Fierce Pharma

SEPTEMBER 18, 2023

With the loss of elasticity in the skin that accompanies aging, platysma bands can become more apparent, protruding from the neck. | Already approved as an injection to reduce wrinkles in the forehead and around the eyes, AbbVie's Botox is in position to expand its cosmetic uses to the moderate to severe form of platysma prominence, a condition which causes muscle bands to protrude from the neck.

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Clarivate

SEPTEMBER 18, 2023

Dr. Henry Small will deliver the lecture to commemorate the 50th anniversary of his groundbreaking paper on co-citation in scientific literature. To commemorate the legacy of Eugene Garfield, founder of the Institute for Scientific Information (ISI) , Clarivate is proud to announce the inaugural Eugene Garfield Memorial Lecture. It will be delivered by Dr.

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Specialization Networking Leads Professional Services 119

Fierce Pharma

SEPTEMBER 18, 2023

Amid Sanofi’s multi-year effort to simplify its product portfolio, the drugmaker is offloading 11 central nervous system (CNS) meds to lifecycle management company Pharmanovia. | The move falls in line with CEO Paul Hudson's mission to focus Sanofi's efforts on "best-in-class" growth drivers, including the immunology superstar Dupixent.

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Management 246

MedCity News

SEPTEMBER 18, 2023

The era of remote patient monitoring is ushering in a new era of healthcare, characterized by data-driven insights, personalized care, and efficient resource utilization.

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Patients Healthcare Healthcare 118

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Fierce Pharma

SEPTEMBER 18, 2023

With backing from an FDA advisory committee and results from a positive phase 3 trial, respectively, Alnylam and BridgeBio are each on track to enter the blockbuster transthyretin amyloidosis cardi | Alnylam and BridgeBio are each on track to enter the blockbuster transthyretin amyloidosis cardiomyopathy (ATTR-CM) market. But doctors say they'll mostly stick with Pfizer's first-to-market offerings.

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Doctors FDA Marketing 238

MedCity News

SEPTEMBER 18, 2023

This year, HCA Healthcare and Google Cloud have expanded their partnership by exploring ways to integrate Google’s generative AI into HCA’s workflows. The most developed project under this initiative is a pilot that began in February in which HCA’s emergency department physicians are testing a voice-enabled medical dictation tool to save them time on clinical documentation.

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Physicians Healthcare Healthcare Medical 118

MedCity News

SEPTEMBER 18, 2023

CardioOne, a startup built at Redesign Health, partners with independent cardiology practices to help them transition to value-based care. On Monday, the company announced it has raised $8 million in seed funding and has three new partners.

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Marketing 114

Fierce Pharma

SEPTEMBER 18, 2023

After inking and expanding a biosimilar production partnership with Pfizer this summer, Korea’s Samsung Biologics is boosting yet another Big Pharma manufacturing agreement. | Samsung Biologics has inked a new deal with Bristol Myers Squibb for large-scale drug substance production on an unnamed commercial cancer antibody. The partners have already been working together on antibody manufacturing and have expanded their relationship over time.

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Manufacturing Pharma 210

MedCity News

SEPTEMBER 18, 2023

The healthcare industry is sitting on a wealth of data gathered from electronic health records, commercial pharmacies, health systems and payers, and health tech companies. So much that it makes up one-third of the world’s data.

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Electronics Healthcare Healthcare Pharmaceutical 111

Fierce Pharma

SEPTEMBER 18, 2023

Since rare disease research gained traction in the 1980s, pharmaceutical investment in orphan drugs has accelerated. | rWGS technology can improve drug discovery, development and commercialization. To advance it, we need pharma investment in cross-industry efforts.

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Pharma Pharmaceutical 130

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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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MedCity News

SEPTEMBER 18, 2023

For the past 30 years, even with the various headwinds over time, consistent winners in MA have adapted and adjusted to new standards required for success. Now is no different. Short-term headwinds are just that – short-term.

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PharmaVoice

SEPTEMBER 18, 2023

An effort to spare the species from blood collection is one of many ways the industry is turning away from animals for R&D.

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Leads 121

MedCity News

SEPTEMBER 18, 2023

Postpartum Depression has been a recognized — but stigmatized — possibility during the so-called “fourth trimester of pregnancy” for generations. However, it is now being firmly addressed through femtech innovations.

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European Pharmaceutical Review

SEPTEMBER 18, 2023

The Cell and Gene Therapy Catapult (CGT Catapult) , supported by Scotland’s national economic development agency, Scottish Enterprise, has launched a new cooperative network to foster collaboration and increase knowledge sharing across the Advanced Therapy Medicinal Products (ATMP) industry in Scotland. Events, as well as talks from industry leaders and networking opportunities, will be coordinated by a new ‘Scottish Advanced Therapy Medicinal Products (ATMP) and Vaccines Network’ to aid individ

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Networking Medicine Manufacturing Medical 97

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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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MedCity News

SEPTEMBER 18, 2023

The Coalition for Epidemic Preparedness Innovations, or CEPI, has pledged up to $90 million to BioNTech’s messenger RNA vaccine candidates for mpox. This research could help advance the scientific understanding of the application of mRNA technology to Orthopoxviruses, which includes mpox, formerly known as monkeypox.

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Biopharma Pharma 100

Pharmaceutical Technology

SEPTEMBER 18, 2023

Embattled biotech giant Illumina has led series A funding into genomics mapping company Broken String Biosciences.

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Leads 116

PharmaTimes

SEPTEMBER 18, 2023

The treatment is the first oral GPCR receptor antagonist class recommended for NHS use - News - PharmaTimes

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Pharmaceutical Technology

SEPTEMBER 18, 2023

The FDA released a draft guidance giving advice on the correct labelling of biosimilar and interchangeable biosimilar products.

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FDA 105

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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

European Pharmaceutical Review

SEPTEMBER 18, 2023

The first and only treatment for anaemic patients with myelofibrosis has been approved by the US Food and Drug Administration (FDA). Ojjaara (momelotinib) is indicated for intermediate or high-risk myelofibrosis, a blood cancer, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythaemia), in adults with anaemia.

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Food and Drug Administration Safety FDA Food 84

Pharmaceutical Technology

SEPTEMBER 18, 2023

Despite major shifts in the IBD landscape, most approaches that go beyond targeting inflammation remain in the earlier stages of development.

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Pharma 98

PharmaTimes

SEPTEMBER 18, 2023

The updated vaccines more closely target current circulating variants - News - PharmaTimes

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FDA 118

European Pharmaceutical Review

SEPTEMBER 18, 2023

The European Medicines Agency (EMA)’s human medicines committee (CHMP) recommended nine new medicines for approval during its meeting in September 2023. The committee recommended granting a marketing authorisation for Ebglyss (lebrikizumab). This medicine is indicated for treating moderate-to-severe atopic dermatitis in adults and adolescents. To treat glioma, a type of brain tumour, the CHMP gave a positive opinion for Finlee (dabrafenib).

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Medicine Marketing Management Pharmaceutical 81

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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

Pharmaceutical Technology

SEPTEMBER 18, 2023

Experts say a wider diverse pool of patients needs to be given a chance to participate in clinical trials to get rare disease drugs faster to market.

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Patients Marketing 64

PharmaTech

SEPTEMBER 18, 2023

Part of the session "Transforming Medicine: Unleashing the Potential of Cell and Gene Therapies," Sadelain discusses CAR-T cells for immunotherapy and the future of cell/gene therapies.

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FDA Medicine 52

Impetus Digital

SEPTEMBER 18, 2023

At Impetus Digital , we put sustainability at the forefront of everything we do and are actively working toward carbon-neutrality! We’re proud of everything we’ve achieved so far and encourage our followers, clients, and competitors to join in the fight. Check out some of our major accomplishments to date below. Impetus' Sustainability Journey Impetus' Sustainability Journey Click here to book a demo of our platform and services The post Infographic: Impetus’ Sustainability Jou

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PharmaTech

SEPTEMBER 18, 2023

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the barriers to the development of continuous manufacturing processes after implementing ICH Q13.

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Manufacturing FDA 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

Copyright Clearance Center

SEPTEMBER 18, 2023

Frontiers is now using the Ringgold Identify Database from CCC as its Persistent Identifier (PID) solution to help power its OA models by normalizing and disambiguating organization data.

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PharmaTech

SEPTEMBER 18, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

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FDA 52

Legacy MEDSearch

SEPTEMBER 18, 2023

CereVasc, Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) supplement to permit the expansion of the study of the eShunt System in patients with Normal Pressure Hydrocephalus (NPH) to additional study participants and clinical sites.

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Food and Drug Administration FDA Patients Recruitment 52

PharmaVoice

SEPTEMBER 18, 2023

The visual inspection of injectable drug product has been a regulatory requirement since 1936, however, successful implementation of the standard has been challenging for many organizations.

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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