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.
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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Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
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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.
Could FDA recommend new antibiotic for hospital-acquired pneumonia?
European Pharmaceutical Review
MAY 19, 2023
A Phase III trial has found that the novel combination antibiotic sulbactam-durlobactam prevents at least as many fatalities of hospital-acquired pneumonia as colistin, the best currently approved treatment. This finding alongside the other data from the trial led the US Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee to recommend the FDA approve the combination antibiotic for often-fatal pneumonia strain carbapenem-resistant Acinetobacter baumannii–calcoaceticus co
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.
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”.
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.
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).
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
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.
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.
Advancing our commitments to global sustainability [Report]
Clarivate
MAY 18, 2023
Marko Damjanovic, Head of Corporate Sustainability at Clarivate, reviews our 2022 ESG milestones and highlights our 2023 goals for advancing our strategic commitments to the United Nations SDGs – all by accelerating our actions and by helping our customers achieve their goals. At Clarivate we put sustainability at the heart of our business goals and we want environment, social and governance issues to be the core of our global culture, serving as guiding principles for every decision we make.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
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.
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
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.
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
Chinook and Ionis partner to develop ASO therapy for kidney disease
Pharmaceutical Technology
MAY 17, 2023
Chinook Therapeutics and Ionis Pharmaceuticals have entered a partnership to develop an antisense oligonucleotide (ASO) therapy to treat a rare, severe chronic kidney disease. The collaboration aims to discover, develop and commercialise an ASO therapy. It will use the precision medicine approach, as well as the deep expertise of Chinook Therapeutics in nephrology and knowledge of Ionis Pharmaceuticals in RNA-targeted therapeutics.
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
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.
Life Biosciences, Forge Biologics Partner for Manufacturing to Advance Gene Therapies
PharmaTech
MAY 15, 2023
Forge will provide adeno-associated virus (AAV) process development, toxicology, cGMP manufacturing, and analytical services to Life Bio, which will occur at Forge’s gene therapy facility in Columbus, Ohio called the Hearth.
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.
Astellas’ nonhormonal hot flashes treatment Veozah wins FDA nod
Pharmaceutical Technology
MAY 15, 2023
The US Food and Drug Administration (FDA) has approved Astellas Pharma’s Veozah (fezolinetant) for use against moderate to severe vasomotor symptoms caused by menopause on May 12 after some delays due to an extended review. This marks the first-ever FDA approval of a nonhormonal neurokinin 3 (NK3) receptor antagonist for use against vasomotor symptoms caused by menopause.
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
FDA Approves Bausch + Lomb Drug With a New Approach to Dry Eye Disease
MedCity News
MAY 19, 2023
Bausch + Lomb drug Miebo is now FDA approved as a new treatment for dry eye disease. Unlike many products that rewet the eye, Miebo is designed to address one of the factors that leads to dry eyes.
Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) : Making Quality Medicines Affordable and Accessible in India
Pharmatutor
MAY 16, 2023
Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) : Making Quality Medicines Affordable and Accessible in India admin Tue, 05/16/2023 - 15:25 About Author Ramraj Choudhary M.Pharma, (Pharmaceutics) Dr. H.S Gour University, Sagar MP Current Position : Sr.
ABM Evolution: How Top Marketers Are Using Account-Based Strategies
Advertiser: ZoomInfo
In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.
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