Pharmaceutical Technology
APRIL 22, 2024
Discover how BioMarin Pharmaceutical's patent for PAL variants offers a groundbreaking method to treat PKU in adolescents. Administering AvPAL variants weekly over 50 weeks effectively reduces blood phenylalanine levels.
Bio Pharma Dive
APRIL 22, 2024
The acquisition of a Nexus Pharmaceuticals facility in Wisconsin could help Lilly better meet demand for injectable medicines, like those it makes for diabetes and obesity.
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Rethinking Clinical Trials
APRIL 23, 2024
In an analysis of data from the TSOS study, younger patients and patients who were publicly insured or uninsured were among several subgroups of patients who were at significant risk of missing follow-up outcome assessments. The report was published this week in Injury. Successful studies of interventions for patients with posttraumatic stress disorder (PTSD) require engaging with injured patients in long-term follow-up.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 23, 2024
In a significant development for healthcare quality assurance in India, the National Accreditation Board for Hospitals & Healthcare Providers (NABH) has announced the implementation plan for the 2nd Edition of NABH Accreditation Standards for Allopathic Clinics.
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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
Pharmaceutical Technology
APRIL 22, 2024
Health Canada has approved Merck’s KEYTRUDA (pembrolizumab), an anti-programmed cell death protein 1 (PD-1) therapy for use in combination with fluoropyrimidine- and platinum-containing-chemotherapy as a first-line treatment for adult gastric cancer patients.
Bio Pharma Dive
APRIL 22, 2024
A partnership with Cellares, worth up to $380 million, is meant to help Bristol Myers speed and scale manufacture of the complex cellular treatments.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Drug Patent Watch
APRIL 23, 2024
Drug repurposing, or identifying new therapeutic uses for existing drugs, is gaining significant momentum as a promising approach to accelerate drug development and reduce costs.
Pharmaceutical Technology
APRIL 22, 2024
GS-6212 is under clinical development by Gilead Sciences and currently in Phase I for Human Immunodeficiency Virus (HIV) Infections (AIDS).
Bio Pharma Dive
APRIL 24, 2024
The mRNA vaccine maker, which has lost most of its value since early 2021, is undergoing an “organizational redesign” that will involve the elimination of 150 positions.
BioSpace
APRIL 22, 2024
The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues.
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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
pharmaphorum
APRIL 22, 2024
Pharmaceutical companies stand to gain significant benefits from technological innovation in the form of improved data analytics, streamlined healthcare processes, and enhanced patient outcomes. Explore the potential advantages for the pharma industry.
Pharmaceutical Technology
APRIL 22, 2024
AST-001 is under clinical development by Ascentawits Pharmaceuticals and currently in Phase II for Non-Small Cell Lung Cancer.
Bio Pharma Dive
APRIL 24, 2024
Led by the founder of a biotech Celgene acquired for $7 billion, the startup is developing two prospects that originated in the labs of other drugmakers.
BioSpace
APRIL 23, 2024
This is the first round in a series of cuts that will cost 75 people their jobs this year, according to a WARN notice. Employees in other states are affected as well.
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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.
pharmaphorum
APRIL 23, 2024
Novartis has proposed ex-BMS CEO Caforio as the successor to chair Joerg Reinhardt when he steps down next year, as it posts a strong set of Q1 results
Pharmaceutical Technology
APRIL 22, 2024
AST-001 is under clinical development by Ascentawits Pharmaceuticals and currently in Phase II for Renal Cell Carcinoma.
Bio Pharma Dive
APRIL 24, 2024
While the company is eager to diversify, CEO Chris Viehbacher said that in the near-term any dealmaking would likely focus on collaborations and early-stage assets.
BioSpace
APRIL 21, 2024
A one-time treatment for Parkinson’s disease could be a ‘market changer,’ experts told BioSpace, adding that cell therapies could limit the adverse effects seen with current drugs.
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.
Antidote
APRIL 23, 2024
Equitable access to medical care is valuable for everyone, and an important part of this equation is health literacy. Health literacy encompasses not just access to medical care, but also the ability to understand and use medical guidance. This can include anything from a doctor’s suggestions, to medication dosage information, and aftercare guidance.
Pharmaceutical Technology
APRIL 22, 2024
AST-001 is under clinical development by Ascentawits Pharmaceuticals and currently in Phase II for Rectal Cancer.
Bio Pharma Dive
APRIL 24, 2024
First quarter sales of Zurzuvae doubled consensus estimates, though analysts are skeptical whether the better-than-expected launch will continue.
pharmaphorum
APRIL 22, 2024
Ireland’s SynOx Therapeutics has completed a second-round financing, raising $75 million, as it prepares to take its drug for tenosynovial giant cell tumour (TGCT) into phase 3 trials. TGCT is a rare disease affecting the joints and tendons caused by overproduction of the protein CSF-1, which stimulates the proliferation of various cell types, inflammation, and destruction of the matrix of the joint.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
BioSpace
APRIL 23, 2024
Biogen on Wednesday exceeded analyst profit estimates for the first quarter of 2024 as the biotech’s cost-cutting measures took hold and sales of its Alzheimer’s disease therapy Leqembi started to pick up.
Pharmaceutical Technology
APRIL 22, 2024
AST-001 is under clinical development by Ascentawits Pharmaceuticals and currently in Phase II for Esophageal Cancer.
Bio Pharma Dive
APRIL 24, 2024
In this three-part podcast series, hear from seasoned experts from Allucent as they discuss a range of topics, including how small and mid-sized companies can take a more strategic approach to pharmacovigilance, a regulatory & development roadmap for ADCs and RDCs, and pre-MAA/NDA inspection readiness.
pharmaphorum
APRIL 23, 2024
After rejecting ImmunityBio’s Anktiva last year, the FDA has now cleared the drug as a treatment for bladder cancer, making it the biotech's first commercial-stage product
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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.
Fierce Pharma
APRIL 22, 2024
Sanofi will pay $100 million—or approximately $25,000 each—to roughly 4,000 claimants who filed lawsuits saying that the French company failed to warn users that its heartburn medicine Zantac (rani | Sanofi will pay approximately $25,000 per person to roughly 4,000 claimants who filed lawsuits saying that the French company failed to warn users that its heartburn medicine Zantac (ranitidine) can cause cancer, Bloomberg reported.
Pharmaceutical Technology
APRIL 22, 2024
Datopotamab deruxtecan is under clinical development by Daiichi Sankyo and currently in Phase I for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer).
Bio Pharma Dive
APRIL 23, 2024
Giovanni Caforio, who left Bristol Myers in November after eight years as CEO, is set to succeed Novartis’ longtime board chair Joerg Reinhardt next year.
pharmaphorum
APRIL 23, 2024
Pfizer’s Emblaveo has been approved in the EU with a first-in-class indication in multidrug-resistant (MDR) infections. The drug – a combination of beta-lactam antibiotic aztreonam with beta-lactamase inhibitor avibactam – is the first drug of this type to get a green light from the European Commission to treat serious infections caused by MDR Gram-negative bacteria in adults.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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