Fri.Mar 24, 2023

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GSK plays defense after California judge approves plaintiff's expert testimony in high-stakes Zantac trial

Fierce Pharma

GSK plays defense after California judge approves plaintiff's expert testimony in high-stakes Zantac trial fkansteiner Fri, 03/24/2023 - 10:05

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SXSW 2023: Moving from NFTs to LSD

PM360

Technology evolves fast. Nothing illustrates that better than attending SXSW each year and noticing how much has changed in just 12 months. In 2022, SXSW was all NFTs and metaverse activations and events, and in 2023 they weren’t anywhere to be found. But a lot was shared at this year’s SXSW that had staying power. In place of NFTs, psychedelics were given their own conference track this year.

Media 119
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Sanofi, Regeneron's Dupixent could hit $20B in peak sales with COPD expansion: analyst

Fierce Pharma

Sanofi, Regeneron's Dupixent could hit $20B in peak sales with COPD expansion: analyst kdunleavy Fri, 03/24/2023 - 07:30

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Oak Street, Interwell Combine Primary Care & Dialysis with New Joint Venture

MedCity News

Oak Street Health teamed up with kidney care management company Interwell Health to create a joint venture called OakWell, which seeks to provide primary care to end-stage kidney disease patients directly in existing dialysis centers. End stage kidney disease patients spend upwards of 12 hours per week in dialysis centers — OakWell is meant to eliminate the barrier of attending separate, additional medical appointments.

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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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Brii Bio shelves once-promising COVID antibody combo that stood up to variants

Fierce Pharma

Brii Bio shelves once-promising COVID antibody combo that stood up to variants kdunleavy Fri, 03/24/2023 - 10:07

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Caregivers Face Financial and Mental Burdens, New Survey Shows

MedCity News

About 28% of Americans consider themselves to be caregivers, and 22% are unpaid, according to a new survey from CVS Health and Harris Poll. These caregivers are facing financial and mental health struggles: 47% said that being a caregiver is a financial burden and 49% said their mental health suffers from being a caregiver.

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Cancer Patient-Support Program Uptake is Low: Here’s How to Change That

PM360

Cancer-support programs provide vital assistance to patients and their caregivers as they face one of the toughest times of their lives. Yet while patients are interested in these programs, new survey data suggests they aren’t taking advantage of them. Results from 825 patients diagnosed with or treated for cancer who were surveyed on Phreesia’s PatientInsights platform as they checked in for their doctors’ appointments revealed that few cancer patients are accessing the support resources availa

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With rejection for slow-release Jakafi, FDA sends shockwaves across Incyte's pipeline: analyst

Fierce Pharma

With rejection for slow-release Jakafi, FDA sends shockwaves across Incyte's pipeline: analyst aliu Fri, 03/24/2023 - 10:04

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4 Steps to Create an Inclusive Workplace by Overcoming Personal Biases

PM360

Unacknowledged personal biases in the workplace can quickly spiral, leaving employees feeling alienated and disengaged. This has far-reaching implications that can also influence external brand experiences with target stakeholders. In the healthcare industry, this is especially concerning as it can contribute to health disparities and impact progress toward health equity : better health and well-being for all.

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Biotech Financing Roundup: Mbiomics, Flare Therapeutics, EpiBiologics & More

MedCity News

Flare Therapeutics, EpiBiologics, and Mbiomics are among the biotech companies that recently unveiled new rounds of financing.

Biopharma 111
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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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How to Stay Compliant with State Drug Price Transparency Reporting

PM360

Drug price transparency (DPT) laws have been in effect in several states for a few years now. Starting with Vermont in 2016, more than half of the U.S. states are now collecting pricing data from manufacturers in the hopes it will assist in creating effective policies to reduce drug prices for their constituents. The question of whether this goal will be realized or not remains unanswered for now.

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Celebrating Women in Health Care Starts with Reimagining your Workforce

MedCity News

These are challenging times for health care, and particularly for women in health care.

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A Firsthand Perspective of Pharma’s Failures with DE&I

PM360

Let’s talk digital transformation! In January, I started my series by identifying five key components of a successful digital transformation. We covered the first one by looking at Organizational Structures , today, let’s dive into the second which is the toughest, not just for pharma, but for the entire country: Diversity, Equity, and Inclusion (DE&I).

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Developing novel therapies for NASH

European Pharmaceutical Review

Following the recent announcement of topline results from 89bio’s Phase IIb trial, ENLIVEN, evaluating FGF21 analogue pegozafermin for nonalcoholic steatohepatitis (NASH), a serious liver condition, EPR spoke with Dr Hank Mansbach, the company’s Chief Medical Officer. NASH currently has no approved treatments. Caused by excess fat, it is referred to as the ‘silent killer’, as most affected individuals don’t exhibit symptoms until liver damage has already occurred.

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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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Making an Impact During Disease Awareness Days, Weeks, and Months

PM360

Pharma marketers often turn to disease awareness days, weeks, and months to inform campaigns as they strategize for the year ahead. With the sheer number of official awareness days out there, it’s no wonder they’ve become a pillar to a marketer’s early plan development. To the pharma marketing industry, these days and months present a clear opportunity to shed light on a particular condition or therapeutic area.

Media 92
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StartUPDATES: New Developments from Healthcare Startups

MedCity News

Check out news from OUI Medical, Vital, Cognito Therapeutics and Reveal HealthTech.

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EMA publishes mid-point regulatory science strategy report

European Pharmaceutical Review

The European Medicines Agency (EMA) has published a report summarising the mid-point achievements of its Regulatory Science Strategy (RSS) to 2025. Initially published in March 2020, the strategy provides a plan for advancing regulatory science over a five-year period. Regulatory science refers to the scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products.

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At London Book Fair, Spotlight on Ukraine

Copyright Clearance Center

The post At London Book Fair, Spotlight on Ukraine appeared first on Copyright Clearance Center.

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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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What would you fix with a ‘magic wand’? Pharma leaders chime in about clinical trials

PharmaVoice

How life science execs would transform clinical trials with a little hocus pocus.

Pharma 98
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Comparison of Humira biosimilars in the US and Europe

Pharmaceutical Technology

Biosimilars for AbbVie’s (US) Humira (adalimumab) have finally launched in the US, bringing an end to Humira’s 20-year reign as the best-selling biologic of all time. Biosimilars are an important tool to facilitate competition, lower the price of drugs, and create savings across the board. Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year.

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PAP 2023: A Summary of Unparalleled Strategies to Drive Access and Affordability

Pharmaceutical Commerce

Pharma Commerce offers a synopsis of some of the conference’s events.

Pharma 96
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2023 PM Society Awards – Winners Announced

PharmaTimes

21GRAMS takes four Golds plus Best in Show AstraZeneca tops the pharma leader board

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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.

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Oncology Market Trends to Watch Out For in 2023

Medico Reach

The American Cancer Society estimates 1,958,310 new cases of cancer in the United States in 2023. As a result, a global approach to healthcare has emerged continually over the years. Even for cancers that are difficult to treat, new treatments and technologies improve patient survival rates. Hence, new oncology market trends will set in as doctors and pharmaceutical companies work towards individualized treatment decisions.

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Ancora Heart’s AccuCinch System Demonstrates Significant Improvement in Quality of Life, Cardiac Structure and Function in Heart Failure Patients

Legacy MEDSearch

Ancora Heart, Inc., a company developing a completely transcatheter device-based therapy to address heart failure (HF), announced that patients treated with the investigational AccuCinch ® Ventricular Restoration System demonstrated improvement in HF patient outcomes and beneficial changes in the structure of the heart. The 12-month data were presented as part of a late-breaking clinical science session at the Technology and Heart Failure Therapeutics conference (THT 2023) and simultaneously pu

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Oncology Market Trends to Watch Out For in 2023

Medico Reach

The American Cancer Society estimates 1,958,310 new cases of cancer in the United States in 2023. As a result, a global approach to healthcare has emerged continually over the years. Even for cancers that are difficult to treat, new treatments and technologies improve patient survival rates. Hence, new oncology market trends will set in as doctors and pharmaceutical companies work towards individualized treatment decisions.

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Moderna and Generation Bio partner for genetic medicines development

Pharmaceutical Technology

Moderna has entered a strategic partnership with Generation Bio for the development of non-viral genetic medicines. Moderna’s biological and technical expertise will be combined with core technologies of the non-viral genetic medicine platform from Generation Bio. The collaboration aims to expand each company’s platform application through the development of new nucleic acid therapeutics, and to expedite their respective non-viral genetic medicines pipelines.

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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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Debiopharm reveals phase 1/2 GaLuCi research results

PharmaTimes

The multi-centre international clinical trial will evaluate company’s Debio 0328 candidate

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Takeda set to build $764m manufacturing facility in Japan

Pharmaceutical Technology

Takeda has unveiled plans to invest almost $764m (JPY100bn) to construct a new manufacturing facility for plasma-derived therapies (PDTs) in Osaka, Japan. The new facility represents the company’s largest-ever investment in the expansion of manufacturing capacity in the country. It is expected to become the largest facility in Japan and to increase the company’s current plasma manufacturing site capacity in Narita almost five-fold.

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EVERSANA® Announces Partnership with ChemoMouthpiece, LLC

PharmExec

The partnership was sealed to support U.S. launch & commercialization of a medical device to help cancer patients manage and treat oral mucositis.

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Destiny releases pivotal phase 2 data involving XF-73 nasal gel

PharmaTimes

Study shows significant reduction of nasal S.

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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.