Fierce Pharma

JUNE 25, 2024

A little over a year after being slapped with an FDA rejection, AbbVie has hit another regulatory wall in its bid to debut a more convenient Parkinson’s disease successor to its established fo | A little over a year after being slapped with an FDA rejection, AbbVie has hit another regulatory wall in its bid to debut a more convenient Parkinson’s disease successor to its established formulation of carbidopa and levodopa.

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Dominic Tyer

JUNE 25, 2024

Customer experience (CX) is not a new discipline for pharma, but it does continue to provide the industry with growing pains

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Fierce Pharma

JUNE 25, 2024

On the market for three years in China, Novo Nordisk’s diabetes drug Ozempic (semaglutide) is racing toward blockbuster sales in the world’s second most populous country. | China’s National Medical Products Administration (NMPA) has blessed Novo Nordisk's Wegovy with marketing approval to treat people with a body mass index (BMI) of at least 30 or between 27 and 30 for those with one weight-related risk factor.

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Sales Marketing Medical 283

European Pharmaceutical Review

JUNE 25, 2024

The European Commission has approved the first twice-yearly injection for relapsing and primary progressive multiple sclerosis (RMS and PPMS). Roche highlighted that as a 10-minute injection, OCREVUS ® (ocrelizumab) subcutaneous has the same twice-yearly schedule as the intravenous (IV) infusion, which was the first therapeutic to be approved for both RMS and PPMS.

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Fierce Pharma

JUNE 25, 2024

In the U.S. Federal Trade Commission’s (FTC) latest campaign against what the agency views as “junk” drug patents listed at the FDA, drugmakers have decided not to play ball. | In the U.S. Federal Trade Commission’s latest campaign against what the agency views as “junk” drug patent listings in the FDA’s database, drugmakers have decided not to play ball.

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PharmaVoice

JUNE 25, 2024

A COVID and flu duo could ease manufacturing and administration, potentially driving higher vaccination rates, said Moderna’s VP of North American medical affairs.

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MedCity News

JUNE 25, 2024

Function Health, a membership-based platform that gives consumers access to more than 100 different lab tests, closed a Series A financing round that brought its total funding to date to $53 million. The round was led by Andreessen Horowitz and included a slew of celebrity investors, including Matt Damon, Zac Efron, Blake Griffin and Colin Kaepernick.

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Fierce Pharma

JUNE 25, 2024

AstraZeneca’s Imfinzi can’t have it all. | While the PD-L1 inhibitor posted a clinical win in muscle-invasive bladder cancer, it also chalked up a failure in early-stage non-small cell lung cancer.

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MedCity News

JUNE 25, 2024

Knowing where healthcare professionals are online, their preferred platforms, and what they do there is crucial for pharma marketers. The post Decoding the Digital Footprint of Healthcare Professionals: A Roadmap for Pharma Marketers appeared first on MedCity News.

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Fierce Pharma

JUNE 25, 2024

As other immunology players make inroads into the giant cell arteritis (GCA) arena, one of Johnson & Johnson’s top-grossing medicines, Tremfya, has come up short in the disease. | As other immunology players make inroads into the giant cell arteritis arena, one of Johnson & Johnson’s top-grossing medicines, Tremfya, has come up short in the disease.

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Medicine 169

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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

JUNE 25, 2024

Pomelo Care’s $46 million Series B funding round was led by existing investors First Round Capital and a16z and included participation from Stripes, Box Group, Operator Partners and SV Angel. The post Pomelo Care Secures $46M To Increase Access to Maternal Health appeared first on MedCity News.

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pharmaphorum

JUNE 25, 2024

Almost half of young adults who participated in a UK survey said they had made a health decision they regret based on misinformation

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MedCity News

JUNE 25, 2024

Managed long-term services and supports (MLTSS) are emerging as essential lifelines for transformation. The post Empowering Independence: The Rising Role of MLTSS in Medicaid Evolution appeared first on MedCity News.

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Management 110

Pharmaceutical Technology

JUNE 25, 2024

Novo Nordisk has unveiled a significant investment plan, committing $4.1bn to construct a second fill and finishing facility in Clayton.

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Manufacturing 98

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MedCity News

JUNE 25, 2024

Liquid biopsy company Grail is now an independent, publicly traded company. While the separation from Illumina ends a protracted antitrust battle, Grail is still in the early stages of a long-term strategy to win regulatory validation and payor coverage for its multi-cancer early detection test. The post Illumina Spin-Off Now Complete, Grail Sets Out on Its Own on the Public Markets appeared first on MedCity News.

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pharmaphorum

JUNE 25, 2024

A survey of pharma industry executives has found that a third of them believe mistrust in the healthcare system has become a significant barrier to getting a diverse range of people to sign up for clinical trials.

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Pharmaceutical Technology

JUNE 25, 2024

Merck’s decision follows the independent committee's analysis that the trial is unlikely to meet its primary endpoints.

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pharmaphorum

JUNE 25, 2024

AstraZeneca’s hopes of positioning Imfinzi as a post-surgery therapy for people with early-stage NSCLC have taken a knock

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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

PharmaVoice

JUNE 25, 2024

The FDA isn’t slated to render a decision about BMS and Karuna’s potential breakthrough schizophrenia med until September — but a biotech is already hoping to be hot on its heels.

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FDA 69

pharmaphorum

JUNE 25, 2024

Two years ago, Merck KgAA was talking up xevinapant as a leap forward in head and neck cancer and one of the brightest stars in its late-stage pipeline, Now, the drug has been abandoned after failing a phase 3 trial.The TrilynX study was testing xevinapant with chemoradiotherapy in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN), but according to an interim look at the data was unlikely to meet its goal of extending event-free survival.

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Patients 74

Pharmaceutical Technology

JUNE 25, 2024

Novavax has sought EMA approval for its updated JN.1 Covid-19 vaccine, NVX-CoV2705, for people aged 12 years and above.

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pharmaphorum

JUNE 25, 2024

Oral ketamine from Douglas Pharma shows efficacy in phase 2 treatment-resistant depression trial and will move into pivotal trials

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Pharma 81

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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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Penrod

JUNE 25, 2024

A Brief Background of the Original OCR Ruling In 2022, the Department of Health and Human Services Office for Civil Rights issued the original OCR ruling. This bulletin laid out specific guidelines on the use of online tracking technologies on mobile applications and websites belonging to HIPAA-regulated agencies. Primarily, the original OCR ruling defined what online trackers are and their uses on sites and apps.

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ALULA

JUNE 25, 2024

E X is t he sum total of all interactions employees have with people , processes, technologies , and their physical working environment. Done properly, a mature and effective EX can boost engagement and productivity, as well as cut down on costly attrition.

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PharmExec

JUNE 25, 2024

Hugues Wallemacq, CEO of EXO Biologics, discusses the company's innovative approach to developing scalable and GMP-compliant exosome therapies and ambitious plans to reshape the global therapeutic landscapes.

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pharmaphorum

JUNE 25, 2024

In a new episode of the pharmaphorum podcast - recorded back in March, during Women’s History Month - web editor Nicole Raleigh spoke with Johan van Hylckama Vlieg, co-founder and chief scientific officer of Freya Biosciences, a Series A-financed, clinical stage, microbial immunotherapy company in women’s health, discussing the role of the vaginal microbiome in fertility, before he was due to speak at the first-of-its-kind Microbes in Women’s Health Congress in Copenhagen.

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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

PharmExec

JUNE 25, 2024

In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses how AbbVie is advancing the development of bispecific biologic therapies in both solid tumors and blood cancers.

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ALULA

JUNE 25, 2024

Can you still create a compelling e mployee e xperience (EX) when you don’t get to see your employees in person? Welcome to the great EX-hybrid challenge.

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PharmExec

JUNE 25, 2024

David Minkin, President & GM at epocrates, offers his insights into the importance of trust, first-party data, and strategic partnerships in ensuring successful marketing campaigns.

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Marketing Pharma 52

Pharmaceutical Commerce

JUNE 25, 2024

The latest news for pharma industry insiders.

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Pharma Medicine Manufacturing 90

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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.

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