Sat.May 13, 2023 - Fri.May 19, 2023

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Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease

Fierce Pharma

Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease zbecker Fri, 05/19/2023 - 16:25

FDA 363
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US FDA approves Bausch + Lomb and Novaliq’s DED treatment Miebo

Pharmaceutical Technology

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.

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How AI Will Change the Way Patients Get Medication

MedCity News

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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Building trust through transparency: Our pledge to provide more clarity around Web of Science journal coverage

Clarivate

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.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Intercept's NASH dreams may be dashed after FDA panel votes against Ocaliva's approval bid

Fierce Pharma

Intercept's NASH dreams may be dashed after FDA panel votes against Ocaliva's approval bid fkansteiner Fri, 05/19/2023 - 17:30

FDA 330
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Treatment options for Crohn’s disease expand after Rinvoq approval

Pharmaceutical Technology

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.

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The 2023 PM360 ELITE 100

PM360

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.

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AbbVie, Genmab's lymphoma drug Epkinly snags FDA approval in heated blood cancer race

Fierce Pharma

AbbVie, Genmab's lymphoma drug Epkinly snags FDA approval in heated blood cancer race aliu Fri, 05/19/2023 - 11:21

FDA 322
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Could FDA recommend new antibiotic for hospital-acquired pneumonia?

European Pharmaceutical Review

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

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Meet the Startup Promising to Deliver the 1st Healthcare-focused Generative AI Model

MedCity News

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.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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EMA issues guidance amidst European medicine shortage

Pharmaceutical Technology

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”.

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FTC seeks to block Amgen's $28B Horizon buy in 'broadly negative' move for biopharma M&A: report

Fierce Pharma

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

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First NICE-recommended treatment for chronic heart failure

European Pharmaceutical Review

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).

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Included Health, DispatchHealth Partner To Combine Virtual Care With Home Care

MedCity News

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.

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How to Stay Competitive in the Evolving State of Martech

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

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Myeloid raises funds to support lead cell therapy programme

Pharmaceutical Technology

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.

Leads 98
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Bausch + Lomb bags FDA approval for dry eye disease treatment Miebo

Fierce Pharma

Bausch + Lomb bags FDA approval for dry eye disease treatment Miebo zbecker Fri, 05/19/2023 - 09:39

FDA 334
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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 – 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.

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Emerging Investigators Are Pivotal for Meeting Current, Future Drug Development Needs

MedCity News

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.

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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.

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Cost of disease-modifying therapies for multiple sclerosis continues to rise in US

Pharmaceutical Technology

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.

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Regulatory tracker: Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type

Fierce Pharma

Regulatory tracker: Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type aliu Wed, 05/17/2023 - 09:41

FDA 307
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Advancing our commitments to global sustainability [Report]

Clarivate

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.

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Mayo Clinic-born Startup Scores $7.7M for Its Clinical AI Deployment Platform

MedCity News

Lucem Health recently closed a $7.7 million Series A funding round. The startup’s platform takes in the data required to fuel AI algorithms that give clinicians insights to improve patient care.

Patients 107
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Chinook and Ionis partner to develop ASO therapy for kidney disease

Pharmaceutical Technology

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.

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AstraZeneca follows AbbVie, Teva in surprising departure from lobbying group PhRMA

Fierce Pharma

AstraZeneca follows AbbVie, Teva in surprising departure from lobbying group PhRMA zbecker Tue, 05/16/2023 - 11:06

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Life Biosciences, Forge Biologics Partner for Manufacturing to Advance Gene Therapies

PharmaTech

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.

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Biotech uniQure Cashes In on Hemophilia Gene Therapy With $400M Royalty Deal

MedCity News

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.

Biopharma 107
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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Astellas’ nonhormonal hot flashes treatment Veozah wins FDA nod

Pharmaceutical Technology

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.

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Teva's new CEO Francis lays out his 'pivot to growth' strategy

Fierce Pharma

Teva's new CEO Francis lays out his 'pivot to growth' strategy kdunleavy Thu, 05/18/2023 - 11:24

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Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) : Making Quality Medicines Affordable and Accessible in India

Pharmatutor

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.

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How a Rural Health System Is Looking at Virtual Care and Remote Patient Monitoring

MedCity News

In a wide-ranging interview, Sanford Health’s president of virtual care explained how virtual care may be well suited to rural populations.

Patients 120
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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

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.