Fierce Pharma

AUGUST 23, 2023

In October of last year, GSK laid out a plan to double its business in China by 2025, with much of that expansion dependent upon the succe | In October of last year, GSK laid out a plan to double its business in China by 2025, with much of that expansion dependent upon the success of shingles vaccine Shingrix. On Wednesday, GSK left little doubt about the benefit of Shingrix as it reported 100% efficacy from a post-licensing trial of the shot.

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MedCity News

AUGUST 23, 2023

Two Florida families allege that tens of thousands of Floridians are being terminated from Medicaid coverage without sufficient information as to why. This comes as the U.S. continues the unwinding of the Medicaid continuous enrollment requirement, which stopped states from disenrolling Medicaid enrollees during the Covid-19 public health emergency.

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Fierce Pharma

AUGUST 23, 2023

After floating the idea earlier this month, Mallinckrodt has formally declared its intention to kick off another round of bankruptcy proceedings in the coming days. | After floating the idea earlier this month, Mallinckrodt has formally declared its intention to kick off another round of bankruptcy proceedings in the coming days. But questions remain on just how much the move will affect the company’s looming opioid payouts.

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MedCity News

AUGUST 23, 2023

The FDA cleared Levita Magnetics’ new abdominal surgery platform, which combines the company’s proprietary magnetic surgical technology with robotic assistance. The system is designed to deliver all the same patient benefits as its original magnetic surgery system — such as reduced incisions, less pain, fewer scars and speedier recovery — while also giving surgeons better control of their instruments.

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FDA Patients 95

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Fierce Pharma

AUGUST 23, 2023

While nothing is certain yet, Apellis may be homing in on the source of a rare but serious side effect tied to its world-first geographic atrophy drug Syfovre. | While nothing is certain yet, Apellis may be homing in on the source of a rare but serious side effect tied to its world-first geographic atrophy drug Syfovre. The safety update comes as the company links the use of its med to eight total cases of retinal vasculitis—a type of inflammation that blocks blood flow to the retina and can pot

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Side effects Safety 130

European Pharmaceutical Review

AUGUST 23, 2023

Eli Lilly and Company ’s highly selective and potent RET kinase inhibitor for advanced medullary thyroid cancer (MTC) has demonstrated superior progression-free survival (PFS) compared to approved multikinase inhibitors. These topline results are from an interim efficacy analysis of a Phase III study that compared Retevmo ® (selpercatinib) against multikinase inhibitors (MKIs) cabozantinib or vandetanib.

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Biopharma Safety Medical Patients 94

European Pharmaceutical Review

AUGUST 23, 2023

Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents, proposed by the USP Microbiology Expert Committee, is now published as a General Announcement. This is in advance of the official open comment period, according to USP. Comments are welcome from 1 November 2023 to 31 January 2024. The new standard was proposed by the committee earlier in 2023.

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Manufacturing Pharmaceutical 92

MedCity News

AUGUST 23, 2023

The founder and CEO of Unlearn.AI seeks to make clinical trials more efficient and less costly by leveraging its Digital Twin technology. If the company is successful, drugs could potentially be brought to market sooner and in a cost effective manner.

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Marketing Biopharma 88

PharmaVoice

AUGUST 23, 2023

The HeLa cell line’s contributions to medical science were obtained without permission, and now biotechs profiting from its use are answering for it.

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Biopharma Medical science Medical 97

MedCity News

AUGUST 23, 2023

Dementia patients require a balanced blend of supportive devices, effective medications such as cholinesterase inhibitors and holistic understanding to truly enjoy the best possible quality of life.

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Medical Patients Biopharma 81

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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.

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Pharmaceutical Technology

AUGUST 23, 2023

Revive has begun the development of a next-generation formulation of Bucillamine to treat public health emergencies.

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MedCity News

AUGUST 23, 2023

Carrie Kincaid, Senior Vice President, Market Development at Priority Health discusses how Priority Health is addressing the gaps in rural healthcare.

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Healthcare Healthcare Marketing 86

Pharmaceutical Technology

AUGUST 23, 2023

CROs need to move with the times as artificial intelligence can help deliver more cost-efficient clinical trials.

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PharmaTimes

AUGUST 23, 2023

The varicella zoster virus that causes shingles and chicken pox is typically present in over 90% of adults globally - News - PharmaTimes

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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

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PharmExec

AUGUST 23, 2023

Program designed to aid life science organizations in improving go-to-market strategy.

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Marketing Sales 98

Pharmaceutical Technology

AUGUST 23, 2023

Celcuity has entered a partnership to use Bayer’s Nubeqa in an upcoming Phase Ib/II prostate cancer trial investigating gedatolisib.

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PharmaTimes

AUGUST 23, 2023

The decision allows Abrysvo to be given to those who are 32 to 36 weeks into their pregnancy - News - PharmaTimes

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FDA 77

PharmaTech

AUGUST 23, 2023

In this episode of Drug Digest, Pharmaceutical Technology editors discuss aseptic processing and manufacturing, including what the future holds in this area and the barriers involved with automated aseptic processing practices.

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Manufacturing Pharmaceutical 52

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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.

Safety

PM360

AUGUST 23, 2023

As Xavier Creative House (XCH) celebrates its 10th anniversary, the agency has announced a refresh of its brand. Going beyond a visual update, the new brand reflects the essence of the agency—a team of visionary brand builders and healthcare strategists dedicated to delivering cutting-edge solutions that resonate with audiences and elevate brand presence.

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Healthcare Healthcare Networking Marketing 52

Legacy MEDSearch

AUGUST 23, 2023

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) announce the U.S. Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension.

Medical 52

Medical Food and Drug Administration FDA Recruitment 52

PharmExec

AUGUST 23, 2023

Julie Louise Gerberding, president and CEO of the Foundation for the National Institutes of Health (FNIH) and former lead of the CDC, shares insight into her experience at the CDC and FNIH in this Q&A with Pharm Exec.

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Leads 52

Legacy MEDSearch

AUGUST 23, 2023

In today’s competitive job market, crafting a resume that stands out from the crowd is essential. Artificial Intelligence (AI) has become a key part of the application process for candidates and employers alike and can be extremely beneficial for candidates in crafting a resume that is Automated Tracking System (ATS) friendly, as well as polished enough to impress a recruiter or hiring manager.

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Recruitment Management Marketing Education 52

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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.

Specialization

PM360

AUGUST 23, 2023

The Boundless Life Sciences Group announced today that Tim O’Sullivan will become the CEO of Boundless AI, a new agency founded by Boundless, and centered on how AI will reinvent the marketing offering. “A new era of creativity is about to be unleashed,” said Kerry Hilton, Founder and CEO, The Boundless Life Sciences Group. “We will stay centered on ideas that improve outcomes and provide improved value for patients and caregivers.

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Recruitment Healthcare Healthcare Government 52

Pharmaceutical Technology

AUGUST 23, 2023

The EC has granted approval to Bristol Myers Squibb’s Opdivo (nivolumab) as an adjuvant treatment for stage IIB or IIC melanoma patients.

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Patients 59

PharmaTech

AUGUST 23, 2023

FDA has approved a new mAb therapy from Regeneron Pharmaceuticals as well as a higher dose version of Eylea, the company’s eye disease therapeutic.

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FDA Pharmaceutical 52

Pharmaceutical Technology

AUGUST 23, 2023

Physicians with experience with using AI in their practices were more open to sales representatives using AI to personalise messaging.

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Physicians Sales 52

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

Leads

PharmaTech

AUGUST 23, 2023

The immunization, meant to protect infants aged six months or lower, is given to pregnant individuals at a gestation period of 32 to 36 weeks.

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Pharmaceutical Technology

AUGUST 23, 2023

The US HHS has granted over $1.4bn for Project NextGen to facilitate the development of new vaccines and therapeutics for Covid-19.

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PharmExec

AUGUST 23, 2023

Uncertainty swirls on just how effective policy competition between the EU and UK on these much-needed products will be.

Competition 52

Competition 52

Pharmaceutical Technology

AUGUST 23, 2023

Obesity and type 2 diabetes (T2D) drugs have provided significant increases in revenue growth for Novo Nordisk and Eli Lilly

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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.

Management