Fri.Jul 14, 2023

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In talc defense, Johnson & Johnson sues 4 doctors over their 'junk litigation opinions'

Fierce Pharma

As Johnson & Johnson awaits a decision on its second attempt to resolve talc lawsuits through a bankruptcy ploy, the company is attempting another legal tactic to free itself from those liabili | As Johnson & Johnson awaits a decision on its second attempt to resolve talc lawsuits through a bankruptcy ploy, the company is attempting another legal tactic to help free itself from those liabilities—suing doctors who say that its iconic baby powder can cause cancer.

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Two Biotechs Break the IPO Dry Spell, Raising $385M Combined

MedCity News

Inflammation and immunology biotech Apogee Therapeutics and Sagimet Biosciences, a company developing a drug for the fatty liver disease NASH, are the latest biotech companies to join the public markets. Both companies upsized their IPOs, raising cash for clinical trials.

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ICER updates cost-effectiveness threshold for bluebird, Vertex and CRISPR's dueling sickle cell gene therapies

Fierce Pharma

The potentially curative promise of gene therapies often carries a steep price tag. | The potentially curative promise of gene therapies often carries a steep price tag. But for a pair of personalized medicine prospects in sickle cell disease (SCD), the cost could be worth it, at least as far as ICER is concerned.

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It’s Time to Make Effective Alternatives a Bigger Part of the CPAP Recall Story

MedCity News

For those unfamiliar with the CPAP recall situation in question, imagine if one-third of all cars on the road were suddenly recalled for potentially life-threatening issues. Now imagine that in the aforementioned hypothetical automobile recall, the media dedicated its energy almost entirely to reporting on the worsening problem without making viewers aware of potential solutions.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Mallinckrodt faces investor lawsuit for allegedly making false statements about its financial health

Fierce Pharma

In June of last year, after Mallinckrodt Pharmaceuticals emerged from a Chapter 11 reorganization and agreed to a $1.

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‘This Is Almost Biblical in Its Impact’: Providers Push Back Against CMS’ New Proposed Rules

MedCity News

CMS recently revealed its proposals to raise reimbursement rates for hospital outpatient departments and cut payments for physicians. Next year, the agency is planning to decrease physicians’ pay by 1.25% and increase outpatient payment rates by 2.8%. Provider groups are unhappy with the news — AMA President Dr. Jesse Ehrenfeld said the new physician fee schedule will be “almost biblical in its impact.

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AI Faces Multiple Creator Lawsuits

Copyright Clearance Center

Copyright infringement lawsuits from authors and artists against creators of Generative AI software are mounting.

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Health Net Invests $46M To Support Unhoused in California

MedCity News

Health Net is making a $46 million investment that will be spread out across 26 counties in California, and will support Continuum of Care programs, which are regional or local planning bodies that help those experiencing homelessness find housing and other services.

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Positive data for Caribou Biosciences’ CB-010 candidate

PharmaTimes

CAR-T cell therapy being researched among patients with relapsed or refractory B cell non-Hodgkin lymphoma - News - PharmaTimes

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Wearable Takes Blood-Free Stress Hormone Samples

Medgadget

Researchers at the University of Birmingham in the UK have developed a wearable that can assist in keeping track of stress hormone levels in the body over time. Disregulated stress hormones can play a role in various disease states, from heart disease to depression. However, until now, researchers had to perform blood draws to measure stress hormone levels, meaning that they could obtain just one snapshot in time of hormone levels or repeated blood draws over time, neither of which are ideal.

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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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Cumulus Neuroscience in partnership with the Universities of Bath and Bristol

PharmaTimes

Collaboration will focus on progressing test for early detection of Alzheimer’s dementia - News - PharmaTimes

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App Converts Smartphone to Clinical Thermometer

Medgadget

Researchers at the University of Washington have developed an app that converts common smartphones into clinical thermometers. Spotting the signs of fever early could make a difference in providing early treatment or beginning a period of isolation to reduce the chance of disease transmission. This is particularly important for viral diseases, such as COVID-19.

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Inspiring Action: Pharma Advertisers as a Force to Address Climate-Related Health Inequities 

Eversana Intouch

The Urgent Need for Action Climate scientists and activists have been tirelessly working to sound the alarm on climate change and its impacts, but despite their efforts, meaningful intervention is too slow in coming. Climate change and health inequities demand immediate attention, and pharma advertisers are uniquely positioned to drive change. Most of us who work in pharma advertising do so because we believe we can make a difference.

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How IRA May Be Affecting Biotech Financing

Pharmaceutical Commerce

Recent data and commentary offer insights into how biologics vs. small molecule patent protections under the Inflation Reduction Act pricing scenarios is impacting investing in the biotech sector.

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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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Allosource Receives FDA 510(K) Clearance for Aceconnex™ Pre-Sutured Fascia for Hip Labral Reconstruction and Augmentation

Legacy MEDSearch

AlloSource ® , one of the largest allograft providers creating innovative cellular and tissue products to help surgeons heal their patients, today announced the U.S. Food and Drug Administration’s 510(K) clearance of AceConnex Pre-Sutured Fascia for hip labral reconstruction and augmentation. This product reinforces AlloSource’s commitment to providing innovative products to support the overall sports medicine market, including hip arthroscopy. “AceConnex Pre-Sutured Fascia was

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Vistagen obtains Canadian Notice of Allowance for AV-101 patent

Pharmaceutical Technology

Vistagen has received a Canadian Notice of Allowance for patent that is related to the use of AV-101 in Parkinson's disease (PD) patients.

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metabion Expands Oligonucleotide Production Capacity in Germany

PharmaTech

German manufacturer metabion is conducting a multi-million euro expansion of its oligonucleotide manufacturing capacity in Munich East.

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Gilead, CHAI and Penta to enhance HIV treatment for children

Pharmaceutical Technology

Gilead Sciences has entered into collaborations with CHAI and Penta ID network to expedite the development of dispersible HIV treatments.

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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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Missed or Delayed Pediatric Preventative Care During COVID-19 Pandemic Influenced By Race, Enabling Factors

Pharmacy Times

Study among the first to examine delayed or missed pediatric preventative care during COVID-19 that considers determinants, race, and ethnic group, according to the authors.

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Health Canada approves AstraZeneca-Merck’s prostate cancer therapy

Pharmaceutical Technology

AstraZeneca and Merck have received conditional approval from Health Canada for Lynparza (olaparib) combination to treat prostate cancer.

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FDA Accepts New Drug Application for Zanubrutinib Combination for R/R Follicular Lymphoma

Pharmacy Times

Zanubrutinib combined with obinutuzumab was previously granted both Fast Track and Orphan drug designations for patients with relapsed or refractory follicular lymphoma.

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Theseus terminates its GI cancer drug development programme

Pharmaceutical Technology

Theseus Pharmaceuticals has terminated its pan-variant tyrosine kinase receptor (KIT) inhibitor (THE-630) drug development programme.

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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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Latest Arbitration Decision Rules in Favor of AHF

Pharmaceutical Commerce

Ruling validates antitrust theory, pushes antitrust arbitration against Prime Therapeutics forward.

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Emmaus gains marketing authorisation for sickle cell treatment in Oman

Pharmaceutical Technology

Emmaus Life Sciences has received marketing authorisation for Endari (L-glutamine oral powder) in Oman for sickle cell disease.

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Flagship, PhRMA prioritize experience in hot summer exec changes

PharmaVoice

With major projects brewing at both organizations, these new leaders will hit the ground running.

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Bicycle Therapeutics plans $200m public offering

Pharmaceutical Technology

The offering follows recent lucrative deals with Novartis and Bayer for the use of Bicycle Therapeutics’ peptide technology.

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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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Changes for Remote Monitoring in the 2024 Proposed Medicare Physician Fee Schedule: What Providers RTM and RPM companies need to know

Nixon Gwilt Law

The Centers for Medicare & Medicaid Services (“CMS”) released its much-anticipated Proposed Medicare Physician Fee Schedule for CY 2024 (the “Proposed Rule”) on July 13, 2023. This year’s Proposed Rule came later than usual, likely because it includes significant changes and clarifications around how services will be provided going forward since the COVID-19 Public Health Emergency (“PHE”) came to an end on May 11th.

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Causaly secures $60 Million in series B funding

Pharmaceutical Technology

Causaly serves 12 of the top 20 pharmaceutical companies with technology that aims to expedite the drug discovery process.

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Michael Rowbotham

Pharma Marketing Network

The post Michael Rowbotham appeared first on Pharma Marketing Network.

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Coherus plans Humira biosimilar sale at 85% discount

Pharmaceutical Technology

Yusimry is priced at $995 per carton of two autoinjectors compared to Humira’s price tag of $6,922 for the same quantity.

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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.