Bio Pharma Dive
JANUARY 8, 2025
The regulator is requiring labeling that warns of Guillan-Barré syndrome, although it said data don’t prove a causal link and affirmed the shots’ benefit outweighs their risks.
Pharmaceutical Technology
JANUARY 8, 2025
GSK has gained US FDA breakthrough therapy designation for GSK'227 to treat adults with relapsed or refractory osteosarcoma.
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Bio Pharma Dive
JANUARY 8, 2025
Alongside plans to spin out a new company, the Belgian drugmaker said it will cut some 300 positions, or about 40% of its current workforce.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 8, 2025
(SDI Productions/E+/Getty Images) The right therapy can dramatically boost the self-healing capabilities of the human heart after heart failure, a new study has found giving the vital organ regenerative powers even beyond those of a healthy heart.
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
Bio Pharma Dive
JANUARY 8, 2025
Maze fits the mold of biotechs that have pulled off successful offerings recently: The seven-year old startup, which raised about $500 million privately, has a drug in Phase 2 testing.
Pharmaceutical Technology
JANUARY 8, 2025
As part of the agreement, Sanofi will provide Alloy with upfront license fees and near-term preclinical milestone payments up to $27.5m.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JANUARY 8, 2025
China's National Medical Products Administration has granted expanded approval to MSD's GARDASIL for use in males aged nine to 26 years.
Bio Pharma Dive
JANUARY 8, 2025
The Arch-backed startup begins life with several assets acquired from Denali Therapeutics. Elsewhere, Jasper got a negative reaction to data for its hives drug and Stoke finalized Phase 3 trial plans.
Pharmaceutical Technology
JANUARY 8, 2025
Araris will use its linker technology to generate multi-warhead ADCs for undisclosed targets provided by Chugai.
Pharma Times
JANUARY 8, 2025
Investment to support RNA therapeutics for epilepsy and neurological disorders
Pharmaceutical Technology
JANUARY 8, 2025
Actuate Therapeutics has gained OMPD from the EMA for elraglusib aimed at treating pancreatic ductal adenocarcinoma (PDAC).
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 8, 2025
The Central Drugs Standard Control Organisation (CDSCO) and Indian Council of Medical Research (ICMR) have together released the draft standard evaluation protocols for the purpose of issuing license for in-vitro diagnostics (IVDs) under the Medical Devices Rules (MDR), 2017.
Pharmaceutical Technology
JANUARY 8, 2025
Orna will receive a $65m upfront payment and is eligible to receive potential milestone payments and royalties.
pharmaphorum
JANUARY 8, 2025
Rybrevant plus Lazcluze extended median OS by more than a year compared to Tagrisso in the MARIPOSA trial in treatment-naive, EGFR-mutated NSCLC
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
JANUARY 8, 2025
With clinical trials facing multiple challenges, digital solutions could provide the answer. We identify the key trends to watch in 2025.
pharmaphorum
JANUARY 8, 2025
Novo Nordisk almost doubles the scale of its R&D alliance with AI specialist Valo Health, which now spans 20 programmes and a value of up to $4.6bn.
Pharmaceutical Technology
JANUARY 8, 2025
Sickle cell patient advocacy groups in the US are calling for greater education on the disease and increasing awareness of blood therapy.
pharmaphorum
JANUARY 8, 2025
Our round-up of recent biotech financings includes a big round for Aviceda, with Orbis, Alebund, XyloCor, and PrimeGene also raising additional cash.
XTalks
JANUARY 8, 2025
The US Food and Drug Administrations (FDAs) new draft guidance , Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products , provides a roadmap for integrating artificial intelligence (AI) into regulatory decisions for drug and biological product development. It targets sponsors, manufacturers and stakeholders, aiming to enhance the credibility of AI models in generating data for evaluating safety, effectiveness and quality.
pharmaphorum
JANUARY 8, 2025
Clarivate has revealed 11 drugs due to launch in 2025 that could top $1 billion in annual sales or be clinical 'game changers' in the next five years.
Pharma Times
JANUARY 8, 2025
New FDA-approved schizophrenia treatment shows promise in clinical trials
pharmaphorum
JANUARY 8, 2025
Belgian biotech Galapagos is mixing things up again via a plan to split in two, separating its drug development and cell therapy operations.
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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.
Crucial Data Soutions
JANUARY 8, 2025
RENO, NV, UNITED STATES, January 8, 2025 /EINPresswire.com/ — Crucial Data Solutions (CDS), a leader in eClinical technology and a. The post Crucial Data Solutions Begins 2025 with AI Breakthroughs and Leadership Momentum appeared first on Crucial Data Solutions.
Pharmaceutical Commerce
JANUARY 8, 2025
What is the value in US adults addressing these risks, and how do social determinants of health play a role?
pharmaphorum
JANUARY 8, 2025
With the Federal Reserve poised to implement interest rate cuts (albeit fewer than earlier forecasts assumed) and FTC leadership turnover anticipated, there may be broader shifts in how capital is both sourced and used in the biopharma industry.
Pharmaceutical Commerce
JANUARY 8, 2025
In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jon Kostas, executive director, Association for Prescription Psychedelics (APP), addresses the importance of stopping the spread of misinformation when it comes to psychedelics.
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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
pharmaphorum
JANUARY 8, 2025
Access to cells for CGT is closer than you think Nicole.
Pharmaceutical Commerce
JANUARY 8, 2025
Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.
Velocity Clinical Research
JANUARY 8, 2025
Congratulations to Paul Evans for being named one of the Top 50 Healthcare Technology CEOs of 2024! With Pauls leadership, Velocity continues to redefine how clinical trials are conducted leveraging VISION technology, centralization, and global site integration to accelerate drug development. His recognition by The Healthcare Technology Report is a nod to his vision and impact on the industry.
CTTI (Clinical Trials Transformation Initiative)
JANUARY 8, 2025
Oracle Exec Maps Data Integration Strategy for Modern Clinical Trials in 2025 and Beyond The post Oracle Exec Maps Data Integration Strategy for Modern Clinical Trials in 2025 and Beyond appeared first on CTTI.
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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.
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