Fierce Pharma

NOVEMBER 12, 2024

Despite generic headwinds to Xarelto and challenges across different sectors of the conglomerate suggesting “twists and turns” in the road ahead, Bayer is confident that the course it’s laid out th | As Xarelto generics continue to eat away at sales, Bayer's Nubeqa and Kerendia are picking up the slack while Regeneron-partnered Eylea makes for a solid base.

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Sales 264

MedCity News

NOVEMBER 12, 2024

Now is the time for health plans to step up and embrace the tools and strategies that will not only meet regulatory demands, but also drive innovation in care delivery. The post Where Medicare Advantage Goes From Here appeared first on MedCity News.

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Fierce Pharma

NOVEMBER 12, 2024

In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval for its liver disease drug Ocaliva has come up short. | Intercept received a complete response letter from the FDA, dashing the company’s hopes of turning Ocaliva’s accelerated green light into a traditional approval for the rare autoimmune disease primary biliary cholangitis.

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MedCity News

NOVEMBER 12, 2024

As radiopharmaceuticals enter a new phase, industry leaders must rethink external services and internal capabilities to master the complexities of delivering advanced therapies. The post Unlocking the Future of Radioligand Therapy: From Discovery to Delivering at Scale appeared first on MedCity News.

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Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Patients

Fierce Pharma

NOVEMBER 12, 2024

Despite China’s investigations into insurance fraud, allegedly illegal importation of unapproved drugs and improper collection of patient data that have implicated senior executives, AstraZeneca CE | Despite China’s investigations that have implicated senior executives, AstraZeneca CEO Pascal Soriot argued that the company did not lose oversight and remains on track to achieve his ambitious $80 billion-by-2030 revenue goal.

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Insurance Patients 214

pharmaphorum

NOVEMBER 12, 2024

Daiichi Sankyo and AstraZeneca give up on their NSCLC application for Dato-DXd, and refile seeking a narrower label

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FDA 105

pharmaphorum

NOVEMBER 12, 2024

Merck KGaA is shaping up to take on Daiichi Sankyo and Ono Pharma in the market for tenosynovial giant cell tumour (TGCT) therapies after its drug candidate pimicotinib cleared a phase 3 trial.The German group said the CSF-1R inhibitor given as a once-daily, oral dose hit its primary endpoint in the MANEUVER study, achieving an objective response rate (ORR) at week 25 of 54% compared to 3.2% for a matched placebo in patients with TGCT, a rare disease affecting the joints and tendons.

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Fierce Pharma

NOVEMBER 12, 2024

Citing a rosy view of the U.S. | AstraZeneca on Tuesday revealed that it’s adding $2 billion more to its current outlay in the U.S., representing a total capital investment of $3.5 billion. The cash will be used to grow the company’s research and production footprint in the States by the end of 2026, generating more than 1,000 new jobs along the way.

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Manufacturing 166

MedCity News

NOVEMBER 12, 2024

Neurogene’s Rett syndrome gene therapy has preliminary data supporting safety and efficacy of the one-time treatment. But a late-breaking report of a serious complication in a patient who received the high dose sent shares of the biotech downward. The post Neurogene Gene Therapy Shows Signs of Efficacy in Small Study, But an Adverse Event Spooks Investors appeared first on MedCity News.

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pharmaphorum

NOVEMBER 12, 2024

'Game-changer' daily pill to quit smoking returns to NHS after three-year absence after a deal between Teva and NHS England

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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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MedCity News

NOVEMBER 12, 2024

Fort Health’s $5.5 million in funding was led by Twelve Below and Vanterra and included participation from Redesign Health, Blue Venture Fund and True Wealth Ventures. The post Fort Health Secures $5.5M to Expand Access to Integrated Pediatric Mental Health Care appeared first on MedCity News.

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pharmaphorum

NOVEMBER 12, 2024

Neurogene says Rett syndrome gene therapy improves clinical symptoms, but a serious adverse event causes shares to fall

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Pharmaceutical Technology

NOVEMBER 12, 2024

The FDA agreed for Novavax to continue trials of its vaccine combo after addressing a serious adverse event that paused trials.

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FDA 90

pharmaphorum

NOVEMBER 12, 2024

Virtual wards (also known as hospital at home) allow patients to get the care they need at home safely and conveniently, rather than being in hospital. The NHS is increasingly introducing virtual wards to support people at the place they call home, including care homes. In today’s podcast, web editor Nicole Raleigh speaks with Dr Samuel Ewing, global head of pharma partnerships at Doccla, about the next generation of digital tools such as wearable medical devices, as well as remote patient monit

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Patients Pharma Healthcare Healthcare 59

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Pharmaceutical Commerce

NOVEMBER 12, 2024

In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.

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FDA 59

pharmaphorum

NOVEMBER 12, 2024

23andMe's big push into drug development, announced with great fanfare almost a decade ago, has ended with a whimper and sweeping job losses.The company that made its name by providing saliva-based genetic testing for health and ancestry to millions of people around the world made the decision as part of a major restructuring drive that will see 40% of its workforce lose their jobs.

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Pharmaceutical Commerce

NOVEMBER 12, 2024

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jonathan Colehower, managing director, global operations & supply chain practice at UST, explains how the use of blockchain technology will become more prominent moving forward.

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European Pharmaceutical Review

NOVEMBER 12, 2024

To boost AstraZeneca’s research and manufacturing footprint by the end of 2026, it is dedicating $3.5 billion of capital investment in the US. Of this amount, $2 billion will generate over 1,000 new jobs, the company added. AstraZeneca highlighted its US footprint is expanding in multiple areas such as: • a state-of-the-art R&D centre in Kendall Square, Cambridge, Massachusetts • next generation biologics manufacturing facility based in Maryland • cell therapy manufacturing capacity on the W

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Manufacturing Biopharma Healthcare Healthcare 59

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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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pharmaphorum

NOVEMBER 12, 2024

AstraZeneca plans to invest a whopping $3.5 billion to expand its R&D and manufacturing operations in the US by 2026 as part of a drive to raise its revenues to $80 billion by the end of the decade.The programme – part of the pharma group's Ambition 2030 effort – will include the construction of a new R&D centre at Kendall Square in the heart of the biopharma hub in Cambridge, Massachusetts, and a biologics manufacturing facility in Maryland.

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Pharmaceutical Technology

NOVEMBER 12, 2024

A team of researchers from Uppsala University and KTH Royal Institute of Technology in Sweden has developed a new antibody, which could potentially treat various types of cancer.

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PM360

NOVEMBER 12, 2024

The 2025 Healthcare CMO Summit is an exclusive invitation-only event designed to bring together Chief Medical Officers (CMOs) and innovative suppliers and solution providers. Scheduled for February 3-4, 2025 , at The Ritz-Carlton Dallas, Las Colinas , the summit will address key clinical healthcare challenges and relevant market developments. Key Topics The summit will cover a range of critical topics, including: Reviving the Hospital Workforce: Addressing staffing shortages and productivity de

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Medical Healthcare Healthcare Safety 52

PharmaTech

NOVEMBER 12, 2024

Spray drying enables the production of amorphous solid dispersions, allowing efficient scale-up from small screening batches to commercial levels. By leveraging small-scale experiments for process design and qualification, a robust validation strategy can be developed to support flexible, scalable manufacturing for small-molecule drug products.

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Manufacturing 52

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PM360

NOVEMBER 12, 2024

The 2025 Healthcare CNO Summit , an exclusive invitation-only event, is scheduled for February 3-4, 2025, at The Ritz-Carlton Dallas, Las Colinas. This premier summit aims to bring together influential Chief Nursing Officers (CNOs) and innovative suppliers to address the evolving challenges in healthcare and foster strategic partnerships. The summit will focus on critical topics essential to the nursing profession, including: CNE Leadership Role: Examining the essential skill set that impacts n

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Healthcare Healthcare Safety Networking 52

Contrarian Sales Techniques

NOVEMBER 12, 2024

Having worked with numerous optical businesses across Malaysia, from bustling Klang Valley to growing cities like Penang and Johor Bahru, I understand the unique challenges of our local market. Let me share proven strategies that have helped Malaysian opticians transform their businesses into thriving enterprises. Understanding the Malaysian Optical Market Landscape The Malaysian optical market is uniquely diverse, serving customers from various cultural backgrounds and income levels.

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PM360

NOVEMBER 12, 2024

Brain health is a notoriously difficult domain of medicine. What recent advancements excite you, and how can we foster continued innovation in this area? Brain health is undoubtedly one of the most challenging areas of medicine, often called the “last frontier.” The brain shapes who we are and how we see the world, yet treating brain health disorders is a monumental challenge.

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PharmExec

NOVEMBER 12, 2024

Approval of Aucatzyl was based on results of the FELIX trial, which demonstrated a 63% overall complete remission rate among efficacy-evaluable patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

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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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Copyright Clearance Center

NOVEMBER 12, 2024

November 12, 2024 – Danvers, Mass. – The Women’s Edge and its partner, The Boston Globe , announced that CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, was named to its annual Top 100 Women-Led Businesses in Massachusetts list. CCC ranked #16. This is the 24 th year that The Women’s Edge, a Boston-based nonprofit organization devoted to advancing women in leadership positions, has created the list through a nomination process and reviewed both for-p

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PharmExec

NOVEMBER 12, 2024

Decision to submit the Biologics License Application of datopotamab deruxtecan was based on feedback from a previously withdrawn application to the FDA for nonsquamous non-small cell lung cancer.

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FDA 52

Pharmaceutical Technology

NOVEMBER 12, 2024

Zai Lab and argenx have announced receipt of approval from the National Medical Products Administration (NMPA) of China for the supplemental biologics license application (sBLA) for VYVGART Hytrulo 1,000mg vial for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

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Medical 52

PharmExec

NOVEMBER 12, 2024

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

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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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