Tue.Aug 13, 2024

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Galderma wins FDA approval for skin condition treatment

Bio Pharma Dive

Nemluvio is now cleared for adults with the chronic itching condition prurigo nodularis, making it a competitor to Sanofi and Regeneron’s Dupixent.

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GLP-1 receptor agonists cut risk of death in inflammatory disease patients, says study

Pharmaceutical Technology

GLP-1RAs may be more effective for patients with immune diseases and type 2 diabetes than DPP-4 inhibitors, as per analysed health records.

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Acelyrin shifts from main drug, lays off staff

Bio Pharma Dive

The company will no longer develop its medicine izokibep in two immune conditions, prioritizing instead another treatment it’s developing for thyroid eye disease.

Medicine 187
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FDA approves Ascendis Pharma’s YORVIPATH for hypoparathyroidism

Pharmaceutical Technology

Ascendis Pharma has obtained US Food and Drug Administration (FDA) approval for its YORVIPATH to treat hypoparathyroidism in adults.

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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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Pfizer appoints AI chief, expanding digital leadership team

Bio Pharma Dive

Berta Rodriguez-Hervas has joined the pharmaceutical company after stints at Stellantis, Nvidia and Tesla.

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CMT Research Foundation invests in research project to develop treatments for CMTs

Pharma Times

The rare, peripheral neuropathy disease affects nearly three million people globally

Research 136

More Trending

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Francis Crick scientists reveal how cells ‘raise the alarm’ when damaged or infected

Pharma Times

The V-ATPase protein, V1H, was found to be involved in the process of raising the alarm

Scientist 136
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Baxter signs over kidney care arm to investment firm in $3.5bn deal

Pharmaceutical Technology

Baxter is handing its kidney care department over to investment firm Carlyle, the company will carry on as its own entity known as Vantive.

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People need to know how to use AI now

pharmaphorum

With the implementation of advancing technologies in industry comes the parallel need for suitable upskilling of the workforce – but this doesn’t as yet always pan out, and in today’s pharmaphorum podcast COO of Enthought Mike Connell discusses the growing skills gap in R&D in life sciences and the 80/20 rule with web editor Nicole Raleigh, as well as the need for correct education of people and machines, both.

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Madrigal plans to solidify Rezdiffra’s position in MASH despite start being slower than expected

Pharmaceutical Technology

In March 2024, Madrigal Pharmaceuticals had a breakthrough moment when, after years of research and anticipation, the US Food and Drug Administration (FDA) granted approval for its Rezdiffra (resmetirom), a pioneering treatment for adults with F2-F3 metabolic dysfunction-associated steatohepatitis (MASH).

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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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To approve Amgen's lung cancer med Imdelltra, FDA saw past 'large number' of missing adverse events

Fierce Pharma

When the FDA approved Amgen’s Imdelltra in May, the T-cell engager was hailed as a breakthrough for the treatment of small cell lung cancer (SCLC) and as the first DLL3-targeting therapy of potenti | In granting an accelerated approval to Amgen's first-in-class DLL3 bispecific Imdelltra, the FDA had to work through a “large number” of missing adverse events from a pivotal trial.

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US judge denies initial attempt by Novartis to block generic Entresto launch

Pharmaceutical Technology

The court rebuffed claims by Novartis that it would experience “irreparable harm” in the absence of an injunction following MSN’s generic roll-out.

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Citius Pharma receives FDA approval for immunotherapy targeting rare blood cancer

BioPharma Reporter

The FDA has given the green light to Lymphir, the first immunotherapy for the treatment of cutaneous T-cell lymphoma (CTCL) to get approval in over five years.

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Astria Therapeutics taps Ypsomed’s autoinjector for hereditary angioedema drug delivery

Pharmaceutical Technology

Astria Therapeutics has selected Ypsomed’s Ypsomate autoinjector as its partner for the administration of STAR-0215 for the treatment of hereditary angioedema (HAE).

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

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Advancing precision medicine: How real-world evidence platforms translate data into action

pharmaphorum

Learn how real-world evidence platforms use real-world data (RWD) to advance precision medicine, bridging the gap between clinical trials and real-world patient outcomes.

Medicine 115
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Safety first: Cognition as a primary safety endpoint provides a competitive advantage

Pharmaceutical Technology

The incorporation of cognition into the safety profiles of both CNS and non-CNS indications is becoming increasingly critical.

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Remembering Paul Bannister, dear friend and finance manager

pharmaphorum

Our longtime Finance Director Paul Bannister was a part of the fabric of pharmaphorum almost from the beginning and an integral part of keeping the publication running. And, most importantly, he was the soul of the place and a friend to all.

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Syros’ stock craters after Phase II AML trial termination due to inefficacy

Pharmaceutical Technology

Syros discontinued enrolment in an acute myeloid leukaemia (AML) trial after a futility analysis found the study was unlikely to succeed.

Trials 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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Pharma Pulse 8/13/24: How Should Biotechs Strategize for 2025, Pfizer Announces Top-Line Results of ABRYSVO for RSV & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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FDA approves Galderma’s prurigo nodularis treatment

Pharmaceutical Technology

The US FDA has approved Galderma’s Nemluvio as a pre-filled pen for subcutaneous injection to treat adult people with prurigo nodularis.

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How personal loss and hope drove Elaine Maynard’s work in clinical trials and patient-centric technologies

BioPharma Reporter

Driven by personal loss and inspired by the progress in disease management, Elaine has dedicated more than 20 years to the clinical trial technology industry.

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China NMPA accepts Junshi Biosciences’ sNDA for melanoma

Pharmaceutical Technology

The China NMPA has accepted for review Junshi Biosciences’ sNDA for toripalimab to treat unresectable or metastatic melanoma.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Judge rebuffs Novartis bid to block generic Entresto

pharmaphorum

Novartis' attempt to stop MSN Pharma from launching a generic version of heart failure blockbuster Entresto is blocked in a US court

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Citius merges oncology subsidiary with TenX Keane

Pharmaceutical Technology

Citius Pharmaceuticals has concluded the merger of its oncology subsidiary with TenX Keane Acquisition, forming Citius Oncology.

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Revolutionizing partner evaluations in pharma outsourcing: expert insights

Outsourcing Pharma

In the rapidly evolving pharmaceutical industry, the process of evaluating outsourcing partners is critical to ensuring quality, efficiency, and innovation.

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FDA approves Galderma’s Nemluvio for chronic skin condition

BioPharma Reporter

The US approval of Nemluvio marks a major milestone for Galderma, a Swiss company developing treatments for a wide range of conditions affecting the skin.

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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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Can Rite Aid Recover?

Drug Channels

Last fall, poor ol’ Rite Aid finally succumbed to bankruptcy. It was pretty much the definition of an expected surprise. To get a comprehensive look at the company’s ever-declining fortunes, DCI rummaged around the compnay's numerous bankruptcy filings. Below, you’ll find our review of Rite Aid’s current financial situation, shrinking store footprint, changing relationship with key wholesaler McKesson, surprisingly optimistic projections, and more.

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First patient dosed with ADC therapy designed to disrupt tumor blood supply

BioPharma Reporter

Angiex has announced the beginning of the first-in-human trial of AGX101, an antibody-drug conjugate (ADC) treatment that targets solid tumors with a unique mode of action.

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FDA approval of needle-free spray, a major breakthrough in anaphylaxis treatment

Outsourcing Pharma

Patients suffering from severe allergic reactions now have access to a new, needle-free treatment option, as the US Food and Drug Administration (FDA) has approved neffy, a 2 mg epinephrine nasal spray developed by ARS Pharmaceuticals, Inc.

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Lexicon to lay off 50% of field force as it prioritizes heart failure drug, potential US diabetes launch

Fierce Pharma

Despite winning an FDA approval in 2023 and gaining clarity in May on the regulatory path forward for its Type 1 diabetes prospect sotagliflozin, Lexicon Pharmaceuticals hasn’t had an easy go of it | As part of a restructuring initiative, Lexicon Pharmaceuticals will lay off more than 75 staffers, or approximately 50% of its current field force, by the end of September.

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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