Fierce Pharma
JANUARY 25, 2023
Merck's Keytruda dealt another blow in prostate cancer but readies new challenge to AZ's Imfinzi aliu Wed, 01/25/2023 - 10:17
MedCity News
JANUARY 25, 2023
The agency’s goal is to spur a macro shift in clinical trials. The FDA is trying to tell these companies what it wants to be different in trials across the board with regards to digital health endpoints, the use of real-world data (RWD) as regulatory-grade data, and diversity in clinical trial inclusion.
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Fierce Pharma
JANUARY 25, 2023
After years of back-and-forth, Gilead's CAR-T Yescarta sways England's cost watchdog NICE fkansteiner Wed, 01/25/2023 - 18:51
MedCity News
JANUARY 25, 2023
Atomic AI combines artificial intelligence analysis with wet lab experiments to discover small molecules capable of drugging RNA. The startup, based on technology initially developed at Stanford, is backed by a $35 million Series A round of financing.
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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
Fierce Pharma
JANUARY 25, 2023
As Scangos bids adieu, Vir taps Bayer dealmaker De Backer as its next CEO fkansteiner Wed, 01/25/2023 - 11:09
MedCity News
JANUARY 25, 2023
Model building is now simplified more than ever because of automation and tool intelligence achieved in model building. With a surplus of MLOps tools, users of all sizes and backgrounds are now focusing on model manufacturing. But the question remains – are all models usable?
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
JANUARY 25, 2023
Covering travel expenses is not an act of altruism for employers. It’s in their financial interest to have their workforce access the specialized care they need to feel better rather than consigning them to an inadequate care treadmill at the local hospital.
Healthcare Success
JANUARY 25, 2023
It’s not your imagination. People really are ruder to each other these days. The pandemic, economy, political unrest, war, and continued uncertainty have taken—and continue to take—a toll on people’s mental health. These all contribute to stress, anxiety, frustration, and anger. And according to Harvard Business Review , frontline workers are taking the brunt of this unrest and aggression.
MedCity News
JANUARY 25, 2023
Healthcare providers will continue having a difficult time retaining employees unless they make necessary changes, such as establishing pay increases and improving company culture. Healthcare ranked last for employee satisfaction with pay among 27 other industries, according to a recent report. A separate report found that many healthcare employees are leaving their jobs because their company’s mission no longer aligns with their values.
PM360
JANUARY 25, 2023
Spurred into action by the pandemic, many pharma brands are undertaking or accelerating their digital transformations. While many have already moved to agile, technology-based approaches for HCP and DTC outreach, it’s time for us to assess our progress and consider a few tweaks to improve our approach. Five key areas impact digital adoption and effectiveness: Organizational Structures Diversity, Equity, and Inclusion Omnichannel Marketing Strategy Creative Development and Deployment Medicare Cha
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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
JANUARY 25, 2023
As healthcare organizations comply with the federal EPCS mandate, artificial intelligence and digital identity technologies should be utilized to detect, reduce, and remediate drug diversion.
European Pharmaceutical Review
JANUARY 25, 2023
Regulators, medicine manufacturers and suppliers have been urged by the World Health Organization (WHO) to take action against contaminated medicines in the supply chain. This is based on recent incidents of over-the-counter cough syrups with high levels of diethylene glycol (DEG) and ethylene glycol (EG). The lingering menace of diethylene glycol / ethylene glycol adulteration Over the past four months, cases from at least seven countries have been associated with over 300 fatalities in three o
MedCity News
JANUARY 25, 2023
This year’s ACA Marketplace enrollment represents a 13% increase, or 1.8 million people, from last year, according to CMS. There were more than 12.7 million returning consumers and more than 3.6 million new consumers.
pharmaphorum
JANUARY 25, 2023
Life sciences marketing has rapidly evolved to mirror that of consumer retail. There are now more ways than ever to interact with customers, from traditional channels like email and phone calls to more modern approaches like social media and texting, and new ways to engage customers are emerging every year. So, how can companies maximise the effectiveness of customer engagement strategies when there are so many digital and physical mediums of interaction to choose from?
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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.
MedCity News
JANUARY 25, 2023
After another insightful conference this year, these are some of the key legal deal trends to expect from the health care and life sciences industries in 2023.
pharmaphorum
JANUARY 25, 2023
Digital therapeutics company Woebot Health has announced enrolment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational therapeutic for postpartum depression (PPD), granted Breakthrough Device designation by the US Food and Drug Administration (FDA) in 2021. The double-blind, randomised, controlled trial will evaluate WB001, a Software as a Medical Device (SaMD) based Cognitive Behavioural Therapy (CBT) program for the treatment of mil
MedCity News
JANUARY 25, 2023
After launching an at-home vaginal microbiome test in 2021, Evvy its expanding its services. After taking a test, consumers can received personalized treatment, which may include prescriptions and one-on-one health coaching.
Pharma Pathway
JANUARY 25, 2023
Cipla Limited – Walk-In Drive for Multiple positions On 29th Jan’ 2023 Job Description Company Profile Cipla Limited is an Indian multinational pharmaceutical company, headquartered in Mumbai, India. Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control and depression. Cipla Limited – Walk-In Drive for Multiple positions -Sterile Manufacturing Officers/ Sterile Manufacturing Operators/ OSD Production/ Quality Positions: Sterile Manuf
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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.
MedCity News
JANUARY 25, 2023
Check out executive hires from SnapNurse, Almaden Genomics, Dr. Evidence, Healthy.io, Wheel, and Sage Bionetworks.
Pharmaceutical Technology
JANUARY 25, 2023
It was an exceptional year for Moderna’s vaccine Spikevax, with forecast sales of $19.5bn in 2022. Despite this, Spikevax’s average annual sales forecast has plummeted by 23% between H1 and H2 2022 according to GlobalData’s Coronavirus Disease 2019 (COVID-19) Sector Forecast reports, due to increasing competition from Pfizer’s Comirnaty, Novavax’s Nuvaxovid, and Covid-19 therapeutics.
MedCity News
JANUARY 25, 2023
It’s no secret that healthcare in the United States has become unaffordable.
pharmaphorum
JANUARY 25, 2023
The 501(c)3 non-profit Tidepool, which seeks to empower the next generation of innovations in diabetes management, has announced that the US Food and Drug Administration (FDA) has cleared Tidepool Loop, an automated insulin dosing app intended for the management of type 1 diabetes (T1D) in those six years old and above. Tidepool, an open-source diabetes non-profit founded in 2013 and driving community-led innovation, has thus made a reality the patient-led project, Tidepool Loop – the first iPho
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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.
Pharmaceutical Technology
JANUARY 25, 2023
The Saudi Food & Drug Authority (SFDA) has approved the manufacturing and distribution of Alvotech and Bioventure’s AVT02 (adalimumab). The monoclonal antibody AVT02 is the approved biosimilar for AbbVie ’s Humira (adalimumab). Humira is commonly indicated to treat rheumatoid arthritis as well as many other inflammatory diseases. AVT02, which inhibits tumour necrosis factor, will be marketed as Simlandi in Saudi Arabia.
Copyright Clearance Center
JANUARY 25, 2023
The post Information Seeking & Consumption Study Results to be Announced Next Wednesday on CCC Webcast appeared first on Copyright Clearance Center.
Contrarian Sales Techniques
JANUARY 25, 2023
When I first started working as a pharmaceutical sales representative, I didn't fully understand the importance of compliance with regulatory requirements. But as I progressed in my career, I came to see just how vital it is to the job. Regulatory requirements such as HIPAA and FDA regulations are put in place to protect patient's safety and ensure that all sales and marketing efforts are compliant.
Pharmaceutical Technology
JANUARY 25, 2023
French biopharmaceutical firm Poxel has received orphan drug designation (ODD) from the European Commission (EC) for its molecules PXL770 and PXL065 to treat adrenoleukodystrophy (ALD). The latest move follows a positive opinion issued by the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP). PXL770 is a new, first-in-class direct activator of adenosine monophosphate-activated protein kinase (AMPK).
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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
JANUARY 25, 2023
As a medical sales rep, I spend my days traveling from hospital to hospital, meeting with doctors and pitching the latest medical technologies. It's a tough job, but I love it because I get to help improve people's lives. Plus, the commission isn't bad either! Being a medical sales rep is not for the faint of heart. We are on the front lines of the healthcare industry, introducing doctors and other healthcare professionals to new medical technologies and treatments.
Pharmaceutical Technology
JANUARY 25, 2023
Development of PROTACs (PROteolysis TArgeting Chimeras) has advanced fairly rapidly as excitement grows over their potential to selectively degrade proteins that are involved in various diseases, including cancer. PROTACs are a type of heterobifunctional degrader that offers multiple advantages over traditional small molecules. They provide a higher ability to regulate protein levels and can affect the non-enzymatic function of the protein while also providing an alternative to targeting drug-re
Contrarian Sales Techniques
JANUARY 25, 2023
Martin Shkreli, also known as "Pharma Bro," is a former pharmaceutical executive who came to public attention in 2015 when his company, Turing Pharmaceuticals, raised the price of a life-saving drug called Daraprim by more than 5,000%. This sparked widespread public outrage and led to increased scrutiny of the pharmaceutical industry's pricing practices.
pharmaphorum
JANUARY 25, 2023
An FDA advisory committee has recommended approval of Cidara Therapeutics’ once-weekly antifungal therapy rezafungin, setting it up to become the first new option for severe infections caused by Candida species in a decade. The panel voted 14 to 1 that the benefits of Cidara and Melinta Therapeutics’ once-weekly echinocandin drug outweighed its risks as a first-line treatment for candidemia and invasive candidiasis in adults who have limited or no alternative treatment options.
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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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