Sat.Oct 05, 2024 - Fri.Oct 11, 2024

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How Enterprise Architecture is Reshaping Modern Medicine

Pharma IQ

Discover how Enterprise Architecture is transforming healthcare operations, enhancing patient care, and addressing technical debt in the industry.

Medicine 130
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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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Video: Why the FTC’s Lawsuit Against PBMs May Have Some Legs

MedCity News

Months before the FTC sued the three largest pharmacy benefit managers, the CEO of Blue Shield of California battled its PBM – CVS Caremark – to bring a lower cost prostate cancer drug to its members. The post Video: Why the FTC’s Lawsuit Against PBMs May Have Some Legs 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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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).

Sales 101
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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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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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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.

Sales 107
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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.

Medical 312
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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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Rural Healthcare Needs More Than Just Telehealth

MedCity News

People working the most vital occupations, like farmers and ranchers, call the most remote areas in this country home. Their health shouldn’t suffer due to their choice of employment. The post Rural Healthcare Needs More Than Just Telehealth appeared first on MedCity News.

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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.

Sales 101
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AstraZeneca heads to regulators after Airsupra asthma trial stops early thanks to 'overwhelming efficacy'

Fierce Pharma

After winning a first-in-class nod for its two-drug inhaler Airsupra l | After winning a first-in-class nod for its two-drug inhaler Airsupra last January, AstraZeneca is bolstering the rescue treatment’s clinical package with new data showing it can cut the risk of asthma exacerbations regardless of patients’ disease severity.

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First real-world study reveals encouraging efficacy for cell therapy

European Pharmaceutical Review

New results from a first-of-its-kind study reports that a CAR-T cell therapy provided similar efficacy and safety to relapsed or refractory multiple myeloma patients administered with the treatment in clinical trials. For example, of the 236 patients who received infusions of ciltacabtagene autoleucel (cilta-cel), data shows that 89 percent responded to the treatment.

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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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Establishing Better Health Care Outcomes through AI

MedCity News

The scaling power of AI can simultaneously remove barriers to access, drive costs down system-wide and elevate the role of the human clinician so they can focus on human touch that their patients need. The post Establishing Better Health Care Outcomes through AI appeared first on MedCity News.

Patients 110
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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.

Media 103
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Amid GLP-1 craze, Novo and Mylan ink patent settlement in Ozempic case

Fierce Pharma

With a new patent settlement, generic partners Mylan and Natco have cleared one hurdle to a potential U.S. launch of their generic to Novo Nordisk's wildly popular Type 2 diabetes drug Ozempic. | Mylan Pharmaceuticals and Novo Nordisk have reached a confidential settlement in a patent lawsuit tied to generic Ozempic, also known as semaglutide, India’s Natco Pharma said.

Pharma 312
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NUHS’s CD7 CAR-T cell therapy shows promise for leukaemia

Pharmaceutical Technology

The CD7 CAR)-T cell therapy has demonstrated potential in treating patients with relapsed or refractory T-cell leukaemia.

Patients 121
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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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Healthcare’s Silver Lining: The Promise of Building a Health System in the Cloud

MedCity News

The idea is to harness the power of digital tools and cloud-based systems to create solutions that understand the root cause of healthcare needs, which will ultimately revolutionize care delivery, improve outcomes and reduce costs. The post Healthcare’s Silver Lining: The Promise of Building a Health System in the Cloud appeared first on MedCity News.

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NHS England to be given a bigger role in GP data sharing

pharmaphorum

UK Health Secretary Wes Streeting has announced plans to allow NHS England to share primary care data with scientific researchers, taking on some of the responsibility held by GPs. The minister told the Royal College of General Practitioners (RCGP) annual conference that, while many UK patients have given their consent for their data to be shared with studies run by the likes of the UK Biobank, Genomics England, and Our Future Health, they "still see, far too often, that this data is not shared

Patients 101
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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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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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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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Scholar Rock Scores $300M for Regulatory Filings & Launch Plans for Neuromuscular Disease Drug

MedCity News

On the heels of Phase 3 data showing muscle improvement in the rare neuromuscular disease spinal muscular atrophy, Scholar Rock raised $300 million in a stock offering. U.S. and European regulatory submissions for the drug are now planned for early 2025. The post Scholar Rock Scores $300M for Regulatory Filings & Launch Plans for Neuromuscular Disease Drug appeared first on MedCity News.

Biopharma 110
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Starboard claims Pfizer 'threatened' former leaders

pharmaphorum

Starboard Value alleges former Pfizer execs Ian Read and Frank D'Amelio were bullied into lending their support to current management

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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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Novo’s GLP-1 Wegovy could improve heart health for millions more than previously thought, AI study finds

PharmaVoice

Through real-world data, an AI company found that popular weight loss drugs could be a preventive measure for patients at risk of heart attack and stroke.

Patients 102
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Video: Besides, Pharma and PBMs, Who Drives Up Drug Costs?

MedCity News

If you thought that Big Pharma and the PBMs were the only bad guys in the saga of unreasonably high prescription drug prices in the United States, you would be wrong. Hear who else is to blame from the CEO of Blue Shield of California. The post Video: Besides, Pharma and PBMs, Who Drives Up Drug Costs? appeared first on MedCity News.

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Lawmaker asks FTC to probe Novo/Catalent deal

pharmaphorum

US Senator Elizabeth Warren asks FTC to scrutinise $16.5bn Novo Holdings/Catalent merger and sale of manufacturing plants to Novo Nordisk.

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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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EMA starts review into hair loss drugs about potential link to suicidal thoughts 

Pharmaceutical Technology

The safety review was requested by the French medicines agency, citing new safety reports that alter the risk profile of finasteride.

Safety 105
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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.