Norgine seeks approval for high-risk neuroblastoma treatment
Pharmaceutical Technology
APRIL 16, 2024
Norgine has sought approval for eflornithine (DFMO) for the treatment of patients with high-risk neuroblastoma (HRNB).
Tue.Apr 16, 2024
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Biotech landlord Alexandria on research clusters and the sector’s recovery
Bio Pharma Dive
APRIL 16, 2024
Joel Marcus, the longtime head of Alexandria Real Estate Equities, sees few near-term challengers to the established biotech hubs of Boston, San Diego and San Francisco.
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India sees insignificant revision to price ceiling in 2024
Pharmaceutical Technology
APRIL 16, 2024
The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies.
Intra-Cellular builds case for depression drug with late-stage trial win
Bio Pharma Dive
APRIL 16, 2024
Shares of the biotech rose 25% after a large trial found adding its drug Caplyta onto antidepressant therapy significantly helped people with major depression.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Risk adjusted net present value: What is the current valuation of Novo Nordisk’s NNC0519-0130?
Pharmaceutical Technology
APRIL 16, 2024
NNC0519-0130 is commercialized by Novo Nordisk, with a leading Phase II program in Type 2 Diabetes.
Cullinan changes name, pivots to autoimmune disease
Bio Pharma Dive
APRIL 16, 2024
The biotech says a dual-pronged antibody it’s developing could become an “off-the-shelf” alternative to cell therapies in development for lupus and other inflammatory conditions.
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J&J sees mixed performance from new multiple myeloma drugs
Bio Pharma Dive
APRIL 16, 2024
Tecvayli sales, which J&J broke out for the first time, surpassed Wall Street forecasts and offset underperformance from Carvykti, which J&J attributed to the "phasing and timing of orders.
Sanofi signs mRNA vaccine development deal with IDT Australia
Pharmaceutical Technology
APRIL 16, 2024
Sanofi has signed an agreement with IDT Australia for preclinical formulation development of its messenger RNA (mRNA) vaccines.
Bio-Rad and Oncocyte partner to develop and commercialise transplant monitoring products
Pharma Times
APRIL 16, 2024
Solid organ transplantation is used to treat end-stage organ failure, including the kidneys
Smart sensor cleared for use with AZ asthma, COPD inhalers
pharmaphorum
APRIL 16, 2024
A smart sensor developed by Adherium has been cleared by the FDA for use with AstraZeneca's asthma inhaler Airsupra and Breztri for COPD.
Harnessing artificial intelligence and digital technologies across the biopharma value chain
Pharmaceutical Technology
APRIL 16, 2024
Artificial intelligence (AI) has the potential to revolutionize drug development through improved efficiency, accuracy, and speed.
Another Caplyta trial win moves Intra-Cellular closer to FDA filing in major depressive disorder
Fierce Pharma
APRIL 16, 2024
Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug. | Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug.
Acorda loses Nasdaq listing to cap biotech’s end
Pharmaceutical Technology
APRIL 16, 2024
Acorda’s closure date is set for 15 June, as Merz Therapeutics looks set to acquire the biotech’s once-prolific assets.
UCL study reveals carbon beads could help reduce progression of liver disease
Pharma Times
APRIL 16, 2024
Liver cirrhosis, caused by long-term liver damage, is estimated to affect around 100 million people worldwide
The New Age of Decentralized Clinical Trials
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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
Jardiance and Ofev propel Boehringer’s human pharma sales
Pharmaceutical Technology
APRIL 16, 2024
Boehringer Ingelheim announced consistent growth across its human pharma sales and R&D investments in 2023.
‘Stiffness’ of cells could give early warning of cancer
pharmaphorum
APRIL 16, 2024
Researchers from the UK have developed an endoscopic device that uses 3D imaging to look at the stiffness of cells and could diagnose cancer earlier.
Two major breakthroughs in Fragile X Syndrome treatments
Pharmaceutical Technology
APRIL 16, 2024
The FDA has cleared Spinogenix’s Phase II trial of SPG601, as the European Commission grants orphan drug status to zatolmilast.
With Vyvgart 'firing' in myasthenia gravis, argenx lays launch plans for next potential autoimmune approval: CEO
Fierce Pharma
APRIL 16, 2024
Despite a pair of clinical misfires in 2023, argenx has stuck by the thesis that its star drug Vyvgart, also known as efgartigimod, could tackle a wide array of autoimmune diseases linked to immuno | Argenx is bolstering its case for Vyvgart’s CIDP potential and preparing for a possible launch later this year—all while the company continues to prove the medication’s worth in its inaugural generalized myasthenia gravis indication.
FDA grants orphan drug status to NovelMed’s PNH treatment
Pharmaceutical Technology
APRIL 16, 2024
NovelMed has received ODD status from the US FDA for NM5072 for treating paroxysmal nocturnal hemoglobinuria (PNH).
Boehringer says R&D pipeline is the best in its long history
pharmaphorum
APRIL 16, 2024
Boehringer Ingelheim says the strongest R&D pipeline in its history is set to deliver 25 new product launches between now and 2030
FDA halts Neumora’s schizophrenia drug trial over convulsions in rabbits
Pharmaceutical Technology
APRIL 16, 2024
The US FDA placed the clinical hold based on the preclinical data that showed that Neumora’s NMRA-266 triggered convulsions in rabbits.
AI-Driven Drug Discovery: Transforming the Landscape of Pharmaceutical Research
Drug Patent Watch
APRIL 16, 2024
The pharmaceutical industry in China is undergoing a significant transformation with the adoption of artificial intelligence (AI) technology.
The New Age of Decentralized Clinical Trials
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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.
Qureight secures Series A funding to accelerate drug development
Pharmaceutical Technology
APRIL 16, 2024
Qureight has secured $8.5m in a Series A funding round led by Hargreave Hale AIM VCT to accelerate drug development.
J&J reports strong sales numbers for Tecvayli, bolstering company's multiple myeloma 'stronghold'
Fierce Pharma
APRIL 16, 2024
For the first time, Johnson & Johnson has reported sales numbers for its novel multiple myeloma treatment Tecvayli and they indicate that the bispecific, which was approved in October 2022, is | For the first time, Johnson & Johnson is reporting sales of its multiple myeloma drug Tecvayli, which is off to a strong launch and contributing to the company's overall strength in treating the disease.
GSK trails after Pfizer in 5-in-1 meningococcal vaccine race
pharmaphorum
APRIL 16, 2024
FDA starts review of GSK’s 5-in-1 meningitis vaccine, cueing up a decision early next year, as it tries to chase down Pfizer's recently-approved Penbraya
Pharma Pulse 4/16/24: Diabetes Weight Loss Drugs Could Reduce Risk of MS, Walmart Health Expands in Texas & more
Pharmaceutical Commerce
APRIL 16, 2024
The latest news for pharma industry insiders.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Intra-Cellular sets up $500m offer on Caplyta depression win
pharmaphorum
APRIL 16, 2024
Shares in Intra-Cellular Therapies rose after it reported Caplyta was effective for major depressive disorder (MDD), in a phase 3 trial.
Risk adjusted net present value: What is the current valuation of Merck’s MK-1084?
Pharmaceutical Technology
APRIL 16, 2024
MK-1084 is a small molecule commercialized by Merck, with a leading Phase I program in Metastatic Colorectal Cancer.
Eli Lilly, plaintiffs agree to scrap $13.5M insulin pricing settlement
Fierce Pharma
APRIL 16, 2024
Almost a year after originally proposing a $13.5 million settlement to end years of litigation relating to alleged insulin overpricing, Eli Lilly and plaintiffs in the nationwide class-action lawsu | The parties walked back the settlement after a recent ruling set back the plaintiffs, which have since filed an amended complaint.
Risk adjusted net present value: What is the current valuation of AbbVie’s ABBV-400?
Pharmaceutical Technology
APRIL 16, 2024
ABBV-400 is a monoclonal antibody conjugated commercialized by AbbVie, with a leading Phase II program in Metastatic Colorectal Cancer.
How Machine Learning Drives Clinical Trial Efficiency
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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.
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