Wed.Apr 06, 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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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.

Marketing 196
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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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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.

Medicine 130
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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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FDA halts Vir, GSK antibody use in response to COVID subvariant's spread

Bio Pharma Dive

The COVID-19 treatment had a brief time in the spotlight as one of the few drugs that's potent against the omicron variant. A substrain called BA.2 is now dominant in the U.S., however.

Antibody 152
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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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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.

Research 130
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'Where's the patient?': Experts question FDA's device recall guidance

Bio Pharma Dive

While the guidance encouraged the use of electronic communications in recalls — a change experts have advocated for — some questioned why the agency did not address more problems with the system.

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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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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).

DNA 105
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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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Alpha brain waves can predict post-surgery pain

Pharma Times

A technique developed by the University of Birmingham demonstrates link between patients’ alpha brain waves and responses to pain

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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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Gilead Sciences opens new drug development hub in Dublin

Pharma Times

New Dublin development office will be responsible for paediatric clinical trials for seven products across 18 countries

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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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Digital health financing bonanza slows in Q1

pharmaphorum

2021 was a big year in investment financing for US digital health companies, but there are signs that it may be a high watermark. In the first three months of this year there were 183 deals worth a total of $6 billion, giving an average size per deal of just under $33 million, according to venture fund Rock Health’s latest update on the sector.

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Amazon Rainforest Foliage Gases Affect the Earth’s Atmosphere

Scienmag

Plant-foliage-derived gases drive a previously unknown atmospheric phenomenon over the Amazon rainforest, according to a recent study by researchers at Pacific Northwest National Laboratory (PNNL). Credit: (Illustration by Nathan Johnson | Pacific Northwest National Laboratory) Plant-foliage-derived gases drive a previously unknown atmospheric phenomenon over the Amazon rainforest, according to a recent study by researchers at […].

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FDA releases draft guidance for cell and gene therapies

BioPharma Reporter

The FDA has released two draft guidance documents: for human gene therapy products incorporating human genome editing, and for CAR T cell products.

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Most US dog owners don’t follow FDA pet food handling guidelines

Scienmag

A new analysis suggests that most U.S. dog owners are unaware of—and do not follow—guidelines on safe pet food and dish handling from the Food and Drug Administration (FDA), but that better education and implementation of the guidelines could reduce contamination. Dr. Emily Luisana of North Carolina State University in Raleigh and colleagues present these […].

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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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DFE Pharma, Harro Höfliger, and Sterling forge respiratory partnership

Outsourcing Pharma

The excipients, equipment, and API companies have joined forces on Inhalation Together, an initiative aimed at advancing dry-powder inhalation solutions.

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Thousands of tonnes of air pollution could be reduced by changing the way we dry our laundry

Scienmag

A new study has revealed that tumble drying a load of laundry releases almost the same amount of potentially harmful microfibres into the air as those released down the drain during machine washing of the same load. Credit: P&G A new study has revealed that tumble drying a load of laundry releases almost the same […].

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UK government ‘not doing enough on early cancer diagnosis’

pharmaphorum

Parliamentarians in the UK have warned that the government is not making the effort needed to reach its target of diagnosing three quarters of cancer cases at an early stage. If urgent action is not taken, England is at risk of remaining a laggard in cancer care among comparable countries like Australia and Canada, according to a new report from the Health and Social Care Committee.

Nurses 64
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Alas, poor Yorick! I knew him…

Scienmag

Kyoto, Japan — Chimpanzees are known to interact with dead members of their species, revisiting corpses, and even showing mourning-like behavior. Elephants are also known to do this, and will even interact with elephant skeletons. Credit: KyotoU/André Gonçalves Kyoto, Japan — Chimpanzees are known to interact with dead members of their species, revisiting corpses, and […].

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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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In India, Parents of Children with Rare Disease Plea for Help Online

NY Times

India makes many of the world’s drugs, but treatments for rare diseases like spinal muscular atrophy are imported and prohibitively costly. In desperation, parents are raising funds on social media.

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Scientists have spotted the farthest galaxy ever

Scienmag

Cambridge, Mass. – An international team of astronomers, including researchers at the Center for Astrophysics | Harvard & Smithsonian, has spotted the most distant astronomical object ever: a galaxy. Credit: Credit: Harikane et al. Cambridge, Mass. – An international team of astronomers, including researchers at the Center for Astrophysics | Harvard & Smithsonian, has spotted the most […].

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Inside a Campaign to Get Medicare Coverage for a New Alzheimer’s Drug

NY Times

The Alzheimer’s Association has pushed relentlessly to get broad access to Aduhelm, despite safety risks and uncertain evidence that it helps patients.

Drugs 67
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Biodegradable gel boosts immune system’s attack on several cancers in mice

Scienmag

MADISON – A new biodegradable gel improves the immune system’s ability to keep cancer at bay after tumors are surgically removed. Credit: UW–Madison MADISON – A new biodegradable gel improves the immune system’s ability to keep cancer at bay after tumors are surgically removed. The gel, tested in mice, releases drugs and special antibodies […].

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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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The Digital Health Start-up Journey: Series A to scale-up

pharmaphorum

Although resources exist for digital health entrepreneurs looking to raise their first key investment round, industry advice on next steps is harder to find. The growth of a start-up after obtaining Series A funding is a transformational phase when scaling up the company becomes critical. The CEO can experience pressure to deliver on the revenue growth goals, whilst still developing their product, growing the team, and implementing core processes for the company.

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Study investigates the effects of DiNP on the colon

Scienmag

Phthalates are commonly used to make products—including artificial leather, footwear, plastic food packaging, and personal care products—more flexible or stable. In particular, di-isononyl phthalate is incorporated in vinyl clothing and construction materials. However, scientists do not completely understand if or how it harms the human body. To do so, researchers looked at the effect of […].

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New patent for Astrazeneca drug LYNPARZA

Drug Patent Watch

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

Drugs 52
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Eating bushmeat could reduce childhood anaemia in Amazon forest communities

Scienmag

Eating wild animals, known collectively as bushmeat or wildmeat, is associated with reduced anaemia cases among children living in the Amazon rainforest, a new study reveals. Credit: Jesem Orellana, of FIOCRUZ Largest study yet looking at childhood anaemia and wildmeat Iron-deficiency is the major cause of anaemia in children and is the leading cause of […].

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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.