Bio Pharma Dive
JANUARY 19, 2024
Phase 3 trial results showed Lutathera cut the risk of disease progression or death by 72% as initial treatment for gastroenteropancreatic neuroendocrine tumors, or GEP-NETs.
Pharmaceutical Technology
JANUARY 19, 2024
BridgeBio Pharma has secured strategic financing of $1.25bn from Blue Owl Capital and CPP Investments for genetic therapies.
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Bio Pharma Dive
JANUARY 19, 2024
The Senate HELP committee, which is seeking testimony from J&J's Joaquin Duato and Merck's Robert Davis, hasn't issued a subpoena since 1981.
Pharmaceutical Technology
JANUARY 19, 2024
The layoffs will free cash resources that will extend financial runways and focus pipeline developmental efforts.
Pharma Mirror
JANUARY 19, 2024
As we step into 2024, the global life science industry finds itself at a crossroads, facing plenty of challenges alongside an abundance of exciting opportunities. The pharmaceutical and contract outsourcing space has shifted, with new trends emerging that will shape the future of this rapidly changing industry. The global stage has witnessed significant upheavals throughout 2023, with wars impacting everything from oil prices to work locations.
Pharmaceutical Technology
JANUARY 19, 2024
Japan has approved argenx’s VYVDURA injection for subcutaneous administration to treat generalised myasthenia gravis (gMG) in adults.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JANUARY 19, 2024
Delayed diagnoses in many Gaucher disease patients contribute to slower-than-optimal initiation of treatment and delayed medical care.
Bio Pharma Dive
JANUARY 19, 2024
The cancer drugmaker is one of about a dozen biotechs that have announced workforce reductions so far in 2024.
Pharmaceutical Technology
JANUARY 19, 2024
Ikena has also paused exploratory research and discovery in addition to workforce reduction, which will occur over Q1 this year.
Fierce Pharma
JANUARY 19, 2024
A jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in federal court in the Southern District of New York. | A federal jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in Manhattan. The jury convicted Amit Dagar, 44, of Hillsborough, N.J., of using advance information on successful trial results for Pfizer’s COVID-19 treatment Paxlovid to make more than $270,000 in stock trades.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
JANUARY 19, 2024
The US FDA has granted fast track designation for Verastem’s avutometinib for treating non-small cell lung cancer (NSCLC).
Drug Discovery World
JANUARY 19, 2024
The DDW Winter issue asks whether AI can deliver better immunotherapies for cancer and includes expert predictions on what to expect from the sector in 2024, alongside a supplement looking at SLAS2024 and an exclusive guide exploring therapeutic antibodies. DDW Winter 2023/2024 The post DDW Winter 2023/2024 appeared first on Drug Discovery World (DDW).
Pharmaceutical Technology
JANUARY 19, 2024
The US FDA has declined to grant approval for Satsuma Pharmaceuticals’ STS101 for acute migraine treatment in adults.
Fierce Pharma
JANUARY 19, 2024
Following public spats with Hungary and Poland, Pfizer and its German mRNA partner BioNTech have kicked off legal proceedings against Romania. | Following public spats with Hungary and Poland, Pfizer and its German mRNA partner BioNTech have kicked off legal proceedings against Romania. The lawsuit marks the latest move in Pfizer’s campaign to press countries to honor COVID-19 vaccine contracts inked by the European Commission in May 2021.
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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
Pharmaceutical Technology
JANUARY 19, 2024
Information gathered from the study will guide an upcoming two-week mission scheduled for launch in March.
Fierce Pharma
JANUARY 19, 2024
More than five years after an FDA accelerated approval in a subtype of progressive colorectal cancer, Bristol Myers Squibb now has data supporting its checkpoint inhibitor doublet in newly diagnose | More than five years after an FDA accelerated approval in a subtype of progressive colorectal cancer, Bristol Myers Squibb now has data supporting its checkpoint inhibitor doublet in newly diagnosed patients.
Intouch Solutions
JANUARY 19, 2024
Now, more than ever, inspiration is at a premium. Artificial Intelligence (AI) applications have high storage capacity demands that can easily start in the terabyte (a unit of information equal to one million million) range and scale into hundreds of petabytes (1024 terabytes). Where, once, we were limited by our data, in an age of AI, where we have more data than we know what to do with, we are only limited by our imaginations.
Fierce Pharma
JANUARY 19, 2024
A month after Novartis made its entry into the paroxysmal nocturnal haemoglobinuria (PNH) field, AstraZeneca’s newest contender Voydeya bolsters the company’s presence in the disease area with a wo | The drug bolsters the company's portfolio in paroxysmal nocturnal haemoglobinuria (PNH) just as the market heats up thanks to new competitors from Novartis and Apellis.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
pharmaphorum
JANUARY 19, 2024
Learn more about Graham Heap, Takeda VP and the lead of TAK-279, in this exclusive live interview at JP Morgan in 2024. Gain insights into Heap's role, achievements, and the future of TAK-279.
Sciensano
JANUARY 19, 2024
The tiger mosquito, an invasive species with the potential to transmit viruses, is making significant strides in Belgium. In 2023 the Institute of Tropical Medicine ( ITM ) in Antwerp and Sciensano found the species in twice as many location compared to 2022. This is a concerning rise. The citizen science platform MuggenSurveillance.be plays an important role in this, and recorded positive reports for the first time in Brussels and Wallonia.
pharmaphorum
JANUARY 19, 2024
AstraZeneca gets its first approval for oral Factor D inhibitor danicopan, in Japan, for treatment of paroxysmal nocturnal haemoglobinuria
Pharmaceutical Commerce
JANUARY 19, 2024
Experts explore ways in which the financial sector refined the healthcare landscape, including its evolutions throughout the years.
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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
JANUARY 19, 2024
Basel, Switzerland, is becoming an innovative biotech hub at the forefront of the digital revolution, proving fertile ground for a variety of start-ups in the healthcare space.
Pharma Times
JANUARY 19, 2024
New stroke therapy delivers electrical pulses to the brain
pharmaphorum
JANUARY 19, 2024
Manufacturing problems have scuppered Satsuma Pharmaceuticals’ chances of a timely FDA approval for its intranasal migraine therapy STS101. The drug – a new dry powder intranasal formulation of the well-established migraine therapy dihydroergotamine mesylate (DHE) – was submitted for approval in the US last March as an easy-to-use, portable treatment option for acute migraine attacks, with or without aura, in adult patients.
Pharma Times
JANUARY 19, 2024
Company will present vital findings at SRI annual meeting
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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.
pharmaphorum
JANUARY 19, 2024
CG Oncology joins the queue of US biotech companies hoping to complete an IPO, aiming to raise $181m for its late-stage bladder cancer therapy.
Fierce Pharma
JANUARY 19, 2024
Use of Amgen’s osteoporosis drug Prolia by those with advanced chronic kidney disease (CKD) can increase the risk of calcium loss in the blood, according to the FDA. | Use of Amgen’s osteoporosis drug Prolia by those with advanced chronic kidney disease (CKD) can increase the risk of calcium loss in the blood, according to the FDA. The U.S. regulator has added a boxed warning for the blockbuster treatment, which has been on the market for 14 years and loses patent protection next year.
Pharmaceutical Commerce
JANUARY 19, 2024
All healthcare stakeholders must participate to dismantle barriers and ensure access to medicines that save lives.
Drug Patent Watch
JANUARY 19, 2024
Annual Drug Patent Expirations for RAVICTI Ravicti is a drug marketed by Horizon Therap Us and is included in one NDA. It is available from one supplier. There are sixteen… The post New patent for Horizon Therap drug RAVICTI appeared first on DrugPatentWatch - Make Better Decisions.
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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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