Sat.Apr 20, 2024 - Fri.Apr 26, 2024

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BioMarin Pharmaceutical gets grant for treatment of adolescent PKU patients using AVPAL variant

Pharmaceutical Technology

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.

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Lilly to buy injectable drug plant in manufacturing ramp-up

Bio Pharma Dive

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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April 23, 2024: Younger, Uninsured Patients Among Those at Greatest Risk for Missing Follow-up Assessments in Trauma Research

Rethinking Clinical Trials

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.

Research 152
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How to Choose Your Right Pharmacy

Pharma Mirror

An article by Aloiz Kara Aging represents a risk factor for many health problems and diseases, which means that as we grow older, there is a high probability that our health will change negatively. While some of those health issues could be attributed to a hectic lifestyle, the same way of living could keep you from getting the necessary prescribed medicine.

Pharmacy 130
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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

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Health Canada approves Merck’s KEYTRUDA for gastric cancer treatment

Pharmaceutical Technology

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.

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Bristol Myers taps startup to boost CAR-T production

Bio Pharma Dive

A partnership with Cellares, worth up to $380 million, is meant to help Bristol Myers speed and scale manufacture of the complex cellular treatments.

More Trending

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Exploring Periodontal Disease: Present Therapies, Emerging Treatments, and Beyond

Pharma Mirror

Periodontal Disease (PD) is a severe, progressive gum infection that targets the gums, inflaming and damaging the soft tissue and supporting bone around the teeth. PD is caused by pathogenic microflora in the biofilm that forms below the gum line adjacent to the teeth. The infection begins as gingivitis, which leads to periodontitis, causing the gums to recede and eventually destroy the bone supporting the teeth causing the teeth to loosen.

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GS-6212 by Gilead Sciences for Human Immunodeficiency Virus (HIV) Infections (AIDS): Likelihood of Approval

Pharmaceutical Technology

GS-6212 is under clinical development by Gilead Sciences and currently in Phase I for Human Immunodeficiency Virus (HIV) Infections (AIDS).

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Former Bristol Myers CEO tapped as Novartis’ next board chair

Bio Pharma Dive

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.

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NABH unveils plan for 2nd Edition of Accreditation Standards for Allopathic Clinics

AuroBlog - Aurous Healthcare Clinical Trials blog

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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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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Virtual Hospital Waiting Room: Usefulness and Development Steps

Pharma Mirror

The healthcare industry is actively digitalizing and employing modern tools to enrich the grade of service. Clinics incorporate virtual waiting rooms, among other software, to boost patient care and improve staff workflow in traditional medical establishments. In this guide, we’ll investigate the advantages of virtual hospital waiting rooms and how they are revolutionizing healthcare.

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AST-001 by Ascentawits Pharmaceuticals for Non-Small Cell Lung Cancer: Likelihood of Approval

Pharmaceutical Technology

AST-001 is under clinical development by Ascentawits Pharmaceuticals and currently in Phase II for Non-Small Cell Lung Cancer.

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Neurocrine scores surprise win with depression drug

Bio Pharma Dive

Shares of the biotech rose about 5% after a medicine licensed from Takeda hit the main and key secondary goals of a mid-stage study focused on major depressive disorder.

Licensing 152
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Novartis nominates former Bristol Myers CEO Giovanni Caforio as its new chair. Will M&A deals follow?

Fierce Pharma

Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. | Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. The recent Big Pharma CEO, known for steering the $74 billion acquisition of Celgene, has been proposed as the new chair at Novartis for 2025.

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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.

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Internet of Things (IoT) in Healthcare Market to be Worth USD 648.94 Billion by 2031

Pharma Mirror

The healthcare landscape is rapidly transforming, fueled by the convergence of technology and medicine. Among the myriad of innovations, the Internet of Things (IoT) stands out as a beacon of hope, promising to revolutionize patient care, streamline operations, and enhance medical outcomes. As we delve into the IoT in Healthcare Market Outlook for 2031, the data paints a vivid picture of an industry poised for unprecedented growth and innovation.

Marketing 130
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AST-001 by Ascentawits Pharmaceuticals for Renal Cell Carcinoma: Likelihood of Approval

Pharmaceutical Technology

AST-001 is under clinical development by Ascentawits Pharmaceuticals and currently in Phase II for Renal Cell Carcinoma.

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Pharmas form joint venture to jumpstart Japanese drug research

Bio Pharma Dive

A new initiative backed by Takeda, Astellas and Sumitomo Mitsui Banking aims to combat a decade-long decline in drug R&D productivity in Japan.

Drugs 177
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FDA Rejects Abeona’s Epidermolysis Bullosa Cell Therapy, Asks for CMC Data

BioSpace

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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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.

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What pharma stands to gain from technological innovation

pharmaphorum

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.

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AST-001 by Ascentawits Pharmaceuticals for Rectal Cancer: Likelihood of Approval

Pharmaceutical Technology

AST-001 is under clinical development by Ascentawits Pharmaceuticals and currently in Phase II for Rectal Cancer.

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FDA rejects Abeona cell therapy, asks for more manufacturing data

Bio Pharma Dive

The complete response letter for Abeona’s treatment is one of several manufacturing setbacks for cell and gene therapy developers in recent years.

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Innovative Strategies in Drug Repurposing

Drug Patent Watch

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.

Drugs 100
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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Novartis names ex-BMS CEO Caforio as chair amid strong Q1

pharmaphorum

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

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AST-001 by Ascentawits Pharmaceuticals for Esophageal Cancer: Likelihood of Approval

Pharmaceutical Technology

AST-001 is under clinical development by Ascentawits Pharmaceuticals and currently in Phase II for Esophageal Cancer.

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Eisai hunts for next Alzheimer’s drug with new research pact

Bio Pharma Dive

A collaboration with BioArctic will focus on a technology designed to more effectively deliver drugs in the brain, following similar efforts by Roche.

Drugs 169
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What is health literacy? Definition and resources

Antidote

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.

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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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Early Data Indicate Cell Therapies Could ‘Reset the Clock’ in Parkinson’s

BioSpace

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.

Marketing 122
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Datopotamab deruxtecan by Daiichi Sankyo for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer): Likelihood of Approval

Pharmaceutical Technology

Datopotamab deruxtecan is under clinical development by Daiichi Sankyo and currently in Phase I for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer).

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Novartis raises forecasts as top drug sales beat Wall Street estimates

Bio Pharma Dive

Sales of Entresto and Cosentyx grew faster in the first quarter than analysts anticipated, helping drive the quarterly beat and raise.

Sales 169
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With $75m cash injection, SynOx plans ph3 rare tumour trial

pharmaphorum

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.

Trials 105
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.