Rethinking Clinical Trials

JULY 23, 2024

In an invited commentary published this month in Circulation: Cardiovascular Quality and Outcomes , authors from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core describe the recurring and emerging ethical issues in pragmatic clinical trials. Coauthors Caleigh Propes, Stephanie Morain, and Pearl O’Rourke discuss 3 key challenges facing pragmatic trials researchers: waivers and alterations of informed consent and their implications for transparency managing and resp

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Trials Clinical Trials Clinical Trials Doctors 315

Pharmaceutical Technology

JULY 23, 2024

Johnson & Johnson is seeking approval for SPRAVATO for treatment-resistant depression with the submission of an sNDA to the US FDA.

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Bio Pharma Dive

JULY 23, 2024

Peter Lebowitz, who for years led J&J’s oncology R&D, is the CEO of the startup, called Third Arc Bio and launched by Omega Funds in 2022.

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Drugs 206

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 23, 2024

Ultra long, thick eyelashes might be in vogue but are they worth the expense – and the risk to health? Our natural eyelashes perform important functions. The eye is exposed to the elements so it’s a window for bacteria and viruses to enter the body – potentially causing death.

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Bacteria Clinical Trials Clinical Trials Trials 174

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Clinical Supply

Bio Pharma Dive

JULY 23, 2024

The drug, a rival to Sanofi and AstraZeneca’s fast-selling Beyfortus, met its main goals in a Phase 3 trial. But undisclosed study results leave its full potential unclear.

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Antibody Trials Drugs 152

Pharmaceutical Technology

JULY 23, 2024

The latest resubmission addressed remaining CMC concerns, with the FDA confirming that the Phase III data was “sufficient”.

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Gene Therapy Gene 162

Pharmaceutical Technology

JULY 23, 2024

A Phase II trial with Johnson and Johnson (J&J) and Addex’s epilepsy drug had failed to meet the primary endpoint in April.

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Trials Drugs 147

BioSpace

JULY 23, 2024

AstraZeneca is proposing to use Imfinzi for resectable non-small cell lung cancer in the perioperative setting—both before and after surgical resection of the tumor. However, ahead of Thursday’s advisory committee meeting, FDA staffers have expressed concerns.

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Pharmaceutical Technology

JULY 23, 2024

The US government will not give bluebird bio the opportunity to offer fertility support to patients covered by federal insurance programmes like Medicaid.

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pharmaphorum

JULY 23, 2024

Agilent has boosted its contract development and manufacturing organisation (CDMO) capacity with a $925 million deal to buy Biovectra, a Canadian provider of fill-and-finish services and active pharmaceutical ingredients (APIs).It's a statement of intent from Agilent, whose primary business is lab instrumentation and equipment, suggesting that it intends to grow the outsourcing side of its business, which is currently focused on the production of oligonucleotide and peptide medicines.

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Manufacturing Medicine Production Development 111

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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

Pharmaceutical Technology

JULY 23, 2024

Telix is eyeing an expansion of the diagnostic imaging indications for its assets and advancing pivotal trials as the radiopharma arena heats up.

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Trials 130

pharmaphorum

JULY 23, 2024

Former Welsh rugby union captain Alum Wyn Jones is the face of a new awareness campaign launching in the UK today to draw attention to atrial fibrillation (AF), an irregular and potentially life-threatening heart rhythm abnormality.

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Pharmaceutical Technology

JULY 23, 2024

Samsung Bioepis has announced the approval of EPYSQLI BLA by the US Food and Drug Administration (FDA) as a biosimilar to Soliris.

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FDA Approval Drugs 130

Fierce Pharma

JULY 23, 2024

After making major manufacturing outlays in places like China and the United States earlier this year, Novo Nordisk is returning to its Danish roots. | Earlier this month, Novo Nordisk purchased a 200-acre site in Odense, Denmark’s third largest city, the company has confirmed. Novo is now set to kick off preparatory excavation work for a potential new production plant.

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Manufacturing Production 78

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Clinical Supply

Pharmaceutical Technology

JULY 23, 2024

Grünenthal has announced the acquisition of Valinor Pharma and its opioid-induced constipation (OIC) therapy Movantik for $250m.

Drugs 130

Drugs 130

pharmaphorum

JULY 23, 2024

GSK has challenged Gilead's HIV behemoth Biktarvy, presenting data that its competing therapy Dovato is equally effective and associated with less weight gain.

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Pharmaceutical Technology

JULY 23, 2024

Agilent Technologies has announced a definitive agreement for the acquisition of Canadian CDMO BIOVECTRA in a deal worth $925m.

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pharmaphorum

JULY 23, 2024

Ionis plans phase 3 trial of its antisense therapy for Angelman syndrome, shortly after Biogen decided against exercising an option to license the drug

Drugs 101

Drugs Licensing Licensing Trials 101

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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

Pharmaceutical Technology

JULY 23, 2024

Final podcast in Sterling's series, examining how a range of factors influence transaction structure and deal terms.

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Life Science 130

BioPharma Reporter

JULY 23, 2024

Dr. Antonella Favit-VanPelt, a distinguished neurologist, has had a lifelong passion for understanding the 'why' behind sickness, ignited by her childhood curiosity.

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Clinical Development Development 96

BioSpace

JULY 23, 2024

While supportive of Amylyx’s acquisition of a GLP-1 drug, analysts say the company’s future hinges on key upcoming readouts from multiple products in its pipeline.

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Marketing Production Drugs 86

BioPharma Reporter

JULY 23, 2024

As a strategic brand consultant at ramarketing, Laura combines her extensive background in clinical research with strategic leadership and creative expression.

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Life Science Branding Clinical Research Research 96

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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

Pharma Times

JULY 23, 2024

The neurological disease is estimated to affect more than ten million people globally

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Research 107

BioPharma Reporter

JULY 23, 2024

The contract development and manufacturing organization (CDMO) arm of the Israeli company Pluri will deploy automated and 3D cell expansion technology to produce cell therapies developed by compatriot firm Kadimastem.

Manufacturing 85

Manufacturing Development Gene Therapy Gene 85

pharmaphorum

JULY 23, 2024

Johnson & Johnson has filed for FDA approval of its antidepressant nasal spray Spravato, hoping to make it the first standalone treatment for adults with treatment-resistant depression (TRD).Spravato (esketamine) is already approved in the US as an add-on to oral antidepressant therapy for TRD, as well as for depressive symptoms in adults with major depressive disorder (MDD) and suicidal thoughts or behaviours.

FDA Approval 85

FDA Approval Drugs 85

BioPharma Reporter

JULY 23, 2024

ViiV Healthcare has released new data demonstrating the safety and efficacy of Apretude (cabotegravir long-acting for PrEP) during pregnancy.

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Drug Delivery Drugs 96

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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

Outsourcing Pharma

JULY 23, 2024

Rusan Pharma Private Limited has announced that its active pharmaceutical ingredient (API) manufacturing facility in Ankleshwar, Gujarat, has been granted Good Manufacturing Practice (GMP) approval by the FDA.

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Manufacturing FDA Approval Drug Delivery Drugs 72

Pharma Times

JULY 23, 2024

The life-threatening medical condition affects 100,000 people in the UK every year

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Protein 99

Fierce Pharma

JULY 23, 2024

Interim results from a phase 3 trial of AstraZeneca’s Imfinzi as a treatment before and after surgery in resectable non-small cell lung cancer (NSCLC) were head scratching as they failed to answer | An FDA advisory committee will discuss AstraZeneca’s application for Imfinzi in early-stage non-small cell lung cancer. The agency is asking external experts to weigh in on whether a new trial is needed to determine the contributions of the therapy on either end of surgery.

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Trials 67

Intouch Solutions

JULY 23, 2024

Google has announced that it will not proceed with its initial plan – previously covered in this POV – to phase out third-party cookies on Chrome. Instead, Google will maintain the use of third-party cookies for those who do not disable them. This decision marks a shift from its previous strategy, which was aimed at enhancing user privacy while preserving advertising effectiveness.

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Compliance Branding Regulation 66

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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