2023

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The Power of Personalization Amid the Changing CRO Landscape

Worldwide Clinical Trials

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. As a result, various CROs have undergone significant consolidations and acquisitions of specialized capabilities to address the escalating complexity in clinical trials.

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‘No tolerance for failure’: An oral history of the first CRISPR medicine

Bio Pharma Dive

A new sickle cell disease therapy developed by CRISPR Therapeutics and Vertex Pharmaceuticals is now approved in the U.S. and U.K. This is the story of how it came to be.

Medicine 356
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As ALS research booms, one treatment center finds itself in the spotlight

Bio Pharma Dive

The Healey center is at the front of ALS research and care, earning acclaim from patients, doctors and scientists. Still, the complexities of the disease and of drug development have brought hard-felt losses.

Research 356
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Hospitals pledge to protect patient privacy. Almost all their websites leak visitor data like a sieve

STAT News

Every hospital in America promises to protect the privacy of its patients and the details of their medical care. And almost every one of them uses sophisticated data tools to track and share the personal information of visitors as soon as they start clicking on their websites. A new study found that 99% of U.S. hospitals employed online data trackers in 2021 that transmitted visitors’ information to a broad network of outside parties, including major technology companies, data brokers, an

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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A decade later, biotech’s CRISPR revolution is still going strong

Bio Pharma Dive

Once the specialty of a few select drugmakers, CRISPR gene editing is now an essential technology for a growing group of biotechs, many led by former students of the field's pioneering scientists.

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HIV vaccine being developed by Johnson & Johnson fails clinical trial

STAT News

Yet another experimental HIV vaccine has failed. The National Institute of Allergy and Infectious Diseases reported Wednesday that a Phase 3 clinical trial of a vaccine was stopped because the vaccine was ineffective at preventing HIV infection. The vaccine was being developed by Janssen, the vaccine division of Johnson & Johnson.

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WHO grants emergency use listing to SK bioscience’s SKYCovione

Pharmaceutical Technology

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.

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Mexican pharmacies are selling pills to U.S.travelers laced with deadly fentanyl

NPR Health - Shots

Researchers say Mexican pharmacies that cater to U.S. tourists and medical travelers are selling medications that look safe but are laced with deadly fentanyl and methamphetamines.

Pharmacy 145
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Done deal: Pfizer completes $43B acquisition of Seagen, doubling its oncology pipeline

Fierce Pharma

Pfizer’s $43 billion acquisition of Seagen is in the books, the company said on Thursda | It’s a done deal. Pfizer’s $43 billion acquisition of Seagen is in the books, as it becomes the largest M&A transaction in the biopharma industry since AbbVie snatched up Allergan for $63 billion in 2019. The buyout of the antibody-drug conjugate specialist has doubled Pfizer’s pipeline to 60 programs.

Antibody 145
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What really killed COVID-19 patients: It wasn't a cytokine storm, suggests study

Medical Xpress

Secondary bacterial infection of the lung (pneumonia) was extremely common in patients with COVID-19, affecting almost half the patients who required support from mechanical ventilation. By applying machine learning to medical record data, scientists at Northwestern University Feinberg School of Medicine found that secondary bacterial pneumonia that does not resolve was a key driver of death in patients with COVID-19.

Scientist 145
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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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Anthos Stops Mid-Stage Atrial Fibrillation Trial Due to ‘Unprecedented’ Efficacy

BioSpace

After evidence of “overwhelming reduction” in bleeding compared to Bayer and J&J’s Xarelto, Anthos Therapeutics has ended its Phase II atrial fibrillation study for abelacimab ahead of schedule.

Trials 141
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Talking techbio with NVIDIA: Accelerated computing, NLP, and GenAI in drug discovery

pharmaphorum

Talking techbio with NVIDIA: Accelerated computing, NLP, and GenAI in drug discovery Mike.

Drugs 138
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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog

By Larry K. Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. On October 10th, based on ability to pay, the U.S. District Court for the Western District of Texas imposed a $275,000 civil penalty on Zarzamora Healthcare LLC, in San Antonio, and its pharmacist-owner.

Pharmacy 139
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GPCR-targeting drugs: A renewed focus on a ubiquitous group of proteins

Bio Pharma Dive

As many as a third of FDA-approved drugs target GPCRs in some fashion, with uses ranging from treating cancer to pain. But biotech startups say there is still room to develop more.

Protein 360
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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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J&J-backed startup launches with $100M to build better brain drugs

Bio Pharma Dive

Rapport Therapeutics aims to find new so-called receptor-associated proteins that could serve as targets for neurological disease medicines. Its most advanced drug is already in early-stage human testing.

Drugs 362
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5 FDA decisions to watch in the first quarter

Bio Pharma Dive

An Alzheimer’s drug from Eli Lilly, BioMarin’s hemophilia gene therapy and a new type of breast cancer treatment are among the top decisions on the agency’s docket through the end of March.

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Three VCs launch Dimension, a new firm with plans to fuel biotech’s ‘digitization’

Bio Pharma Dive

The veteran investors see the marriage of tech and life sciences as the “largest opportunity in venture today,” said co-founder and former Lux Capital general partner Adam Goulburn.

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FDA approves first RSV vaccine, clearing GSK’s Arexvy for older adults

Bio Pharma Dive

The decision represents the first fruits of a scientific breakthrough a decade ago that gave drugmakers, among them GSK, Pfizer and Moderna, a blueprint for an effective shot against the virus.

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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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Pfizer begins plan to challenge Shingrix with an mRNA vaccine

Bio Pharma Dive

The pharma and partner BioNTech have kicked off the first human trial of a messenger RNA shot for shingles, believing there’s room to clear the high bar set by GSK’s rival vaccine.

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J&J sees trial data supporting earlier CAR-T use in multiple myeloma

Bio Pharma Dive

The results, which partially leaked in April, show Carvykti’s potential to be used after a drug called Revlimid fails, rather than reserved for only after several treatments do.

Trials 351
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Verve gets FDA green light to run base editing study in US

Bio Pharma Dive

The trial, which is ongoing in the U.K. and New Zealand, has been on hold in the U.S. since late last year as the FDA sought more details on Verve’s in vivo treatment for heart disease.

In-Vivo 341
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Al Sandrock on his short retirement and taking on a biotech turnaround project

Bio Pharma Dive

In a conversation at the J.P. Morgan Healthcare conference, the longtime Biogen executive discussed his hesitance to jump back into an executive role and why an opportunity to run Voyager Therapeutics drew him in.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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FDA approves new ALS medicine in precedent-setting decision

Bio Pharma Dive

Biogen’s drug failed the key study meant to show it can slow the nerve-destroying disease, but the drug’s effect on a protein of interest led the FDA to conditionally clear it for market.

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Roivant’s Matt Gline on the hub-and-spoke biotech model and lessons learned from Axovant

Bio Pharma Dive

This year could stay turbulent for the biotech sector as investors look for what the Roivant CEO described in an interview with BioPharma Dive as “safe harbors in a storm.

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JPM23: Califf on accelerated approvals, biotech startups’ looming cliff and an explanation from Editas

Bio Pharma Dive

The FDA commissioner shared advice for drugmakers at the J.P. Morgan Healthcare conference, while venture investors cautioned of a coming funding crunch for young biotechs.

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Pfizer to cut costs, lay off staff on waning demand for COVID products

Bio Pharma Dive

Sales of Pfizer's antiviral Paxlovid and shot Comirnaty have been slower than it anticipated, while a shift to the commercial market for the antiviral has been delayed.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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J&J antibody drug combination shows promise in multiple myeloma

Bio Pharma Dive

A pair of dual-acting antibodies displayed early potential to become a new type of drug regimen for the blood cancer, but led to a high rate of side effects as well.

Antibody 357
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Teva puts rival to Prometheus, Pfizer drugs at center of turnaround plans

Bio Pharma Dive

At an investor day, executives highlighted an experimental inflammatory disease drug targeting the protein TL1A as important to their long-term growth prospects.

Drugs 360
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FDA to convene advisers on review of RSV vaccines from GSK, Pfizer

Bio Pharma Dive

The agency is currently assessing applications filed by the two companies for what they hope will become the first vaccines against the virus in older adults.

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Cancer vaccine from BioNTech, Roche shows potential in small study

Bio Pharma Dive

The companies’ personalized shot generated tumor-specific T cells that researchers hope could help prevent pancreatic cancer from returning after surgery.

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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.