Mon.Oct 14, 2024

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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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Lundbeck’s Neuro-Rare Pipeline Lands Cornerstone Drug via $2.6B Longboard Pharma Acquisition

MedCity News

Lundbeck says Longboard Pharmaceuticals’ drug, bexicaserin, has potential applications in a range of rare epilepsies. Last month, the biotech began a Phase 3 clinical trial testing the drug in Dravet syndrome. The post Lundbeck’s Neuro-Rare Pipeline Lands Cornerstone Drug via $2.6B Longboard Pharma Acquisition appeared first on MedCity News.

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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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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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Catalent offloads New Jersey manufacturing plant, HQ to Belgian CDMO Ardena

Fierce Pharma

Awaiting a potential acquisition by Novo Holdings, Catalent is giving its contract manufacturing compatriot a boost as Ardena plots its U.S. debut. | Catalent is selling its oral solids facility in Somerset, New Jersey, to Belgium’s Ardena for an undisclosed sum. The site also doubles as Catalent's current corporate headquarters.

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Precision Psychiatry is Possible — Especially if We Use Evidence-based Neural Measures to Drive Better Mental Health Treatment and Outcomes

MedCity News

By moving beyond subjective and heterogeneous criteria and embracing objective brain function measures, the field of psychiatry can achieve greater precision and efficacy in addressing complex disorders. The post Precision Psychiatry is Possible — Especially if We Use Evidence-based Neural Measures to Drive Better Mental Health Treatment and Outcomes appeared first on MedCity News.

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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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Samsung Biologics’ Manufacturing Capabilities for Complex Biomedicines

Fierce Pharma

By Lalit Saxena, Senior Director of MSAT, and Sungkeum Seo, Director of MSAT Labs Upstream Processing at Samsung BiologicsIntroduction | The biopharmaceutical industry is expanding rapidly, driven by an increasing demand for complex biomedicines. Today, manufacturing biomolecules presents unique challenges, like cost pressure and market uncertainty.

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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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Leqembi's vial design could result in hundreds of millions in annual Medicare waste: study

Fierce Pharma

As payers tally up the potential costs of anti-amyloid antibodies for Alzheimer’s disease, a new study suggests that the vial design for Eisai and Biogen’s Leqembi could result in hundreds of milli | As payers tally up the potential costs of anti-amyloid antibodies for Alzheimer’s disease, a new study suggests that the vial design for Eisai and Biogen’s Leqembi could result in hundreds of millions of dollars in wasted spending each year for Medicare.

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

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GSK asthma hope depemokimab works in second indication

pharmaphorum

GSK's six-monthly IL-5 inhibitor depemokimab clears two phase 3 trials in chronic rhinosinusitis with nasal polyps (CRSwNP), its second indication

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Community Pharmacies Fill Critical Healthcare Gaps in Rural Areas — Here’s How We Can Empower and Support Them

MedCity News

We need to equip pharmacists with technology that can help them to make impactful clinical interventions in the pharmacy and reimburse them for these services, which would help to address the provider shortage. The post Community Pharmacies Fill Critical Healthcare Gaps in Rural Areas — Here’s How We Can Empower and Support Them appeared first on MedCity News.

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CEPI-backed trial of Rift Valley fever jab starts in Kenya

pharmaphorum

For the first time, a vaccine candidate for Rift Valley fever, developed by Oxford University, has been advanced into a phase 2 trial backed by CEPI.

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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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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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Leveraging Influencer Networks in Pharma Marketing: Strategies for Building Trust and Engagement

Pharma Marketing Network

In the ever-evolving landscape of pharmaceutical marketing, the traditional methods of reaching healthcare professionals and consumers are gradually being supplemented by innovative digital strategies. Among these, influencer marketing has emerged as a powerful tool for pharma companies seeking to build trust and foster engagement with their target audiences.

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‘Selling a Vision’: Today’s Playbook for Startups

PharmExec

The Big Pharma commercialization playbook doesn’t work for emerging life sciences companies bootstrapping their way up. Exploring three strategies that could be the ingredients of a winning formula for startups.

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Navigating the Evolving Pharma Industry: Key Marketing Strategies for Pharma Executives

Pharma Marketing Network

The pharmaceutical industry is undergoing unprecedented changes driven by technological advancements, regulatory shifts, and a more informed patient base. As the landscape evolves, pharma executives must adapt their marketing strategies to remain competitive and effectively reach their target audiences. This article explores the key trends reshaping the industry and offers insights into innovative marketing approaches and strategies that pharma executives can employ to navigate these changes suc

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Rafaat Rahmani: Beating the Odds

PharmExec

Rafaat Rahmani, president and founder of Lifescience Dynamics, grew up in abject poverty, but such hardships—and a later violent brush with racism—would ultimately end up fueling a determined and entrepreneurial path in the life sciences.

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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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Haemophilia treatment with new delivery method approved

European Pharmaceutical Review

The first anti-tissue factor pathway inhibitor (anti-TFPI) treatment for haemophilia A or B in the US has been approved by the US Food and Drug Administration (FDA). Hympavzi (marstacimab-hncq) is authorised for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in individuals 12 years of age and over with haemophilia A or haemophilia B without inhibitors.

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FDA Approves Pfizer’s Hympavzi for Prophylaxis in Patients with Hemophilia A or B

PharmExec

Hympavzi is the first anti-tissue factor pathway inhibitor therapy to be approved in the United States for routine prophylaxis of bleeding in patients with hemophilia A or B without inhibitors.

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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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Lundbeck Agrees to Terms to Acquire Longboard Pharmaceuticals

PharmExec

Acquisition of Longboard grants Lundbeck access to bexicaserin, 5-HT2C receptor agonist that has demonstrated promise in treating seizures associated with rare developmental epileptic encephalopathies.

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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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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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Tech Transfer Considerations

PharmaTech

Ahmed Youssef, senior manager, USP Process Development at Ascend, provides insight on tech transfer when developing and manufacturing emerging therapies and new modalities.

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AI: A Value Advantage? Maximizing Your Brand Outreach

PharmExec

Practical ways product teams can leverage the benefits of generative artificial intelligence as a strategic advantage in pharmaceutical and life sciences commercialization.

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FDA rethinking block on compounding of Lilly's obesity drug

pharmaphorum

Faced with lawsuit, FDA rethinks block on compounding pharmacies making Eli Lilly's diabetes and obesity drug tirzepatide

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Study: Redispensing Unused Medication Greatly Reduces Waste in Shift Toward Sustainability

PharmExec

JAMA study finds that redispensing oral anticancer drugs reduces approximately two-thirds of medication waste as healthcare stakeholders seek more sustainable practices.

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Navigating the Complexities of Drug Formulation

PharmaTech

For the pharmaceutical industry, drug formulation is a cornerstone, crucial for converting bioactive molecules into effective, stable, and patient-friendly medications.

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Effective Resolutions to Supply Chain Issues

Pharmaceutical Commerce

Lucy Alexander, capabilities lead, global supply chain and strategy, AstraZeneca, discusses examples of how effective communication can resolve supply chain issues.

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Will a Medicare boost propel digital therapeutics to the mainstream?

PharmaVoice

Digital therapeutics have languished in the background of traditional medicines for years, but a recent reimbursement push may have gotten the ball rolling.

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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.