Fri.Sep 24, 2021

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Insurers sue Merck for 'monopolistic scheme' to delay generics of blockbuster cholesterol drug

Bio Pharma Dive

The suits allege an agreement between Merck and a generic manufacturer kept low-cost versions of the drugmaker's widely used Zetia off the market for years.

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What is Biogen and can they repair their reputation?

World of DTC Marketing

SUMMARY: If I were to ask you, “what type of company is Biogen?” what would be your response? I tried asking that of several colleagues in the industry, and they couldn’t come up with an answer. Biogen has lost its way and is in desperate need of a corporate rebranding. This week two colleagues, who worked at Biogen, left the company because they knew that the ax was coming after the failure of Aduhelm.

Drugs 222
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Lilly, Novartis, other pharmas could face fines for violating 340B law

Bio Pharma Dive

The U.S. health department asked its inspector general to review the refusals of six drugmakers to offer discounts to safety net hospitals through community pharmacy partnerships.

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Dr. Daniel Pauly’s extraordinary life and work revealed in new book

Scienmag

Dr. Daniel Pauly is the world’s most-cited fisheries scientist, but life for the UBC professor has been far from easy. The biracial son of a French woman and an American GI, he was born in Paris and kidnapped as a child to be a live-in servant for a Swiss family. He escaped to Germany at […].

Scientist 110
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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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UK trial to evaluate existing drugs for secondary breast cancer

Pharma Times

Trial will test if radium-223 plus avelumab can improve outcomes for metastatic breast cancer patients

Trials 125
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Contact-tracing apps ‘could improve COVID vaccination strategy’

pharmaphorum

Targeting people for COVID-19 vaccination using contract-tracing apps could be a shortcut to achieving herd immunity in the population using fewer doses, according to Canadian researchers. According to Mark Penney, Yigit Yargic and colleagues from the Perimeter Institute for Theoretical Physics in Ontario, targeting vaccines to people who have more exposure than others is the most effective way to reduce transmission of SARS-CoV-2.

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A 3D printed vaccine patch offers vaccination without a shot

Scienmag

CHAPEL HILL, N.C. – Scientists at Stanford University and the University of North Carolina at Chapel Hill have created a 3D-printed vaccine patch that provides greater protection than a typical vaccine shot. Credit: University of North Carolina at Chapel Hill CHAPEL HILL, N.C. – Scientists at Stanford University and the University of North Carolina at […].

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Recent Inclination of Pharma Companies, Emerging Pipeline Therapies Drive the IgA Nephropathy Market Share Growth

Delveinsight

Chronic diseases (CDs) pose a significant challenge to healthcare in the 21st century. Factors such as population aging, lifestyle-modifiable risk factors, a decline in early-life infectious diseases, sedentary lifestyle, unhealthy food habits have resulted in the emergence of chronic diseases as a major global health threat. Among CDs, Chronic kidney disease (CKD) is particularly of huge concern owing to the increasing prevalence and severe financial implications it imparts leading to CVDs and

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New data demonstrates long-term benefit of Crysvita for XLH patients

Pharma Times

Results showed treatment with Crysvita reduces disease burden for patients

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W.H.O. Backs Antibody Treatment For High-Risk Covid Patients

NY Times

The expensive treatment, developed by the U.S. drug maker Regeneron and the Swiss biotech company Roche, has garnered attention as backstop for those who shun vaccines.

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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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Cancer care backlog in England could take ‘over a decade’ to clear, report finds

Pharma Times

Research shows that the backlog has been ‘starkest’ in diagnostics

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Update on FDA COVID approvals, actions, and advice

Outsourcing Pharma

As COVID-19 and its variants continue their attack, the agency maintains its position of overseer and giver of advice on various treatments and vaccines.

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Positive results for Lynparza plus abiraterone in metastatic prostate cancer

Pharma Times

Interim analysis showed significant improvement in radiographic progression-free survival

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Salarius Pharmaceuticals forms research partnership with Fox Chase Cancer Center

Outsourcing Pharma

The cancer-centric pharma firm will work with the Houston-based cancer center to pinpoint new indications and biomarkers for its drug candidate, seclidemstat.

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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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INTCR 2021 winners announced

Pharma Times

The winners of the 2021 International Clinical Researcher have been announced, find out who emerged victorious.

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Clinical Research Advice and Creating Clinical Research Tools

ECRG Media's Clinical Research Podcast

Clinical Research Advice and Creating Clinical Research Tools Don't forget to Subscribe for new content! Merch: [link] Subscribe: [link] Email: eliteclinicalgroup@gmail.com Podcast: [link] [link] eliteclinicalgroup@gmail.com Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link] Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Elite Clinical Research Group

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New patent for Vero Biotech drug GENOSYL

Drug Patent Watch

Annual Drug Patent Expirations for GENOSYL Genosyl is a drug marketed by Vero Biotech and is included in one NDA. There are nineteen patents protecting this drug. This drug has…. The post New patent for Vero Biotech drug GENOSYL appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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These Tools Can Save 3 Hours On Site

ECRG Media's Clinical Research Podcast

These Tools Can Save 3 Hours On Site?? Don't forget to Subscribe for new content! Merch: [link] [link] eliteclinicalgroup@gmail.com Podcast: [link] [link] eliteclinicalgroup@gmail.com Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link] Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Elite Clinical Research Group or ECRG for short is a content creating

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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 Therapeuticsmd Inc drug IMVEXXY

Drug Patent Watch

Annual Drug Patent Expirations for IMVEXXY Imvexxy is a drug marketed by Therapeuticsmd Inc and is included in one NDA. It is available from one supplier. There are twelve patents…. The post New patent for Therapeuticsmd Inc drug IMVEXXY appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Clinical Research Advice and Creating Clinical Research Tools

ECRG Media's Clinical Research Podcast

Clinical Research Advice and Creating Clinical Research Tools. Don't forget to Subscribe for new content! Merch: [link]. Subscribe: [link]. Email: eliteclinicalgroup@gmail.com Podcast: [link] [link] eliteclinicalgroup@gmail.com Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link] Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education.

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Living with spinal cord injury: Resilience leads to better health outcomes

Scienmag

September is Spinal Cord Injury (SCI) Awareness month. According to the National Spinal Cord Injury Statistical Center, approximately 296,000 Americans are currently living with SCI, with around 17,900 new cases occurring each year. Credit: MUSC – Jessica Yurinko September is Spinal Cord Injury (SCI) Awareness month. According to the National Spinal Cord Injury Statistical Center, […].

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These Tools Can Save 3 Hours On Site

ECRG Media's Clinical Research Podcast

These Tools Can Save 3 Hours On Site?? Don't forget to Subscribe for new content! Merch: [link] [link] eliteclinicalgroup@gmail.com Podcast: [link] [link] eliteclinicalgroup@gmail.com Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link] Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education.

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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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An NJIT-led team secures $3.7 million to tackle a disabling, concussion-induced eye disorder

Scienmag

Nearly half of adolescents and young adults with lingering symptoms of concussion suffer from an eye coordination disorder that causes blurred and double vision, headaches and difficulties concentrating. There is no proven method for treating the condition when it occurs after a head injury. Credit: NJIT Nearly half of adolescents and young adults with lingering symptoms […].

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RGIS Continues to Deliver on Its International Growth Strategy With the Acquisition of WIS UK and WIS Mexico

BioTech 365

RGIS Continues to Deliver on Its International Growth Strategy With the Acquisition of WIS UK and WIS Mexico RGIS Continues to Deliver on Its International Growth Strategy With the Acquisition of WIS UK and WIS Mexico RGIS has acquired the … Continue reading →

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The Lundquist Institute receives prestigious CIRM Scholar Research Training Award

Scienmag

LOS ANGELES (September 24, 2021) — The Lundquist Institute (TLI) announced that it has received a generous $5 million, 5-year grant from the California Institute for Regenerative Medicine (CIRM) that will allow its PhD students, postdoctoral fellows and clinical fellows to pursue careers in stem cell biology and regenerative medicine. This award will also support […].

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The Growing Importance of Food Industry Cybersecurity

XTalks

While the faces of those involved in cyberattacks are rarely revealed, high-tech criminals are highlighting the growing importance of food industry cybersecurity. Earlier this week, Iowa-based farm services firm NEW Cooperative Inc. experienced a cybersecurity incident that forced its systems offline before the US farm belt harvest. Luckily, the threat was contained, but the outcome could have been detrimental to agriculture. .

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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 European University Alliance FORTHEM welcomes new partners and strengthens its network with the university cities’ administrations and chambers of commerce

Scienmag

This week the European University Alliance FORTHEM gathered in Mainz, Germany, for its first on-site meeting. Alongside the seven university partners from all over Europe, representatives of the FORTHEM partner cities and their chambers of commerce and industry were invited so that they could meet one another in person and exchange ideas. “We were extremely […].

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Identifying KOLs in Growing and Emerging Markets

pharmaphorum

The process of discovering HCPs who are leading key opinion leaders (KOLs) in emerging and growing markets is not as straightforward as it is in other countries. When identifying KOLs within emerging markets, the need to conduct solid, primary research becomes paramount. Relying solely on the typical quantitative methodologies such as examining publications, citations, clinical trials, guideline development committees, etc., often yields low numbers of experts for several reasons.

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Shrinking waveforms on electrocardiograms predict worsening health and death of hospitalized COVID-19 and influenza patients

Scienmag

Specific and dynamic changes on electrocardiograms (EKGs) of hospitalized patients with COVID-19 or influenza can help predict a timeframe for worsening health and death, according to a new Mount Sinai study. The work, published in the September 24 online issue of the American Journal of Cardiology, shows that shrinking waveforms on these tests can be […].

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PROpel study backs Lynparza combo in first-line prostate cancer

pharmaphorum

AstraZeneca and Merck & Co PARP inhibitor Lynparza is already used to treat prostate cancer associated with a specific genetic mutation, but could see the drug’s use broadened after a positive phase 3 trial. The results of the PROpel study showed that a combination of Lynparza (olaparib) and Johnson & Johnson’s hormonal therapy Zytiga (abiraterone acetate) given as a first-line treatment to an -all-comer’ population of men with metastatic castration-resistant prostate c

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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.