Mon.Aug 14, 2023

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Pfizer attempts to ward off generic competition to pricey heart med Vyndamax with patent lawsuit

Fierce Pharma

Just four years into the rollout of Pfizer's pricey heart medication Vyndamax, the company is already playing patent defense against a potential copycat. | Along with the Scripps Research Institute, the drug giant claims the proposed copycat would step on a Pfizer patent and two Scripps patents.

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Maintaining the Right To Work as Independent Nursing Professionals Is a Fight for Equality

MedCity News

Staffing agencies are convincing hospitals that it is dangerous to hire nurses like me, telling them that us independent nurses are not equipped to provide quality patient care, and that hiring independent nurses could open the door for legal ramifications.

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Thermo Fisher lays off 200-plus at clinical-stage cell and gene therapy factory in Florida

Fierce Pharma

As layoffs continue to roil the biotech industry, bigger drugmakers and manufacturers such as Bristol Myers Sq | As layoffs continue to roil the biotech industry, bigger drugmakers and manufacturers like Bristol Myers Squibb and Emergent BioSolutions haven’t been immune. Now, Thermo Fisher Scientific is among the latest to plot hundreds of job cuts.

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HHS Launches Civil Rights Investigation Into Vanderbilt’s Sharing of Transgender Patient Data

MedCity News

Vanderbilt University Medical Center is under federal investigation after it turned transgender patients’ medical records over to Tennessee’s attorney general. HHS launched the investigation a couple weeks after two VUMC patients filed a class-action lawsuit against the hospital for releasing their records to the attorney general.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Chasing AstraZeneca and Pfizer, Johnson & Johnson snags FDA nod for prostate cancer combo Akeega

Fierce Pharma

Following FDA approvals for fellow PAPR inhibitors made by AstraZeneca/Merck and Pfizer, Johnson & Johnson has got its own combo approval in prostate cancer. | Following FDA approvals for fellow PAPR inhibitors made by AstraZeneca/Merck and Pfizer, Johnson & Johnson has got its own combo approval in prostate cancer. The tablet treatment, known commercially as Akeega, combines J&J’s Zytiga and niraparib.

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House Reps Introduce Bill To Ease State Medicaid Staffing Shortages Amid Redeterminations

MedCity News

The Medicaid Staffing Flexibility and Protection Act was introduced by Representative Earl L. “Buddy” Carter (R-Georgia) and Representative Neal Dunn (R-Florida). It would allow state Medicaid agencies to hire outside contractors to help with Medicaid redeterminations, as many agencies don’t have the workforce to handle the return to the redetermination process.

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FDA Approves J&J Combo Drug for Prostate Cancers With Certain Genetic Signature

MedCity News

Johnson & Johnson’s Akeega is approved for treating advanced prostate cancer with a BRCA mutation. The drug, which interferes with a way cancer cells repair themselves, will compete against recently approved drugs from Pfizer and partners AstraZeneca and Merck.

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Lilly completes biopharma acquisitions

European Pharmaceutical Review

Eli Lilly and Company has completed acquisition of two biopharmaceutical companies – Versanis Bio and Sigilon Therapeutics – and their lead assets focused on obesity and diabetes. Lilly announced the successful completion of its acquisition of clinical-stage Versanis Bio and its lead asset bimagrumab, an anti-obesity medicine. Under the terms of the deal – first announced in July – Versanis shareholders could receive up to $1.925 billion in cash, inclusive of the upfront payment and subs

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Harmony Bio’s Zynerba Buyout Brings Cannabinoid That Doesn’t Spark Euphoria

MedCity News

Zynerba Pharmaceuticals’ lead drug candidate is designed to bring the therapeutic effect of cannabinoids without also causing euphoric effects. The synthetic cannabinoid in a topical gel formulation includes none of the psychoactive compounds from the cannabis plant.

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The Power of Digitalization: Online Investigator Meetings

Impetus Digital

This is a guest article and does not necessarily reflect the views and values of Impetus Digital. As the world evolves in the digital age, investigator meetings are no exception. Now, instead of meeting in person, investigators (and their stakeholders) are using tools like Skype and teleconferencing to save time and money. Let’s look at the radical changes that technology has brought about for investigator meetings.

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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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4 New Femtech Innovations Demystifying and Normalizing Menstruation

MedCity News

FemTech is at the forefront of providing effective solutions to menstrual challenges, and the efforts to normalize and destigmatize menstruation are paving the way for the democratization of women’s healthcare.

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HebeCell and Logomix partner to develop PSC-NK cells

Pharmaceutical Technology

HebeCell has forged a strategic collaboration with Logomix for researching and developing gene-edited natural killer cells (NK cells).

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CMS Lowers No Surprises Act Fee After Court Nixes Price Hike

MedCity News

CMS recently announced that it will change the administrative fee that providers and insurers must pay when initiating a reimbursement dispute under the No Surprises Act — the agency is lowering the fee from $350 to $50. This move came a week after the Texas Medical Association won a court case challenging HHS over its 600% price hike on the fee.

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Riding the mRNA wave, HDT Bio closes in on cancer-fighting vaccine

PharmaVoice

The company believes its platform could deliver safer and more efficient mRNA options for cancer and infectious diseases.

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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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New App Aims To Support Teens with Sickle Cell Disease

MedCity News

HPC International launched Pinpoint, an app that helps teens manage their sickle cell disease. It allows them to learn about the disease, track their pain and communicate with their physicians.

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KKR To Acquire Simon & Schuster for $1.62B

Copyright Clearance Center

The post KKR To Acquire Simon & Schuster for $1.62B appeared first on Copyright Clearance Center.

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Botulinum battle heats up with FDA approving Daxxify for cervical dystonia

Pharmaceutical Technology

Daxxify becomes the latest botulinum toxin to make the jump from aesthetics to therapeutics.

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Novo Nordisk Announces Acquisition of Inversago Pharma

PharmExec

Purchase aims to develop therapies for people living with metabolic diseases.

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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.

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CymaBay begins phase 3 liver disease study

PharmaTimes

IDEAL study aims to determine the impact of seladelpar on alkaline phosphatase levels - News - PharmaTimes

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H1 Launches Life Sciences Support App

PharmExec

H1 Mobile to offer latest information and research in multiple fields.

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Healthcare Networking: Leveraging Expert Contact Lists for Success

Scott’s Directories

The world of healthcare is ever-evolving, and staying connected within this expansive industry is crucial for any professional. One effective way to ensure you remain plugged into the vital hubs of this field is by leveraging a reputable healthcare industry mailing list. Understanding the Importance of a Comprehensive Mailing List Direct communication in the digital age has become an essential tool for networking, outreach, and fostering business relationships.

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How to Optimize Content for SEO to Rank Higher

Healthcare Success

Today’s trusted healthcare sites feature up-to-date, accurate information. They also boast SEO-optimized content. To stay ahead of your competitors in organic search results and reach the right target audience, you must regularly update your content for SEO. In this blog, I share how to do this in five steps. First, let’s define content optimization.

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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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FDA approval for Janssen’s prostate cancer treatment

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Janssen’s Akeega (niraparib and abiraterone acetate), for the treatment of adult patients BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). Akeega is the first-and-only orally administered, once daily dual action tablet of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, an androgen biosynthesis inhibitor.

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Kerecis to Donate FDA-Approved Fish Skin for Burn Victims of Maui Wildfires

Legacy MEDSearch

Kerecis ® , the company pioneering the use of fish skin and fatty acids for tissue regeneration and protection, is donating its GraftGuide ® fish-skin burn product for victims of the fires on Maui, Hawaii. Qualified medical personnel wanting to get fish-skin burn-treatment products for their patients should call 703-287-8752 or email wildfires@kerecis.com.

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Astellas and Poseida Therapeutics Plan to Invest in Redefining Cancer Cell Therapy

PharmaTech

Additionally, Poseida has approved Astellas as a board observer seat, which gives Astellas the right to attend Poseida’s scientific advisory board meetings and certain notice rights related to any potential change of control over Poseida.

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The Creative Floor Awards Named a Finalist for The Lord Mayor’s Dragon Awards 2023

PM360

The Creative Floor Healthcare Awards have been shortlisted at The Lord Mayor’s Dragon Awards. The Dragon Awards, founded in 1987, recognizes businesses and community organizations that go above and beyond their core work to significantly impact the regeneration of communities. All finalists are invited to an annual awards ceremony hosted by the Lord Mayor at Mansion House.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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United Kingdom Biotech Report Finds 29% Uptick in Funding

PharmaTech

A report from the UK Bioindustry Association report indicated that biotech venture and public financing rose from £295 million in the first quarter to £382 million in the second quarter.

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Jeff Jarvis on “The Gutenberg Parenthesis”

Copyright Clearance Center

Printed books engendered a culture of communication that endured for centuries. In his new book, The Gutenberg Parenthesis, media analyst Jeff Jarvis places us outside the era of print and beyond the world that print created.

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CNX acquires four cancer drugs from Clinigen

PharmaTimes

The purchased therapies concerned are Cardioxane, Totect, Ethyol and Savene - News - PharmaTimes

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Pharma’s rare disease rush

PharmaVoice

Biogen’s acquisition of Reata Pharmaceuticals is the latest in a string of high-dollar rare disease deals over the last few months. What does it mean for industry?

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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.