Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease
Fierce Pharma
MAY 19, 2023
Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease zbecker Fri, 05/19/2023 - 16:25
Sat.May 13, 2023 - Fri.May 19, 2023
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How AI Will Change the Way Patients Get Medication
MedCity News
MAY 14, 2023
There is a huge opportunity for PBMs and health systems to use AI to help address the challenges surrounding the affordability and accessibility of medicines, from navigating formularies to resolving prior authorization. More automation in pharmacies and with ordering workflows is one piece of that puzzle.
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US FDA approves Bausch + Lomb and Novaliq’s DED treatment Miebo
Pharmaceutical Technology
MAY 19, 2023
The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED). Formerly known as NOV03, Miebo is a first-in-class eye drop designed for preventing the evaporation of excessive tears and restoring tear balance in evaporative DED patients.
Building trust through transparency: Our pledge to provide more clarity around Web of Science journal coverage
Clarivate
MAY 18, 2023
As part of our on-going commitment to research integrity, we recently shared that we planned to investigate how we can provide greater transparency regarding which journals are covered in the Web of Science Core Collection. We thank our many community partners for their feedback and acknowledge the request for even more clarity around which journals are added or removed.
AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work
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What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.
Intercept's NASH dreams may be dashed after FDA panel votes against Ocaliva's approval bid
Fierce Pharma
MAY 19, 2023
Intercept's NASH dreams may be dashed after FDA panel votes against Ocaliva's approval bid fkansteiner Fri, 05/19/2023 - 17:30
Why Patients Are Demanding a More Digital Healthcare Payment Process
MedCity News
MAY 15, 2023
Patient demand for digital payment communication — both reminders about bills, as well as text messages that enable bill payment — is on the rise, according to a recent report. This is in line with growing consumerism trends in the U.S. — patients want their healthcare payment experience to mimic the convenience and ease they have when they pay for things like travel or retail goods.
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The 2023 PM360 ELITE 100
PM360
MAY 15, 2023
Maya Angelou said, “If you’re going to live, leave a legacy. Make a mark on the world that can’t be erased.” For nine years, we have looked to recognize those people in healthcare and life sciences who are making a mark on our industry, on patients, on colleagues, on the world. These people represent our ELITE 100: the individuals and teams who throughout their careers are building legacies marked by helping people live better—and hopefully longer—lives.
FTC seeks to block Amgen's $28B Horizon buy in 'broadly negative' move for biopharma M&A: report
Fierce Pharma
MAY 16, 2023
FTC seeks to block Amgen's $28B Horizon buy in 'broadly negative' move for biopharma M&A: report aliu Tue, 05/16/2023 - 09:41
Meet the Startup Promising to Deliver the 1st Healthcare-focused Generative AI Model
MedCity News
MAY 16, 2023
Hippocratic AI emerged from stealth, as well as announced $50 million in seed funding through a round co-led by General Catalyst and Andreessen Horowitz. The Palo Alto-based startup bills itself as the first large language model designed specifically for healthcare.
First NICE-recommended treatment for chronic heart failure
European Pharmaceutical Review
MAY 19, 2023
Final draft guidance has been published for the first National Institute for Health and Care Excellence (NICE)-recommended treatment for symptomatic chronic heart failure with preserved or mildly reduced ejection fraction. The regulatory body’s decision means up to 150,000 patients would be eligible for AstraZeneca-made dapagliflozin (Forxiga).
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Treatment options for Crohn’s disease expand after Rinvoq approval
Pharmaceutical Technology
MAY 19, 2023
The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Whilst there is a range of FDA-approved biologics for Crohn’s disease, Rinvoq is the first approved oral product for the moderate to severe type of the disease.
Bausch + Lomb bags FDA approval for dry eye disease treatment Miebo
Fierce Pharma
MAY 19, 2023
Bausch + Lomb bags FDA approval for dry eye disease treatment Miebo zbecker Fri, 05/19/2023 - 09:39
Included Health, DispatchHealth Partner To Combine Virtual Care With Home Care
MedCity News
MAY 19, 2023
Included Health and DispatchHealth are partnering to combine Included’s virtual care services with DispatchHealth’s home care services. If an Included physician notices a patient requires in-person support, the physician will send DispatchHealth to the patient’s home.
Recent developments in stem cell therapies
European Pharmaceutical Review
MAY 16, 2023
So far, 2023 has seen several major developments in stem cell-based therapies. Stem cells have the ability to self-renew. Their potential to differentiate into cells of different tissues makes them particularly interesting for applications in regenerative medicine. 1 Since the first therapy using stem cells was developed in 1957, only few stem cell-based therapies have entered the clinic 1 as advanced therapy medicinal products (ATMPs).
EMA issues guidance amidst European medicine shortage
Pharmaceutical Technology
MAY 18, 2023
The European Medicines Agency (EMA) has published recommendations to increase communication and planning efforts in a bid stop the current medicine shortages becoming even worse. Within the 14-page document , published by an EMA special task force, are 10 recommendations of best practices that “marketing authorisation holders, wholesalers, distributors, and manufacturers can consider adopting to ensure continuity of medicinal product supply and reduce the impact of shortages”.
AbbVie, Genmab's lymphoma drug Epkinly snags FDA approval in heated blood cancer race
Fierce Pharma
MAY 19, 2023
AbbVie, Genmab's lymphoma drug Epkinly snags FDA approval in heated blood cancer race aliu Fri, 05/19/2023 - 11:21
Emerging Investigators Are Pivotal for Meeting Current, Future Drug Development Needs
MedCity News
MAY 14, 2023
We must engage, train and support more physicians as investigators to enable the opportunity for their patients to have access to clinical trials. As an industry, we should be adding anywhere from 10% to 20% new investigators every year to meet the patient access needs for clinical trials.
RWE shows efficacy of nirsevimab for infant RSV
European Pharmaceutical Review
MAY 15, 2023
Infants under 12 months who received a single dose of monoclonal antibody (mAb) nirsevimab showed an 83.21 percent reduction in hospitalisations due to respiratory syncytial virus (RSV) -related lower respiratory tract disease (LRTD), according to new real-world data from a Phase IIIb trial. Results from the Hospitalized RSV Monoclonal Antibody Prevention (HARMONIE) study were presented at 41st Annual Meeting of the European Society for Paediatric Infectious Diseases.
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.
Myeloid raises funds to support lead cell therapy programme
Pharmaceutical Technology
MAY 19, 2023
Myeloid Therapeutics has raised $73m to support the continued clinical development of its lead cell therapy programme, MT-101, in Phase I/II trials for T cell lymphoma. Led by Hatteras Investment Partners, the financing round has seen participation from existing investors, including 8VC, Alexandria Venture Investments and Newpath Partners, along with new investors Moore Strategic Ventures and ARCH Venture Partners.
Regulatory tracker: Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type
Fierce Pharma
MAY 17, 2023
Regulatory tracker: Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type aliu Wed, 05/17/2023 - 09:41
How a Rural Health System Is Looking at Virtual Care and Remote Patient Monitoring
MedCity News
MAY 16, 2023
In a wide-ranging interview, Sanford Health’s president of virtual care explained how virtual care may be well suited to rural populations.
EMA guidance aims to prevent medicine shortages
European Pharmaceutical Review
MAY 18, 2023
A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA. Shortages can lead to medicine rationing, delay in critical treatments and can mean patients may need to use less-effective alternatives and face an increased risk of me
How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales
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Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten
MIF invests in Nectin to investigate multiple myeloma drug candidate
Pharmaceutical Technology
MAY 17, 2023
Multiple Myeloma Research Foundation’s (MMRF) venture philanthropy subsidiary Myeloma Investment Fund (MIF) has made an undisclosed investment in Nectin Therapeutics to assess the potential of NTX1088 to treat multiple myeloma. Along with the MIF’s investment, Nectin has so far secured more than $33m from aMoon, Peregrine Ventures, Israel Biotech Fund, Cancer Focus Fund and Integra.
AstraZeneca follows AbbVie, Teva in surprising departure from lobbying group PhRMA
Fierce Pharma
MAY 16, 2023
AstraZeneca follows AbbVie, Teva in surprising departure from lobbying group PhRMA zbecker Tue, 05/16/2023 - 11:06
AbbVie’s Rinvoq Lands FDA Approval as First Oral Drug for Crohn’s Disease
MedCity News
MAY 18, 2023
FDA approval of blockbuster AbbVie drug Rinvoq makes it the first oral therapy for moderately to severely active Crohn’s disease. The regulatory nod is the seventh for the drug, which belongs to a class of therapies called JAK inhibitors.
CCC Named a Stevie® Award Winner for Customer Service Department of the Year in the 2023 American Business Awards®
Copyright Clearance Center
MAY 16, 2023
May 16, 2023 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, was named a Bronze Stevie® Award winner for Customer Service Department of the Year in the 21 st annual American Business Awards ®. The American Business Awards are the premier business awards program in the U.S. Nicknamed the “Stevies” for the Greek word meaning “crowned,” the competition receives over 12,000 entries each year from organizations in 70 countries.
How to Stay Competitive in the Evolving State of Martech
Advertiser: ZoomInfo
Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr
Cost of disease-modifying therapies for multiple sclerosis continues to rise in US
Pharmaceutical Technology
MAY 19, 2023
Multiple sclerosis (MS) is a primary autoimmune disease in which inflammation is a core contributor to the degeneration of the central nervous system (CNS), leading to neurological disability and affecting sensory, visual, motor, and autonomic systems. While MS is not a terminal diagnosis, the effect of the disease on the CNS can significantly impact patients’ independence and disturb their daily lives.
Teva's new CEO Francis lays out his 'pivot to growth' strategy
Fierce Pharma
MAY 18, 2023
Teva's new CEO Francis lays out his 'pivot to growth' strategy kdunleavy Thu, 05/18/2023 - 11:24
Biotech uniQure Cashes In on Hemophilia Gene Therapy With $400M Royalty Deal
MedCity News
MAY 15, 2023
By selling partial royalties to approved hemophilia gene therapy Hemgenix, uniQure gains immediate cash to support its pipeline, including a Huntington’s disease gene therapy already in the clinic. The royalty deal extends uniQure’s cash runway into 2026.
First treatment conditionally licensed for chronic hepatitis D
European Pharmaceutical Review
MAY 18, 2023
Hepcludex ® (bulevirtide) is the first medicine to be conditionally licensed for chronic hepatitis delta virus (HDV) infection in Great Britain” The National Institute for Health and Care Excellence (NICE) has recommended NHS use of Hepcludex ® (bulevirtide). It is the first medicine to be conditionally licensed for chronic hepatitis delta virus (HDV) infection in Great Britain.
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