Fierce Pharma

AUGUST 10, 2023

After Pfizer allegedly fired a compliance manager for raising the flag on potential fraud activity in China, the former employee is hitting back. | Frank Han, Pfizer's former director of global compliance analytics, has filed a civil complaint against the drugmaker. Han claims he was terminated for identifying potential issues relating to the Foreign Corrupt Practices Act.

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Management 246

Clarity Engagement Solutions

AUGUST 10, 2023

August 10, 2023 Episode 1: The Role of ChatGPT in Strategic Account Management Adipiscing elit dapibus, vulpu tate in donec tempor ultricies venenatis erat, aliquam posuere urna habitant rutrum euismod maecenas varius tortor nibh, sit amet tempor nibh finibus et. Episode 201: Leveling Up Your Career with Jane Chapman [link] Nulla porttitor accumsan tincidunt.

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Management 91

Fierce Pharma

AUGUST 10, 2023

Johnson & Johnson is digging its multiple myeloma moat deeper thanks to FDA approval for another novel drug. | Johnson & Johnson is digging its multiple myeloma moat deeper. The FDA has signed off on the company's Talvey, a first-in-class bispecific antibody targeting GPRC5D.

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FDA 218

PharmExec

AUGUST 10, 2023

Hernandez details how the non-profit organization advocates for improved access to care at the community, state, and federal levels, and amplifies education and awareness efforts within its social media communities.

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Fierce Pharma

AUGUST 10, 2023

As Regeneron anxiously awaits an FDA decision on a high-dose version of Eylea (aflibercept), the company has continually referred to its durability compared to that of Roche’s upstart Vabysmos—whic | As Regeneron anxiously awaits an FDA decision on a high-dose version of Eylea (aflibercept), the company has continually referred to its staying power compared to that of Roche’s upstart Vabysmos—which has taken the macular degeneration (AMD) market by storm since receiving approval 19 months ago.

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FDA Marketing 213

European Pharmaceutical Review

AUGUST 10, 2023

The US Food and Drug Administration (FDA) has granted accelerated approval of TALVEY (talquetamab-tgvs) to treat multiple myeloma. Janssen Pharmaceutical Companies of Johnson & Johnson’s first-in-class bispecific T-cell engaging antibody showed an overall response rate (ORR) of over 70 percent in heavily pre-treated multiple myeloma. Based on this data, TALVEY is indicated for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, includin

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Food and Drug Administration Food Pharmaceutical Patients 98

PharmExec

AUGUST 10, 2023

The application of artificial intelligence is steadily finding a home in the pharma industry, but these tools may have unprecedented potential in a more nascent niche along the life sciences continuum: drug development.

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Pharma 98

Fierce Pharma

AUGUST 10, 2023

As Novo Nordisk works through supply constraints, Wegovy again stole the show at the Danish drugmaker. | As Novo Nordisk works through supply constraints, Wegovy again steals the show at the Danish drugmaker. The star obesity med crossed the blockbuster threshold in a single quarter for the first time.

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MedCity News

AUGUST 10, 2023

This week, virtual care company Babylon Health permanently closed its U.S. operations and laid off 94 employees. The news came after the company’s rescue merger fell apart — Babylon had planned to go private through a deal with Swiss digital therapeutics firm MindMaze and Babylon creditor AlbaCore Capital.

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Fierce Pharma

AUGUST 10, 2023

Astellas has won FDA approval for a geographic atrophy therapy that the company obtained from its acquisition of Iveric Bio. | Astellas has won an FDA nod for a geographic atrophy therapy from its acquisition of Iveric Bio. A Fierce Biotech report examined Singapore's search for its big biotech success story. AstraZeneca signed an mRNA vaccine manufacturing deal with China's CanSino Biologics.

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FDA Pharma Manufacturing 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.

Safety

MedCity News

AUGUST 10, 2023

In the future, research in personalized nutrition needs to focus on understanding the role of nutrition throughout the entire lifespan and address diet-related conditions through comprehensive interventions that go beyond simply choosing healthy foods.

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Food Medicine 96

Impetus Digital

AUGUST 10, 2023

The Problem With in-person meetings resuming after the end of COVID-19-related restrictions, many of our clients have been eager to get back to these meetings, thinking that’s what their Key Opinion Leaders (KOLs) want. Traditionally, external pharmaceutical meetings such as national advisory boards are held at upscale hotels in large cities, no more than once or twice a year.

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Pharmaceutical Transportation Food Biopharma 95

MedCity News

AUGUST 10, 2023

Johnson & Johnson’s stable of multiple myeloma drugs has grown to five products with the FDA approval of Talvey. The bispecific antibody is the first in a new class of new drugs designed to go after the novel multiple myeloma target GPRC5D.

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European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. In this paper, the US FDA highlighted that between 2018 and 2022, the quantity of warning letters issued were highest in the US in 2019 (55) and 2022 (47).

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FDA Food and Drug Administration Media Manufacturing 86

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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

MedCity News

AUGUST 10, 2023

Only 44% of Medicare Advantage enrollees said they “fully understand” their plan, while 50% said they “somewhat understand” it and 6% said they don’t understand it, according to a recent survey.

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Eversana Intouch

AUGUST 10, 2023

The industry challenges faced in marketing in the rare disease space are not new. Small populations. Limited understanding of the patient or disease. Diagnostic odysseys that last, on average, seven years and are riddled with misdiagnosis. What is new, however, is the opportunity. At EVERSANA INTOUCH, our rare expertise and advanced technologies are helping solve some of the most difficult challenges in rare disease marketing.

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Patients Competition Marketing Healthcare 82

MedCity News

AUGUST 10, 2023

Novo Nordisk isn’t putting all of its weight loss drug hopes in the same basket. Its acquisition of Inversago Pharma for up to $1 billion will bring a biotech whose lead drug candidate has early clinical trial data showing significant weight loss.

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European Pharmaceutical Review

AUGUST 10, 2023

Novo Nordisk A/S has agreed to acquire Inversago Pharma for up to $1.075 billion. Inversago Pharma is developing CB1 receptor-based therapies for the potential treatment of obesity, diabetes and complications associated with metabolic disorders. What Novo Nordisk will gain from the acquisition Through the acquisition agreement, the pharma company Novo Nordisk intends to investigate Inversago Pharma’s lead development asset, a potential first-in-class small molecule CB1 receptor (CB1r) blocker CB

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Pharma Safety Leads Medicine 80

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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

MedCity News

AUGUST 10, 2023

During my 25 years in oncologic drug discovery, development and commercialization, I have seen how economic cycles can skew priorities and slow progress – but we cannot let that happen.

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Biopharma 92

Pharmaceutical Technology

AUGUST 10, 2023

AI is essential in drug discovery and development and a growing number of start-ups now operate in this area

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MedCity News

AUGUST 10, 2023

Amazon selected Maven Clinic to provide fertility and family building support to its global employees across 50 countries. This includes support from care advocates and unlimited access to its virtual specialists like OB/GYNs and reproductive endocrinologists.

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PharmaTimes

AUGUST 10, 2023

The therapy reaches and activates areas of the brain that are central to cognitive enhancement - News - PharmaTimes

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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

MedCity News

AUGUST 10, 2023

Suvida Healthcare — a startup providing primary care for Medicare-eligible Hispanic adults — is adopting Elation Health’s primary care-specific technology platform. The platform comprises an EHR, as well as software for patient engagement, telehealth and revenue cycle management. Suvida’s chief medical officer said Elation beat out the competition due to its focus on both primary care and value-based care.

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Healthcare Healthcare Competition Management 82

PharmaTimes

AUGUST 10, 2023

UBS Asset Management and Reef Group secure approval for the Stevenage-based facility - News - PharmaTimes

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Management 78

Scott’s Directories

AUGUST 10, 2023

Healthcare professionals and institutions necessitate immediate access to accurate and comprehensive medical information in today’s fast-paced world. The advent of online medical databases has revolutionized how we gather and utilize healthcare data. Among the numerous resources available, the Canadian Medical Directory online stands out as a beacon of reliability and comprehensiveness.

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Medical Healthcare Healthcare Prospecting 52

PharmaTech

AUGUST 10, 2023

Highlights from a wide ranging discussion on COVID-19 pandemic response from Kate Broderick, Chief Innovation Officer at Maravai LifeSciences, and Tom Madden, President & CEO at Acuitas Therapeutics.

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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

Legacy MEDSearch

AUGUST 10, 2023

Acorai, a start-up medical device manufacturer from Sweden, today announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Acorai’s Heart Monitor, a device for the non-invasive estimation of diastolic pulmonary artery pressure (dPAP), systolic pulmonary artery pressure (sPAP), and mean pulmonary artery pressure (mPAP) in patients with Stage C Heart Failure who have been referred for hemodynamic monitoring.

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PharmaTech

AUGUST 10, 2023

The site was acquired by AGC Biologics in July 2020, and the Milan location is the first cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies.

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Manufacturing 52

Star OUTiCO

AUGUST 10, 2023

Pf is proud to announce a new FREE webinar focused on firing up pharma brands and boosting commercial potential. Register for FREE to join the ‘Maximising pharma’s commercial impact with brand optimisation’ webinar Are you looking to enhance your brand’s performance to achieve commercial excellence? As we head into brand planning season, it’s critical that you’re on the best path for brand success.

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Pharma Media Marketing Sales 52

PharmaVoice

AUGUST 10, 2023

July’s announcement from the beleaguered drugmaker signals the kind of shift the industry could see more of as M&A and IPOs tick up once again.

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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