it difficult to distinguish them. However, after repeatedly encountering specific objects, the brain can identify them even if they become indistinct. The exact mechanism contributing to the perception of low-contrast familiar objects remains unknown. […].

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Sanofi invests $180 million equity in Owkin’s artificial intelligence and federated learning to advance oncology pipeline

The Pharma Data

Combined efforts will work to build robust disease models while preserving privacy of large data sets from various research institutions and hospitals Collaboration to focus on four types of cancer. Sanofi blazoned moment an equity investment of$ 180 million and a new strategic collaboration with Owkin comprised of discovery and development programmes in four exclusive types of cancer, with a total payment of$ 90 million for three times plus fresh exploration corner- grounded payments.

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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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New patent for Sol-gel Technologies drug TWYNEO

Drug Patent Watch

Annual Drug Patent Expirations for TWYNEO Twyneo is a drug marketed by Sol-gel Technologies and is included in one NDA. There are two patents protecting this drug. This drug has…. The post New patent for Sol-gel Technologies drug TWYNEO appeared first on DrugPatentWatch - Make Better Decisions.

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Leveraging real-world data to meet payers’ needs

pharmaphorum

Payers are becoming savvier in accepting real-world data. Certara’s Lee Stern and Shawn Bates discuss the challenges and how pharma can use real-world data to meet payers’ needs. For years, clinical trial data was king. But as healthcare costs continue to be squeezed, there is pressure on pharmaceutical companies to actually deliver on clinical trial efficacy in the real world.

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New patent expiration for Cumberland Pharms drug CALDOLOR

Drug Patent Watch

Annual Drug Patent Expirations for CALDOLOR Caldolor is a drug marketed by Cumberland Pharms and is included in one NDA. It is available from one supplier. There are ten patents…. The post New patent expiration for Cumberland Pharms drug CALDOLOR appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Could safety scupper Ionis, Pfizer’s cholesterol drug vupanorsen?

pharmaphorum

Ionis has reported phase 2b trial data for its Pfizer-partnered antisense drug vupanorsen for cholesterol lowering that showed it met its main efficacy targets, but raised a few safety concerns as well. The top-line results of the TRANSLATE-TIMI 70 study – in dyslipidaemia patients with elevated non-HDL cholesterol and triglycerides – showed that vupanorsen was able to significantly reduce levels of both those blood lipids at all seven doses on test.

Drugs 52
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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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Cybin Announces Additional Adelia Milestone Achievements

BioTech 365

Cybin Announces Additional Adelia Milestone Achievements Cybin Announces Additional Adelia Milestone Achievements TORONTO–(BUSINESS WIRE)–Cybin Inc. (NEO:CYBN) (NYSE AMERICAN:CYBN) (“Cybin” or the “Company”), a biotechnology company focused on progressing “Psychedelics to Therapeutics™”, is pleased to announce that Adelia Therapeutics Inc.

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Which pharmaceutical companies have the most SPCs in Lithuania?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Lithuania. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating…. The post Which pharmaceutical companies have the most SPCs in Lithuania? appeared first on DrugPatentWatch - Make Better Decisions.

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Assure Announces $435,000 Private Placement with Management and Board Participation

BioTech 365

Assure Announces $435,000 Private Placement with Management and Board Participation Assure Announces $435,000 Private Placement with Management and Board Participation DENVER, Nov. 26, 2021 (GLOBE NEWSWIRE) — Assure Holdings Corp.

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Taking new aim at COVID-19

Scienmag

DURHAM, N.C. — To the untrained eye, the loops, kinks and folds in the single strand of RNA that makes up the coronavirus genome look like a jumble of spaghetti or tangled yarn. But to researchers like Amanda Hargrove, a chemistry professor at Duke University, the complex shapes that RNA takes on as it folds […].

RNA 82
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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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Akero Therapeutics to Present at the Evercore ISI 4th Annual HealthCONx Virtual Conference

BioTech 365

Akero Therapeutics to Present at the Evercore ISI 4th Annual HealthCONx Virtual Conference Akero Therapeutics to Present at the Evercore ISI 4th Annual HealthCONx Virtual Conference SOUTH SAN FRANCISCO, Nov. 26, 2021 (GLOBE NEWSWIRE) — Akero Therapeutics, Inc.

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Psyence Group Inc. files Q2 Unaudited Condensed Consolidated Interim Financial Statements and MD&A

BioTech 365

Psyence Group Inc. files Q2 Unaudited Condensed Consolidated Interim Financial Statements and MD&A Psyence Group Inc. files Q2 Unaudited Condensed Consolidated Interim Financial Statements and MD&A TORONTO, Nov. 26, 2021 (GLOBE NEWSWIRE) — Psyence Group Inc.

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Canadian Red Cross opens online registration portal for people impacted due to B.C. flooding and extreme weather

BioTech 365

Canadian Red Cross opens online registration portal for people impacted due to B.C. flooding and extreme weather Canadian Red Cross opens online registration portal for people impacted due to B.C. flooding and extreme weather VANCOUVER, British Columbia, Nov.

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Teleflex Incorporated Announces Worldwide Recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR

BioTech 365

Teleflex Incorporated Announces Worldwide Recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR Teleflex Incorporated Announces Worldwide Recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR WAYNE, Pa., Nov.

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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.