Fierce Pharma

APRIL 7, 2023

Clovis sells off remaining assets—including cancer drug Rubraca—for $70M-plus kdunleavy Fri, 04/07/2023 - 10:33

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PharmExec

APRIL 7, 2023

Eli Lilly debuts its first Mounjaro TV commercial amid high demand for the diabetes injection, which also shows promise in weight loss applications and outperformed rivals Ozempic and Wegovy in clinical trials.

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Fierce Pharma

APRIL 7, 2023

Merck and Eisai's Lenvima-Ketruda combo flunks first-line melanoma trial fkansteiner Fri, 04/07/2023 - 09:49

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Pharmaceutical Technology

APRIL 7, 2023

Enanta Pharmaceuticals has secured the US Food and Drug Administration’s (FDA) fast track designation for EDP-323 to treat respiratory syncytial virus (RSV). In vitro data of EDP-323 showed a significant reduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B. Consistent potency was also observed across a range of RSV clinical isolates in several cell types.

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Fierce Pharma

APRIL 7, 2023

After 2022's M&A spree, Amgen CEO Bradway collects $21.

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MedCity News

APRIL 7, 2023

By more precisely improving care orchestration by reimagining patient flow across disparate care settings, health systems can improve demand, capacity, and throughput challenges.

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Patients 107

PM360

APRIL 7, 2023

The idea of what constitutes the “point of care” is evolving. At its heart, the point of care has always revolved around the when and where patients are making decisions about their health. Often, these moments are happening in the presence of their healthcare provider (HCP), especially in-person at doctor’s offices. But now patients can also see an HCP via telehealth or chat with them through an online patient portal.

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Education Doctors Patients Physicians 98

MedCity News

APRIL 7, 2023

By properly selecting and implementing the right technologies for your practice you can reduce burnout and increase earnings. Follow these steps to double your reward.

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Physicians 100

PM360

APRIL 7, 2023

PM360 asked experts in developing market access strategies about how the Inflation Reduction Act will impact drug pricing negotiation and other access-related issues as well as what other big trends in the space will force companies to rethink their strategies. Specifically, we asked them: What impact should market access professionals expect from the Inflation Reduction Act (IRA)?

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Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth. The decision was made after studies did not prove the effectiveness of the drug in preventing preterm birth. Makena was approved by the FDA under the accelerated approval pathway in 2011 to reduce the risk of preterm birth in women with a singleton pregnancy who hav

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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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MedCity News

APRIL 7, 2023

Oshi Health recently entered a value-based care contract with Aetna. The New York-based startup provides specialized virtual care for patients with digestive disorders, focusing on dietary and behavioral health interventions to reduce the root cause of patients’ symptoms.

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Specialization Patients 93

Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth. The decision was made after studies did not prove the effectiveness of the drug in preventing preterm birth. Makena was approved by the FDA under the accelerated approval pathway in 2011 to reduce the risk of preterm birth in women with a singleton pregnancy who hav

Food and Drug Administration 95

Food and Drug Administration FDA Pharma Food 95

PharmExec

APRIL 7, 2023

It’s time for pharma brands to recognize the potential of TikTok as a promotional platform and develop a strategy to not only stand out but make an impact.

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Pharma Marketing 98

European Pharmaceutical Review

APRIL 7, 2023

A new, sustained-release chemotherapy delivery device inserted into the bladder, facilitated tumour response, a study has reported. The treatment was given to elderly patients with advanced bladder cancer who were medically unfit for standard treatment. The intravesical device, TAR-200, provides continuous, low-dose, local delivery of gemcitabine chemotherapy. “TAR-200 was generally safe, well tolerated, and had beneficial effects on bladder cancer outcomes,” commented lead author Dr

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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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PharmExec

APRIL 7, 2023

Marketing leaders discuss the powerful role life sciences companies can play in the expanding digital landscape for healthcare communications—as “one of the helpful voices” in driving the customer and patient conversations that matter most.

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PharmaTech

APRIL 7, 2023

The agency is dealing with high demand for staff because of a surge in the development of cell and gene therapies.

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FDA 98

Copyright Clearance Center

APRIL 7, 2023

The post On Capitol Hill, Humans Battle AI Over Authorship appeared first on Copyright Clearance Center.

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PM360

APRIL 7, 2023

The health-conscious among us pay special attention to actively managing our sleep, exercise, vitamins, etc. The list goes on. We imagine a bygone era when people ate differently, got more exercise by default, and didn’t have to fit “health” into a busy schedule. Another essential health factor that is increasingly falling by the wayside due to lifestyle changes: Personal human interaction.

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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

Pharma Leaders

APRIL 7, 2023

The FDA has identified undisclosed deficiencies in Ascendis Pharma’s new drug application (NDA) for TransCon PTH (palopegteriparatide) for treatment of hypoparathyroidism, an uncommon condition in which the body produces low levels of the parathyroid hormone. In a letter to the company, the agency did not detail the deficiencies, but said they would preclude the agency from holding discussions with the company about labeling and postmarketing commitments, Ascendis said.

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FDA 52

PM360

APRIL 7, 2023

When comparing the challenges presented in emerging markets with more mature markets, the obvious starting point is healthcare expenditure. Having less to spend means a difference in priorities for governments—the focus in emerging markets continues to be more on building capacity in both physical infrastructure and human capital. Developed markets with infrastructure in place prioritize efficient utilization and high-service quality.

Marketing 52

Marketing Government Insurance Healthcare 52

Legacy MEDSearch

APRIL 7, 2023

restor3d, a research-driven medical device company, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. The Axiom PSR (patient-specific resection) System is additively manufactured from titanium alloy, making it the first all-metal, patient-specific instrument system cleared for use with an ankle arthroplasty system.

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PM360

APRIL 7, 2023

Grifols and Selagine Tackle Dry Eyes The two eyecare leaders have entered a research, development, and sublicense agreement to develop and commercialize immunoglobulin eye drops for dry eye disease. Selagine, Inc. , a company from the University of Illinois at Chicago will be building upon 19 years of research and the first-in-human pilot clinical trial of immunoglobulin drops, while Grifols , a global leader in plasma-derived therapies, committed to funding the development though FDA approval a

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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

PharmExec

APRIL 7, 2023

Kevin Hagan, president and CEO of the PAN Foundation, spoke to PharmExec about the recent IRA changes that impact Medicare, as well as the Foundation's near-term goals.

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Networking Pharma Patients 52

PM360

APRIL 7, 2023

Patient Pages: How Healthcare Costs Affect Insured Patients Today A new study shows an insured American with an employer-sponsored health insurance plan can expect to spend more than $320,000 (including insurance premiums and out-of-pocket costs) during his/her adult lifetime. This amount could reach $700,000 for Americans who purchase their own insurance or suffer from chronic illnesses.

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Healthcare Healthcare Insurance Physicians 52

PharmExec

APRIL 7, 2023

Janssen, Johns Hopkins Dermatology’s Ethnic Skin Fellowship Program partnership focuses on improving clinical care and advancing research in for skin-of-color patients.

Patients 52

Patients 52

PM360

APRIL 7, 2023

It is no secret artificial intelligence (AI) has become increasingly powerful and more widely used in a variety of applications. From self-driving cars to facial recognition, AI has become an integral part of our lives, and the implications are far-reaching. But risks come with any technology and innovation, and when put in the wrong hands, AI could be used for malicious purposes.

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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

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Pharmaceutical Commerce

APRIL 7, 2023

Although there is no ‘one size fits all’ solution, the process is influenced by factors such as lifestyle stage, competitive outlook, and market constraints.

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Competition Patients Marketing 52

PM360

APRIL 7, 2023

No one has ever described the pharma market access landscape as simple or easy to understand, and the passage of the Inflation Reduction Act (IRA) is not likely to change that. “Quantifying the Impact of the IRA is a challenge. Most immediately, it will add confusion in the healthcare space,” explains Daniel Sontupe, Associate Partner, Managing Director, The Bloc Value Builders.

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Marketing Pharma Manufacturing Healthcare 52

PharmExec

APRIL 7, 2023

Sunil Verma, SVP, Global Head of Oncology, Medical, AstraZeneca discusses how the Medical Affairs role will become more strategic and effective with data.

Medical 52

Medical Pharma 52

PM360

APRIL 7, 2023

It’s never too early in the research and development (R&D) process to identify and measure a product’s projected clinical outcomes in order to meet the needs and expectations of payers and healthcare professionals (HCPs) who are the final arbiters of a product’s commercial success. The shift toward longer, more adequate timeframes to establish proof of concept can be as long as three to four years, 1 given the complex requirements for developing and launching specialty drugs and cell and gen

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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