Mon.Dec 16, 2024

article thumbnail

FDA approves Galderma’s Nemluvio to treat atopic dermatitis

Pharmaceutical Technology

The US FDA has approved Galderma's Nemluvio (nemolizumab), for individuals aged 12 years and above with moderate-to-severe atopic dermatitis.

article thumbnail

Abnormal Patterns in Brain Waves May Indicate ADHD, Expert Says

AuroBlog - Aurous Healthcare Clinical Trials blog

Children with attention deficit hyperactivity disorder ( ADHD) do not have a behavioural disorder, nor are they lazy, or lacking in manners and boundaries. Their brains mature in a different way, with different patterns of neurological activity and a number of neurochemical differences. For this reason, ADHD is considered to be a neurodevelopmental disorder.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

ADCs breach barriers to become mainstream cancer treatment

Pharmaceutical Technology

Manufacturing practices are evolving to advance antibody drug conjugates (ADCs) for cancer treatment through a targeted approach.

Antibody 147
article thumbnail

Merck calls quits on two immunotherapies for cancer

Bio Pharma Dive

133
133
article thumbnail

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

article thumbnail

Pharma prepares for CDMO growth in 2025 as CPHI Milan reports record attendance

Pharma Mirror

CPHI Milan the worlds largest pharma event hosted last month in Milan saw a new record attendance of 59,000 pharma executives buoyed by returning confidence and increased deal-making on site. The post Pharma prepares for CDMO growth in 2025 as CPHI Milan reports record attendance appeared first on Pharma Mirror Magazine.

130
130
article thumbnail

The future of third-party logistics in an evolving biopharmaceutical world

Pharmaceutical Technology

The biopharmaceutical industry faces a future full of risks and rewards. But what role will 3PL suppliers play?

130
130

More Trending

article thumbnail

Denmark’s HTA evolution

Pharmaceutical Technology

New HTA statistics produced by Denmarks Medicinrdet for 2024 have prompted GlobalData to assess evolving HTA trends in the Nordic market.

Marketing 130
article thumbnail

Are we overlooking something critical in cell and gene therapy research?

Bio Pharma Dive

article thumbnail

EMA recommends expanding approval of Ofev to children and adolescents

Pharmaceutical Technology

Boehringer Ingelheims blockbuster Ofev could be set for an expanded indication in children and adolescents with fibrosing ILDs.

130
130
article thumbnail

Jazz to search for new chief as CEO plans retirement

Bio Pharma Dive

100
100
article thumbnail

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

article thumbnail

Small cell lung cancer: Navigating the global clinical trial landscape

Pharmaceutical Technology

Discover the latest advancements in small cell lung cancer through Novotech CROs in-depth disease analysis.

article thumbnail

Novo builds up manufacturing; Pepgen Duchenne trial put on hold

Bio Pharma Dive

article thumbnail

Reprieve for WuXi as Biosecure vote likely pushed to 2025

Pharmaceutical Technology

WuXi AppTec and WuXi Biologics are looking to sell off sites in the US and Europe as the prospect of the Biosecure Act is deterring potential clients.

130
130
article thumbnail

Edgewise weighs fast approval path for muscular dystrophy drug

Bio Pharma Dive

Drugs 100
article thumbnail

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

article thumbnail

EMA CHMP recommends Lilly’s Crohn’s therapy for EU approval

Pharmaceutical Technology

The EMA's CHMP has recommended Lillys Omvoh (mirikizumab) for approval in the EU to treat Crohn's disease.

130
130
article thumbnail

Novo Holdings’ purchase of Catalent set to close after regulators’ green light

Bio Pharma Dive

article thumbnail

AbbVie to acquire Nimble Therapeutics for $200m

Pharmaceutical Technology

AbbVie has entered into a definitive agreement to acquire Nimble Therapeutics in a deal valued at $200m in cash.

130
130
article thumbnail

Could the gut microbiome hold the key to fighting cancer?

Bio Pharma Dive

100
100
article thumbnail

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.

article thumbnail

Checkpoint Therapeutics takes on Merck's mighty Keytruda with FDA approval for Unloxcyt in skin cancer

Fierce Pharma

article thumbnail

CSL receives positive opinion for garadacimab in hereditary angioedema

Pharma Times

New treatment could revolutionise care for HAE patients

76
article thumbnail

Novo sets aside $1.2bn for rare diseases plant

pharmaphorum

73
article thumbnail

Beckley Psytech announces positive results for ELE-101 in depression trial

Pharma Times

Phase 2a study shows promising antidepressant effects

Trials 75
article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

article thumbnail

FDA clears Neurocrine drug for rare adrenal disorder

pharmaphorum

Drugs 71
article thumbnail

FDA blesses atopic dermatitis label expansions for Organon's Vtama, Galderma's Nemluvio

Fierce Pharma

63
article thumbnail

HeartBeam’s Credit Card-Sized Cardiac Monitor Cleared for At-Home Use

XTalks

Imagine having a heart monitoring device small enough to fit in a purse or a wallet, ready to record critical heart data whenever symptoms arise. This device by HeartBeam, Inc. is a breakthrough in at-home cardiac care, allowing patients to capture high-quality electrocardiograms (ECGs) wherever they are. When symptoms occur, patients simply place the device on their chest and follow prompts from a companion app.

article thumbnail

New drugs 'benefit patients, but maybe not populations'

pharmaphorum

Drugs 61
article thumbnail

2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

article thumbnail

The Beatles Revolutionized the Music Industry by Using Recording Studios — Will AI Revolutionize the Medical Writing Industry Next?

XTalks

Maria Hopfgarten Head of Global Medical Writing PPD Clinical Research Business of Thermo Fisher Scientific Artificial intelligence (AI) is revolutionizing industries worldwide, and medical writing is no exception. With the integration of human intelligence (HI) with AI, the field is discovering new efficiencies and maintaining, or even improving, the rigor required for quality and compliance.

article thumbnail

Novo Nordisk blueprints $1.2B rare disease production plant in Denmark, where it plans to hire on 400 new staffers

Fierce Pharma

article thumbnail

Trade & Channel Strategies 2024: A GTN Bubble Balancing Act

Pharmaceutical Commerce

A panel examines the gross-to-net bubble across various product mixes, how pricing impacts market access, and more.

article thumbnail

Neurocrine's Crenessity ends 70-year drought with FDA nod for rare genetic disease

Fierce Pharma

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time