Fierce Pharma
MARCH 18, 2024
Kyowa Kirin’s bet on Orchard Therapeutics has paid off, furnishing the Japanese drugmaker with a newly approved gene therapy in the U.S. | The FDA on Monday gave a thumbs up to Lenmeldy as the first gene therapy in the U.S. for kids with certain types of metachromatic leukodystrophy (MLD).
MedCity News
MARCH 18, 2024
After a healthcare cyberattack, the impacted organization often doesn’t want to divulge a lot of information, Intermountain Health CISO Erik Decker said last week at HIMSS. However, he thinks healthcare organizations should be more transparent with their peers after an attack because “no one system operates independent of everybody else.
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Fierce Pharma
MARCH 18, 2024
Two months after GSK sold a significant chunk of its stake in Haleon, Pfizer is | Two months after GSK sold a significant chunk of its stake in Haleon, Pfizer is prepared to do the same with a larger selloff, according to the consumer healthcare company. Pfizer is set to reduce its stake in Haleon from 32% to 24% by selling 630 million shares in a public offering.
MedCity News
MARCH 18, 2024
Generic drugs are the pharmaceutical products mainly affected by the missile attacks disrupting shipping in the Red Sea. While the extra costs borne by drug companies aren’t causing an immediate spike in product prices, experts say they’ll eventually be factored into prices if the attacks become a long-term problem.
Fierce Pharma
MARCH 18, 2024
As bluebird bio works to make the most of three gene therapy launches, cash-flow concerns have been looming over the drugmaker. | The funding should extend bluebird bio's cash runway through the first quarter of 2026 as it advances three gene therapy launches. Previously, the company expected its cash to run out by this year's second quarter.
Pharmaceutical Technology
MARCH 18, 2024
Akums Drugs and Pharmaceuticals has introduced Hydroxyurea oral suspension, a room temperature-stable drug for treating sickle cell disease.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
MARCH 18, 2024
As GenAI and other technologies advance the speed of development and the precision of drugs, pharma commercial teams need to make sure they are harvesting the right data with the right AI tools in order to ultimately reach the right patients.
Pharmaceutical Commerce
MARCH 18, 2024
In this Pharmaceutical Commerce video interview, Joerg Tritschler, a partner in Simon-Kucher’s life sciences division, discusses the positive signs from rising activity levels in biopharma M&A— and what the momentum may mean for industry dealmaking and partnership efforts in the months ahead.
MedCity News
MARCH 18, 2024
Orchard Therapeutics gene therapy Lenmeldy won FDA approval for treating the rare enzyme deficiency metachromatic leukodystrophy. In January, Kyowa Kirin completed its acquisition of Orchard, which now operates as a subsidiary of the Japanese drugmaker.
Clear Pivot
MARCH 18, 2024
If you’re in the SaaS business, you know how incredibly tough the competition is. There are startups that seemingly never sleep. There are huge, legacy solutions that so many enterprises are locked into, we may wonder how to even begin to reach that echelon of success. Somewhere in the middle are most SaaS companies. You’ve got a great solution, have made some progress, are consistently adding users and delighting them, but you’re always looking to improve.
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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.
European Pharmaceutical Review
MARCH 18, 2024
A study has determined that intermittent low-intensity far-UVC light can inhibit mould growth below the threshold limit value of 23 mJ/cm 2. At 222nm, far-UVC light was shown to prevent development of common mould-producing fungi , specifically Penicillium candidum. The on-off duty cycle pattern of the far-UVC light used in the study is “consistent with its use in real-world settings”, the corresponding paper stated.
pharmaphorum
MARCH 18, 2024
FDA advisors have said that two BCMA-targeted CAR-T therapies can be used earlier in the treatment pathway for multiple myeloma, setting up FDA approvals for use in a broader patient population.
MedCity News
MARCH 18, 2024
Milu Health’s $4.8 million seed round was led by Andreessen Horowitz (a16z) Bio + Health and included participation from BoxGroup, PagsGroup and 81 Collection.
European Pharmaceutical Review
MARCH 18, 2024
A Phase III trial has shown that compared oral drug delivery, administering levodopa through an infusion pump led to nearly two hours of day (1.72) of additional time in which the medicine reduced symptoms in Parkinson’s patients. There were 381 Parkinson’s patients enrolled in the trial. Levodopa was delivered for 24 hours via a subcutaneous infusion pump, which was shown to be a safe method of drug delivery, the research found.
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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
MedCity News
MARCH 18, 2024
Will American healthcare go the way of the banking sector’s consolidation into a handful of all-powerful titans?
pharmaphorum
MARCH 18, 2024
Agreement has been reached in the EU on a European Health Data Space (EHDS), which will make it easier to exchange and access electronic health data.
MedCity News
MARCH 18, 2024
Contineum Therapeutics, which emerged from a Verant Ventures startup creation engine, has filed paperwork for an IPO. The biotech’s clinical-stage pipeline spans multiple sclerosis, idiopathic pulmonary fibrosis, and depression.
Pharmaceutical Technology
MARCH 18, 2024
The US FDA's ODAC has recommended Johnson & Johnson’s CARVYKTI to treat relapsed or refractory multiple myeloma (R/R MM).
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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.
pharmaphorum
MARCH 18, 2024
The PM Society’s 38th annual awards were held last week, on Friday 15th March, at the JW Marriott Grosvenor House London, at which over 900 industry professionals came together to celebrate the best in creative, impactful, and innovative communications in pharma and healthcare.
European Pharmaceutical Review
MARCH 18, 2024
Download this report to discover key environmental monitoring trends impacting pharmaceutical manufacturers today, including the latest requirements for contamination control, the shift towards rapid methods and the latest regulations on bacterial endotoxin testing. Expert insights from environmental monitoring and microbiology professionals: Dr Tim Sandle, Bio Products Laboratory Marsha Steed, Senior Associate/Sterility Assurance Expert at Jeff Yuen & Associates, Inc.
pharmaphorum
MARCH 18, 2024
AI software designed to tackle missed appointments and reduce waiting lists will see its use by NHS England ramp up after a successful pilot deployment.
PharmaTimes
MARCH 18, 2024
Up to 20% of prostate cancer cases are classified as castration-resistant
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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.
pharmaphorum
MARCH 18, 2024
Bristol-Myers Squibb gets its $14bn takeover of Karuna Therapeutics over the finish line, taking control of schizophrenia candidate KarXT ahead of an FDA decision in September
MedTechVets
MARCH 18, 2024
MAR 18th – We were proud to interview MedTechVet Academy Mentor, Bryan Wayman. Bryan is the Director of Project Management at Emergent Biosolutions. “For veterans, your military experience brings tremendous value in the MedTech industry. There are many roles and organizations that would be great fits for your post-military career.” What led you to obtain a role within the MedTech space?
pharmaphorum
MARCH 18, 2024
GSK's PD-1 inhibitor Jemperli improves overall survival when used first-line in an all-comer endometrial cancer trial
PharmaTimes
MARCH 18, 2024
The centre will deliver free training, outreach materials and programmes
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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
pharmaphorum
MARCH 18, 2024
Contineum Therapeutics joins IPO queue, seeking $150m for its pulmonary fibrosis and multiple sclerosis candidates
PharmExec
MARCH 18, 2024
In this Pharmaceutical Executive video interview, Kaveh Vahdat, Founder and President of RiseOpp, discusses the impact AI will have on thelong-term well-being of founders and CEOs.
pharmaphorum
MARCH 18, 2024
Orchard's gene therapy for MLD finally gets US approval Jonah.
PharmaTech
MARCH 18, 2024
Cellares CEO Fabian Gerlinghaus discusses the nuts and bolts of counterflow centrifugal elutriation and electroporation innovations and optimization, while hinting at big news on future release testing of products, as a product itself.
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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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