Fierce Pharma
FEBRUARY 27, 2024
Over-the-counter self-care specialist Perrigo is poised to leave hundreds of workers by the wayside as it embarks on the next leg of its corporate journey. | As part of a cost-cutting and restructuring initiative dubbed "Project Energize," Perrigo expects to trim roughly 6% of its total staff, the company said in a fourth-quarter earnings release Tuesday.
MedCity News
FEBRUARY 27, 2024
The weight loss achieved by Viking Therapeutics’ obesity drug tops results posted by Eli Lilly’s Zepbound in its pivotal test. But Viking still needs to show its results can hold up in a larger Phase 3 clinical trial.
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Fierce Pharma
FEBRUARY 27, 2024
AstraZeneca and FibroGen have finally reached the end of the road for their U.S. collaboration on the oral anemia drug roxadustat. | More than two years after a high-profile FDA rejection, AstraZeneca has backed out of a collaboration with FibroGen for the latter’s oral anemia drug roxadustat in the U.S. Still, AZ left the partners' China pact intact.
MedCity News
FEBRUARY 27, 2024
A Janux Therapeutics T cell engager has early clinical data showing improvement in cases of advanced prostate cancer, validating the technology platform that produced the therapy. Janux is now leveraging its soaring stock price to raise $175 million in a stock offering.
Fierce Pharma
FEBRUARY 27, 2024
Over the last few days, as the FDA rejected one antibiotic combination treatment for complicated urinary tract infections (cUTIs), it has approved another. | Over the last few days, as the FDA rejected one antibiotic combination treatment for complicated urinary tract infections (cUTIs), it has approved another. The U.S. regulator has signed off on Allecra Therapeutics’ Exblifep as a treatment for cUTIs, including the severe kidney condition pyelonephritis.
European Pharmaceutical Review
FEBRUARY 27, 2024
Amgen has opened a new biomanufacturing plant in Central Ohio, US. It is the company ’s most advanced manufacturing facility to date. The new facility, known as Amgen Ohio, “was designed with the latest innovation and technology to deliver safe, reliable medicines for ‘every patient, every time,'” stated Robert Bradway, Chairman and Chief Executive Officer at Amgen. “As part of Amgen’s global biomanufacturing network, Amgen Ohio will play an important role in helping us
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MedCity News
FEBRUARY 27, 2024
In the venture capital community, there’s a bit of a debate about what matters more to digital health investors in today’s fundraising environment — growth or profitability. Cathy Gao, a partner at Sapphire Ventures, thinks VCs are still putting a premium on growth, but she noted that the conversation is very nuanced.
Fierce Pharma
FEBRUARY 27, 2024
BioMarin has provided documents to the U.S. | BioMarin has provided documents to the U.S. Department of Justice in response to a subpoena which requested information on the company’s government-sponsored testing programs for enzyme replacement therapies Vimizim and Naglazyme.
Clarivate
FEBRUARY 27, 2024
When global trademark filing activity fell in 2022 , questions rose around what this signified. Would 2023 data show a second year of decline, indicating uncertain economic outlooks? Or would filing activity recover? To answer this question, we dove into curated trademark data from CompuMark to analyze application and filing history. With access to over 147 million trademark records, including application and filing history gathered directly from Patent and Trademark Offices (PTOs) such as the E
Fierce Pharma
FEBRUARY 27, 2024
A seismic shift has occurred in the healthcare landscape. | Delivering on these heightened expectations has fueled the urgency to invest in patient engagement and support. As pharmaceutical companies' channel ever-increasing resources into these transformative initiatives, the need for robust and comprehensive measurement becomes not just an option, but an imperative, in order to validate allocation of resources and effectiveness of the investment.
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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
FEBRUARY 27, 2024
The Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), Dame June Raine, will step down in the Autumn following five years in the role. Dame June will remain in the position until then to support the new Chief Executive’s transition into the role. Leading the MHRA – a five year journey Professor Graham Cooke, interim chair of the MHRA board, remarked that Dame June’s “leadership of the MHRA over the last five years, particularly during the COVID-19 pand
MedCity News
FEBRUARY 27, 2024
As the role of AI in healthcare settings continues to evolve and generate debate, here are seven things to keep an eye on.
Pharmaceutical Technology
FEBRUARY 27, 2024
Bristol Myers Squibb (BMS) has announced the conclusion of its acquisition of RayzeBio, a radiopharmaceutical company, for $4.1bn.
MedCity News
FEBRUARY 27, 2024
The FMT era has been productive, but now it’s time to rally together as an industry to accelerate next-generation LBP drug discovery, development and FDA approval.
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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
pharmaphorum
FEBRUARY 27, 2024
The FDA has approved Allecra Therapeutics' Exblifep, a combination antibiotic for complicated urinary tract infections (cUTIs) that will now launch later this year, but turned down a rival product from Venatorx.
MedCity News
FEBRUARY 27, 2024
Blackbird Health’s $17 million Series A funding round was led by Define Ventures and included participation from Frist Cressey Ventures and GreyMatter. In total, the startup has raised nearly $23 million.
Pharmaceutical Technology
FEBRUARY 27, 2024
Novo Nordisk has partnered with US startup Neomorph to develop multiple molecular glue degraders for cardiometabolic and rare diseases.
MedCity News
FEBRUARY 27, 2024
There is a ubiquitous lack of understanding and regulation surrounding the HCSM coverage which leaves hospitals stuck with the bill and negatively impacts the bottom line.
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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
FEBRUARY 27, 2024
UK cancer survival is lagging 10-15 years behind other countries due to lower rates of chemotherapy and radiotherapy, says UCL study backed by CRUK.
PharmaTech
FEBRUARY 27, 2024
CSL will share access to Cytegrity, its proprietary stable production system for lentiviral vector production, with Genezen.
pharmaphorum
FEBRUARY 27, 2024
UK biotech Curve Therapeutics raises $51 million in a Pfizer-led Series A that will support its platform for screening drugs within cells.
Pharmaceutical Technology
FEBRUARY 27, 2024
Making therapies feasible from biological, regulatory, and commercial standpoints drives scalable genetic medicine.
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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
FEBRUARY 27, 2024
FDA has turned down Minerva Neurosciences' marketing application for roluperidone as a treatment for the negative symptoms of schizophrenia
PharmaTimes
FEBRUARY 27, 2024
Eight out of ten patients who took the test were discharged without needing further testing
pharmaphorum
FEBRUARY 27, 2024
Novo Nordisk has signed a wide-ranging deal with US molecular glue biotech Neomorph that could be worth up to $1.46 billion.
PharmaTimes
FEBRUARY 27, 2024
The white paper outlines three strategic recommendations to support further research
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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
PharmaTech
FEBRUARY 27, 2024
The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.
Pharmaceutical Technology
FEBRUARY 27, 2024
The industry must utilise AI with the mindset to innovate over the desire to slash drug costs and reduce time to commercialisation.
Clarify Health
FEBRUARY 27, 2024
In the United States, an aging population and the rising prevalence of chronic disease highlight the limitations of most healthcare systems, putting increased pressure on providers. Artificial intelligence (AI) can be a potent tool providers and healthcare leaders can use to help identify inefficiencies and reduce costs without compromising quality.
Evolve Your Success
FEBRUARY 27, 2024
Some of us thrive with more freedom, and so often, that means embracing entrepreneurship in this space. If you are looking for inspiration to go from medical sales to medical entrepreneurship, this is the episode for you. Samuel Adeyinka introduces us to Tim Lew , who takes us on a journey through his unique academic background to a successful career in medical device sales and distributorship.
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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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