Mon.Oct 28, 2024

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Top 10 CDMO Services You Didn’t Know You Needed

Drug Patent Watch

The pharmaceutical industry relies heavily on Contract Development and Manufacturing Organizations (CDMOs) to streamline the drug development and manufacturing process. CDMOs provide a wide range of services that cater to the diverse needs of pharmaceutical companies, from early-stage development to commercial manufacturing.

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Redlining’s lasting impact on asthma disparities

Pharmaceutical Technology

The enduring effects of redlining on public health, particularly on asthma prevalence, provide a striking example of how discriminatory housing policies from the 20th century continue to shape the well-being of marginalised communities affected by this practice today.

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Don’t let your samples slip: Why every clinical trial needs biospecimen management

Bio Pharma Dive

Assure the integrity and efficiency of your clinical trials with support from a Biospecimen Manager.

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FDA approves Iterum’s ORLYNVAH NDA for uUTI treatment

Pharmaceutical Technology

The US FDA has approved Iterum Therapeutics' NDA for ORLYNVAH to treat uncomplicated urinary tract infections (uUTIs).

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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AbbVie to acquire a J&J-backed brain drugmaker for $1.4B

Bio Pharma Dive

Buying Aliada Therapeutics would hand AbbVie a clinical-stage Alzheimer’s medicine and a drugmaking technology that may be useful for a variety of brain diseases.

Medicine 239
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EU Critical Medicines Act: closer to ending overreliance on Asian manufacturers

Pharmaceutical Technology

China's virtual monopoly on the supply of many APIs could be dangerous for the security of medicine supply to Western countries.

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More Trending

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Transforming pharmaceutical R&D: the impact of digital technologies on drug discovery and development

Pharmaceutical Technology

The Pharmaceutical Automation and Digitalisation Congress (AUTOMA+) 2024 is a strategic platform for discussion and collaboration among decision makers, researchers and technologists who understand and follow this tendency.

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How pharmaceutical companies can leverage print to remain agile and competitive

Bio Pharma Dive

Learn why print remains a preferred channel for healthcare communications, and how printed materials can help build relationships with patients, develop brand loyalty and maintain brand consistency.

Branding 147
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Novartis, Apellis drop dueling datasets as they race for approval in rare form of kidney disease

Fierce Pharma

Novartis and Apellis Pharmaceuticals have rolled out detailed data on iptacopan and pegcetacoplan, respectively, as they race for the prize in a type of rare kidney disease. | Novartis and Apellis dropped new data on their respective meds, iptacopan and pegcetacoplan, in the rare kidney disease C3 glomerulopathy. While Apellis' drug seems to have an efficacy edge based on a cross-trial comparison, Novartis may have gotten the jump by filing for approvals ahead of its competitor.

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Preparing for DSCSA transition with tech-led compliance

Pharmaceutical Technology

Ahead of the upcoming DSCSA November deadline, pharma companies reimagine track-and-trace to tackle the US counterfeit drug landscape.

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

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With new diversity guidance, EHR data plus AI will be critical

Bio Pharma Dive

With the new clinical trial diversity guidelines, the combination of EHR data and AI will be essential.

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UPFs fuelling ‘alarming rise of chronic diseases’ in india

Pharmaceutical Technology

UPFs have become a staple of many diets worldwide, but overconsumption is contributing to an obesity epidemic in India.

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Biogen shows its IgAN hand with felzartamab data

pharmaphorum

Biogen has revealed encouraging phase 2 results with its anti-CD38 antibody felzartamab in rare kidney disease IgA nephropathy (IgAN), which it hopes could join a series of first-in-class therapies for the disorder.Data reported at the Kidney Week 2024 congress in San Diego showed that felzartamab was able to achieve "substantial" reductions in proteinuria and stabilised kidney function in the 54-subject IGNAZ study that extended for 18 months after the last dose of the antibody.

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What is the pharmacy of the future?

Pharmaceutical Technology

As the retail drug pharmacy space undergoes significant change, new formats and designs that centre on the consumer are emerging.

Pharmacy 130
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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MSD, Moderna start phase 3 adjuvant lung cancer trial

pharmaphorum

MSD and Moderna start a third phase 3 trial of their V940 cancer vaccine, their second in early-stage lung cancer.

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FDA grants ODD to Modalis’ MDL-101 to treat LAMA2-CMD

Pharmaceutical Technology

The US FDA has granted orphan drug designation (ODD) to Modalis Therapeutics’ MDL-101, aimed at treating LAMA2-CMD.

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Apple wins in Masimo lawsuit, but its a shallow victory

pharmaphorum

Apple wins in patent infringement lawsuit with wearable maker Masimo, but fails to get the injunction on sales that it sought

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UAE’s clinical trials space matures with experience from Covid-19

Pharmaceutical Technology

At the Outsourcing in Clinical Trials conference, Rohan Simon from the UAE CRO IROS, spoke about the region’s clinical trials landscape.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Viva in vivo: The next generation of cell therapy is fast approaching

pharmaphorum

Discover the latest advancements in cell therapy with the next generation of innovative treatments that are revolutionising healthcare. Explore the future of medicine today.

In-Vivo 111
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Social media engagement boosts rare disease outreach

Pharmaceutical Technology

Motivated patients with rare diseases are using social media widely, making it an effective way to reach patients for trial recruitment.

Trials 130
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Novartis eyes year-end filing in US for Fabhalta in C3G

pharmaphorum

Novartis says Fabhalta shows sustained efficacy in rare disease C3G over 12 months, as it prepares for an FDA filing later this year

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Astellas withdraws Europe ACP application for AMD treatment

Pharmaceutical Technology

Astellas has announced the withdrawal of its MAA for ACP from the EMA to treat geographic atrophy (GA) secondary to AMD.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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National Diabetes Month 2024: Take Charge of Tomorrow — Preventing Diabetes Health Problems

XTalks

November is National Diabetes Month. This year’s theme of National Diabetes Month 2024, “Take Charge of Tomorrow: Preventing Diabetes Health Problems,” highlights how today’s actions can shape healthier futures. On National Diabetes Month 2024, healthcare organizations, policymakers and community programs are raising awareness for the nearly 29.3 million Americans with diagnosed diabetes, alongside 9.7 million undiagnosed and 115.9 million at risk with prediabetes, based on the Ameri

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Astellas pulls geographic atrophy drug filing in the EU

pharmaphorum

Astellas confirmed today it will withdraw its EMA filing for avacincaptad pegol as a treatment for eye disorder geographic atrophy in the EU

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October 28, 2024: New Living Textbook Contribution Explains Differences Between Medicare Data Sources

Rethinking Clinical Trials

Research-identifiable Medicare data can come from traditional fee-for-service Medicare claims or from Medicare Advantage claims. A new contribution to the Living Textbook of Pragmatic Clinical Trials published this month, Use of Medicare Data in PCTs , describes the important differences between these data. At the healthcare system level, differences in incentives for documenting diagnoses can affect the reliability and relevance of data used for pragmatic clinical trials.

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Go slow to go fast: Setting a content transformation journey up for success

pharmaphorum

In a recent pharmaphorum webinar, we sat down with Melanie Walsh, Senior Director, IBD Franchise Customer Experience and Digital Innovation, at Takeda, to learn some tips for successful content transformation.

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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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After prior trial flop, EyePoint's Duravyu bounces back with promising data in DME

Fierce Pharma

Earlier this year, EyePoint Pharmaceuticals’ drug-device combo Duravyu missed the mark in a non-proliferative diabetic retinopathy (NPDR) study, raising doubts about the product’s potential in seve | EyePoint released new diabetic macular edema data Monday that a Mizuho Securities analyst described as "very promising." The trial win provides a needed turnaround for the company's lead candidate Duravyu, which failed a study in non-proliferative diabetic retinopathy earlier this yea

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Healthcare: Raising the standards of customer experience through real-person communication

pharmaphorum

Discover how the healthcare industry is raising customer experience standards through meaningful real-person communication. Learn why this approach is vital for patient satisfaction and better outcomes.

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Astellas doesn't see eye to eye with Europe on geographic atrophy drug Izervay

Fierce Pharma

While Astellas’ Izervay and Apellis’ Syfovre battle for market share in geographic atrophy (GA) in the United States, both companies are struggling to reach patients in the indication in Europe.&nb | While Astellas’ Izervay and Apellis’ Syfovre battle for market share in geographic atrophy (GA) in the United States, both companies are struggling to reach patients in the indication in Europe.

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Rentschler Biopharma to Construct New Buffer Media Facility in Germany

Pharmaceutical Commerce

With the design of the new 360,000 square-foot building, the CDMO’s goal is to continue to modernize its Laupheim site.

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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.