Galderma wins FDA approval for skin condition treatment
Bio Pharma Dive
AUGUST 13, 2024
Nemluvio is now cleared for adults with the chronic itching condition prurigo nodularis, making it a competitor to Sanofi and Regeneron’s Dupixent.
Tue.Aug 13, 2024
182 
FDA approves Ascendis Pharma’s YORVIPATH for hypoparathyroidism
Pharmaceutical Technology
AUGUST 13, 2024
Ascendis Pharma has obtained US Food and Drug Administration (FDA) approval for its YORVIPATH to treat hypoparathyroidism in adults.
Join 21,000+
Insiders
Sign Up for our Newsletter
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Acelyrin shifts from main drug, lays off staff
Bio Pharma Dive
AUGUST 13, 2024
The company will no longer develop its medicine izokibep in two immune conditions, prioritizing instead another treatment it’s developing for thyroid eye disease.
GLP-1 receptor agonists cut risk of death in inflammatory disease patients, says study
Pharmaceutical Technology
AUGUST 13, 2024
GLP-1RAs may be more effective for patients with immune diseases and type 2 diabetes than DPP-4 inhibitors, as per analysed health records.
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
Pfizer appoints AI chief, expanding digital leadership team
Bio Pharma Dive
AUGUST 13, 2024
Berta Rodriguez-Hervas has joined the pharmaceutical company after stints at Stellantis, Nvidia and Tesla.
To approve Amgen's lung cancer med Imdelltra, FDA saw past 'large number' of missing adverse events
Fierce Pharma
AUGUST 13, 2024
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.
Sign up to get articles personalized to your interests!
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
More Trending
Baxter signs over kidney care arm to investment firm in $3.5bn deal
Pharmaceutical Technology
AUGUST 13, 2024
Baxter is handing its kidney care department over to investment firm Carlyle, the company will carry on as its own entity known as Vantive.
People need to know how to use AI now
pharmaphorum
AUGUST 13, 2024
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.
Madrigal plans to solidify Rezdiffra’s position in MASH despite start being slower than expected
Pharmaceutical Technology
AUGUST 13, 2024
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).
CMT Research Foundation invests in research project to develop treatments for CMTs
Pharma Times
AUGUST 13, 2024
The rare, peripheral neuropathy disease affects nearly three million people globally
US judge denies initial attempt by Novartis to block generic Entresto launch
Pharmaceutical Technology
AUGUST 13, 2024
The court rebuffed claims by Novartis that it would experience “irreparable harm” in the absence of an injunction following MSN’s generic roll-out.
Advancing precision medicine: How real-world evidence platforms translate data into action
pharmaphorum
AUGUST 13, 2024
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.
Astria Therapeutics taps Ypsomed’s autoinjector for hereditary angioedema drug delivery
Pharmaceutical Technology
AUGUST 13, 2024
Astria Therapeutics has selected Ypsomed’s Ypsomate autoinjector as its partner for the administration of STAR-0215 for the treatment of hereditary angioedema (HAE).
Citius Pharma receives FDA approval for immunotherapy targeting rare blood cancer
BioPharma Reporter
AUGUST 13, 2024
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.
The New Age of Decentralized Clinical Trials
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Safety first: Cognition as a primary safety endpoint provides a competitive advantage
Pharmaceutical Technology
AUGUST 13, 2024
The incorporation of cognition into the safety profiles of both CNS and non-CNS indications is becoming increasingly critical.
Remembering Paul Bannister, dear friend and finance manager
pharmaphorum
AUGUST 13, 2024
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.
Syros’ stock craters after Phase II AML trial termination due to inefficacy
Pharmaceutical Technology
AUGUST 13, 2024
Syros discontinued enrolment in an acute myeloid leukaemia (AML) trial after a futility analysis found the study was unlikely to succeed.
Francis Crick scientists reveal how cells ‘raise the alarm’ when damaged or infected
Pharma Times
AUGUST 13, 2024
The V-ATPase protein, V1H, was found to be involved in the process of raising the alarm
FDA approves Galderma’s prurigo nodularis treatment
Pharmaceutical Technology
AUGUST 13, 2024
The US FDA has approved Galderma’s Nemluvio as a pre-filled pen for subcutaneous injection to treat adult people with prurigo nodularis.
Pharma Pulse 8/13/24: How Should Biotechs Strategize for 2025, Pfizer Announces Top-Line Results of ABRYSVO for RSV & more
Pharmaceutical Commerce
AUGUST 13, 2024
The latest news for pharma industry insiders.
China NMPA accepts Junshi Biosciences’ sNDA for melanoma
Pharmaceutical Technology
AUGUST 13, 2024
The China NMPA has accepted for review Junshi Biosciences’ sNDA for toripalimab to treat unresectable or metastatic melanoma.
Lexicon to lay off 50% of field force as it prioritizes heart failure drug, potential US diabetes launch
Fierce Pharma
AUGUST 13, 2024
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.
The New Age of Decentralized Clinical Trials
Advertisement
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.
Citius merges oncology subsidiary with TenX Keane
Pharmaceutical Technology
AUGUST 13, 2024
Citius Pharmaceuticals has concluded the merger of its oncology subsidiary with TenX Keane Acquisition, forming Citius Oncology.
CORRECTED: After icodec rejection, Novo Nordisk won’t file application for once-weekly insulin and semaglutide combo in US
Fierce Pharma
AUGUST 13, 2024
CORRECTED: After icodec rejection, Novo Nordisk won’t file application for once-weekly insulin and semaglutide combo in US fkansteiner Tue, 08/13/2024 - 13:42
Judge rebuffs Novartis bid to block generic Entresto
pharmaphorum
AUGUST 13, 2024
Novartis' attempt to stop MSN Pharma from launching a generic version of heart failure blockbuster Entresto is blocked in a US court
How personal loss and hope drove Elaine Maynard’s work in clinical trials and patient-centric technologies
BioPharma Reporter
AUGUST 13, 2024
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.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
Advertisement
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
Revolutionizing partner evaluations in pharma outsourcing: expert insights
Outsourcing Pharma
AUGUST 13, 2024
In the rapidly evolving pharmaceutical industry, the process of evaluating outsourcing partners is critical to ensuring quality, efficiency, and innovation.
Novartis loses bid to thwart launch of MSN's Entresto generic—for now
Fierce Pharma
AUGUST 13, 2024
After seeking to block the launch of MSN Pharmaceuticals’ recently approved Entresto generic, Novartis has hit a snag in its multiyear crusade to thwart copycats of its top-selling heart failure dr | After seeking to block the launch of MSN Pharmaceuticals’ recently approved Entresto generic, Novartis has hit a snag in its multiyear crusade to thwart copycats of its top-selling heart failure drug.
First patient dosed with ADC therapy designed to disrupt tumor blood supply
BioPharma Reporter
AUGUST 13, 2024
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.
Investor activism resurfaces at Aurinia after CEO’s board role, exec pay lost majority support
Fierce Pharma
AUGUST 13, 2024
A deal to bring back former CEO Robert Foster, Ph.D., didn’t completely quell investors’ concerns about Aurinia Pharmaceuticals. | A deal to bring back former CEO Robert Foster, Ph.D., didn’t completely quell investors’ concerns about Aurinia Pharmaceuticals.
How Machine Learning Drives Clinical Trial Efficiency
Advertisement
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.
Let's personalize your content