Fri.Oct 11, 2024

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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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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.

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Evonik telegraphs another 260 layoffs amid multiyear reorganization

Fierce Pharma

Earlier this year, Evonik unveiled a restructuring project that will result in up to 2,000 layoffs. | After Evonik in March unveiled a restructuring project that will result in up to 2,000 layoffs, the company is now announcing another round of job cuts as it retools portions of its drug ingredients and nutrition businesses.

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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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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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Teva hands over $450M to resolve kickback lawsuits involving MS drug Copaxone and generics

Fierce Pharma

A little over four years after being sued by the United States, Teva is putting longstanding allegations that it paid kickbacks on a popular multiple sclerosis drug to bed. | Teva Pharmaceuticals USA and Teva Neuroscience have agreed to pay a combined $450 million to resolve claims that the company violated the United States' Anti-Kickback Statute and the False Claims Act, the U.S.

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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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Medicare Advantage Star Ratings Drop Again

MedCity News

For 2025, the average star rating for Medicare Advantage Prescription Drug contracts was 3.92, compared to 4.07 for 2024, 4.14 for 2023 and 4.37 for 2022. The post Medicare Advantage Star Ratings Drop Again appeared first on MedCity News.

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Fierce Pharma Asia—AstraZeneca-CSPC heart med deal; Astellas' gene therapy pact, new cell therapy site

Fierce Pharma

AstraZeneca has bagged a cardiovascular disease candidate from China's CSPC Pharma in a deal potentially worth $2 billion. | AstraZeneca has bagged a cardiovascular disease candidate from China's CSPC Pharma in a deal potentially worth $2 billion. Astellas is shuffling its cell therapy research team and investing in a dementia gene therapy candidate.

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Roche gets FDA green light for breast cancer drug Itovebi

pharmaphorum

FDA gives Roche the first approval for PI3K inhibitor Itovebi, clearing the drug for certain types of advanced breast cancer

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

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From Crawling to Caring: The Evolution of Clinical Practice with AI and Its Transformative Impact on Healthcare

MedCity News

As clinicians begin to rely more on AI, they will also need to cultivate new skills, particularly around critical interpretation of AI-generated insights, to fully leverage its potential in patient care. The post From Crawling to Caring: The Evolution of Clinical Practice with AI and Its Transformative Impact on Healthcare appeared first on MedCity News.

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Vaccines “essential” for addressing AMR, says WHO

European Pharmaceutical Review

A new report by the World Health Organization (WHO) has emphasised the importance of vaccines in addressing antimicrobial resistance (AMR) globally. For example, the report explained that “vaccines against 24 pathogens could reduce the number of antibiotics needed by 22 percent or 2.5 billion defined daily doses globally every year”. Vaccines are a key part of helping to reducing AMR because they “prevent infections… and slow the emergence and spread of drug-resistant pathogens”, WHO explained.

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Aiming to Outdo Rivals in Severe Asthma, Upstream Bio Upsizes IPO to $225M

MedCity News

Upstream Bio will use its IPO haul to continue clinical testing of verekitug, which it contends be a better treatment option for severe asthma compared to a commercialized Amgen and AstraZeneca drug. CAMP4 Therapeutics and Ceribell also priced IPOs to join the public markets. The post Aiming to Outdo Rivals in Severe Asthma, Upstream Bio Upsizes IPO to $225M appeared first on MedCity News.

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CPHI Milan 2024: Pharma Industry Growth and Investment

PharmaTech

Pharmaceutical Technology Europe spoke with John McQuaid, president and managing director at Almac Pharma Services, at CPHI Milan 2024, held October 8–10, in Milan, Italy, about how the pharmaceutical industry is growing and what might drive investment in the future.

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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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Improve Patient Care or Keep Data Secure in Healthcare? Yes.

Salesforce

The rapid evolution of the healthcare landscape is nothing short of revolutionary. Technological innovations such as mobile health apps, wearable devices, and AI are transforming how care is delivered. Regulatory shifts, changing consumer demographics, cutting-edge research, landmark policies like the Patient Protection and Affordable Care Act, and the push towards outcomes-based reimbursement have raised the stakes for healthcare organizations.

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Workforce Shortages? Attract and Retain Top Talent With Employer Branding

Healthcare Success

Are you struggling to fill critical positions in your healthcare organization? You’re not alone. With competition for top talent at an all-time high, hospitals and health systems must prioritize employer branding to attract and retain skilled professionals. Why Employer Branding Matters Employer branding isn’t just a marketing buzzword—it’s a critical strategy for healthcare organizations.

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Evonik Wins Award at CPHI Milan for Plant-based Parenteral Drug Delivery Adjuvant

PharmaTech

Evonik won the CPHI Excellence in Pharma Award in the “Sustainability” category in recognition of its plant-based squalene, PhytoSquene, used in parenteral drug delivery applications.

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LogiPharma USA 2024: Confronting Conflicting Priorities Between Supply Chain Partners

Pharmaceutical Commerce

Lucy Alexander, capabilities lead, global supply chain and strategy, AstraZeneca, discusses how to handle opposing concerns between supply chain teams and offers communication solutions.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA Approves Roche’s Itovebi for Endocrine-Resistant, PIK3CA-Mutated Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

PharmExec

Approval was based on results from the Phase III INAVO120 trial, which found that Itovebi in combination with palbociclib and fulvestrant significantly improved progression-free survival in patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer.

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Syneos Health Appoints Costa Panagos as Chief Executive Officer

PM360

Colin Shannon Appointed Executive Chairman Seasoned Executive Further Strengthens Company’s Leadership Team MORRISVILLE, N.C., Oct. 09, 2024 (GLOBE NEWSWIRE) — Syneos Health ® , a leading fully integrated biopharmaceutical solutions organization, today announced the appointment of Costa Panagos as CEO and a member of the Company’s Board of Directors, effective immediately.

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Harnessing Grit: A Key to Thriving in Healthcare with Scott Burrows, Inspirational Keynote Speaker 

Scott Burrows

In the demanding world of healthcare, grit can be the differentiator between merely surviving the day and truly thriving in your profession. As someone who faced life-altering challenges after a devastating accident, I’ve come to understand that grit—characterized by perseverance, resilience, and passion—can transform how we approach both our work and our lives.

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BMS’ next act for Cobenfy — and other highs and lows in Alzheimer’s

PharmaVoice

The Alzheimer’s space is booming, from a new use for a schizophrenia drug to discovered pathways linked to the disease — but there’s been stumbles too.

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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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Building Resilience to Maintain A Growth Mindset

Scott Burrows

This month on Instagram, Facebook, and LinkedIn, we’re diving into the power of Mindset. A strong mindset is key to achieving your goals—but how do you maintain it during hardships and adversity? The answer lies in one word: Resilience. Resilience is the ability to bounce back from setbacks and adapt to challenges. It’s not just about enduring tough times, but growing stronger through them.

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Integrating Digital Solutions to Enhance Traceability and Safety in Drug Administration

PharmExec

Laura Johnson, senior director, sales, life sciences, Loftware, discusses integrating digital solutions with traceability and drug administration.

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FDA Approves Marstacimab-hncq for Adults, Adolescents With Hemophilia A or B Without Inhibitors

Pharmacy Times

This approval marks the first and only anti-tissue factor pathway inhibitor approved in the US for the treatment hemophilia A or B, and the first approved hemophilia treatment to be administered via a pre-filled, auto-injector pen.

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How to Rally a Team Around Building a New Business

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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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Global awareness and geographic variations of plaque psoriasis

Pharmaceutical Technology

Plaque psoriasis is a chronic condition that affects millions yet is often misunderstood or underappreciated in terms of its broader impact

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Trading Quality for Convenience? The New Tech Balancing Act

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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CPHI Milan: Targeting supply chain bottlenecks key for cell and gene therapies

Pharmaceutical Technology

At CPHI Europe, Angela Vollstedt, global director of Cell & Gene Therapies at Novartis discussed scale up strategies for cell therapies.

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Amazon Targeting the Transactional in the Pharma Market

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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.