Wed.Sep 25, 2024

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Pfizer issues global market withdrawal of sickle cell disease therapy Oxbryta

Fierce Pharma

Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to a $5.4 billion acquisition the New York pharma made two years ago. | Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to its $5.4 billion acquisition of Global Blood Therapeutics two years ago.

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Novo Nordisk CEO reticent on lowering semaglutide prices

pharmaphorum

Novo Nordisk chief executive Lars Fruergaard Jørgensen was taken to task by US lawmakers over the price of the company's semaglutide drugs for diabetes and obesity at a congressional hearing yesterday – but would not commit to reducing them. Jørgensen danced around the topic of price cuts, saying Novo Nordisk supported "anything that helps patients get access and affordability […] we will look into.

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Citing enrollment challenges, Bristol Myers and 2seventy scrap Abecma trial in first-line myeloma

Fierce Pharma

Bristol Myers Squibb’s struggling CAR-T therapy Abecma has hit a major setback. | Bristol Myers Squibb’s CAR-T therapy Abecma has hit a major setback. Bristol and its partner 2seventy bio have decided to pull the plug on the phase 3 KarMMa-9 trial in first-line myeloma after struggling to enroll patients.

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Considering Covering GLP-1s? Here’s What You Need to Know

MedCity News

Though chronic disease treatment is rapidly expanding, balancing the latest medication with proven initiatives can help employers manage rising healthcare costs wherever you fall on the GLP-1 coverage spectrum. The post Considering Covering GLP-1s? Here’s What You Need to Know appeared first on MedCity News.

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

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Private equity firms bid on Sanofi's $16B+ consumer health business: Bloomberg

Fierce Pharma

As private equity firms reportedly place their bids, Sanofi may soon follow in the footsteps of GSK and Johnson & Johnson with the separation of its consumer health unit. | Sanofi has received two private equity offers for its consumer health business, which could be valued at 15 billion euros ($16.7 billion) or more, Bloomberg reported Tuesday, citing people close to the matter.

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Aurion launches eye disease cell therapy in its first market

pharmaphorum

Aurion Biotech has launched its cell therapy Vyznova for serious eye disorder bullous keratopathy in Japan, its debut market, becoming an alternative to corneal replacement using donor tissue.Vyznova (neltependocel, formerly AURN001) is the world's first allogeneic cell therapy for corneal endothelial disease, according to the Seattle, Washington-based company.

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Qure.AI Snags $65M to Expand Its Presence in US Market

MedCity News

Qure.ai — which is headquartered in India — closed a $65 million Series D financing round. When asked whether the startup is thinking about a public exit anytime soon, CEO Prashant Warie said that for now, the company’s focusing is on continuing to build its market globally and “venturing deeper into meeting the healthcare challenges of the U.S.” The post Qure.AI Snags $65M to Expand Its Presence in US Market appeared first on MedCity News.

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With success in myasthenia gravis trial, Amgen's Uplizna looks set up to add new indication

Fierce Pharma

Three months after Amgen revealed that Uplizna had aced a phase 3 trial in immunoglobulin G4-related disease (IgG4), the company said the anti-CD-19 antibody has excelled in a study against another | Three months after Amgen revealed that Uplizna had aced a phase 3 trial in IgG4, the company said the anti-CD-19 antibody has excelled in a study against another neurologic disorder, myasthenia gravis.

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AI firm Generate signs $1bn discovery deal with Novartis

pharmaphorum

Flagship Pioneering-backed artificial intelligence startup Generate:Biomedicines has attracted another big pharma partnership, this time with Novartis.The wide-ranging deal, worth up to $1 billion, covers multiple targets and disease areas and focuses on the discovery and development of protein-based therapeutics using Generate's generative AI (genAI) platform.

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50 States of Interoperability: Why One-Size-Fits-All Tech Solutions Can’t Bridge Gaps in Behavioral Health

MedCity News

The lack of consistent data standards poses a major barrier to the exchange of information across stakeholders. As providers and administrators struggle to identify the best next step to meet new standardization rules, they need a strategy tailored to the intricacies of their program, based on their specific data workflows — which might look vastly different state to state.

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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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Pfizer pulls sickle cell med Oxbryta off market after deaths

pharmaphorum

Pfizer is voluntarily withdrawing its sickle cell drug Oxbryta after a review revealed an imbalance of deaths in clinical trials

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Two Venture Investors Offer Their Takes on the State of Biotech Investing Today

MedCity News

The way venture capital firms invest in biotech startups has changed. Veteran VCs Chris Garabedian and Arjun Goyal offered their perspectives during a panel discussion at the World Medical Innovation Forum. The post Two Venture Investors Offer Their Takes on the State of Biotech Investing Today appeared first on MedCity News.

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Lilly gets second approval, in Japan, for Alzheimer's drug

pharmaphorum

Eli Lilly has opened up a second market for its new Alzheimer's disease therapy Kisunla, after Japan followed the US in approving the drug

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Centivo Snags $75M To Make Healthcare More Accessible and Affordable for Workers

MedCity News

Centivo’s $75 million raise includes funding from new investors Cone Health Ventures and MemorialCare Innovation Fund, as well as existing investors B Capital, Cox Enterprises, F-Prime Capital, Ingleside Investors and Morgan Health. The post Centivo Snags $75M To Make Healthcare More Accessible and Affordable for Workers appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA Approves Treatments for Niemann-Pick Disease, Type C

PharmaTech

Two drugs, Miplyffa (arimoclomol) and Aqneursa (levacetylleucine), have been approved by FDA to treat neurological symptoms associated with Niemann-Pick disease, type C in adults and children.

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Surfing on new Duchenne data, Wave charges $175m offering

pharmaphorum

Phase 2 results with Wave Life Sciences' Duchenne muscular dystrophy candidate WVE-N531 pushed the company's share price to its highest level in a year and could lead to discussions with regulators about a route to market.

Leads 59
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The Power Of Value Propositions & Strategic Timing in Medical Sales With TJ Quigley

Evolve Your Success

Unlock the secrets to mastering medical sales and marketing in our latest episode featuring TJ Quigley, Marketing expert. TJ brings a wealth of knowledge about targeting emergency department doctors through precise messaging, the significance of measuring marketing outcomes, and the dynamic strategies his team employs based on real-time feedback. His insights into the role of digital marketing in the respiratory healthcare space are invaluable for anyone looking to elevate their marketing game.

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LogiPharma USA 2024: How IoT Can Help Us Shape A More Sustainable Supply Chain

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Arnon Lopes, head, customer experience, pharma & healthcare, JAS, discusses ways that IoT can support sustainable supply chains at LogiPharma USA in Boston.

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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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The Power Of Value Propositions & Strategic Timing in Medical Sales With TJ Quigley

Evolve Your Success

Unlock the secrets to mastering medical sales and marketing in our latest episode featuring TJ Quigley, Marketing expert. TJ brings a wealth of knowledge about targeting emergency department doctors through precise messaging, the significance of measuring marketing outcomes, and the dynamic strategies his team employs based on real-time feedback. His insights into the role of digital marketing in the respiratory healthcare space are invaluable for anyone looking to elevate their marketing game.

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Microbial contamination detection with rapid spectroscopy

European Pharmaceutical Review

Researchers have demonstrated a novel approach that uses machine-learning aided UV absorbance spectroscopy to detect contamination during the manufacture of cell therapy products. Based on the findings, the cost-effective and non-invasive method provides a “rapid output (30 minutes) with minimal sample preparation and sample volume (<1mL)”. In their paper, the researchers stated that considering the limitations of current manufacturing processes, there is a need for sterility testing of cell

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Securities Litigation Arising from Alzheimer's Drug Treatments

PharmExec

The legal challenges surrounding Biogen’s Aduhelm and Cassava Sciences’ simufilam underscore the ongoing difficulties in Alzheimer's drug development, leading to securities litigation over allegedly misleading statements about trial results and commercialization efforts.

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Global reach, personal touch: Mastering customer engagement at scale

pharmaphorum

Discover how to balance personalised engagement with regulatory compliance across global pharma markets in an upcoming webinar presented by EVERSANA INTOUCH. Join industry leader Denise Dalton, VP of worldwide omnichannel strategy at Bristol Myers Squibb, as she explores the challenges of achieving personalisation at scale in today's interconnected pharmaceutical landscape.

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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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Lonza and Vertex Enter Commercial Supply Agreement for CASGEVY, the Sickle Cell Disease Gene-Edited Cell Therapy

PharmaTech

Lonza signed a long-term supply agreement to manufacture CASGEVY (exagamglogene autotemcel) for Vertex at its facility in Geleen, the Netherlands, and plans to expand manufacturing to Portsmouth, NH, in the United States.

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Selecting & Developing a Mega Campus

PharmExec

In this part of his Pharmaceutical Executive video interview, Jonathan Scheinberg, of the Northeast Science and Technology Center, identifies key factors that pharmaceutical and biotech companies should consider when selecting and developing mega campuses.

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Oncology today: EVERSANA and pharmaphorum at ESMO 2024

pharmaphorum

The ESMO congress always disseminates the latest results of cancer research, a vibrant gathering and sharing of the latest data, communicating the next promising steps in oncological scientific development, ever seeking to address unmet patient needs.

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Pharma Horizons: Biologics

European Pharmaceutical Review

This report delves into the latest developments impacting the pharmaceutical biologic drug sector today. Inside, articles explore current key topics including biosimilars, antibody drugs, manufacturing, drug delivery and vaccines. Stay up to date with the latest developments in biologics including articles on: Navigating the demanding biosimilar landscape and improving patient access to biologic therapies Preventing infectious diseases with innovative vaccine development Current trends and fut

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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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Bluebird to lay off another 25% of workforce in latest restructuring

PharmaVoice

The announced job cuts are the latest in a series of steps Bluebird has taken to preserve cash and break even financially amid slow uptake of its marketed gene therapies.

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Hatch-Waxman Amendments Turn 40

PharmaTech

FDA’s Darby Kozak provided commentary on the anniversary of the Drug Price Competition and Patent Term Restoration Act of 1984.

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Managing temperature-sensitive injectable drugs in fill finish operations

Pharmaceutical Technology

This article explores the strategies that fill finish CDMOs use to effectively manage temperature-sensitive drug products during the fill finish process.

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Pharma Pulse 9/25/24: Coverage from LogiPharma USA 2024, The Joys of Talking to ChatGPT & more

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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.