Sat.Apr 02, 2022 - Fri.Apr 08, 2022

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Regeneron, in search of an eye gene therapy, turns to a young biotech

Bio Pharma Dive

Facing mounting competition to its top-selling drug Eylea, Regeneron is teaming up with ViGeneron to develop a genetic medicine for an inherited retinal disease.

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About those online metrics

World of DTC Marketing

It’s time to stop using worthless online ad metrics. Click-through rates are the most used KPI in marketing, but they are useless. Click-through rates don’t correlate with any meaningful brand metrics. Billions of dollars are “optimized” based on nothing but noise. “One impression’ is one web browser making one server request for one advertisement.

Branding 199
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CellCentric Strengthens Leadership Team

Pharma Mirror

Cambridge, UK, CellCentric, aclinical stage, private biotechnology company pioneering small molecule inhibition of p300/CBP to treat cancer, today announces the appointments of Kris Frese as Director of Cancer Biology, and Andrew Hughes, who joins the Board as a Non-Executive Director. Both have stellar experience and track records in oncology research and development.

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The value of method of use patent claims in protecting your therapeutic assets

Drug Patent Watch

This is a guest post by Ray Miller and Megan E. Bowers, Ph.D. at DLA Piper. Ray may be contacted at raymond.miller@dlapiper.com. When it comes to protecting therapeutic assets, I…. The post The value of method of use patent claims in protecting your therapeutic assets appeared first on DrugPatentWatch - Make Better Decisions.

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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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Medicare finalizes policy limiting coverage of Biogen Alzheimer's drug

Bio Pharma Dive

Treatment with Aduhelm would only be covered for patients enrolled in a clinical trial under the policy, which largely follows a draft proposal released in January.

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The four biggest challenges facing DTC marketers

World of DTC Marketing

DTC marketing has evolved. Those DTC managers who use the exact roadmap will waste a lot of money when accountability is increasing. Challenges await, and there isn’t one set of guidelines for every product category. Challenge #1 – DIGITAL MARKETING. Pharma companies are increasing digital budgets, but they are wasting too much money because of internal staffing issues and inexperience with online marketing.

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Upskilling in a digital health world

pharmaphorum

It’s no secret that digital technologies are playing a significant role when it comes to shaping the next era of healthcare. Necessity accelerated the adoption of new and sophisticated technologies and systems throughout the COVID-19 pandemic, but this seismic shift towards digital health has opened up a gap in education. To successfully navigate the potential of digital technologies in healthcare, attention must be focused on upskilling professionals in the field to equip them with the necessar

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Top Novartis executives to depart as company restructures

Bio Pharma Dive

The Swiss pharma said its plan to merge multiple business units and cut yearly costs by $1 billion is likely to impact jobs, but declined to specify which roles and how many.

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Product launch metrics are changing in pharma

World of DTC Marketing

The old model of looking at performance in the first six months of product launch isn’t relevant. Today, colossal budget product launches are not returning the same ROI as before. Product launches are going to need to be micro-targeted to specific audiences. What is the definition of a successful pharma product launch? Usually, it’s reaching a certain sales level within a specified time, but that metric is not relevant anymore.

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How to Deal with A Terminal Illness Diagnosis?

Pharma Mirror

Let’s face it, dealing with a terminal illness diagnosis will never be an easy task and there’s not much you can do to mitigate the pain. However, there are a few steps that you can take to make the whole ordeal a bit more manageable for the person diagnosed and those around them. There are a few emotional chapters you’ll need to close as well as some practical matters that you should get out of the way if you are diagnosed with a terminal illness.

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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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Catalent buys UK vaccine manufacturing centre

BioPharma Reporter

US company Catalent is acquiring the UKâs Vaccine Manufacturing and Innovation Centre in Harwell: a facility which had been planned to support COVID-19 and wider vaccine production and which is still under construction.

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FDA clears second Novartis plant for gene therapy manufacturing

Bio Pharma Dive

The 170,000-square-foot plant located in North Carolina can now fulfill its primary function: producing commercial-grade Zolgensma, which has become one of the Swiss pharma's top-selling drugs.

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NIH funds study to evaluate long-term COVID in children

pharmaphorum

The National Institutes of Health (NIH) is funding a nationwide study in the US to support research on long-COVID, chronic COVID, or as it’s scientifically known, post-acute sequelae of SARS-CoV-2 (PASC) in children. An estimated 10% to 30% of adults who contract COVID-19 suffer from long COVID. Though speciality departments and independent institutions have opened to study chronic COVID in adults, little research has been done to evaluate the long-term effects of the virus on children.

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Hataali wins US patent for the use of blockchain in advanced medicinal therapy products

Pharma Mirror

London, ATMPS Ltd/Hataali – the leader in blockchain-based data sharing platforms for advanced therapies – announces it has been granted a patent from the United States Patent and Trademark Office (USPTO) for the use of blockchain technologies in personalised medicines. The company also has applications pending in both Europe and Asia as it looks to cement its technological advantage in the rapidly growing advanced therapy space globally.

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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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Personalized Blood Test Detecting ctDNA Can Help Predict Lung Cancer Relapse

XTalks

The personalized ctDNA blood test uses the RaDaR™ assay, a liquid biopsy platform developed by the company Inivata. Photo source: Inivata. Lung cancer is the most common cancer in men and the third most common cancer in women, according to global lung cancer statistics by the World Cancer Research Fund. Around 85 percent of cases are non-small cell lung cancer (NSCLC).

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Akebia to lay off 42% of workforce, suspend trials after FDA drug rejection

Bio Pharma Dive

The layoffs come after safety concerns led the FDA to rebuff its anemia pill, similar to the agency's spurning of FibroGen's rival drug last year.

Drugs 286
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Game-based therapies and the attraction of engaging patients

pharmaphorum

Ensuring that patients remain consistent with their therapies is one of the major challenges facing healthcare, so what if you could make treatment a game? That’s the potential behind game-based digital therapeutics and it’s drawing a lot of interest, finds Ben Hargreaves. The impact of video games on modern culture can be felt by even those that have little or no interest in them.

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eTheRNA Announces Relocation and Expansion of R&D Facility

Pharma Mirror

GENT, BELGIUM, eTheRNA immunotherapies NV (“eTheRNA”), an mRNA technology discovery and development company with a full platform of integrated capabilities, is pleased to announce the relocation of its R&D group to a new and larger site in Gent, Belgium. The upgraded R&D facility is in the Zwijnaarde Science Park, where a cluster of biotech companies are located, and includes state-of-the-art laboratories together with allied services.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Milestone approval for Kite CAR-T cell therapy

BioPharma Reporter

The US FDA has approved Yescarta, Kite's CAR-T cell therapy, for initial treatment in adults with large B-cell lymphoma (LBCL) that is refractory to one prior therapy or that relapses within 12 months of first-line chemoimmunotherapy.

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CAR-T treatment moves earlier as FDA widens approval of Gilead's Yescarta

Bio Pharma Dive

Yescarta, previously cleared only for use in treating late-stage lymphoma, can now be used after initial treatment has failed, a first for the cellular drugs.

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NICE recommends Koselugo for the treatment of neurofibromatosis type 1

Pharma Times

Alexion Pharma UK, AstraZeneca’s Rare Disease group, announces the recommendation of its pivotal neurofibromatosis treatment

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CPHI North America opens as 65% of US companies forecast growth in excess of 20% in 2022

Pharma Mirror

New York, Kicking off the season for pharmaceutical professionals to come together digitally (09-27 May, 2022) as well as in-person (17-19 May, 2022). CPHI North America will be held as a SMART event, with three weeks of dedicated pharma learning and partnering. The benefit for the CPHI pharma community, which relies on a widening global supply chain, is that a SMART event format stimulates greater collaboration within the industry.

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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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Intouchers Spend Afternoon in Service to Displaced Ukrainians

Intouch Solutions

Philanthropy at Intouch has always been a big deal. From raising funds for animal-related charities to helping the folks at our local Ronald McDonald House , to granting a young boy’s wish to visit Disney World, even to shaving our heads to support a good cause … we take giving back seriously. Since 2019, we’ve been partnering with Heart to Heart International to spread the giving further than outside our own doors — helping to provide support for those working on the fro

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A new approach for post-marketing safety studies

Bio Pharma Dive

The large quantity of digitized healthcare data in the U.S. presents an enormous opportunity to shift dramatically how post-marketing safety studies can and should be conducted.

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World Health Day 2022: The Importance of Sustainable Food Systems for Personal and Planetary Health

XTalks

Each year, April 7 marks World Health Day, an initiative created by the World Health Organization (WHO) to spread awareness about health-related issues. While last year’s theme was “building a fairer, healthier world for everyone,” the theme for World Health Day 2022 is “our planet, our health,” which aims to direct global attention toward the well-being of our planet and the humans living on it.

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The power of mRNA: The technology's potential to tackle global health threats

BioPharma Reporter

After the success of mRNA with COVID-19 vaccines, a new partnership between Moderna and IAVI will seek to use the tech to target HIV/AIDS, tuberculosis, and antimicrobial-resistant enteric infections.

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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 Melinta drug BAXDELA

Drug Patent Watch

Annual Drug Patent Expirations for BAXDELA Baxdela is a drug marketed by Melinta and is included in two NDAs. It is available from one supplier. There are thirteen patents protecting…. The post New patent for Melinta drug BAXDELA appeared first on DrugPatentWatch - Make Better Decisions.

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FDA advisers grapple with how to update COVID-19 vaccines

Bio Pharma Dive

About half of eligible Americans haven't received a booster and may be less protected should cases surge. Health officials hope to soon ready an updated shot, but experts on the committee struggled to identify the best approach.

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Ukraine Crisis Causing Sunflower Oil Shortage

XTalks

A sunflower oil shortage is looming as Europe’s leading bottler of cooking oils, Edible Oils , warned that only a few weeks’ supplies remain. Because Ukraine and Russia produce about 60 percent of the world’s sunflower oil, the ongoing war is disrupting exports. As a result, the company said it was switching to other oils, and food manufacturers are reviewing their recipes.

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Boehringer plans €25bn R&D spend, fuelled by Jardiance

pharmaphorum

Boehringer Ingelheim says it is planning to invest a hefty €25 billion ($27 billion) in its pipeline over the next five years, as it reinvests healthy sales revenue from Eli Lilly-partnered SGLT2 inhibitor Jardiance. The German group has just reported a 28% increase in Jardiance (empagliflozin) sales to €3.9 billion in 2021, buoyed by new approval in heart failure, which was accompanied by a 25% gain for pulmonary fibrosis therapy Ofev (nintedanib) to €2.5 billion.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.