Fri.Feb 23, 2024

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To BioMarin CEO Alexander Hardy, hemophilia A gene therapy Roctavian needs 3 stars to align

Fierce Pharma

Even Alexander Hardy, the former Genentech leader who managed the blockbuster hemophilia drug Hemlibra, can’t immediately bend the laggard launch trajectory of BioMarin’s gene therapy Roctavian.

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AI in Pharma: Navigating New Frontiers in Drug Discovery and Development

Pharma IQ

Bringing a new drug to market typically takes a decade or more and approximately US$2.5 billion. However, new technology, including AI, can dramatically shorten the drug discovery process and reduce t.

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Travere's Filspari, J&J's Carvykti win support from CHMP in blitz of positive recommendations

Fierce Pharma

A narrow miss in a confirmatory trial has | Along with host of other positive recommendations, European drug regulators rendered a positive opinion on Travere's Filspari for full approval in Berger’s disease.

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The AI-Powered Path to Revolutionising Rare Disease Research

Pharma IQ

Explore how AI/ML can accelerate rare disease research and clinical trials, by enhancing inclusivity and efficiency, to deliver new drugs and therapeutics to patients. With insights from Dr. Harsha Ra.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Congressional lawmakers strike back at Biden admin's 'march-in' proposal to corral drug costs

Fierce Pharma

As the Biden administration’s exploration of “march-in rights" draws support from powerful entities like the Federal Trade Commission (FTC), a group of lawmakers on both sides of the aisle have war | As the Biden administration’s exploration of “march-in rights" draws support from powerful entities like the Federal Trade Commission, a small group of lawmakers on both sides of the aisle have warned the approach could “hamstring” U.S. innovation.

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‘Nation-State’ Cyberattack Hits Change Healthcare, Disrupting Pharmacy Services Across the Country

MedCity News

Pharmacies across the country are facing disruptions following a cyberattack on Change Healthcare — which is owned by Optum, a subsidiary of UnitedHealth Group. In a filing with the SEC, UnitedHealth stated that the unauthorized party that gained access to Change Healthcare’s systems was a “suspected nation-state associated cyber security threat actor.

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Driving Accessibility in HealthTech: 3 Things Founders should Consider for Thoughtful AI Implementation in 2024

MedCity News

The benefits of artificial intelligence in healthcare are apparent. With careful planning, we can ensure that these developments benefit everyone, leaving no one behind in the goal of a healthier and more equal future.

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Oncopeptides' Pepaxto reaches end of the line in US after FDA yanks approval

Fierce Pharma

Following a contentious advisory committee meeting and an FDA request for the withdrawal of Oncopeptides’ multiple myeloma drug Pepaxto from the U.S. | Following a contentious advisory committee meeting and an FDA request for withdrawal of Oncopeptides’ multiple myeloma drug Pepaxto from the U.S. market in late 2022, the other shoe has dropped.

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For Moderna, COVID vaccines were a ‘proof of concept’ — now comes the big test

PharmaVoice

Following Moderna’s COVID-19 vaccine success, therapeutics head Dr. Kyle Holen discusses scaling mRNA development to bring candidates to the finish line in oncology and more.

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'The Top Line': Breaking down Eli Lilly’s ESG formula

Fierce Pharma

This week on “The Top Line,” we explore the impact of environmental, social and governance measures, commonly known as ESG, on the pharmaceutical industry. | This week on "The Top Line," we explore the impact of environmental, social, and governance measures, commonly known as ESG, on the pharmaceutical industry. Fierce Pharma's Fraiser Kansteiner engages in a conversation with Jim Greffet, Head of ESG Strategy at Eli Lilly, to gain insights and discuss Lilly's specific ESG

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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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Bavarian Nordic gets swift EU review of chikungunya shot

pharmaphorum

Bavarian Nordic will get an accelerated review of its chikungunya vaccine CHIKV VLP at the EMA, as it tries to chase down a lead held by rival Valneva. The Danish pharma group said it is planning to file for approval of its vaccine in the first half of this year, adding the EU regulator’s human medicine committee, the CHMP, has said it will cut the review time from 210 to 150 days under its accelerated assessment procedure.

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Is AI in Prior Authorization Promising or Dangerous?

MedCity News

AI can improve the prior authorization process, but there needs to be more transparency, experts said during a recent panel held by KFF.

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Identifying Trends Surrounding the Use of In-House Pharmacies for High-Cost Drugs

Pharmaceutical Commerce

A cross-sectional study investigates how this supply chain link helps increase Medicare Part D spending on self-administered specialty drugs.

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Analysis reveals “superior efficacy” of long-acting injectable HIV treatment

European Pharmaceutical Review

An interim analysis of a Phase III trial has demonstrated superior efficacy of the long-acting injectable antiretroviral treatment (ART) for HIV, Cabenuva ( cabotegravir + rilpivirine), for HIV patients with a history of ART adherence challenges. “The interim data indicating the superiority of long-acting therapy compared to daily oral therapy in individuals who have difficulty taking pills for HIV every day is a remarkable outcome,” shared Dr Kimberly Smith, MPH, Head of R&D at ViiV Healt

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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FDA will decide in June on Dupixent for COPD

pharmaphorum

The FDA has started a priority review of Sanofi and Regeneron’s Dupixent as a treatment for chronic obstructive pulmonary disease (COPD), which could become the first new treatment for the widespread and life-threatening disease in over a decade.

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FDA generic drug approvals rose in 2023 in bid for improved access

Pharmaceutical Technology

The FDA Office of Generic Drugs reported a rise in generic drug approvals, as several first-time generics entered the market.

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AI improves adenoma detection in colonoscopies

pharmaphorum

AI software developed by Israeli medtech Magentiq-Eye has been shown to improve detection rates for adenoma, a precursor to colorectal cancer, in colonoscopy procedures

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GSK and Vir Terminate Influenza Alliance a Year After Ending Covid-19 R&D Pact

MedCity News

GSK and Vir Biotechnology have ended their influenza collaboration, a move that follows last year’s Phase 2 failure for one of the partnered programs. Vir is now free to continue its flu research on its own, but the company says it’s actively pursuing other partners.

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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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After Roche’s exit, Blueprint passes Gavreto on to Rigel

pharmaphorum

After losing Roche as a partner, Blueprint Medicines has sold US commercial rights to RET inhibitor Gavreto to Rigel Pharma in a deal worth up to $117.

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AbbVie announces its new CEO

European Pharmaceutical Review

AbbVie’s current President and Chief Operating Officer (COO) is set to replace the company’s existing CEO later this year. Robert Michael will become AbbVie’s new CEO on 1 July 2024. Richard Gonzalez will retire as the company’s CEO to become Executive Chairman, having served as the company’s CEO since its launch in 2013, AbbVie noted.

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Network With Healthcare Investors at MedCity INVEST 2024!

MedCity News

The conference, scheduled for May 21-22 at the Ritz Carlton hotel in Chicago, brings together healthcare investors, startups, and innovative-minded executives. Register today!

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CSL, Travere close on EU approval of IgAN drug sparsentan

pharmaphorum

Travere and partner CSL Vifor close on EU approval of sparsentan for rare kidney disease IgA nephropathy, after CHMP's positive opinion on the drug.

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Accelerating Clinical Supply Through Integrated Drug Development

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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NHS offers preventative bowel cancer screening for patients with Lynch syndrome

PharmaTimes

In England, around 1,100 cases of bowel cancer are caused by the inherited condition every year

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Navigating the Future: Experts Discuss the Intersection of Copyright, AI, and Innovation in Upcoming Virtual Town Hall

Copyright Clearance Center

The post Navigating the Future: Experts Discuss the Intersection of Copyright, AI, and Innovation in Upcoming Virtual Town Hall appeared first on Copyright Clearance Center.

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AbbVie’s Skyrizi shows promise as personalised treatment for psoriasis

PharmaTimes

The immunosuppressant reduced inflammation in patients with the skin condition after three days

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How hospitals can enhance operational efficiency with data analytics

Clarify Health

Hospitals that effectively leverage healthcare data analytics benefit from having access to precise insights that help lead to better decisions for patients and the hospital’s bottom line. Healthcare data comes from countless places, including claims, clinical outcomes, and administrative data, plus patient surveys, electronic health records, pharmaceutical data, patient registries, and clinical trials.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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Exploring Pharmaceutical Sales Reps Salaries: A Deep Dive

Rep-Lite

As a pharmaceutical sales rep, you undergo a rigorous training program, develop strong relationships with healthcare professionals, and work tirelessly to meet sales targets. You also deal with the challenges of an ever-changing industry landscape, including stiff competition from generic drugs and strict regulation policies. Despite these challenges, pharmaceutical sales reps play a crucial role in driving revenue for their companies and promoting life-saving medication to patients.

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Nixon Gwilt Law Expands Corporate, M&A, and Venture Capital Capabilities with Four New Attorneys

Nixon Gwilt Law

Nixon Gwilt Law (NGL) is excited to announce a significant expansion of our core capabilities through the addition of four attorneys with expertise in healthcare mergers and acquisitions , fundraising and venture capital , and corporate/business counsel. These new team members collectively add decades of experience working with healthcare innovation companies of all sizes, greatly expanding our capacity to serve new and existing clients’ needs in these areas.

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Dupixent sBLA Gets FDA Priority Review for Treatment of COPD With Type 2 Inflammation

Pharmaceutical Commerce

Trial data show Dupixent is the first and only novel biologic drug to significantly improve lung function and reduce severe acute exacerbations in adults with uncontrolled chronic obstructive pulmonary disease.

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The 2024 PM360 Pharma Choice Awards – Professional Website Bronze Winner

PM360

RevHealth for Corium OZURDEX® Interactive Sales Aid We tackled this on two fronts. The first was a total redesign to modernize our look and feel and develop clean layouts. The second was ensuring UI and content delivered an intuitive experience. Together, this creative process made our transition to interactive selling as seamless as possible.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.