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NIH study shows Bavarian Nordic's mpox shot elicits immune response in teens

Fierce Pharma

With the clade 1 outbreak of mpox (formerly monkeypox) raging through the Congo and other countries in Central Africa, younger people have become markedly

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12 Compelling Sessions to Check Out at HLTH 2024

MedCity News

HLTH 2024, scheduled for October 20-23 at the Venetian Expo Center in Las Vegas, will highlight the shifting landscape of healthcare innovation in many different settings. Register today! The post 12 Compelling Sessions to Check Out at HLTH 2024 appeared first on MedCity News.

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In win for compounders, FDA will review its decision to put Eli Lilly's tirzepatide on shortage list

Fierce Pharma

Four days after a compounding industry group filed a lawsuit against the FDA | Four days after a compounding industry group filed a lawsuit against the FDA for removing Eli Lilly’s tirzepatide products from its shortage list, the U.S. regulator is taking a second look at its decision.

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Lilly pledges £279m to UK for biotech hub and obesity plan

pharmaphorum

Eli Lilly may invest $364m in the UK and work with the government to tackle serious public health challenges including obesity.

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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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AlphaFold’s Nobel Prize is ‘the dawn of a new era’ in mapping drug development potential

PharmaVoice

A Nobel Prize in chemistry for Google’s DeepMind protein-structure mapping is the tip of the iceberg for advances in drug discovery and development.

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Cell and gene therapy approvals drive paradigm change in manufacturing

Pharmaceutical Technology

Trends in gene therapy approvals in recent years are rapidly shaping the future of manufacturing capabilities in the pharmaceutical industry.

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Nurturing the Nurturers: The Role of Parental and Caregiver Wellness in Supporting Children’s Mental Health

MedCity News

Healthcare providers play a critical role in helping caregivers recognize potential imbalances. Encouraging caregivers to access resources for self-care and respite isn’t just a nicety, it’s a clinical necessity. The post Nurturing the Nurturers: The Role of Parental and Caregiver Wellness in Supporting Children’s Mental Health appeared first on MedCity News.

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Lundbeck drops in on epilepsy drug with $2.6bn Longboard bid

pharmaphorum

Neuroscience specialist Lundbeck has agreed to buy Longboard Pharmaceuticals for $2.6 billion, expanding its pipeline with an epilepsy drug tipped as a future blockbuster.The Danish drugmaker has offered $60 per share for California biotech Longboard, with the main asset in the deal bexicaserin, an oral, centrally acting serotonin 5-HT 2C receptor super-agonist in late-stage testing for seizures associated with rare forms of epilepsy.

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CPHI Milan 2024: What Does the Future Pharma Workforce Look Like?

PharmaTech

Five speakers discussed the impact of the COVID-19 pandemic, the rise of artificial intelligence, more women in leadership tracks in the industry, and various emerging technologies.

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Healing begins with research: Promising development program on stem cells in rare diseases

Pharmaceutical Technology

RHEACELL has been researching ABCB5-positive stem cell therapies for patients with severe immune and inflammation-related diseases for which there are currently no adequate treatment options. Positive feedback from the regulatory authorities on the study program now gives reason to hope that those affected will be able to benefit from this new approach to regenerative medicine in the near future.

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

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On road to crowded Crohn's disease market, Lilly's Omvoh bests J&J's Stelara in head-to-head study

Fierce Pharma

On a mission to collect a key Crohn’s disease approval and build out its inflammatory bowel disease (IBD) profile, Eli Lilly has notched a trial win over a major rival in a head-to-head study.&nbsp | Eli Lilly's drug outperformed Johnson & Johnson's established Stelara in a phase 3 study that looked at histologic disease responses over 52 weeks.

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Finding the Cure for Data Interoperability in Value-Based Care

MedCity News

Payers and providers alike are struggling with data interoperability. It’s clear that a more unified approach to data management is essential for payers to effectively navigate the complexities of value-based care. The post Finding the Cure for Data Interoperability in Value-Based Care appeared first on MedCity News.

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GSK turns its guns on Moderna in mRNA jab patent dispute

pharmaphorum

GSK has filed lawsuits against Moderna, claiming infringement of patents covering mRNA vaccines for COVID-19 and RSV

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EMA publishes EU strategy to 2028

European Pharmaceutical Review

A draft joint EU network strategy to 2028 has been published by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA). This is updated strategy replaces the original five-year strategy, which was developed to cover from 2021 to 2025 (EMANS 2025). Revised strategy – adapting to change The draft strategy covers the following focus areas up to 2028: Accessibility to support pathways for medicine access in the EU Leveraging data, digitalisation and artificial intelligen

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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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Sanofi in talks to sell stake in consumer healthcare unit to CD&R

Pharmaceutical Technology

Sanofi has announced negotiations with Clayton Dubilier & Rice (CD&R), regarding the potential sale of a 50% controlling stake in Opella.

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Pfizer doubles down with its 2nd FDA hemophilia approval in 6 months

Fierce Pharma

Six months after scoring FDA approval for hemophilia B gene therapy Beqvez, Pf | For the second time in six months, the FDA approved a Pfizer treatment for hemophilia. On Friday the U.S. regulator signed off on Hympavzi, an anti-tissue factor pathway inhibitor for patients age 12 and older with hemophilia A or B.

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Suki Secures $70M To Expand AI Offerings

MedCity News

Suki’s $70 million Series D financing round was led by Hedosophia and included participation from Venrock, March Capital, Flare Capital, Breyer Capital and inHealth Ventures. The post Suki Secures $70M To Expand AI Offerings appeared first on MedCity News.

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Sanofi in talks to sell stake in consumer health spinout

pharmaphorum

Rumours that Sanofi was in discussion with private equity groups over the sale of its consumer health business Opella have been confirmed – at least partially.The French pharma group confirmed this morning that it has entered into talks with US-based Clayton Dubilier & Rice to sell a controlling 50% stake in the unit for what has been estimated by Reuters to be in the region of €15 billion ($16.4 billion).

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Facing Potential Drug Shortages, FDA Delays Enforcement of DSCSA Compliance Deadline, with Stipulations

Pharmaceutical Commerce

The now-11-year odyssey to track drugs by item through the supply chain will be under a regulatory exemption for up to two years.

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GITEX GLOBAL 2024: Huawei launches a series of industrial digital and intelligent transformation solutions, and flagship products

Pharmaceutical Technology

Huawei hosted GITEX's Industrial Digital and Intelligent Transformation Summit and launched joint solutions with partners for ten industries.

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Inaccurate Provider Data Hinders Value-based Care, But it Doesn’t Have To

MedCity News

Healthcare is a data-driven industry, but it’s held together by incompatible, siloed data systems. Providers and payers need the ability to exchange data and update directories in real time; otherwise, they cannot ensure patients will access the high-quality care they deserve. The post Inaccurate Provider Data Hinders Value-based Care, But it Doesn’t Have To appeared first on MedCity News.

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UK celeb seeks funds to challenge NICE's Enhertu verdict

pharmaphorum

Media personality Nadia Sawalha is heading a fundraising effort to launch an appeal against NICE's recent rejection of a breast cancer therapy Enhertu.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Celltrion unveils promising dose escalation results for subcutaneous infliximab

PharmaTimes

Study reveals potential new strategy for managing inflammatory bowel disease

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AAV gene therapy manufacturing gets £1.4m boost

European Pharmaceutical Review

Three industry partners have agreed to collaborate to develop an intensified perfusion process for manufacturing adeno-associated virus (AAV) vectors, leading to improved gene therapy production. The two-year project is supported by a £1.4 million grant through the Innovate UK Transforming Medicines Manufacturing (TMM) Programme, and involves the Cell and Gene Therapy (CGT) Catapult , Pharmaron Biologics (UK) Ltd and Complement Therapeutics.

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Roche burnishes breast cancer portfolio with FDA approval for Itovebi, a threat to Novartis and AZ

Fierce Pharma

As Roche comes under competitive pressure on its breast cancer business, the Swiss company hopes a new drug will add a 2-billion-Swiss-francs luster to the once high-flying portfolio. | As Roche comes under competitive pressure on its breast cancer business, the Swiss company hopes a new drug will add a 2-billion-Swiss-francs luster to the once high-flying portfolio.

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Can AI Reduce Healthcare Disparities? Health Execs Debate

MedCity News

During the Reuters Total Health conference, two healthcare leaders debated whether AI has the potential to reduce healthcare disparities. One argued that the technology is not there yet, while the other argued that it’s about how people use AI. The post Can AI Reduce Healthcare Disparities? Health Execs Debate appeared first on MedCity News.

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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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Baxter medicines in short supply after hurricane hits plant

pharmaphorum

Damage to a Baxter manufacturing facility caused by Hurricane Helene, which rolled across the east US a couple of weeks ago, has led to shortages in some critical medicines.The plant in North Cove, North Carolina, was severely affected by flooding and had to be shut down at the end of September. It is Baxter's biggest manufacturing site and is also the largest supplier of intravenous and peritoneal dialysis solutions to the US market.

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Lundbeck to acquire Longboard Pharmaceuticals for $2.6bn

Pharmaceutical Technology

Lundbeck is to acquire Longboard for $2.6bn equity value in a move set to enhance its capabilities within neuro-rare conditions.

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Direct to Patient Healthcare

Healthcare Success

Struggling with burnout while maintaining high-quality healthcare services that patients love? Tune in to our latest podcast as Lee Aase, founder of HELPCare, LLC, shares how he transitioned from his pioneering social media work at Mayo Clinic to lead an innovative membership-based direct-to-patient healthcare business. This podcast is a must-listen for healthcare leaders and primary care practitioners seeking innovative ways to enhance patient access, optimize care delivery, and address challen

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Activist investor Starboard accuses Pfizer of strong-arming former execs into backing CEO Bourla ahead of strategy meeting

Fierce Pharma

Activist investor Starboard accuses Pfizer of strong-arming former execs into backing CEO Bourla ahead of strategy meeting zbecker Thu, 10/10/2024 - 11:03

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time