Tue.Oct 08, 2024

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Compounders sue FDA for removing Eli Lilly's tirzepatide from shortage list

Fierce Pharma

With an estimated 2 million people in the United States taking copycat vers | A compounding industry group has sued the FDA, claiming its action to remove Eli Lilly’s Mounjaro and Zepbound from its drug shortage list is a “reckless and arbitrary decision—lacking any semblance of lawful process.” In declaring the end of the shortage, the FDA has halted the ability of compounding pharmacies to manufacture the in-demand products.

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The 2024 PharmaVoice 100

PharmaVoice

This year’s PharmaVoice 100 encompasses the industry’s ongoing revolutions and leaders who are not only navigating these changes, but at times, forging new paths for others to follow.

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Pfizer, bracing for Hurricane Milton, pledges aid to emergency services and health support

Fierce Pharma

Editor's Note: Is your company bracing for Milton or working to provide aid in anticipation of the storm? | Pfizer—which opened a global hub in Tampa, Florida, in 2021—is setting out to bolster emergency services, pool donations and ease medical supply needs as Hurricane Milton touches down this week.

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Building Rapport In Sales Is An Essential Selling Skill – Here’s Why

Integrity Solutions

Building rapport in sales is essential for establishing trust and fostering long-term relationships with clients. While technology has made it easier than ever for buyers to access information, B2B buyers in particular are looking for insights and advice from a salesperson they can trust and who they believe has their best interests in mind to help them make good decisions.

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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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Merck's Keytruda stages comeback in head and neck cancer with trial win in earlier-stage disease

Fierce Pharma

Merck & Co. hopes a new positive trial readout can return Keytruda to glory in head and neck cancer. | Merck & Co. hopes a new positive readout can return Keytruda to glory in head and neck cancer about two years after a prior failure.

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EHRs Are Overloading Mental Health Clinicians — Can AI Save the Day?

MedCity News

When AI is directly integrated into the EHR it not only improves efficiency but also ensures that patient data remains secure within the same trusted system. The post EHRs Are Overloading Mental Health Clinicians — Can AI Save the Day? appeared first on MedCity News.

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Scholar Rock preps filings after SMA antibody clears trial

pharmaphorum

Shares in Scholar Rock have gone into overdrive after the biotech reported positive phase 3 results with apitegromab in patients with spinal muscular atrophy (SMA), setting up regulatory filings in early 2025.The stock rocketed 362% after the announcement, taking Scholar Rock's market cap above $2.7 billion, as analysts started to talk about a blockbuster sales opportunity for the selective myostatin inhibitor.

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Popular proposals would result in no reductions, or modest reductions, in 2031 prices: CBO

Fierce Pharma

With the U.S. | The Congressional Budget Office found that only one out of the seven policies it reviewed would create notable reductions in prices. Still, that approach could affect market dynamics outside the U.S.

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Point Solution Fatigue? Zooming Out to the Population Level Can Help

MedCity News

The best solutions, in summary, are those that facilitate better outcomes while reducing costs — combining member health and satisfaction with healthcare savings. The post Point Solution Fatigue? Zooming Out to the Population Level Can Help appeared first on MedCity News.

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A revival in neuro therapeutics

Fierce Pharma

The neuroscience sector has seen a surge in investment over the past year, leading to breakthroughs and high-stakes dea | This week on "The Top Line," Fierce Pharma's Fraiser Kansteiner chats with industry leaders about the surge in neuroscience investment, breakthroughs and future targets in neuropharmaceuticals.

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

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Another Astellas Gene Therapy Deal, This Time $50M for Option on AviadoBio Dementia Program

MedCity News

Astellas secured an exclusive option to license global rights to an AviadoBio gene therapy in development as a one-time treatment for a certain type of frontotemporal dementia. A Phase 1/2 test of the AviadoBio gene therapy is ongoing. The post Another Astellas Gene Therapy Deal, This Time $50M for Option on AviadoBio Dementia Program appeared first on MedCity News.

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NICE turns down Takeda colorectal cancer drug

pharmaphorum

Takeda's recently approved advanced colorectal cancer therapy Fruzaqla has been rejected by NICE for use by the NHS in draft guidance

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Boehringer kickstarts two Phase III trials as MASH therapy wins breakthrough status

Pharmaceutical Technology

The Phase III trials will evaluate survodutide in metabolic dysfunction-associated steatohepatitis (MASH), fibrosis and cirrhosis.

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Biogen, Talkiatry team up on postpartum depression

pharmaphorum

Biogen teams up with Talkiatry on telehealth programme for postpartum depression that could help drive sales of Zurzuvae

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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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CPHI Milan 2024: Flavonoids in Pharmaceuticals

PharmaTech

Pharmaceutical Technology® Europe sat down with Álvaro Nocete Díaz, Pharma Division Manager at HTBA, about the benefits of flavonoids and their use in the pharmaceutical industry.

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Astellas places $2bn+ bet on AviadoBio dementia gene therapy

pharmaphorum

Astellas adds a gene therapy for frontotemporal dementia to its pipeline, via a $2.2bn+ option deal with UK biotech AviadoBio.

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Kyowa Kirin announces positive interim data for lymphoma treatment

PharmaTimes

Real-world studies show effectiveness of mogamulizumab in routine practice

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AZ and Owkin partner on AI to speed up BRCA testing

pharmaphorum

AstraZeneca and Owkin form alliance to develop an AI tool to pre-screen breast cancer patients for BRCA mutations from digital pathology slides.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Astellas, AviadoBio Strike Exclusive Option, License Agreement for Potential Treatment for Frontotemporal Dementia

PharmExec

Under terms of the deal, Astellas will obtain the license for the global development and commercialization of AVB-101 to treat frontotemporal dementia with progranulin mutations.

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Setback for J&J's TAR-200 bladder cancer programme

pharmaphorum

J&J's TAR-200 drug fails a phase 3 bladder cancer trial, but the company is still confident in the blockbuster potential of the programme

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Thermo Fisher Launching New CDMO, CRO Services at CPHI Milan

PharmaTech

The introduction of Accelerator Drug Development follows expansions of sites in Cincinnati, Ohio, and Bend, Ore., earlier in 2024 to enable R&D, manufacturing, and testing.

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Developing a Winning Healthcare Brand Strategy: Essential Insights for Pharma Marketers

Pharma Marketing Network

In an ever-evolving industry like healthcare, building a robust brand strategy is no longer optional but essential for pharma marketers. The dynamic landscape demands a comprehensive approach that not only elevates brand visibility but also fosters trust and credibility among consumers. As healthcare continues to integrate with technology, pharma marketers must navigate these changes adeptly to develop a winning healthcare brand strategy.

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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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Train Your Brain with the Power of Prompts

ALULA

Unlock Your Mental Potential This National Train Your Brain Day We've all heard "use it or lose it" when it comes to physical fitness, but did you know your brain follows the same principle? Just as you train your muscles, you can train your brain.

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Magazine: Cell and gene therapy approvals drive paradigm change in manufacturing

Pharmaceutical Technology

In this issue: The manufacturing shift to meet growing cell and gene therapy demand, applying lessons from the Covid-19 pandemic to address mpox, a ten-year review of Opdivo and Keytruda, and more.

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CPHI Milan 2024: Exploring Current Trends and Purification Innovations

PharmaTech

Stacey Treichler, senior director of global marketing and strategy, Purolite, an Ecolab company, spoke about current trends in the biopharma industry and innovations in purification resins at CPHI Milan.

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BD, ten23 health to Roll Out Prefillable Syringes with RFID Capabilities

Pharmaceutical Commerce

With the implementation of unit-level traceability, the collaboration is expected to provide additional visibility not only within the aseptic manufacturing process, but the entire supply chain overall.

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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 Grants Breakthrough Therapy Designation to Boehringer Ingelheim’s Survodutide for Non-Cirrhotic Metabolic Dysfunction-Associated Steatohepatitis

PharmExec

Breakthrough Therapy designation for survodutide was based on preliminary clinical data showing potential improvement in patients with non-cirrhotic metabolic dysfunction-associated steatohepatitis over existing therapies.

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High-profile CEO appointment signals major new growth phase for class-leading pharmacovigilance specialist Qinecsa

PM360

Veteran safety & PV leader Adam Sherlock will capitalize on Qinecsa’s deep domain expertise and comprehensive technology-powered solutions to pharma’s most complex product safety challenges London, UK – October 8th, 2024 – Qinecsa , the global, class leader in technology-powered pharmacovigilance services, has announced the appointment of life sciences safety services mover and shaker Adam Sherlock as its new CEO, spearheading a major new growth phase for the company.

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CCC Announces Collaboration with Morressier to Address Research Integrity

Copyright Clearance Center

October 8, 2024 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, announces a collaboration with Berlin-based Morressier GmbH, creators of Integrity Manager , the online publishing platform that empowers publisher clients with proactive research integrity, from initial assessment and peer review to ongoing investigations and post-publication audits.

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KOL Collaboration Series: Enhancing Pharmacy Resilience

Pharmaceutical Commerce

In this video interview with Pharma Commerce Editor Nicholas Saraceno, John Stefankiewicz, VP of Analytics, Cencora, describes the value of advocacy and other solutions in under-served areas.

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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.