Fierce Pharma

MAY 31, 2024

When companies introduce an injectable version of an intravenously infused drug, better convenience with comparable efficacy is typically the goal. | When companies introduce an injectable version of an intravenously infused drug, better convenience with comparable efficacy is typically the goal. But to Johnson & Johnson’s surprise, a subcutaneous formulation of its lung cancer med Rybrevant proved to work better than the original infusion.

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Patients 271

MedCity News

MAY 31, 2024

Moderna’s mResvia is now the third FDA-approved RSV vaccine and the first one based on mRNA technology. It will compete for market share against RSV shots from GSK and Pfizer that won their FDA nods last year. The post FDA Approves Moderna RSV Vaccine, an mRNA Alternative to GSK and Pfizer Products appeared first on MedCity News.

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Fierce Pharma

MAY 31, 2024

Just one week after Summit Therapeutics and Akeso’s bispecific antibody ivonescimab passed muster with Chinese regulators, the drug has pulled off another feat by staring down the PD-1 king Keytrud | In the phase 3 HARMONi-2 trial, solo ivonescimab delivered a statistically significant and clinically meaningful improvement in progression-free survival over Keytruda monotherapy.

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pharmaphorum

MAY 31, 2024

Novartis is just months away from filing for approval of oral BTK inhibitor remibrutinib as a treatment for chronic spontaneous urticaria – also known as chronic hives – after reporting long-term data from two phase 3 trials.

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Fierce Pharma

MAY 31, 2024

With the FDA nod, Moderna's RSV vaccine becomes the company's second product to secure the FDA's backing.

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FDA 298

pharmaphorum

MAY 31, 2024

The US FDA has started a fresh review of Astellas' zolbetuximab, trying to become the first claudin (CLDN) 18.2-targeting drug to reach the US market, after turning it down earlier this year.

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FDA Marketing 102

pharmaphorum

MAY 31, 2024

Sanofi and Regeneron’s immunology juggernaut Dupixent is on the brink of another big new indication after it was recommended by the EMA’s human medicines committee for chronic obstructive pulmonary disease (COPD). The CHMP’s positive opinion sets up Dupixent (dupilumab) to become the first biologic therapy for COPD in the EU and the first new treatment approach for the disease in over a decade.

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Fierce Pharma

MAY 31, 2024

Takeda is planning more than 600 layoffs in Massachusetts. AstraZeneca and Daiichi Sankyo's Dato-DXd failed to show an overall survival benefit in a lung cancer study. | Takeda is planning more than 600 layoffs in Massachusetts. AstraZeneca and Daiichi Sankyo's Dato-DXd failed to prove an overall survival benefit in a lung cancer study. Japan's Asahi Kasei is moving to buy rare disease drugmaker Calliditas for about $1 billion.

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Pharma 143

MedCity News

MAY 31, 2024

In this month’s episode, Senior Reporter Katie Adams explored some executive moves and layoffs that recently occurred in the healthcare world. She also interviewed Courtney Fortner, who stepped into the CEO role at population health company Navvis this month. The post MedCity Moves Podcast: Recent Hires, Layoffs & an Interview with Courtney Fortner, CEO of Navvis appeared first on MedCity News.

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Healthcare Healthcare 91

Fierce Pharma

MAY 31, 2024

A highly anticipated decision on Sanofi and Regeneron’s Dupixent to become the first biologic to treat chronic obstructive pulmonary disorder (COPD) is on hold in the United States but is speeding | A highly anticipated decision on Sanofi and Regeneron’s Dupixent to become the first biologic to treat chronic obstructive pulmonary disorder (COPD) is on hold in the United States but is speeding along in Europe.

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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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Pharmaceutical Technology

MAY 31, 2024

The US FDA has granted RMAT designation for BlueRock Therapeutics' cell therapy, bemdaneprocel (BRT-DA01), for Parkinson's disease.

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FDA 105

European Pharmaceutical Review

MAY 31, 2024

The first treatment approved in the EU to target a genetic cause of amyotrophic lateral sclerosis (ALS), has been authorised by the European Commission (EC). QALSODY ® (tofersen) is indicated for adults with ALS associated with a mutation in the superoxide dismutase 1 gene ( SOD1 -ALS). The treatment is an antisense oligonucleotide (ASO) designed to bind to SOD1 mRNA to reduce SOD1 protein production, Biogen shared.

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Pharmaceutical Medicine Patients Marketing 91

MedCity News

MAY 31, 2024

What contributes to the stress and what BCBA employers can do to alleviate it The post Experiencing BCBA Burnout? Why It Happens and Tips to Combat It appeared first on MedCity News.

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pharmaphorum

MAY 31, 2024

Gilead's TROP2 ADC Trodelvy has missed the target in another clinical trial, this time in urothelial carcinoma.

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MedCity News

MAY 31, 2024

Talkspace and Ovia Health by Labcorp introduced the Women’s Health Coalition for Digital Solutions. Other founding member companies of the coalition include Conceive, Evernow, FitOn, Nurx, Cove and Nutrium. The post Talkspace, Labcorp’s Ovia Health Launch Digital Women’s Health Coalition appeared first on MedCity News.

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PharmaTimes

MAY 31, 2024

The CVLP platform will speed up access to BioNTech and Genentech’s mRNA personalised cancer vaccines

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MedCity News

MAY 31, 2024

How work friction takes shape, how it costs organizations, and how leaders can uncover long-term solutions The post Work Friction: The Sleeper Crisis Plaguing Healthcare Contact Centers appeared first on MedCity News.

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Healthcare Healthcare 76

PharmaTimes

MAY 31, 2024

The projects will focus on a range of research areas, including Down’s syndrome and ALS

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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

MAY 31, 2024

Gilead Sciences reported Trodelvy’s Phase 3 test in metastatic urothelial cancer fell short of showing a statistically significant benefit on the overall survival main goal. The antibody drug conjugate had received accelerated FDA approval for this type of cancer in 2021. The post Gilead Sciences ADC Flunks Its Confirmatory Test in Advanced Bladder Cancer appeared first on MedCity News.

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Pharmaceutical Commerce

MAY 31, 2024

The latest news for pharma industry insiders.

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Pharma 104

MedCity News

MAY 31, 2024

Here is a selection of recent executive hires, promotions, retirements and layoffs occurring across the healthcare industry. The post Healthcare Moves: A Monthly Summary of Hires and Layoffs appeared first on MedCity News.

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Healthcare Healthcare Pharma 64

PharmExec

MAY 31, 2024

In an interview with Pharm Exec Associate Editor Don Tracy, Karen Rodriguez-Lorenc, Global Program Head of Linvoseltamab, Regeneron talks about the possibility of linvoseltamab becoming a frontline treatment for multiple myeloma (MM) as well as the company's VelociSuite technology.

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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

MAY 31, 2024

1. Personalize Collection Strategies Looking at your historical data can help you create a compelling collection plan for specific patients. Another invaluable tool is the data from a financial clearing house. It’ll help you identify the likelihood of a patient paying and those that might not. You can use this information to determine the best course of action, including decisions to send a patient’s account to a professional collection agency.

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PharmExec

MAY 31, 2024

Results of a Phase III trial indicated that Scemblix was more effective than standard-of-care tyrosine kinase inhibitors in treating newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

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Rep-Lite

MAY 31, 2024

The medical device industry is booming with innovations, but a significant challenge persists with the talent gap. As demand for skilled medical sales representatives in medical device sales continues to rise, companies often struggle to find the right talent to drive their business forward. However, not anymore. At Rep-Lite , an experienced medical sales recruitment agency , we find and hire the most competent healthcare sales representatives for medical device sales.

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PharmExec

MAY 31, 2024

In an interview with Pharm Exec Associate Editor Don Tracy, Karen Rodriguez-Lorenc, Global Program Head of Linvosoltamab, Regeneron talks about the possibility of linvoseltamab becoming a frontline treatment for multiple myeloma (MM) as well as the company's Velocsuite technology.

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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

MAY 31, 2024

The EC has approved Biogen's QALSODY to treat adults with amyotrophic lateral sclerosis (ALS) linked to SOD1-ALS mutation.

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PharmExec

MAY 31, 2024

Under terms of the deal, Akili will become a wholly owned subsidiary of Virtual Therapeutics, with Akili shareholders receiving $0.4340 per share of common stock in cash.

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Pharmaceutical Technology

MAY 31, 2024

Midland Pharmaceuticals has launched to focus on the development of a therapeutic for spinal cord injury and cerebrovascular disease.

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Pharmaceutical 52

PharmExec

MAY 31, 2024

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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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