Fierce Pharma

JUNE 17, 2024

The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by senio | The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by seniors to protect against the bacterial infection.

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FDA 312

MedCity News

JUNE 17, 2024

Two senators recently introduced a bill that seeks to regulate private equity firms’ involvement in the healthcare industry. If passed, the act would establish a criminal penalty of up to six years in prison for private equity executives whose business decisions result in a patient’s death. The post If Passed, This New Bill Could Send PE Execs to Jail for Hospital Mismanagement appeared first on MedCity News.

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Healthcare Healthcare 140

Fierce Pharma

JUNE 17, 2024

Two back-to-back pivotal trial wins have rekindled hopes at GSK that once-failed multiple myeloma drug Blenrep could reach more than 3 billion pounds sterling in peak sales after all. | Two back-to-back pivotal trial wins have rekindled hopes at GSK that once-failed multiple myeloma drug Blenrep could reach more than 3 billion pounds sterling in peak sales after all.

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Pharmaceutical Technology

JUNE 17, 2024

Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

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FDA 145

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Fierce Pharma

JUNE 17, 2024

Novo Nordisk CEO Lars Fruergaard Jorgensen has agreed to face questions at a Senate hearing in September after Sen. | Novo Nordisk CEO Lars Fruergaard Jorgensen has agreed to face questions at a Senate hearing in September after Sen. Bernie Sanders, I-Vermont, threatened to subpoena the company over its pricing of popular weight loss drugs Ozempic and Wegovy.

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MedCity News

JUNE 17, 2024

Takeda Pharmaceutical’s soticlestat did not meet Phase 3 goals in Dravet syndrome and Lennox-Gastaut syndrome, two rare forms of epilepsy. But the pharma giant points to results on secondary goals and subgroup analyses, and plans to discuss with regulators the “totality of data.” The post Takeda Drug Fails Pivotal Tests in 2 Rare Epilepsies; Path Forward Depends on Regulatory Flexibility appeared first on MedCity News.

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Impetus Digital

JUNE 17, 2024

A version of this article was previously published in the Journal of mHealth. The days of cookie-cutter medical education sessions and unengaging, didactic data presentations are–mostly–over. These days, medical education and training programs are all about customization, personalization, and innovation. In this article, we take a look at 10 of the hottest trends in medical education and learning programs. 1.

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Fierce Pharma

JUNE 17, 2024

The failure of Marinus Pharmaceuticals’ trial for ganaxolone as a treatment for persistent seizures has left the Philadelphia company facing the daunting prospect of conducting a new study to | The failure of Marinus Pharma’ trial for ganaxolone as a treatment for persisting seizures has left the Philadelphia company facing the daunting prospect of conducting a new study to keep its hopes alive in the indication.

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MedCity News

JUNE 17, 2024

We recently spoke with Nicole Bulochnik, senior vice president of drug strategy for Abarca, about what payers need to consider as demand for this group of weight-loss drugs remains high. The post Are GLP-1 Drugs Here to Stay? appeared first on MedCity News.

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Fierce Pharma

JUNE 17, 2024

Six weeks after revealing that an interim analysis of a phase 3 trial showed that AstraZeneca’s blood cancer drug Calquence plus chemoimmunotherapy worked in previously untreated mantle c | In the ECHO study, adding Calquence to the chemotherapy combination of bendamustine and rituximab reduced the risk of disease progression or death by 27%. And there's a positive trend in overall survival.

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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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European Pharmaceutical Review

JUNE 17, 2024

Johnson & Johnson Innovative Medicine is planning to invest a total of €580 million in Italy over the next five years. A portion of the investment, €125 million, is intended to support greater production capacity at its Latina site, which is a key part of the firm’s worldwide supply chain network, the company stated. For example, the plant produces over four billion tablets every year, spanning approximately 30 different products, J&J confirmed.

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Fierce Pharma

JUNE 17, 2024

As argenx homes in on the next indication for its pipeline-in-a-product Vyvgart (efgartigimod), the company is preparing for the next leg of its commercial journey. | As part of Vision 2030, argenx will touch on its continuing commitment to tackle severe autoimmune diseases with Vyvgart. The company also plans to highlight its next potential commercial product empasiprubart and its broader antibody-based pipeline.

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Pharmaceutical Technology

JUNE 17, 2024

TC-110 is under clinical development by Adaptimmune Therapeutics and currently in Phase II for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia).

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Fierce Pharma

JUNE 17, 2024

AstraZeneca’s Imfinzi has followed GSK’s Jemperli into endometrial cancer. And like its compatriot competitor, the FDA approval is limited to a subgroup of patients. | AstraZeneca’s Imfinzi has followed GSK’s Jemperli into endometrial cancer with a limited FDA nod. Two questions remain for the PD-1/L1 inhibitor class in the broader endometrial cancer field.

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Pharmaceutical Technology

JUNE 17, 2024

Equecabtagene autoleucel is under clinical development by Nanjing IASO Biotherapeutics and currently in Phase II for Refractory Multiple Myeloma.

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Pharmaceutical Commerce

JUNE 17, 2024

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

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Pharmaceutical Technology

JUNE 17, 2024

Equecabtagene autoleucel is under clinical development by Nanjing IASO Biotherapeutics and currently in Phase II for Relapsed Multiple Myeloma.

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MedCity News

JUNE 17, 2024

During a panel discussion at AHIP 2024, several executives shared their healthcare calls to action, including leveraging AI and rebuilding trust. The post Healthcare Execs’ Urgent Calls To Action appeared first on MedCity News.

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Healthcare Healthcare 90

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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

Pharmaceutical Technology

JUNE 17, 2024

DFV-890 is under clinical development by Novartis and currently in Phase II for Coronary Artery Disease (CAD) (Ischemic Heart Disease).

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pharmaphorum

JUNE 17, 2024

Two executives at telehealth startup Done Global have been arrested and face allegations of fraud involving the distribution of medicines for ADHD

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Distribution Medicine 104

Pharmaceutical Technology

JUNE 17, 2024

MAS-825 is under clinical development by Novartis and currently in Phase II for Coronary Artery Disease (CAD) (Ischemic Heart Disease).

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pharmaphorum

JUNE 17, 2024

Takeda’s experimental epilepsy drug soticlestat has failed phase 3 trials in Dravet syndrome and Lennox-Gastaut syndrome

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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

Pharmaceutical Technology

JUNE 17, 2024

OCT-461201 is under clinical development by Oxford Cannabinoid Technologies and currently in Phase I for Neuropathic Pain (Neuralgia).

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pharmaphorum

JUNE 17, 2024

Stanford Medicine study finds risk of secondary cancers with CAR-T therapies is low and likely unrelated to the treatments themselves

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Medicine 102

Pharmaceutical Technology

JUNE 17, 2024

Olanzapine ER is under clinical development by Teva Pharmaceutical Industries and currently in Phase III for Schizophrenia.

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Pharmaceutical 98

MedCity News

JUNE 17, 2024

5G can play a substantial role in transforming healthcare delivery by fostering care anywhere. The post Why Conditions are Ripe for Enabling Care Everywhere appeared first on MedCity News.

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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 17, 2024

OCT-461201 is under clinical development by Oxford Cannabinoid Technologies and currently in Phase I for Visceral Pain.

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pharmaphorum

JUNE 17, 2024

Sanofi and Innate Pharma NK cell engager therapy SAR443579 shows promising efficacy in AML patients in a phase 1/2 trial reported at EHA.

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Pharmaceutical Technology

JUNE 17, 2024

Olanzapine is under clinical development by Neurelis and currently in Phase I for Bipolar Disorder (Manic Depression).

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PharmaTimes

JUNE 17, 2024

Cancer was estimated to be responsible for more than 18 million cases worldwide in 2020

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Patients 104

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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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