Kansas AG accuses Pfizer of misrepresenting COVID vaccine, hiding safety risks in lawsuit
Fierce Pharma
JUNE 18, 2024
Kansas Attorney General is accusing Pfizer of "misrepresenting" its vaccine's safety and efficacy in a 179-page civil suit.
Tue.Jun 18, 2024
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Avoiding the pharma ‘junk pile’ with launch readiness, pipeline rigor and ‘quick kills’
PharmaVoice
JUNE 18, 2024
Drug launches have underperformed expectations at a high rate, and pharmas need to get better at thinning the pipeline to make room for the real wins, says a life sciences consultant.
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AstraZeneca's Truqap misses the mark in late-stage triple-negative breast cancer trial
Fierce Pharma
JUNE 18, 2024
While AstraZeneca’s Truqap bears the distinction of being the first AKT inhibitor to pass muster with the U.S. | In the late-stage CAPItello-290 study, Truqap plus the chemotherapy paclitaxel failed to help extend the lives of patients with locally advanced or metastatic triple-negative breast cancer (TNBC) over paclitaxel and placebo alone, AstraZeneca said Tuesday.
Talkiatry Raises $130M To Expand Behavioral Health Access
MedCity News
JUNE 18, 2024
Talkiatry’s funding round was led by Andreessen Horowitz. With the financing, the company will bring on more providers and advance value-based care. The post Talkiatry Raises $130M To Expand Behavioral Health Access appeared first on MedCity News.
Intra-Cellular's Caplyta scores again in major depressive disorder as blockbuster expansion comes within reach
Fierce Pharma
JUNE 18, 2024
Intra-Cellular Therapies’ surging antipsychotic Caplyta has scored again with remarkable trial results, fueling its bid for a third and potentially most lucrative indication—major depressive disord | Intra-Cellular Therapies’ surging antipsychotic Caplyta has scored again with remarkable trial results, fueling its bid for its third and potentially most lucrative indication—major depressive disorder.
Innovation Alone Isn’t Enough: Addressing the Legacy of Administrative Burdens in Healthcare
MedCity News
JUNE 18, 2024
Administrative inefficiencies create a bottleneck that hinders the entire healthcare system. The post Innovation Alone Isn’t Enough: Addressing the Legacy of Administrative Burdens in Healthcare appeared first on MedCity News.
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3 Things to Know About the Cybergang that Attacked Ascension
MedCity News
JUNE 18, 2024
Ransomware group Black Basta has quickly gained prominence as one of the biggest threats to healthcare providers’ cybersecurity. The group, which is responsible for the Ascension cyberattack, has hit more than 500 organizations across the globe since it first appeared in April 2022. The post 3 Things to Know About the Cybergang that Attacked Ascension appeared first on MedCity News.
Three ways to solve the ‘Patient Support Paradox’
Fierce Pharma
JUNE 18, 2024
Authors: Arlene Pineda, Senior Director, Patient Support Services, IQVIA Kristina Jones, Principal, Patient Services Technology & Analytics, IQVIA | In a curious twist, patient support programs — often designed to alleviate the burden on patients — sometimes create unintended challenges. These large, intricate, and costly initiatives can paradoxically complicate the lives of the very individuals they aim to assist.
Novel immunotherapy combination approved for endometrial cancer
European Pharmaceutical Review
JUNE 18, 2024
The US Food and Drug Administration (FDA) has approved the first anti-PD-1 therapy in combination with chemotherapy for adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status. Merck (MSD outside of the US and Canada)’s KEYTRUDA (pembrolizumab) is authorised alongside treatment with carboplatin and paclitaxel, followed by KEYTRUDA monotherapy, for these patients.
Cancer Biotech Day One Biopharma Expands to ADCs, Paying $55M to Nab a Phase 1-Ready Drug
MedCity News
JUNE 18, 2024
Day One Biopharmaceuticals is adding an antibody drug conjugate to its pipeline, licensing rights to a molecule from MabCare Therapeutics. The MabCare ADC addresses PTK7, a protein found in many types of solid tumors. The post Cancer Biotech Day One Biopharma Expands to ADCs, Paying $55M to Nab a Phase 1-Ready Drug appeared first on MedCity News.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Embracing Challenges: The Power of “What” Questions
Scott Burrows
JUNE 18, 2024
In the dynamic world of business, how we approach challenges can define our path to success. Instead of being bogged down by adversity, we have the power to transform it into opportunity simply by changing the way we ask questions. From “Why” to “What” During tough times, it’s natural to ask ourselves, “Why is this happening to us?
9 Requirements for an Optimal Genetic Test Benefit Program
MedCity News
JUNE 18, 2024
Health plans should be sure the following elements are incorporated into their genetic testing benefits framework. The post 9 Requirements for an Optimal Genetic Test Benefit Program appeared first on MedCity News.
Johnson & Johnson submits BLA to FDA for lung cancer drug
Pharmaceutical Technology
JUNE 18, 2024
Johnson & Johnson has filed a BLA with the US FDA seeking approval for SC amivantamab for the treatment of non-small cell lung cancer.
FDA says yes to MSD’s 21-valent adult pneumococcal jab
pharmaphorum
JUNE 18, 2024
The rivalry between Pfizer and MSD in pneumococcal vaccines has dialled up a notch with the FDA approval of MSD’s new shot Capvaxive, the first to be aimed specifically at adults.The 21-valent product – formerly known as V116 – covers a wider range of Streptococcus pneumoniae serotypes than any of MSD’s earlier vaccines and eight that are not covered by any other approved pneumococcal vaccine.
Roche and Ascidian Therapeutics Collaborate on Treatments for Neurological Diseases
PharmaTech
JUNE 18, 2024
The research collaboration and licensing agreement will focus on the discovery and development of RNA exon editing therapeutics.
Can supermarket pharmacies plug urgent healthcare gaps?
Pharmaceutical Technology
JUNE 18, 2024
As Asda sets up a nationwide retail pharmacy in the UK and US grocer pharmacies expand, scaling up this model will be the next frontier.
FDA clears Roche digital pathology platform for diagnosis
pharmaphorum
JUNE 18, 2024
Roche’s move into the digital pathology category has been boosted by FDA approval of a lab instrument and toolkit for use as an aid to clinical diagnosis.The clearance covers Roche’s Ventana DP 200 slide scanner, digital pathology workflow software, and a display that can be used to review and interpret digital images of scanned pathology slides.
SPH-4336 by Shanghai Pharmaceutical Group for Well Differentiated Liposarcoma: Likelihood of Approval
Pharmaceutical Technology
JUNE 18, 2024
SPH-4336 is under clinical development by Shanghai Pharmaceutical Group and currently in Phase II for Well Differentiated Liposarcoma.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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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.
KalVista files first oral on-demand HAE drug with FDA
pharmaphorum
JUNE 18, 2024
KalVista files sebetralstat with the FDA, aiming to make it the first oral, on-demand treatment for rare disease hereditary angioedema (HAE)
The lasting impacts of the pandemic on cybersecurity in healthcare
Pharmaceutical Technology
JUNE 18, 2024
The high speed of the transition meant many information technology security teams had insufficient time to install adequate cybersecurity.
How to Implement Object Associations in a HubSpot CRM Migration
Clear Pivot
JUNE 18, 2024
Learn how to maintain object associations in a CRM migration to HubSpot. Follow a two-stage process to import contacts, accounts, and opportunities seamlessly.
FDA approves MSD’s KEYTRUDA for advanced endometrial cancer
Pharmaceutical Technology
JUNE 18, 2024
The US FDA has granted approval for MSD’s KEYTRUDA regimen to treat primary advanced or recurrent endometrial carcinoma in adults.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
AZ has another setback with Truqap after failed TNBC trial
pharmaphorum
JUNE 18, 2024
AstraZeneca’s AKT inhibitor Truqap was unable to improve overall survival in a phase 3 triple-negative breast cancer (TNBC) trial
CRTE-7A2 by Beijing Corregene Biotechnology for Anal Cancer: Likelihood of Approval
Pharmaceutical Technology
JUNE 18, 2024
CRTE-7A2 is under clinical development by Beijing Corregene Biotechnology and currently in Phase I for Anal Cancer.
Novo Nordisk CEO agrees to testify on semaglutide pricing
pharmaphorum
JUNE 18, 2024
Novo Nordisk CEO agrees to appear at a Senate hearing to defend the pricing of Ozempic and Wegovy in the US.
Ability Biologics closes extended $18m seed funding round
Pharmaceutical Technology
JUNE 18, 2024
Since emerging from stealth in December 2023, the company has begun establishing its laboratories in Montreal.
Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics
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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
The new frontier of microbiome-directed human health
pharmaphorum
JUNE 18, 2024
The microbiome is ever more frequently spoken about of late, and so the pharmaphorum podcast invited Leo Grady, founder and CEO of Jona, to speak about at-home personal microbiome profiling, uncovering the relationship between human health and the gut.
Muvalaplin by Eli Lilly and Co for Atherosclerosis: Likelihood of Approval
Pharmaceutical Technology
JUNE 18, 2024
Muvalaplin is under clinical development by Eli Lilly and Co and currently in Phase II for Atherosclerosis.
UMC Utrecht and VectorY collaborate to identify biomarkers of ALS in new study
PharmaTimes
JUNE 18, 2024
The progressive neurological disorder currently affects more than 200,000 people worldwide
Is There a Doctor on the Plane?
MedCity News
JUNE 18, 2024
Three reasons you should hire physicians for your product teams The post Is There a Doctor on the Plane? appeared first on MedCity News.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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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