December, 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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Trade & Channel Strategies 2023: Aligning Patient Access

Pharmaceutical Commerce

Panel uncovers ways to handle the increasing complexities and risks surrounding commercialization.

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December 5, 2023: Applications Open for HDRN Canada Pragmatic Trials Training Program

Rethinking Clinical Trials

Health Data Research Network (HDRN) Canada is now accepting applications for its Pragmatic Trials Training Program. This 2-year, virtual, pan-Canadian program will provide training to advanced learners across 3 streams: (1) future trial leaders (faculty-level trainees), (2) postdoctoral fellows, and (3) highly qualified personnel employed in the public and private sectors.

Trials 328
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Life Science Trends to Look Out for in 2024

XTalks

As we step into 2024, the life sciences continue to evolve at an unprecedented pace, driven by technological innovation, a deeper understanding of human biology and the application of new technologies in areas like drug development and health wearables. Below are some of the key trends that will be shaping the future of the life sciences in 2024 and beyond.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Partnerships for prevention: Biopharma, patients, and digital technology

pharmaphorum

Partnerships for prevention: Biopharma, patients, and digital technology Mike.

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ASH23: Pharma branding, Editas’ high bar and clinical trial diversity

Bio Pharma Dive

Editas had the tall task Monday of convincing ASH attendees its gene therapy for sickle cell disease could improve on Casgevy and Lyfgenia.

More Trending

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Pfizer’s initiative to return clinical trial data to patients

pharmaphorum

Pfizer’s initiative to return clinical trial data to patients Mike.

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Overcoming scalability challenges in real-world data processing for transformative patient care

Bio Pharma Dive

Accurate and timely processing of data is imperative to create robust analytical datasets that can be used in the RWE setting.

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Seattle Children’s Hospital launches BrainChild Bio for CNS therapies

Pharmaceutical Technology

Seattle Children's launched BrainChild Bio to focus on expediting the development of CAR T-cell therapies in central nervous system tumours.

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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 144
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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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Merck’s Keytruda, Anti-TIGIT Combo Fails Phase II NSCLC Trial

BioSpace

A combination of Merck’s experimental anti-TIGIT antibody vibostolimab and anti-PD-1 drug Keytruda failed to hit its endpoints in a mid-stage non-small cell lung cancer study.

Antibody 122
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To fight rare diseases, win the data battle first

pharmaphorum

To effectively combat rare diseases, it is essential to prioritise the collection and analysis of data. This article explores how pharmaceutical companies are leveraging AI and focusing on orphan drugs to tackle rare diseases.

Drugs 126
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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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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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Pharma breakthroughs: 10 novel drug approvals that made headlines in 2023 

Pharmaceutical Technology

Pharmaceutical Technology outlines some of the biggest US Food and Drug Administration (FDA) drug approvals announced in 2023 that are set to make an impact in the coming years.

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Pfizer warns of further sales decline for COVID products, plots $500M in additional cost cuts

Fierce Pharma

Using Tuesday to announce good news—that its $43 billion acquisition of Seagen would be | Using Tuesday to announce good news—that its $43 billion acquisition of Seagen would be finalized on Thursday—Pfizer sandwiched its bad news, which came on Wednesday with its 2024 guidance. The company expects revenue to reach between $58.5 billion and $61.5 billion next year, coming up short of the analyst consensus of $63.2 billion, largely because of the plummeting demand for its COVID-19 products.

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10 achondroplasia facts to note

Antidote

Achondroplasia, a term meaning “without cartilage formation,” is a genetic disorder leading to disproportionate short stature. Sometimes called achondroplastic dwarfism or ACH , this condition has few treatment options and no known cure. However, individuals diagnosed with this condition can typically lead fulfilling, healthy lives with proper management.

Genetics 121
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Oncologists Defend CAR-T After FDA Advisory

BioSpace

The agency is investigating reports of secondary blood cancers in patients who have received certain CAR T cell therapies, but experts say the risk is low and is outweighed by the terminal nature of some cancers.

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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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BioNTech wins round in CureVac mRNA patent dispute

pharmaphorum

Shares in CureVac have plummeted after a German court ruled that a patent it holds on mRNA-based COVID-19 vaccines was invalid. The validity of the patent is at the heart of patent litigation between CureVac and fellow German biotech BioNTech and its partner Pfizer, claiming infringement by their Comirnaty coronavirus shot.

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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 357
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Quality and sustainability: The balancing act for pharma manufacturing  

Pharmaceutical Technology

Trends in sustainability and quality assurance were key themes discussed at the recent CPHI Europe 2023 meeting, although the data reveals a lack of implementation of sustainable solutions.

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Europe names hundreds of critical medicines in quest to counter drug shortages

Fierce Pharma

Over the past several years, drug shortages have vexed doctors and patients on both sides of the Atlantic, prompting lawmakers and government agencies to take action in both Europe and the U.S. | Tuesday, the European Medicines Agency laid out a list of more than 300 critical generic drugs that could fall prey to future shortages. Inclusion in the list doesn’t mean a particular drug is likely to experience a shortage anytime soon, the EMA said.

Medicine 138
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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 is chronic spontaneous urticartia (chronic hives)?

Antidote

Chronic spontaneous urticaria, also called chronic idiopathic urticaria, is a type of chronic hives that come and go unexpectedly. These hives persist daily for a minimum of six weeks without a clear cause or trigger. While this condition can affect anyone at any point, women experience it twice as often as men , and it’s most common between the ages of 20 and 40.

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FDA Denies Accelerated Approval for Clene’s ALS Candidate

BioSpace

Clene disclosed Thursday the FDA has determined that biomarker Neurofilament Light Chain reduction in its Phase II programs “were insufficient to support accelerated approval at this time.

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MSD, Moderna cancer vaccine aces melanoma study

pharmaphorum

MSD and Moderna’s individualised cancer vaccine mRNA-4157 has shown impressive efficacy in a phase 2b trial in skin cancer melanoma, leaving the partners speculating about a possible regulatory filing.

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CRISPR therapy for sickle cell approved by FDA in gene editing milestone

Bio Pharma Dive

In addition to clearing Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy, the FDA also granted an early OK to Bluebird bio’s sickle cell treatment Lyfgenia.

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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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Q&A: Tackling the rise of fake anti-obesity drugs on the market

Pharmaceutical Technology

Professor Timothy Mackey talks about the recent reports of fraudulent Ozempic pens and the challenges in chasing drug counterfeiters.

Drugs 278
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2024 forecast: M&A saw an uptick in 2023. Analysts expect the trend to continue

Fierce Pharma

Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise. | Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise.

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Patient perspectives: From public relations executive to chronic pain patient

Antidote

Because Antidote’s key focus is connecting patients to clinical trials , hearing directly from individuals serves as a great reminder of why we do what we do. One patient we’ve had the pleasure of speaking with is Linda VandeVrede, a former high-tech PR executive who shared her story of chronic pain, clinical trials, and personal experience.

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Moving RNA Therapeutics Beyond the Liver

BioSpace

From the skin to the lungs to the central nervous system, biotech companies are making progress toward delivering RNA therapeutics to multiple targets throughout the body. But challenges remain.

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g