Mon.Jan 20, 2025

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$590m to Moderna from HHS for mRNA ‘flu vax development

Pharmaceutical Technology

Moderna is set to receive $590m in funding from the HHS to expedite the development of mRNA-based pandemic influenza vaccines.

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Top 10 Pharma and Biotech M&As in the Past Decade

XTalks

The pharma and biotech sector has witnessed impressive growth over the past decade, driven by innovations and strategic partnerships. Among these, mergers and acquisitions (M&As) have played a pivotal role in reshaping the industry landscape, enabling companies to bolster their portfolios, enhance R&D capabilities and expand their global market reach.

Marketing 104
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AstraZeneca secures first BTK approval in first-line mantle cell lymphoma

Pharmaceutical Technology

AstraZeneca has received approval from the FDA for its BTK inhibitor, Calquence (acalabrutinib), for first-line use in MCL.

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UK sees 70% increase in phase I advanced therapy clinical trials in 2024

Pharma Times

Cell and Gene Therapy Catapult reveals significant growth in UK trials

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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FDA’s START and CoGenT pilot programmes: Streamlining rare disease drug approvals

Pharmaceutical Technology

This week, at the J.P. Morgan Healthcare Conference and the Biotech Showcase, discussions underscored the growing focus on innovation in cell and gene therapies.

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The Hidden Pitfalls of Searching Drug Patents on Google Patents

Drug Patent Watch

The Hidden Pitfalls of Searching Drug Patents: What You Need to Know As a professional in the pharmaceutical industry, you're likely no stranger to the importance of staying on top of the latest patent developments. But have you ever stopped to think about the potential pitfalls of searching for drug patents on Google Patents? At first glance, Google Patents may seem like a convenient and user-friendly resource for searching patent data.

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Datapharm expands into US market through partnership with phactMI

Pharma Times

Collaboration aims to enhance accessibility of medicines information

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Interleukin inhibitors remain a strong growth driver in dermatology    

Pharmaceutical Technology

If the results from the clinical development plans are positive, it may well reflect a paradigm shift for clinical care.

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Pfizer’s PD-1 Inhibitor Sasanlimab in Combo with Standard of Care Shown to Improve Event-Free Survival in High-Risk Bladder Cancer

XTalks

Pfizer announced promising results from its Phase III trial investigating the efficacy of sasanlimab, an anti-PD-1 monoclonal antibody, in combination with standard of care Bacillus Calmette-Guerin (BCG) immunotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are BCG-nave. The Phase III CREST trial met its primary endpoint, demonstrating that as a first-line treatment, the combination significantly improved event-free survival (EFS) compared to BCG monotherapy.

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Feinstein Institutes gains NIH grant to explore ghrelin for GI-ARS

Pharmaceutical Technology

Northwell Healths Feinstein Institutes for Medical Research has received a $2.9m grant from the NIH to explore the use of human ghrelin.

Research 147
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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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Pfizer’s Sasanlimab in Combo with Standard of Care Improves Event-Free Survival in High-Risk Bladder Cancer

XTalks

Pfizer announced promising results from its Phase III trial investigating the efficacy of sasanlimab, an anti-PD-1 monoclonal antibody, in combination with standard of care Bacillus Calmette-Guerin (BCG) immunotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are BCG-nave. The Phase III CREST trial met its primary endpoint, demonstrating that as a first-line treatment, the combination significantly improved event-free survival (EFS) compared to BCG monotherapy.

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Arrowhead’s plozasiran set for FDA review as Tryngolza challenge looms 

Pharmaceutical Technology

An FDA approval later this year for Arrowheads plozasiran in FCS would put it in direct competition with Ionis Tryngolza.

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The new gold standard in sequencing technology

Drug Discovery World podcast

In this sponsored DDW Sitting Down With podcast we speak to experts from Lonza and Oxford Nanopore about their collaboration to bring direct mRNA sequencing (including N1-Methyl-pseudouridine) to a regulated environment and establish the new gold standard in sequencing technology. We discuss how nanopore sequencing will be used to perform unbiased identity testing while enabling the simultaneous analyses of multiple critical quality attributes such as integrity (mRNA length and poly-A tail lengt

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FDA approves Amgen’s combo therapy for colorectal cancer

Pharmaceutical Technology

Amgens LUMAKRAS and Vectibix combination has received approval from the US FDA for treating KRAS G12C-mutated mCRC.

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

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Informa Connect's Patient Assistance & Access Programs (PAP)

Drug Channels

Informa Connect's Patient Assistance & Access Programs (PAP) March 18-20, 2025 | Sheraton Philadelphia Downtown PA Pre-Conference Workshops on March 17, 2025 Drug Channels readers save 10% on their registration with code 25DC10 When it comes to patient affordability, its difficult to imagine a more complex time for our industry. Navigating policy updates, disarming AFPs, considering compliance risks There are countless barriers to medication access and it remains our responsibility as an in

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DDW Highlights: 20 January 2025

Drug Discovery World podcast

The latest episode of the DDW Highlightspodcast is now available to listen to below. DDWs Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. This week we have seen a number of positive announcements related to the early clinical and preclinical development of immunotherapies, including an islet cell therapy for diabetes, an antibody-drug conjugate and a CAR-T therapy for multiple myeloma, and a peptide-drug conjugate and a vaccin

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Effectiveness of Empagliflozin vs Dapagliflozin for Kidney Outcomes in Type 2 Diabetes

JAMA Internal Medicine

This cohort study compares kidney outcomes between initiation of empagliflozin vs dapagliflozin in adults with type 2 diabetes who were receiving antihyperglycemic treatment.

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Lindus Health: AI instrumental for predicting trial outcomes and shaping study design

Outsourcing Pharma

We ran a Q&A With Michael Young, co-founder of Lindus Health on the challenges of 2024 and the companys goals for 2025.

Trials 74
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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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Individual SGLT-2 Inhibitors and Cardiovascular and Safety Outcomes

JAMA Internal Medicine

This comparative effectiveness research study uses target trial emulation to examine the effectiveness of individual sodium-glucose cotransporter 2 (SGLT-2) inhibitors canagliflozin or dapagliflozin compared with empagliflozin using a composite outcome.

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Addressing Legal Battles in the Pharma Space

Pharmaceutical Commerce

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Donald Prentiss, founder and CEO, Qualthera, explains how collaboration between compounding pharmacies, drug manufacturers, and telehealth platforms can drive success, despite the various litigations pertaining to GLP-1s that currently taking place.

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Regulatory bodies placing more importance on patient centricity, says pharma executive

Outsourcing Pharma

We ran a Q&A with John Clarke, associate director in patient recruitment at Innovaderm on the changing landscape of patient centricity in terms of clinical trials and how the industry can navigate the evolving regulatory expectations around it.

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The Digital Transformation Reshaping Hospitals and Medication Management

Pharmaceutical Commerce

Despite challenges surrounding communication overload, drug shortages, and cybersecurity risks, this term is revolutionizing medication management and patient care through the use artificial intelligence and predictive forecasting.

Drugs 59
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Smart search to seamless care: How AI will transform experiences in 2025

pharmaphorum

AI technology, such as GenAI and ChatGPT, is set to revolutionise experiences in 2025 across various industries, including life science. Learn more about the future of AI and its impact on the way we interact and innovate.

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Pharma Pulse 1/20/25: Rare Drug Development and Chrysalis Genetics, Evaluating the Cost-Effectiveness of NSCLC Treatment & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Life Sciences Industry Report – Part 4

pharmaphorum

Discover key insights on data analytics, wearable health devices, and AI-driven models in the life sciences industry in this informative report - Part 4. Stay informed on the latest trends and advancements shaping the industry.

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FDA Recommends Disclosure of Plant Source in Draft Guidance on Labeling Plant-Based Alternatives

FDA Law Blog

By Sophia R. Gaulkin & Ritte van Laack Readers of this blog likely are familiar with the ongoing, often contentious battle over the labeling of plant-based foods (see, e.g., here , here , and here ). Nearly two years after FDA issued draft guidance on Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements , on January 6, 2025, FDA released draft guidance document on plant-based labeling, Labeling Plant-Based Alternatives to Animal-Derived Foods.

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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.