Fierce Pharma

JUNE 7, 2023

Merck has taken the lead, filing a lawsuit seeking to overturn drug pricing measures in the Inflation Reduction Act (IRA). | Merck has filed a lawsuit seeking to overturn drug-pricing measures in the Inflation Reduction Act (IRA). Now, emboldened by the New Jersey drugmaker, other biopharma CEOs are making their concerns known. At the BIO International Convention, Biogen CEO Chris Viehbacher registered severe criticism of the IRA and said his company was considering filing its own lawsuit.

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MedCity News

JUNE 7, 2023

Google Cloud and Mayo Clinic recently announced a partnership focused on generative AI — the health system will be deploying a new HIPAA-compliant Google Cloud service called Gen App Builder. The tool enables providers to create a search system for their data, equipped with conversational features powered by Google’s large language models.

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Patients Healthcare Healthcare 106

Fierce Pharma

JUNE 7, 2023

As Alzheimer's disease partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval. | As Alzheimer's partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval. On Wednesday, that vision came into better focus as the FDA released a document showing how the agency views the drug.

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MedCity News

JUNE 7, 2023

Healthcare brands should always build their own digital marketing strategy from scratch – rather than using a blueprint from another successful digital industry.

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Marketing Healthcare Healthcare Biopharma 108

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Fierce Pharma

JUNE 7, 2023

The rush to provide revolutionary weight-loss drugs to obese patients has reached the U.K. | The rush to provide revolutionary weight-loss drugs to obese patients has reached the U.K. On Wednesday, the government unveiled a two-year pilot program that will allow Novo Nordisk’s Wegovy to be given to more overweight participants, even though the treatment has yet to be launched there.

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MedCity News

JUNE 7, 2023

A study published in JAMA Internal Medicine discovered that the cost of providing evidence-based solutions for food, housing, transportation and care coordination is $60 per member per month on average. Existing federal funding covers $27 per member per month, less than half of the total cost.

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Pharmaceutical Technology

JUNE 7, 2023

Eli Lilly has achieved significant gains in the past quarter, leading to it becoming the most valuable pharmaceutical company in the world, with a market cap of $420bn, surpassing Johnson & Johnson. The recent rallying of Lilly’s market value has come as the result of two major announcements: its blockbuster type 2 diabetes (T2D) drug Mounjaro (tirzepatide) successfully completed its second final-stage trial for obesity, and its experimental treatment for Alzheimer’s disease completed its Ph

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Fierce Pharma

JUNE 7, 2023

Legend Biotech and Johnson & Johnson are moving fast in their efforts to forward their CAR-T standout Carvykti. | Legend Biotech and Johnson & Johnson have filed with the FDA for expanded use of Carvykti. After gaining approval 16 months ago for the CAR-T to treat multiple myeloma patients following four or more lines of therapy, the companies hope to get the U.S. regulator to sign off on its use at an earlier stage of treatment.

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MaBiCo

JUNE 7, 2023

Medical Sales Strategies: How to Drive Doctors’ Recommendations Medical sales are a set of activities and skills whose purpose is to influence health care professionals to recommend or prescribe a product. Whether you are in the pharmaceuticals, dermoceuticals, OTC, medical devices, or whatever business relates with patients and their health, you need to have a clearly defined strategy on how to approach physicians.

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Sales Strategy Medical sales Doctors Sales 98

Fierce Pharma

JUNE 7, 2023

After GSK nabbed a coveted world-first approval for its adult respiratory syncytial virus (RSV) vaccine in the U.S., it has scored the same title in Europe with Arexvy. | After scoring its world-first approval in May, GSK's RSV vaccine for older adults bagged a nod in Europe. The company and its rivals are gearing up to launch their products ahead of the fall RSV season.

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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.

Safety

Pharmaceutical Technology

JUNE 7, 2023

ZyVersa Therapeutics has received a notice of intention to grant from the European Patent Office for its patent application for the cholesterol efflux mediator VAR 200 (2-hydroxypropyl-beta-cyclodextrin). The application was filed for the treatment of diabetic nephropathy/diabetic kidney disease. The Phase IIa-ready VAR 200 is being developed to reduce renal cholesterol and the lipid accumulation that damages the filtration system of kidneys in glomerular diseases patients.

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MedCity News

JUNE 7, 2023

On any given day there may be more pressing issues to handle, and many companies believe “it won’t happen to us” – that is, until it does happen to you, and then it’s more important than ever to be prepared and confident with your crisis communications plan.

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Pharmaceutical Technology

JUNE 7, 2023

Shanghai Fosun Pharmaceutical (Group) is to collaborate with the International Finance Corporation (IFC) to construct a new pharmaceutical production facility and distribution hub near Abidjan, Côte d’Ivoire. The IFC will provide two loans totalling $53.49m (€50m) to Fosun Pharma’s subsidiaries. The funding will support the new production plant and distribution hub, which is aimed at enhancing access to high-quality medicines in Africa.

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MedCity News

JUNE 7, 2023

Creating a successful primary data marketing campaign relies on asking the right questions, keeping the end user in mind, proper analysis and a long-term plan for its use.

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Marketing Biopharma Patients Healthcare 90

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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

Distribution

European Pharmaceutical Review

JUNE 7, 2023

As its first facility in Scotland, the Cell and Gene Therapy Catapult (CGT Catapult) has opened new laboratories located in the Edinburgh BioQuarter, at the University of Edinburgh’s Institute of Regeneration and Repair. With its new 350m 2 high-specification laboratory space, CGT Catapult aims to provide expertise, resources and technology to help cell therapy developers improve their manufacturing processes and navigate the complex regulatory requirements involved in bringing these therapies t

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MedCity News

JUNE 7, 2023

Upperline Health, a provider network focused on value-based specialty care, recently raised $58 million. The startup identifies patients who are seeing specialists four or more times a year and provides them with an interdisciplinary care team that treats them at a clinic, in their home or via phone.

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Networking Patients 88

European Pharmaceutical Review

JUNE 7, 2023

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published its annual report , summarising the organisations 2022 highlights. Petra Doerr, Director of EDQM, Council of Europe, commented in the report on the current challenges of drug shortages in the pharmaceutical supply chain and its impact on the industry’s resilience and goals towards sustainability.

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MedCity News

JUNE 7, 2023

Yuvo Health — a startup focused on enabling value-based care at FQHCs — recently raised $20.2 million in Series A funding. The company is using the money to expand its reach from New York to Ohio.

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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

JUNE 7, 2023

The global biopharma industry’s resilience has decreased since 2021, a report by Cytiva has found. Using feedback from 1250 pharma and biopharma executives in 22 countries, the research sought to find out how has the biopharma industry has evolved over the past two years and what areas the industry should seek to improve. The five areas evaluated for resilience were: Supply chain resilience Access to talent Strength of the R&D ecosystem Manufacturing agility Effectiveness of government

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Biopharma Government Manufacturing Pharma 78

MedCity News

JUNE 7, 2023

Through American Cancer Society and Color Health’s new partnership, employers and unions will have better access to cancer screenings, cancer education and clinical support.

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Education 78

PharmaTimes

JUNE 7, 2023

Therapy treats patients with specific types of ovarian, fallopian tube or primary peritoneal cancer - News - PharmaTimes

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Patients 75

MedCity News

JUNE 7, 2023

A breadth of healthcare data, including EMR data, claims, and patient-reported available for innovative use cases offer examples of how modular API solutions have improved outcomes.

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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

JUNE 7, 2023

Clinical-stage biotechnology company Acepodia has raised $100m in a Series D financing round to advance the first-in-class cell therapies being developed using the antibody-cell conjugation (ACC) platform. The financing round, led by Digital Mobile Venture, has also seen participation from other existing investors. The latest funding brings the total venture capital financing secured by the company so far to $259m.

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PharmaTimes

JUNE 7, 2023

Companies will incorporate cells and technology to create a ‘clinical trial in a dish’ - News - PharmaTimes

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Clarify Health

JUNE 7, 2023

It’s harder than ever for hospital networks to thrive — today’s healthcare landscape is characterized by shrinking operating margins, rising costs, and labor shortages. In order to maintain a healthy financial position, hospitals and health systems must understand the importance of using data to evaluate the expected performance of their networks. Big data is now an integral part of modern healthcare administration.

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PharmExec

JUNE 7, 2023

This month, we deliver deep dives into the industry's commercial output and outlook and how drugmakers are faring in their public trust mandate—two areas where respective growth pursuits can often go hand-in-hand.

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Pharma 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

Pharmaceutical Technology

JUNE 7, 2023

Baudax Bio revealed has additional results from a Phase II trial investigating its neuromuscular blockade (NMD) agent BX1000 in patients undergoing elective surgery demonstrating favourability to rocuronium. The company now plans to combine it with its pipeline reversal blocking agent. Shares in the US-based company previously surged after the topline data reveal in April.

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Legacy MEDSearch

JUNE 7, 2023

Innova Vascular, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Laguna Clot Retriever System and its Malibu Aspiration Catheter System for use in the peripheral vasculature. The two new devices are collectively known as the Laguna Thrombectomy System. “Removing clots quickly, safely, and in large volumes from the body is the holy grail of innovation in vascular interventions right now,” says Dr.

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Pharmaceutical Technology

JUNE 7, 2023

Covid-19 vaccine compositions should be updated to provide protection against XBB Omicron variant strains in preparation for the autumn vaccination campaign, say EU agencies in a joint 6 June statement. This reflects decisions made at past meetings by members of the International Coalition of Medicines Regulatory Authorities on 8 May and elsewhere. There, organisations determined that the compositions of Covid-19 vaccines need to be updated to reflect the evolution of the virus.

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PharmaTech

JUNE 7, 2023

Under the €35 million (US$37 million) investment, MilliporeSigma will expand its sites in Glasgow and Stirling, Scotland, to increase biosafety testing for drug development and commercialization.

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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