Fierce Pharma

JANUARY 25, 2024

Three months after launching an investigation into the risk of patients developing secondary T-cell cancers after receiving a CAR-T drug, the FDA has shared more information on the cases it has see | Three months after launching an investigation into the risk of secondary T-cell cancers after treatment with a CAR-T medicine, the FDA has shared more information on the cases that it has seen.

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Safety FDA Medicine Patients 258

MedCity News

JANUARY 25, 2024

The California Department of Health Care Services launched the Behavioral Health Virtual Services Platform last week. The platform includes two digital health solutions: BrightLife Kids (developed by Brightline) for parents/caregivers and kids ages 0 to 12 and Soluna (developed by Kooth) for teens and young adults ages 13 to 25.

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Fierce Pharma

JANUARY 25, 2024

A decade after Translarna's initial marketing authorization in Europe, it looks like the drug's run in the region is coming to an end. | A decade after Translarna's initial marketing authorization in Europe, it looks like the drug's run in the region is coming to an end.

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Marketing 222

MedCity News

JANUARY 25, 2024

Key trends such as the resilience of the emerging biopharma space, the complexities of Medicare, and the revolutionary role of data and AI are shaping the future of the industry.

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Fierce Pharma

JANUARY 25, 2024

Two months ago, in presenting quarterly earnings, CEO Barry Greene said Sage Ther | Two months ago, in presenting quarterly earnings, CEO Barry Greene said Sage Therapeutics was on its way to becoming a “leaner and stronger company.” Part of that mission will come to fruition later this year with a move of its headquarters in Cambridge, Massachusetts.

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MedCity News

JANUARY 25, 2024

CG Oncology’s upsized IPO will support pivotal testing of cretostimogene, an oncolytic virus for non-muscle invasive bladder cancer. The clinical program spans tests of the engineered virus as a monotherapy and as part of combination treatments.

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Engineering Biopharma Pharma 114

MedCity News

JANUARY 25, 2024

AWS is funneling an additional $20 million into its health equity initiative, bringing the company’s total investment in the program to $60 million. As AWS continues to advance the mission of this program, the company is focusing on three main priorities: increasing access to high quality care, building resilient communities, and mitigating the harmful effects of climate change.

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Fierce Pharma

JANUARY 25, 2024

The FDA will convene an advisory committee to discuss Johnson & Johnson and Legend's Carvykti filing in earlier multiple myeloma. | The FDA will convene an advisory committee to discuss Johnson & Johnson and Legend's Carvykti filing in earlier multiple myeloma. AstraZeneca has won a world-first approval for its rare blood disorder add-on therapy in Japan.

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MedCity News

JANUARY 25, 2024

Despite the significant challenges to improving U.S. health outcomes while reducing healthcare spending, I am heartened by the exciting ways in which government organizations and the private sector are innovating and deploying new technologies that can achieve these goals.

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Government Patients Healthcare Healthcare 101

European Pharmaceutical Review

JANUARY 25, 2024

Eli Lilly and Company’s Executive Vice President of Global Quality, Johna Norton, is ending her lengthy tenure with the company this summer and retiring after 34 years of service. However, she will continue in her current role and remain as part of Eli Lilly’s Executive Committee of until 31 July 2024. “Johna’s career has been built on her commitment to ensuring that our medicines are produced with the highest quality standards.

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Manufacturing Medicine Pharmaceutical Patients 91

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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.

Safety

MedCity News

JANUARY 25, 2024

Panel discussions will include investment trends, women’s health, value-based care, employer health and more. Startups will also have the opportunity to meet with investors as part of our Ask the Investor program. The conference will be held May 21-22 at the Ritz Carlton in Chicago. Register today!

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pharmaphorum

JANUARY 25, 2024

UK government is reported to be considering financial aid for AstraZeneca to seal a deal to expand a vaccines manufacturing facility in Speke

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Government Manufacturing 95

European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. These standardised documents provide meticulously curated and scientifically approved information. They detail the medication’s intended use, proper administration, potential side effects and precautions. They are vital to ensuring the safe and effective use of medicines, making them an integral part of healthcare in Europe.

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Healthcare Healthcare Electronics Safety 84

pharmaphorum

JANUARY 25, 2024

NICE firms up guidance backing NHS use of five digital health wearables for remote monitoring of Parkinson's disease patients

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Patients 92

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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

Distribution

PharmaTimes

JANUARY 25, 2024

Around 50% of babies born with the condition are affected by heart defects

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pharmaphorum

JANUARY 25, 2024

Our latest crop of biotech financings features rounds for Synnovation Therapeutics and Adicet Bio, Calluna Pharma, Accent Therapeutics, GenEdit and IMU Bio

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Pharma 74

Copyright Clearance Center

JANUARY 25, 2024

January 25, 20 24, Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, has been named a winner for the second year in a row for Customer Service Department of the Year by Best in Biz Awards 2023 International. Winners in the 11 th annual program were determined based on scoring from an independent panel of judges from a variety of top-tier publications and media outlets representing 15 countries from across six continents.

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Media 75

pharmaphorum

JANUARY 25, 2024

Indian pharma Glenmark has licensed rights to subcutaneous PD-L1 inhibitor envafolimab from China’s Alphamab and 3D Medicines

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Medicine Pharma 81

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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.

Safety

Pharmaceutical Technology

JANUARY 25, 2024

Evaxion Biotech has announced plans to develop customised cancer vaccines by targeting a category of AI-discovered tumour antigens.

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Rep-Lite

JANUARY 25, 2024

What’s the purpose of a career clinical recruiter? Clinical recruiters are specialized professionals within the healthcare industry, dedicated to filling vacancies in roles directly related to patient care or clinical research. They connect qualified candidates to institutions and companies while leveraging their in-depth knowledge of the healthcare field, specific specialties, and the intricacies of hiring within each domain.

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Recruitment Specialization Healthcare Healthcare 52

ALULA

JANUARY 25, 2024

In today’s workplace, it’s easy to wake up and find ourselves in a funk. A short break, chat with a mentor, or bit of self-care usually does the trick! But what happens when an entire team gets in a funk? The solution is less clear, and the impac t can strike a long-term blow to p erformance and engagement.

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Pharmaceutical Commerce

JANUARY 25, 2024

Zynrelef was initially approved by the FDA for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours following bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty.

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FDA 52

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Specialization

ALULA

JANUARY 25, 2024

The first month of 2024 is almost over , and leaders are already finding themselves feeling like a pinball at work: bouncing around between meetings, reports, and decisions without finding – or taking – opportunities to prioritize something that guarantees swift productivity and progress: performance coach ing their people.

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PharmaTech

JANUARY 25, 2024

The 2024 Pharmapack Europe Award winners include companies involved in ground-breaking innovations in novel drug delivery solutions, reusable connected devices, and recyclable packaging.

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PharmExec

JANUARY 25, 2024

FDA leadership notes that the overall rate of secondary T-cell cancers among patients administered CAR T-cell therapies appears to be low, even if all reported cases are assumed to be related to treatment.

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FDA Patients 52

Pharmaceutical Commerce

JANUARY 25, 2024

FDA adds Boxed Warning that the osteoporosis medication increases the risk for severe hypocalcemia in patients with advanced chronic kidney disease, especially among those undergoing dialysis

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FDA Patients Medical 52

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

Leads

Clarify Health

JANUARY 25, 2024

In the healthcare sector, the strategic use of predictive analytics is crucial for providers aiming to maintain competitiveness. Leveraging data allows them to more accurately anticipate and adapt to market shifts and evolving patient needs. By effectively employing predictive analytics, healthcare providers can ensure they remain responsive and ahead of competitors.

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Healthcare Healthcare Marketing Healthcare Provider 52

PharmExec

JANUARY 25, 2024

Severe hypocalcemia was found to be more common among patients with advanced chronic kidney disease with mineral and bone disorder who are taking Prolia for osteoporosis.

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FDA Patients 52

Pharmaceutical Commerce

JANUARY 25, 2024

Patients treated with Tremfya (guselkumab) saw major improvements in scalp psoriasis clearance, itch reduction, and patient-reported health-related quality of life.

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Patients 52

Pharmaceutical Technology

JANUARY 25, 2024

The milestone-based payment came from Roche after Repare dosed the first patient with personalised solid-tumour treatment camonsertib.

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Patients 59

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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

Management