Pharmaceutical Technology

APRIL 26, 2023

AstraZeneca , Teva Pharmaceuticals , and Novartis , and other companies, are expanding their reach in the asthma space by capitalizing on digital technologies to enhance the patient experience. But experts say the complete integration of these devices and platforms into the healthcare system remains to be seen. Dr. Amy Chan, senior clinical research fellow at the School of Pharmacy, University of Auckland, says digital inhalers have existed for almost 30 years.

Electronics 115

Electronics Medical Patients Government 115

Fierce Pharma

APRIL 21, 2023

In heavyweight obesity fight, Eli Lilly launches Mounjaro head-to-head trial against Novo Nordisk's Wegovy aliu Fri, 04/21/2023 - 22:35

363

363

Pharmaceutical Technology

APRIL 19, 2023

The US Food and Drug Administration (FDA) has made changes to the emergency use authorisations (EUAs) of the Pfizer -BioNTech and Moderna bivalent mRNA Covid-19 vaccines. The latest amendment aims to simplify the vaccination schedule for most people. The changes mean that the current bivalent vaccines for the original and Omicron BA.4/BA.5 strains can now be utilised for all doses administered to those aged six months and above.

FDA 133

FDA Food and Drug Administration Food Leads 133

MedCity News

APRIL 28, 2023

In some ways, the Drug Enforcement Agency’s (DEA) proposed rules for prescribing controlled substances via telemedicine are a sign of progress.

127

127

Advertisement

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

Distribution

MedCity News

APRIL 26, 2023

Kaiser Permanente announced that it expects to acquire Pennsylvania-based Geisinger Health. Kaiser’s move is part of a larger plan — Geisinger will be the first health system to join Risant Health, a new company Kaiser launched to operate nonprofit health systems under value-based care models. Kaiser said it expects to invest $5 billion in Risant and fold five or six health systems into the company over the next five years.

125

125

Medgadget

APRIL 18, 2023

Researchers at MIT have developed lipid nanoparticles that are highly efficient at delivering mRNA therapies to lung cells. Getting therapeutic agents into the lungs can be challenging, but there are a variety of medical challenges that could be addressed by efficiently targeting lung cells with nanoparticle technologies. These latest particles are highly efficient at delivering mRNA which can then encode therapeutically useful proteins in the lungs.

Engineering 122

Engineering Medical Patients Medicine 122

Fierce Pharma

APRIL 19, 2023

Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations zbecker Wed, 04/19/2023 - 11:04

FDA 364

FDA 364

European Pharmaceutical Review

APRIL 13, 2023

Psychedelics are a class of psychoactive substances that produce temporary changes in perception, mood and cognitive processes. 1 Some psychedelics are found in nature, including psilocybin, a naturally occurring molecule found in almost 150 species of mushrooms which turns into psilocin once ingested, causing psychedelic effects. Other psychedelics are man-made, such as lysergic diethylamide (LSD), which was first synthesised in 1938 by Albert Hofmann at a laboratory in Switzerland. 2 LSD is wi

Medicine 115

Medicine Food and Drug Administration Doctors Government 115

Pharmaceutical Technology

APRIL 14, 2023

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. Serum Institute of India (SIIPL), manufacturer and licence holder of the vaccine, has been notified of the registration by Ghana’s FDA.

Manufacturing 111

Manufacturing FDA Food Safety 111

MedCity News

APRIL 23, 2023

The healthcare sector has been notoriously slow to adopt new technologies in the past, but Chat-GPT has already begun to enter the field. Technology experts at the HIMSS conference in Chicago said that while the AI model is certainly exciting, the healthcare sector must establish an accountability framework for it’s going to address the risks of new technologies like ChatGPT moving forward.

Healthcare 137

Healthcare Healthcare Ethics 137

Advertisement

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.

Safety

PharmaTech

APRIL 28, 2023

Todd Andrews, global director of Applications and Business Development at CPC, discusses sterile aseptic connectors, flexibility in manufacturing, and more in an interview held at INTERPHEX 2023.

Manufacturing 105

Manufacturing 105

Clarivate

APRIL 27, 2023

Our latest Global Research Report from the Institute for Scientific Information (ISI) , “U.S. research trends: The impact of globalization and collaboration,” raises important questions about how well past investment has prepared the U.S. scientific enterprise to achieve its goals. Our findings suggest that while the U.S. remains a leading science and technology power, it must acknowledge its shrinking domestic research capacity and work collaboratively with resourceful competitors to maintain i

Competition 105

Competition Engineering Government Networking 105

Fierce Pharma

APRIL 3, 2023

After Johnson & Johnson loses again in bankruptcy case, it's game on for talc lawsuits kdunleavy Mon, 04/03/2023 - 06:44

350

350

European Pharmaceutical Review

APRIL 19, 2023

“The approval of Omisirge is a significant development in hematopoietic stem cell transplantation” Omisirge ® (omidubicel-onlv), now US Food and Drug Administration (FDA) approved , is the first allogeneic stem cell transplant therapy to be given marketing authorisation based on results from a global, randomised Phase III clinical study. The treatment is indicated for patients 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation, following myeloablati

FDA 110

FDA Food and Drug Administration Food Patients 110

Advertiser: ZoomInfo

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

Competition

Pharmaceutical Technology

APRIL 13, 2023

Dyadic International has announced expansion of a licence agreement for its C1-cell protein expression platform with South African consortium Rubic One Health. The expanded licence will include the development of vaccines and therapeutic proteins beyond Covid-19 for human and animal health markets in Africa. During the Covid-19 pandemic, vaccination rates of many countries in Africa were significantly trailing the rest of the world.

Distribution 111

Distribution Manufacturing Media Marketing 111

MedCity News

APRIL 25, 2023

In just 2020, deaths from gun violence cost the U.S. healthcare system $290 million, or about $6,400 per patient, according to a report from the Commonwealth Fund. These costs are mostly covered by Medicaid and other government insurance programs.

Healthcare 130

Healthcare Healthcare Insurance Government 130

PharmExec

APRIL 17, 2023

J&J's Janssen Pharmaceutica NV collaborates with Pipeline Therapeutics in a $50 million licensing deal for oral MS drug PIPE-307, with potential earnings of up to $1 billion for Pipeline.

103

103

PM360

APRIL 25, 2023

No one disputes how much the media landscape has evolved over the last two decades. What has been discussed, at times very passionately, is the role and reputation of media in today’s environment. As marketing and communications professionals, we wanted to take a deeper look into how media is perceived, how social media has changed the game, and how we can best adapt to this ever-evolving dynamic.

Media 98

Media Physicians Ethics Medical 98

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.

FDA

Fierce Pharma

APRIL 26, 2023

Eli Lilly's weight-loss drug passes 2nd trial with flying colors, setting up likely approval aliu Wed, 04/26/2023 - 22:30

330

330

European Pharmaceutical Review

APRIL 10, 2023

The high reliability of matrix-assisted laser desorption/ionization (MALDI) time-of-flight (TOF) mass spectrometry (MS) systems for microbiological identification offer an alternative to serological-based methods, according to a review by researchers. “New technologies for the accurate and rapid identification of bacteria are essential in various fields of applied microbiology.

Media 110

Media Healthcare Healthcare Pharmaceutical 110

Pharmaceutical Technology

APRIL 3, 2023

The World Health Organisation (WHO) has revised its recommendations regarding the use of Covid-19 vaccines following a meeting of the agency’s Strategic Advisory Group of Experts on Immunisation (SAGE). The latest guidance applies to the current phase of the pandemic and reflects the impact of the Omicron variant, which has led to high levels of immunity in all age groups through both vaccination efforts and infections across the globe.

Healthcare 111

Healthcare Healthcare Patients 111

MedCity News

APRIL 17, 2023

Innovaccer launched a new product called Sara, a conversational AI assistant designed to help executives at health systems and payers make better use of their data. It allows executives can ask complex questions about their organization’s patients or members and get immediate answers on clinical, financial or operational metrics.

Patients 130

Patients Healthcare Healthcare 130

Advertisement

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

Copyright Clearance Center

APRIL 18, 2023

April 18, 2023 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, is hosting a panel discussion on “Reading the Data Compass: The Guiding Role of Metadata in an Increasingly Complex Scholarly Research Ecosystem” during the Research & Scholarly Publishing Forum at The London Book Fair on 20 April, 11:40 -12:10 in the Olympia Theatre.

Government 98

Government Media Management Leads 98

PharmExec

APRIL 10, 2023

Agency hopes to attract more seasoned expertise in manufacturing; also looking to add field inspectors.

Manufacturing 123

Manufacturing FDA 123

Fierce Pharma

APRIL 20, 2023

'The Top Line': How Pfizer became the first in Big Pharma history to break $100B in sales, plus this week's headlines tcarey Thu, 04/20/2023 - 14:46

Sales 290

Sales Pharma 290

European Pharmaceutical Review

APRIL 25, 2023

The R21/Matrix-M malaria vaccine, developed by the University of Oxford , has been approved for use in Ghana (13 April 2023) and was authorised for use in Nigeria on 17 April. [Regulatory] approval of the [R21/Matrix-M ] malaria vaccine in Ghana was the first in the world” Approval of the malaria vaccine in Ghana was the first in the world. Granted full national licensure by the country’s Food and Drugs Authority (FDA Ghana), it is authorised for children aged 5 to 36 months.

Manufacturing 107

Manufacturing Safety Food Medicine 107

Advertisement

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

Pharmaceutical Technology

APRIL 7, 2023

Enanta Pharmaceuticals has secured the US Food and Drug Administration’s (FDA) fast track designation for EDP-323 to treat respiratory syncytial virus (RSV). In vitro data of EDP-323 showed a significant reduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B. Consistent potency was also observed across a range of RSV clinical isolates in several cell types.

FDA 110

FDA Food Pharmaceutical Medical 110

MedCity News

APRIL 21, 2023

By combining in-home and virtual care, we can meet patients literally where they are. More importantly, we can improve outcomes, reduce costs and help patients get back to a normal life while giving therapists the flexibility and opportunity to provide more customized care for their patients.

Patients 128

Patients 128

PharmaVoice

APRIL 18, 2023

How an “international” childhood sent Dr. José Trevejo, Tarsus’s chief medical officer, on a mission to fight infectious diseases.

Leads 98

Leads Medical 98

PharmaTech

APRIL 27, 2023

Yaakov Nahmias, founder and chief scientific officer of Tissue Dynamics, discusses the barriers in implementing organ on a chip technology.

98

98

Advertisement

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

Patients