Fri.Aug 16, 2024

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Novo Nordisk plans new $220M raw ingredients plant in Denmark

Fierce Pharma

Even as supplies of Novo Nordisk’s immensely popular GLP-1 drugs Ozempic and Wegovy start to stabilize, the Danish drugmaker continues to announce manufacturing and capacity upgrades at a rapid cli | Novo Nordisk Pharmatech, a unit that specializes in producing drug ingredients, is spending 1.5 billion Danish kroner ($220 million) to build a plant in Køge, Denmark, that will make raw materials, the company said Friday.

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Bend the Curve: Schools’ Crucial Role in Early Intervention for Youth Mental Health

MedCity News

To change the trajectory of the youth mental health pandemic, we must commit to “bending the curve” by building strong, prevention-oriented partnerships. Collaboration between caretakers, schools, and mental health professionals is vital. The post Bend the Curve: Schools’ Crucial Role in Early Intervention for Youth Mental Health appeared first on MedCity News.

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GSK notches another Zantac win as Florida court tosses expert testimony linking heartburn drug to cancer

Fierce Pharma

After knocking out multiple personal injury lawsuits this summer, GSK has prevailed on another front in its long-running Zantac litigation. | After knocking out multiple personal injury lawsuits this summer, GSK has prevailed on another front in its long-running Zantac litigation, thanks to a decision in Florida that put the kibosh on suspect expert testimony.

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When Foes Become Friends: Abbott Teams Up With Medtronic

MedCity News

Abbott and Medtronic — typically regarded as competitors — have recently joined forces. The two companies teamed up to collaborate on a continuous glucose monitoring system that combines Abbott’s FreeStyle Libre technology with Medtronic’s automated insulin delivery system. The post When Foes Become Friends: Abbott Teams Up With Medtronic appeared first on MedCity News.

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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FDA signs off on AZ's Imfinzi in NSCLC despite concerns about trial design

Fierce Pharma

AstraZeneca has scored an FDA approval in the advancement of its hi | AstraZeneca has scored an FDA approval in the advancement of its high-flying cancer therapy Imfinzi that comes with some controversy. The nod is for Imfinzi to treat patients with resectable non-small cell lung cancer perioperatively.

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Keeping Counterfeit Goods Out of the Supply Chain

Pharmaceutical Commerce

In the final part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ Senior Director of DSCSA/Serialization Compliance Services, comments on other ways to limit ‘bad actors’ attempts to sneak counterfeit drugs into the supply chain, aside from the DSCSA.

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Fair Square Medicare Unveils Generative AI Platform for Medicare Organizations

MedCity News

Fair Square Medicare launched a new generative AI platform called Vox. It’s meant to be used by Medicare carriers and brokerages and has three main features: AI voice agents, generative AI-driven insights and AI-powered coaching. The post Fair Square Medicare Unveils Generative AI Platform for Medicare Organizations appeared first on MedCity News.

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Fierce Pharma Asia—Merck-Curon bispecific deal; Legend's path forward; Missing adverse events in Amgen FDA filing

Fierce Pharma

Merck licensed a bispecific from a Chinese biotech with plans to target oncology and autoimmune diseases. Legend Biotech is taking a close at its business as M&A has emerged as an option. | Merck licensed a bispecific from a Chinese biotech with plans to target oncology and autoimmune diseases. Legend Biotech is taking a close at its business as M&A has emerged as an option.

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Pfizer, BioNTech Flu and Covid-19 Combo Vaccine Falls Short Against Influenza B Strain

MedCity News

Despite achieving strong responses against influenza A, a Phase 3 test of a Pfizer and BioNTech flu and Covid-19 combination vaccine did not meet goals against less common influenza B. These results come two months after Moderna’s combination vaccine succeeded in its Phase 3 trial. The post Pfizer, BioNTech Flu and Covid-19 Combo Vaccine Falls Short Against Influenza B Strain appeared first on MedCity News.

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Incyte looks to widen Monjuvi's net with label expansion bid after phase 3 lymphoma win

Fierce Pharma

Months after securing the full rights to anti-CD19 antibody Monjuvi (tafasitamab) from partner MorphoSys, Incyte has the data to potentially back a label expansion into lymphoma. | The company looks to file its drug for a follicular lymphoma indication as part of a later-line triple combo therapy by the end of the year.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Medicare Unveils Results of First-Round Drug Price Negotiations

Pharmaceutical Commerce

By 2026, the first 10 drugs for individuals with Part D coverage—whose medications are mainly used to treat cancer, diabetes, and heart disease—will see discounts off of list prices ranging from 38-79%.

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Is treatment for multiple sclerosis about to change fundamentally?

Fierce Pharma

Multiple sclerosis (MS) treatment could be on the brink of a significant breakthrough thanks to innovative research by Immunic Therapeutics. | Immunic Therapeutics CEO Daniel Vitt details the firm’s new oral MS therapy, vidofludimus calcium. Learn how this dual-action treatment could revolutionize MS care by addressing both relapses and disease progression.

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StartUPDATES: New Developments from Healthcare Startups

MedCity News

Check out news from Alpha Sophia, MD Ally, Guardoc Health, and more. The post StartUPDATES: New Developments from Healthcare Startups appeared first on MedCity News.

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The New Penal Processes in Pharmacy Act

Pharmatutor

The New Penal Processes in Pharmacy Act admin Fri, 08/16/2024 - 15:29 ABOUT AUTHOR Dr. R. S. Thakur Former Secretary, Pharmacy Council of India. Email : drramsthakur@gmail.

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A

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Corporate Compliance in the Era of TEFCA

MedCity News

A culture of compliance means truly valuing an adherence to industry standards, rather than looking at SOPs as a series of boxes that need to be checked in order to claim that requirements have been met. The post Corporate Compliance in the Era of TEFCA appeared first on MedCity News.

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AstraZeneca wins approval for Imfinzi in NSCLC perioperative setting

Pharmaceutical Technology

The FDA approval of Imfinzi in this indication comes a month after the agency called for an overhaul of perioperative lung cancer trials.

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With FDA okay, AZ takes on MSD in early-stage lung cancer

pharmaphorum

AstraZeneca has claimed FDA approval for its immunotherapy Imfinzi before and after surgery for non-small cell lung cancer, setting up a contest with MSD's rival Keytruda.PD-L1 inhibitor Imfinzi (durvalumab) has been cleared for use in adult patients who need surgery for early-stage (IIA-IIIB) NSCLC and have no ALK or EGFR mutations that would make them suitable for targeted therapies.

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Pfizer and BioNTech’s Covid-19/flu combination vaccine falters in Phase III readout

Pharmaceutical Technology

While the vaccine demonstrated high responses for neutralizing influenza A titers, it failed to show sufficient efficacy against influenza B.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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As WHO calls mpox emergency, NIH says only drug ineffective

pharmaphorum

As WHO declares mpox an emergency, the only recognised drug treatment for the virus, Siga's tecovirimat, fails a clinical trial.

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The Genomic Medicine Revolution: Multi-Modality Approaches in Advanced Therapies 

Pharmaceutical Technology

Genomic medicines offer new techniques for treating conditions once thought to be intractable - a world of opportunity awaits.

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Biden, Harris 'just getting started' on IRA drug price cuts

pharmaphorum

Joe Biden and Kamala Harris reaffirm commitment to Medicare drug pricing negotiations in first joint rally since ticket swap.

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Bavarian Nordic seeks authorisation for mpox vaccine’s use in adolescents

Pharmaceutical Technology

Bavarian Nordic aims to gain a label expansion for adolescents in Europe in Q4 this year, whilst it prepares a trial in children in Africa.

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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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Lykos co-founder Doblin to step down after MDMA setback

pharmaphorum

Lykos Therapeutics is slashing staff after the FDA turned down its MDMA-assisted therapy for PTSD, while founder Rick Doblin is stepping down.

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Researchers map interactions of 144 active substances to identify drug benefits

PharmaTimes

The study yielded over one million dose-responsive curves for existing cancer drugs

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Pharma Pulse 8/16/24: The Future of Launch Excellence is GenAI, Will Negotiated Drug Prices Actually Save Money? & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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What are the differences between 1:1 and 1:many email tools?

Clear Pivot

When I've been talking with prospects over the past few months, I've been seeing increasing confusion in what types of sales and marketing email tools there are and how they should be used. But it is VERY important to know the differences and why. If you use the wrong tools for the wrong job, you could cause some real damage, including even getting suspended by your email marketing provider or burning down your email domain reputation.

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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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Genmab appoints new EVP and Chief Technology Officer

European Pharmaceutical Review

Rayne Waller will be joining the Genmab A/S Executive Committee as Executive Vice President and Chief Technology Officer. The company stated that the creation of this new role in its committee will support Genmab’s innovation development as a biotech firm. In addition, Executive Vice President and Chief Operating Officer Anthony Mancini will step down, “to pursue other opportunities”, according to the company.

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What are the differences between 1:1 and 1:many email tools?

Clear Pivot

When I've been talking with prospects over the past few months, I've been seeing increasing confusion in what types of sales and marketing email tools there are and how they should be used. But it is VERY important to know the differences and why. If you use the wrong tools for the wrong job, you could cause some real damage, including even getting suspended by your email marketing provider or burning down your email domain reputation.

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FDA Grants Accelerated Approval to Gilead Treatment for Primary Biliary Cholangitis

PharmaTech

A Phase III study showed that 62% of patients given Livdelzi achieved the primary endpoint of composite biochemical response after 12 months, compared to 20% of participants taking placebo.

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Divergent Paths: Pharm Exec Profiles Five Recent Drug Launches

PharmExec

Pharm Exec’s latest sampling of notable biopharma brand approvals and launches all have unique stories to tell—from the winding journeys to innovative “firsts” to new momentum for milestones to come.

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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.