Fierce Pharma

APRIL 1, 2024

While the market for COVID-19 vaccines has been shrinking lately, an investigation into text messages between Pfizer CEO Albert Bourla and the European Commission’s President Ursula von der Leyen r | The European Public Prosecutor’s Office (EPPO) took over the investigation into COVID vaccine negotiations between the European Commission's president and Pfizer's CEO Albert Bourla, Politico reports.

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Marketing 301

MedCity News

APRIL 1, 2024

The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. But Otsuka must overcome hurdles facing digital therapeutics products, which have yet to gain traction among payers. The post FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

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Fierce Pharma

APRIL 1, 2024

Like clockwork, AstraZeneca CEO Pascal Soriot’s pay is under fire again. | Like clockwork, AstraZeneca CEO Pascal Soriot’s pay is under fire again. The two most influential proxy advisory firms are rallying investors to vote against the 2024 pay proposal for Soriot at the company’s annual general meeting this month.

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MedCity News

APRIL 1, 2024

The FDA approved AstraZeneca drug Voydeya as an add-on to standard therapies for paroxysmal nocturnal hemoglobinuria, a rare blood disorder. Alexion, now AstraZeneca’s rare disease subsidiary, added the small molecule to its pipeline via a 2019 acquisition.

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Fierce Pharma

APRIL 1, 2024

Shortly after Gilead Sciences teamed up with Carlyle’s Abingworth to fuel further research on its antibody-drug conjugate Trodelvy, Teva is following a similar pathway with an asthma resc | Shortly after Gilead Sciences teamed up with Carlyle’s Abingworth to fuel further research on its antibody-drug conjugate Trodelvy, Teva is following a similar pathway for an asthma rescue inhaler.

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MedCity News

APRIL 1, 2024

Ever since the Covid-19 pandemic pushed telehealth to the forefront of American healthcare modalities, the genie has emerged from the lamp to quite a mixed crowd of cheerleaders and cheaters.

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Healthcare Healthcare 112

PharmaVoice

APRIL 1, 2024

Eledon Therapeutics is developing a drug that could facilitate organ transplants from animals to humans as the procedure gains steam.

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Fierce Pharma

APRIL 1, 2024

With AstraZeneca’s dominance in the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH) threatened by the recent approval of the first pill on the market for the condition, Novartis’ Fabha | With AstraZeneca’s dominance in the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH) threatened by the recent approval of the first pill on the market for the condition, Novartis’ Fabhalta, AstraZeneca has answered in the United States for its add-on oral treatment in the indication.

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PharmaVoice

APRIL 1, 2024

Gender diversity in leadership “doesn’t just happen,” — it requires institutional change, from investing in women’s startups to providing more generous family leave.

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Fierce Pharma

APRIL 1, 2024

After years relying on the U.S. government to stockpile and distribute Jynneos, Bavarian Nordic is launching the mpox vaccine into the commercial market. | After years relying on the U.S. government to stockpile and distribute Jynneos, Bavarian Nordic is launching the mpox vaccine into the commercial market.

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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

APRIL 1, 2024

Discover the groundbreaking patent by Merck & Co Inc for Tricyclic Heterocycle Compounds to combat HIV infection. Learn about the innovative formula and treatment methods for a potent solution in antiretroviral therapy.

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MedCity News

APRIL 1, 2024

When developing or deploying new algorithms, hospitals and healthcare AI developers must pay close attention to the quality of training datasets, as well as take active steps to mitigate biases, said Divya Pathak, chief data officer at NYC Health + Hospitals, during a recent panel.

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Training Healthcare Healthcare 87

pharmaphorum

APRIL 1, 2024

Otsuka and Click Therapeutics’ Rejoyn has become the first prescription digital therapeutic (DTx) to be approved by the FDA for people with major depressive disorder

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FDA Prescription 88

MedCity News

APRIL 1, 2024

The American Medical Association, the Association for Community Affiliated Plans and several other organizations came out in support of the Biden administration’s new rule on short-term health plans. The rule limits the plans to shorter time periods and requires them to be clearer about what they do and do not cover.

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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

APRIL 1, 2024

FDA has granted fast track designation to LISCure Biosciences’ investigational drug LB-P8, for the treatment of PSC.

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FDA 98

MedCity News

APRIL 1, 2024

The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. But Otsuka must overcome hurdles facing digital therapeutics products, which have yet to gain traction among payers.

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FDA Medical Pharmaceutical Biopharma 75

pharmaphorum

APRIL 1, 2024

Eisai has filed to extend the label for its Alzheimer’s drug Leqembi to include a once-monthly maintenance regimen

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MedCity News

APRIL 1, 2024

Certain features, commonplace on most e-commerce platforms, can help transform clinical trial search databases.

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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.

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Pharmaceutical Commerce

APRIL 1, 2024

Cross-sectional study explores the impact of this monumental Supreme Court ruling.

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Management Medical 101

MedCity News

APRIL 1, 2024

When developing or deploying new algorithms, hospitals and healthcare AI developers must pay close attention to the quality of training datasets, as well as take active steps to mitigate biases, said Divya Pathak, chief data officer at NYC Health + Hospitals, during a recent panel discussion. The post ‘Garbage In Is Garbage Out’: Why Healthcare AI Models Can Only Be As Good As The Data They’re Trained On appeared first on MedCity News.

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Training Healthcare Healthcare 75

Pharmaceutical Commerce

APRIL 1, 2024

Patients should not have to wait to access the medication they need.

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Patients Medical 104

MedCity News

APRIL 1, 2024

The modern healthcare environment will require ambidextrous experts in healthcare and AI

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Healthcare Healthcare Training Medical 102

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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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pharmaphorum

APRIL 1, 2024

AstraZeneca’s Voydeya has been approved by the FDA as an add-on to treatment with Soliris or Ultomiris for rare disease PNH

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FDA 77

Pharmaceutical Commerce

APRIL 1, 2024

The latest news for pharma industry insiders.

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Pharma 104

Pharmaceutical Technology

APRIL 1, 2024

Discover the innovative patent by Jubilant Pharmova Ltd for a stable radiopharmaceutical composition of tetrofosmin, ensuring high purity and effectiveness in diagnostic imaging.

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Spotio

APRIL 1, 2024

What comes to mind when you think about field sales training? Maybe you imagine stuffy conference rooms or outdated video lessons. Good news: it doesn’t have to be that way! You can design awesome training programs for your sales team. Doing so will improve the performance of your individual reps by an average of 20% ! (This is especially true when it comes to sales training for field techs, who need a solid understanding of the basics.

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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

APRIL 1, 2024

Treatment approved in combination with ravulizumab or eculizumab, representing minority demographic still suffering after receiving C5 inhibitor therapy for extravascular haemolysis.

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FDA 52

Penrod

APRIL 1, 2024

What CMS-0057-F Means for Health Insurance Companies In January 2024, CMS finalized its interoperability and prior authorization rule that requires various healthcare insurance entities to abide by the latest electronic health information exchange and prior authorization process for clinical services. These policies aim to enhance prior authorization and efficiency for care providers, payers and patients.

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Electronics Insurance Healthcare Healthcare 52

PharmExec

APRIL 1, 2024

In this Pharmaceutical Executive video interview, Optum Rx clinical pharmacist, Arash Sadeghi, discusses developments for non-invasive diagnostics for liver disease and how such advancements could potentially impact the landscape of conditions like NASH.

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Patients Pharmaceutical 52

Penrod

APRIL 1, 2024

Challenges of Manual Prior Authorization The big irony is that most healthcare facilities still utilize manual prior authorization in today’s digital climate. This process burdens care providers, patients and insurance companies. According to the American Medical Association, 34% of healthcare providers say that manual PA has caused severe effects on patient outcomes, including injuries, disabilities and hospitalization.

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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