AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 29, 2024

The implementation of Revised Schedule M is set to revolutionize the pharma industry landscape by not only enhancing quality standards but also by streamlining regulatory processes, notably by minimizing duplicative inspections by various regulatory bodies of different countries, according to a senior Central Drugs Standard Control Organisation (CDSCO) official.

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Drugs Clinical Trials Clinical Trials Clinical Research 166

Bio Pharma Dive

APRIL 29, 2024

Consideration of sustainability early in process development, throughout the entire development cycle, and across the entire supply chain must also become common practice.

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Manufacturing Development 265

Pharmaceutical Technology

APRIL 29, 2024

Pfizer has received approval from the US Food and Drug Administration (FDA) for its one-time gene therapy BEQVEZ for haemophilia B.

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Gene Therapy Gene FDA Approval Drugs 245

Bio Pharma Dive

APRIL 29, 2024

The drug benefited people whose tumors have “ultralow” levels of HER2 protein, a result that could extend its reach in HER2-positive breast cancer.

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Protein Drugs 260

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Clinical Supply

Pharmaceutical Technology

APRIL 29, 2024

Experts hold scalability challenges and high costs accountable for market failures within the cell and gene therapy landscape.

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Gene Therapy Gene Marketing 246

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 29, 2024

A unique genetic mutation in two siblings – that has never been seen in anyone else – has been discovered by UK researchers at the University of Exeter, pointing the way towards new treatment options for type 1 diabetes.

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Gene Genetics Protein Research 190

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 29, 2024

Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports. The guidance provides instructions about how the individual case safety reports (ICSRs) from investigational new drug (IND) need to be supported with Adverse Event Reporting System (AERS).

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Clinical Trials Clinical Trials Trials Drugs 179

Pharmaceutical Technology

APRIL 29, 2024

AstraZeneca has recently announced that Fasenra has been approved for severe asthma, specifically for the eosinophilic phenotype, in children aged 6-11 years in more than 80 countries, including the US, EU, and Japan.

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Bio Pharma Dive

APRIL 29, 2024

The company will soon start a Phase 1/2 study of its treatment for chronic granulomatous disease, a milestone for the search-and-replace gene editing technology.

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Gene Editing Gene Trials 148

Pharmaceutical Technology

APRIL 29, 2024

US regulators have added more Chinese biotech companies to the list of firms posing national security risks to the US.

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Regulation 147

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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

Clinical Trials

Bio Pharma Dive

APRIL 29, 2024

Applying a systems thinking framework to clinical trial design prompts purposeful and productive collaboration among stakeholders.

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Clinical Trials Clinical Trials Trials Production 139

Pharmaceutical Technology

APRIL 29, 2024

PharmaLink has partnered with Recall Results for accurate and responsive drug recalls, withdrawals and market actions in the pharma industry.

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Drugs Marketing 130

Bio Pharma Dive

APRIL 29, 2024

Risks associated with the tests have increased, requiring greater oversight to protect patients, the agency contends.

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Development 139

Pharmaceutical Technology

APRIL 29, 2024

Clinical trials across the globe are investigating new treatments for Duchenne Muscular Dystrophy, improving muscular and skeletal health.

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Clinical Trials Clinical Trials Trials 130

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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

Clinical Research

Bio Pharma Dive

APRIL 29, 2024

For Japan-based Ono Pharmaceutical, buying Deciphera offers a way to build out in cancer research as well as get a stronger foothold in the U.S. and European markets.

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Marketing Research 114

Pharmaceutical Technology

APRIL 29, 2024

Ono will gain access to Deciphera’s kinase inhibitor pipeline, which includes the CSF-1 inhibitor vimseltinib and ULK inhibitor DCC-3116.

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pharmaphorum

APRIL 29, 2024

Get to know Dr Jay Shah, a prominent figure in the field of cardiovascular medicine, as he answers 12 intriguing questions about his role as Chief Medical Officer at Aktiia and his insights into the field.

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Medicine 124

Pharmaceutical Technology

APRIL 29, 2024

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended vibegron for OAB in adults.

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Medicine Production 130

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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.

Clinical Trials

pharmaphorum

APRIL 29, 2024

A partnership between Huma Therapeutics and Merck KGaA to develop digital support tools for cancer patients has borne fruit with the launch of a bladder cancer app in the UK

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Development 119

Pharmaceutical Technology

APRIL 29, 2024

Sino Biological has concluded the acquisition of SignalChem Biotech (SCB) for $48m, expanding its portfolio and global presence.

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Fierce Pharma

APRIL 29, 2024

The price tag includes both the approved cancer drug Qinlock and another Deciphera candidate heading to the FDA’s desk in the coming months.

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Drugs 130

Pharmaceutical Technology

APRIL 29, 2024

The expanded approval of Biktarvy was based on the Phase I trial data showing efficacy in pregnant HIV-positive individuals.

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Trials 130

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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.

Clinical Supply

BioSpace

APRIL 29, 2024

Enlaza Therapeutics on Tuesday announced financing led by the Life Sciences Group of J.P. Morgan Asset Management’s Private Capital division, which the California-based company will use to build its pipeline of covalent biologics.

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Life Science 117

Pharmaceutical Technology

APRIL 29, 2024

Biodexa’s worldwide rights of eRapa come with a $17m grant from CPRIT to support the asset into Phase III clinical trials.

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Licensing Licensing Clinical Trials Clinical Trials 130

pharmaphorum

APRIL 29, 2024

Patients in the US with the ultra-rare disease WHIM syndrome now have their first approved treatment, after X4 Pharma’s Xolremdi was given a green light by the FDA. Oral CXCR4 antagonist Xolremdi (mavorixafor) can be used in patients aged 12 and over with WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome, a congenital immunodeficiency characterised by low neutrophil counts that affects fewer than 1,000 people in the US.

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Drugs 111

Pharmaceutical Technology

APRIL 29, 2024

The AHF Global Public Health Institute has voiced concerns over WHO's proposed pandemic agreement.

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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.

Clinical Trials

pharmaphorum

APRIL 29, 2024

Japan’s Ono Pharma has bolstered its cancer pipeline with a $2.4 billion agreement to buy Deciphera Pharma of the US and its fast-growing gastrointestinal stromal tumour (GIST) therapy Qinlock. Ono is offering $26.50 per share in cash for the Waltham, Massachusetts-based company, saying the deal will enable it to “build a robust presence in oncology,” one of the group’s key priority areas.

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BioSpace

APRIL 29, 2024

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu significantly improved progression-free survival in metastatic breast patients with low and ultralow HER2 expression levels who had received at least one line of systemic treatment.

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Antibody Drugs 114

pharmaphorum

APRIL 29, 2024

CHMP backs EU approval of J&J's Rybrevant as a first-line therapy for NSCLC with EGFR exon 30 insertion mutations, filling a void left after Takeda's Exkivity was pulled from sale

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Sales 110

BioSpace

APRIL 29, 2024

Under the latest teaming between the two companies, who have worked together since 2010, Novartis will pay $180 million upfront to PeptiDream to find new radioligand therapies.

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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

Clinical Supply