Mon.Apr 01, 2024

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European prosecutors take over investigation into deal for Pfizer COVID vaccines: Politico

Fierce Pharma

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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FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

MedCity News

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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Teva snares up to $150M in Abingworth funding to propel late-stage asthma rescue inhaler

Fierce Pharma

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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AstraZeneca’s Rare Disease Pipeline Notches Another FDA Approval

MedCity News

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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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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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AstraZeneca CEO's 2024 pay proposal under fire from influential proxy advisers

Fierce Pharma

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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With a rise in animal-human organ transplants, a drugmaker aims for a new standard of care

PharmaVoice

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

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Healthcare Docket: The Telehealth Boom is Inciting Action by Lawmakers and Fraudsters Alike

MedCity News

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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AstraZeneca's rare disease add-on therapy Voydeya scores FDA nod

Fierce Pharma

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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To advance women’s leadership, an effort ‘has to be purposeful,’ says EMD Serono exec

PharmaVoice

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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Bavarian Nordic begins commercial launch of mpox vaccine Jynneos in US

Fierce Pharma

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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How Machine Learning Drives Clinical Trial Efficiency

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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Merck gets grant for patent granted for tricyclic heterocycle compounds for treating HIV

Pharmaceutical Technology

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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FDA clears first DTx for depression from Otsuka, Click

pharmaphorum

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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‘Garbage In Is Garbage Out’: Why Healthcare AI Models Can Only Be As Good As The Data They’re Trained On

MedCity News

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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US FDA grants fast track status to LISCure’s LB-P8 drug for PSC

Pharmaceutical Technology

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

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Roles and Responsibilities of Specialized Clinical Supply Experts

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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‘Garbage In Is Garbage Out’: Why Healthcare AI Models Can Only Be As Good As The Data They’re Trained On

MedCity News

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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Leqembi maintenance dose filed in US, but SC form delayed

pharmaphorum

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

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FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

MedCity News

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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How Dobbs v Jackson Women’s Health Organization Decision Influenced Self-Management Medication Use

Pharmaceutical Commerce

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

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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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Search, Click, Enroll? What Clinical Trials Can Learn from E-commerce

MedCity News

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

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FDA clears AZ’s new PNH therapy Voydeya

pharmaphorum

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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AI Disruption is Coming. Are Healthcare Professionals Ready?

MedCity News

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

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Fail-First Policies Are Harming Patients

Pharmaceutical Commerce

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

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Accelerating Clinical Supply Through Integrated Drug Development

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.

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Jubilant Pharmova gets grant for radiopharmaceutical composition for diagnostic imaging with stable attributes

Pharmaceutical Technology

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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Pharma Pulse 4/1/24: Uncertainties Associated with Accelerated Approval, Understanding DSCSA & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Field Sales Training: Essential Strategies and Tools for Success

Spotio

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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FDA Approves Alexion’s Voydeya as Add-on Treatment for Adults with Extravascular Hemolysis

PharmExec

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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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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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Complying with the CMS Interoperability and Prior Authorization Rule

Penrod

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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Opening the Door for More NASH Patients

PharmExec

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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How to Automate Prior Authorization with Salesforce

Penrod

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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Redx Pharma gets grant for ROCK inhibitors for treating ROCK mediated diseases

Pharmaceutical Technology

Discover Redx Pharma's groundbreaking patent for novel compounds targeting ROCK1 and ROCK2 inhibitors. Learn about the formula, structural features, and pharmaceutical applications covered in this exclusive patent.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.