Fri.Jan 20, 2023

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JPM23: Pfizer, Moderna and more look to combine COVID and flu vaccine markets

Fierce Pharma

JPM23: Pfizer, Moderna and more look to combine COVID and flu vaccine markets zbecker Fri, 01/20/2023 - 14:48

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3 Data Management Lessons Healthcare Should Learn from Other Industries

MedCity News

Healthcare could learn from the data improvement strategies that other industries have implemented in the past decade, a new report said. For example, the military, aerospace industry and aviation sector have all developed ways to standardize data, decrease silos and make information more accessible between organizations.

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Martin Shkreli runs afoul of FTC for potentially skirting lifetime pharmaceutical industry ban

Fierce Pharma

Martin Shkreli runs afoul of FTC for potentially skirting lifetime pharmaceutical industry ban fkansteiner Fri, 01/20/2023 - 15:34

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Biotech Financing Roundup: Belharra, NextPoint, Pathalys & More

MedCity News

Cancer continues to be a hot area of investment, and it’s the therapeutic focus of several biotech companies that have closed recent rounds of financing. Meanwhile, the investment arm of a big pharmaceutical company has an infusion of new cash to deploy in therapeutic and digital investments.

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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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AbbVie jacks up Humira price by 8%, joining many other companies with January hikes: report

Fierce Pharma

AbbVie jacks up Humira price by 8%, joining many other companies with January hikes: report kdunleavy Fri, 01/20/2023 - 10:06

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Top 5 IP Considerations for Medtech Companies Transitioning To Data-enabled Product Solutions

MedCity News

Investor and strategic partner mindsets have shifted toward optimal ways to protect their intellectual property (IP) requirements, especially given evolving laws and social concerns.

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The No Surprises Act and ‘Good Faith Estimate’: What Is It and When Is It Required

MedCity News

For patients that are uninsured or not using their insurance and choosing to pay out of pocket, providers are required to give a patient an estimate of all reasonably expected costs ahead of time, referred to as the Good Faith Estimate (GFE).

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Google Ads for Senior Living Communities: An Introductory Guide

Clear Pivot

The approach to Google ad campaigns for senior living communities is different from any other industry. Making the choice to move into senior living can be a nerve-wracking process for your future resident and their adult children alike, and the need for empathy is more pronounced than in almost any other line of work. There are plenty of individuals that would thrive in your community, so it’s crucial to make sure they know about it.

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Why Now Is the Time for Health Plans to Take Control of Pharmacy Benefits

MedCity News

Health plans today must consider what they want out of their pharmacy benefits and how to achieve something better for their members. And when they look at new platforms and processes that provide greater transparency, improved member experience, and simplicity in establishing and maintaining the technology, they’re likely to find that they don’t have to do things the way they always have.

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Moderna takes aim at global expansion plans with manufacturing ramp-up

Pharmaceutical Technology

This week, at the World Economic Forum Annual Meeting, Moderna CEO Stéphane Bancel, said the company plans to build on its exponential growth through the pandemic by expanding its operations globally over the next few years. In 2020, Moderna made a net loss of $747 million while its investigational mRNA vaccines were under development. However, during the Covid-19 pandemic, the US-based biotech rose to prominence as it was one of the first companies to develop Covid-19 vaccines with its mRNA tec

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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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We Are in COPD Season, but It Doesn’t Have To Overwhelm the Healthcare System.

MedCity News

Colder weather will always pose an additional risk to people with COPD, but this COPD season does not need to be so detrimental. To turn the tide, payers and providers must invest in preventive care to meet patients where they are before their conditions deteriorate.

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Balance Boards to Stay Active in the Offfice: Interview with Joel Heath, CEO of FluidStance 

Medgadget

Fun and durable, the FluidStance balance board deck can be found at many offices these days as working professionals with desk jobs look for ways to stay active and healthy. Long hours slumped over at a desk means that your muscles remain inactive for long periods of time – a running hypothesis is that long periods of inactivity lead to issues with glucose regulation, as muscles cease their regular glucose uptake and the body adapts to a sedentary lifestyle.

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StartUPDATES: New Developments from Healthcare Startups

MedCity News

Check out news from BioMEMS Diagnostics, Rx Redefined, Ferrum Health and Avanlee Care.

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The Legacy MEDSearch Layoff Survival Guide

Legacy MEDSearch

As the economy slows, layoffs, unfortunately, become more common. It’s never easy to be laid off, but our team has a couple of tips to share to help you recover quickly and find a new role that is right for you. Stay calm and focused. It can be hard to stay calm in an overwhelming and unexpected situation, like being laid off, but it is important to do so.

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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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Biobots Use Optogenetic Muscle Actuators for Movement

Medgadget

Researchers at the University of Illinois at Urbana-Champaign have developed centimeter-scale biobots that combine soft materials, mouse muscle tissue, and wireless electronic components. The tiny devices can be controlled remotely through optogenetics. The muscle within the devices forms an optogenetic actuator and creates movement when exposed to light.

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FDA issues complete response letter for donanemab

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has issued a complete response letter for the accelerated approval submission of donanemab for early Alzheimer’s, Eli Lilly and Company revealed. Meaning of the FDA’s complete response letter Ultimately, the FDA has not granted the accelerated approval, explained Dr Howard Fillit, Co-Founder and Chief Science Officer of the Alzheimer’s Drug Discovery Foundation (ADDF) in a responding statement.

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FDA blocks early nod for Lilly’s Alzheimer’s drug donanemab

pharmaphorum

Eli Lilly has been unable to secure an accelerated FDA approval for its anti-amyloid Alzheimer’s disease therapy donanemab based on mid-stage clinical results, but says it remains on track to file a traditional submission around the middle of this year. The complete response letter (CRL) from the FDA ends Lilly’s hopes of quickly following Eisai and Biogen’s Leqembi (lecanemab) onto the US market, after their anti-amyloid therapy claimed an accelerated approval earlier this mon

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NICE recommends PTC Therapeutics’ Translarna reimbursement

PharmaTimes

The NICE recommendation followed data from clinical trials and real-world evidence

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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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How Syneos Health and VBI Vaccines delivered a new kind of partnership model

pharmaphorum

For millions of people around the world living with infectious disease and cancer, the arrival of a new prophylactic or therapeutic vaccine on the market can be life changing. But in order for a treatment to reach patients, it needs to be launched. Commercialising a vaccine, even one that targets an unmet need, is a challenging task for companies. To bring therapies and medicines to patients with unmet needs, forming new strategic partnerships can be key, giving smaller organisations access to t

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NICE recommends Takeda’s Ninlaro triplet regimen

PharmaTimes

Therapy involves patients living with relapsed or refractory multiple myeloma

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BeiGene’s Brukinsa receives UK marketing authorisations to treat cancers

Pharmaceutical Technology

BeiGene has received marketing authorisations for Brukinsa (zanubrutinib) in Great Britain from the Medicines and Healthcare products Regulatory Agency (MHRA) to treat chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL). Brukinsa has been approved to treat CLL and MZL in adult patients who have previously received a minimum of one anti-CD20-based therapy.

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Unmedicated nation: COVID cuts heart drug use in GB

pharmaphorum

Hundreds of thousands of people in Great Britain have missed out on receiving medication that could protect them from serious cardiovascular disease (CVD) as a result of the COVID-19 pandemic, says a new study. The research – carried out by the British Heart Foundation charity and published in the journal Nature Medicine – suggests that reduced use of drugs for high blood pressure and lowering cholesterol is placing patients at increased risk of an avoidable heart attack or stroke.

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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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Providing a Snapshot of the Industry

PharmaTech

CRB’s latest industry report includes an expanded audience to include many European countries, which has provided some interesting insights.

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Pharmacy Focus - Big Picture for Health-System Pharmacies

Pharmacy Times

Carina Dolan, PharmD, BCOP, senior director for Clinical Oncology and Pharmaceutical Outcomes at Vizient Inc, discusses the highlights and big picture moving forward for hospitals and health-system pharmacies.

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UBC crowns Bekki Brown as its new CEO with a clear mandate to grow

PharmaVoice

The first-time CEO is tapping into decades of operational expertise to help bring real-world data into the mainstream.

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Study Shows That Breast Milk of Those Vaccinated Against COVID-19 Protects Infants

Pharmacy Times

Antibodies help neutralize the virus, though the levels decrease at the 6-month mark, data indicate.

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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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AMB-05X Receives EMA PRIME Designation for Treatment of Tenosynovial Giant Cell Tumor

PharmaTech

The efficacy data across multiple clinical endpoints and a favorable safety profile support the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT regardless of surgical resectability.

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Cancer Survivor: ‘I Wish I Could Have Spoken to a Pharmacist,’ Received More Pain Management Support

Pharmacy Times

Sarah McDonald, cancer survivor and author of The Cancer Channel, discusses her experience battling 2 different unrelated cancers and the value oncology pharmacists could have provided with a greater presence on her care team.

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Asimov and Center for Breakthrough Medicines Collaborate for Viral Vector Production

PharmaTech

The partnership led to Asimov licensing its clonal GMP HEK293 suspension cell line to CBM for pre-clinical and clinical production of viral vectors for its clients.

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Dentists Not Associated with Changing Duration of Opioid Prescriptions, Despite Statewide Limits

Pharmacy Times

Dental opioid prescriptions are associated with risk of addiction and overdose, but most states are enacting policies that limit the duration of prescriptions for acute pain.

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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.