Fierce Pharma
JULY 31, 2023
GSK has won the first FDA approval for an immunotherapy to treat certain patients with newly diagnosed endometrial cancer. But the industry-first go-ahead is tempered with a label limitation. | GSK has won the first FDA approval for an immunotherapy to treat certain patients with newly diagnosed endometrial cancer. But the industry-first go-ahead is tempered with a label limitation.
PharmExec
JULY 31, 2023
Rebekah Martin, senior VP of reward, inclusion, and talent acquisition at AstraZeneca, discusses ways to address the need for talent in pharma, how pharma can increase more interest in young talent, and how many roles in pharma will require a degree in the coming years in this Pharmaceutical Executive Podcast video.
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Fierce Pharma
JULY 31, 2023
Johnson & Johnson’s attempt to end its talc litigation with a sweeping $8.9 billion settlement didn’t pass muster at the bankruptcy court, which instead dismissed the company's latest bankruptc | U.S. Bankruptcy Judge Michael Kaplan ruled that J&J's LTL Management subsidiary didn't establish immediate financial distress when it applied for bankruptcy protections.
MedCity News
JULY 31, 2023
The average cost of a healthcare data breach is now $10.93 million, up from $10.10 million in 2022, according to a new report. Healthcare has the highest data breach costs of all industries — breaches are second costliest in the financial sector, where the average cost is $5.9 million.
Fierce Pharma
JULY 31, 2023
An accelerated approval for a potential growth driver for Takeda is in danger. | Takeda's targeted non-small cell lung med Exkivity has failed in a phase 3 trial in newly diagnosed patients, just days after Johnson & Johnson touted a win for its rival EGFR inhibitor.
MedCity News
JULY 31, 2023
Just 10% of women who had post-miscarriage depression during the pandemic received the “full spectrum of treatment” through therapy and antidepressants, according to a new report by Evernorth Research Institute.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
JULY 31, 2023
Biopharma companies are harnessing AI tools for multiple aspects of drug development such as identifying drug development targets, modeling a drug’s effect on the body, and more.
Fierce Pharma
JULY 31, 2023
Citius Pharmaceuticals’ $40 million bet on a Dr. Reddy’s drug to replace the withdrawn cancer med Ontak has hit a snag in the U.S. | Citius' application for Lymphir (denileukin diftitox) in relapsed or refractory cutaneous T-cell lymphoma (CTCL) has been rejected by the FDA. The regulator is requiring Citius to bolster its application with enhanced product testing and “additional controls agreed to with the FDA during the market application review,” the company said.
MedCity News
JULY 31, 2023
Amazon recently unveiled HealthScribe, an API that software companies can use to create clinical note generation apps that providers can later adopt. With this approach, Amazon is seeking to collaborate with companies that are building clinical documentation AI apps rather than compete with them. Some think this approach is clever, but others think it does little to facilitate bi-directional EHR integration and create standardization.
Fierce Pharma
JULY 31, 2023
For Apellis Pharmaceuticals, the emergence of rare but serious side effects has cast a pall over the launch of the company’s geographic atrophy med Syfovre. | While touting the “strong commercial execution” of Syfovre’s launch, Apellis’ CEO Cedric Francois, M.D., Ph.D., admitted the company has become aware of several cases of retinal vasculitis tied to the drug’s use.
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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.
MedCity News
JULY 31, 2023
Kindbody is now on Quantum Health’s Comprehensive Care Solutions platform, which offers a selection of benefits solutions that the company’s more than 500 employer clients can choose to contract with.
European Pharmaceutical Review
JULY 31, 2023
The first treatment for children and adolescents who have epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) has been approved in the EU by the European Commission (EC). EC has granted approval of ZTALMY ® (ganaxolone) oral suspension as adjunctive treatment in CDD patients from two to 17 years old. The European regulatory body’s decision “represents a significant milestone” according to Dr Scott Braunstein, Chairman and Chief Executive Off
MedCity News
JULY 31, 2023
A Phase 2b-ready Cyclerion Therapeutics drug candidate for a rare mitochondrial disease gets new life under a new startup led by a familiar face. Starup Tisento Therapeutics acquired the Cyclerion drug and is backed by a Series A round financing.
PharmaVoice
JULY 31, 2023
180 Life Sciences is on a mission to see if the anti-TNF technology that produced a blockbuster could work for a range of other conditions.
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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
MedCity News
JULY 31, 2023
A schizophrenia drug candidate from partners Sumitomo Pharma and Otsuka Pharmaceutical failed to outperform a placebo in two Phase 3 studies. The compound is the most advanced program from psychiatry and neurology collaboration spanning four drugs discovered by an artificial intelligence technology platform.
Pharmaceutical Technology
JULY 31, 2023
While messenger ribonucleic acid (mRNA)-based cancer vaccines have been in development for decades, their development had languished.
MedCity News
JULY 31, 2023
OptumRx’s Chief Clinical Officer shares his insights on the latest developments and trends he’s seen in the healthcare industry.
Pharmaceutical Technology
JULY 31, 2023
Alexion has signed a definitive agreement for acquiring and licencing Pfizer’s early-stage gene therapy portfolio for rare diseases.
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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.
European Pharmaceutical Review
JULY 31, 2023
Biogen has agreed to acquire Reata Pharmaceuticals for a total of $7.3 billion. This follows the first and only approved treatment for rare neuromuscular disease Friedreich’s ataxia authorised by the US Food and Drug Administration (FDA) in February 2023. Reata Pharmaceuticals’ orphan drug SKYCLARYS ® (omaveloxolone) is under review by the European Medicines Agency (EMA) for market authorisation in Europe.
Pharmaceutical Technology
JULY 31, 2023
Deploying robots in pharmaceutical manufacturing will remove snags in cell and gene therapies and enable breakthroughs
Pharmaceutical Commerce
JULY 31, 2023
Product is expected to maintain a steady temperature setting between 65°F (18°C) and 80°F (27°C).
Pharmaceutical Technology
JULY 31, 2023
Pharma sales have undergone a seismic transformation after Covid-19, with the adoption of artificial intelligence tools.
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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.
PharmaTimes
JULY 31, 2023
The phase 2 study involves company’s eftilagimod alpha therapy - News - PharmaTimes
PharmaTech
JULY 31, 2023
The new facility is set to utilize and extend SCG's capabilities in advanced cell therapy manufacturing and off-the-shelf human-induced Pluripotent Stem Cell (iPSC) technology.
PharmaTimes
JULY 31, 2023
Novel therapy, OK-101, offers a potential way of relieving neuropathic corneal pain - News - PharmaTimes
Clarivate
JULY 31, 2023
Today, the Dialog Solutions brand has been integrated into Clarivate. Following the acquisition of Dialog Solutions as part of the ProQuest M&A in December 2021, Dialog Solutions products and services will be folded into the Clarivate portfolio of offerings for Life Sciences & Healthcare. The versatile capabilities of Dialog Solutions cater to various industries and use cases including a modular, end-to-end approach to surveillance solutions makes it a valuable asset for pharmacovigilanc
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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
Contrarian Sales Techniques
JULY 31, 2023
Hi there Sales Managers and Team Leaders! Leading a sales team is no easy task, right? But when it comes to sales, assertiveness can be the game-changer. Let's explore how assertive sales techniques can enhance your team's performance. Assertive Sales Techniques: What's All the Fuss About? First, let's clarify: assertiveness isn't about being aggressive.
PharmExec
JULY 31, 2023
While clinical registries are a valued source of longitudinal, real-world data, registries also provide expanded options for research and advancing randomized clinical trials. Understanding when and how to use registries in these use cases is quite nuanced and mandates a targeted approach and innovative expertise. In this video, we dive deep into the expanded use of registries as external control arms in clinical trials.
Contrarian Sales Techniques
JULY 31, 2023
Hey there fellow sales warriors! If you've been in the field for a while, you know how important it is to be assertive, right? Not aggressive, but assertive. This blog post is here to walk you through assertive sales techniques that can skyrocket your sales performance. Assertive Sales Techniques: More Than Just Confidence So, what does it mean to be assertive in sales?
Referral MD
JULY 31, 2023
In today’s fast-paced world, where efficiency is critical, healthcare providers constantly seek innovative solutions to streamline their processes and improve patient care. One area that has undergone significant transformation is referral tracking. With the advent of referral management software, healthcare professionals can now revolutionize how they manage referrals , reducing wait times and enhancing the overall experience for patients.
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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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