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billion, another sign of large drugmakers’ reentry into neuroscience and a sizable purchase that will provide a boost as the industry gathers for one of its largest events of the year. Intra-Cellular last month filed the drug with U.S. Johnson & Johnson said Monday it would buy Intra-Cellular Therapies in a deal worth $14.6
The Unseen Heroes of Generic DrugDevelopment: Pharmacovigilance As a generic drugdeveloper, you're no stranger to the challenges of bringing affordable medications to market. But have you ever stopped to think about the unsung heroes of generic drugdevelopment?
I’m writing to you from San Diego, where STAT held an event during the American Academy of Neurology annual meeting this past weekend. We’ll get into a highlight from the event below, along with all the other biotech news today. Sign up to get our biotech newsletter in your inbox. Good morning.
Revolutionizing Generic DrugDevelopment: The Power of Digital Transformation As the pharmaceutical industry continues to evolve, one thing is clear: digital transformation is no longer a luxury, but a necessity. So, what does this mean for the future of generic drugdevelopment? Share your thoughts in the comments below!
A pain relief drugdeveloped by Vertex Pharmaceuticals succeeded in late-stage clinical trials, the company announced Tuesday, bringing the biopharma giant a step closer to launching what observers believe could be a potential blockbuster and upending decades of pharma failure in a complicated field.
Recursion, a biotechnology firm that uses machine learning for drugdevelopment and and which was announcing that it is rolling out AI-driven drug discovery software with tech giant Nvidia, decided to seize the moment. It was going to rain.
The inaugural Prostate Cancer DrugDevelopment Summit is the only industry-led meeting uniting large pharma, biotech and pioneering academics with the ambitious objective of accelerating the clinical development of safe and effective therapies to treat prostate cancer. Download the full event guide to learn more.
The 2nd annual Mitochondria-Targeted DrugDevelopment Summit returns as the only industry-led meeting focused on overcoming the challenge of treating unmet medical needs caused by mitochondrial dysfunction. Download the full event guide for the speaker faculty and session details.
In honor of JPM Week, you’re reading a special edition of our biotech newsletter, The Readout. To stay on top of the latest scoops and live reporting from the San Francisco conference, join our newsletter list.
The 2nd NSCLC DrugDevelopment Summit returns for its second year to unite biopharma and academic leaders during an exciting era of personalized medicine. Improve your drugdevelopment rationale across all lines of NSCLC and address challenges when moving therapies forward. Progress sequencing and combination approaches.
If you’ll also be there, come to our STAT event on Sunday night! I’ll be talking with researchers about the potential of using GLP-1 drugs for neurological conditions, and my Readout co-writer Meghana will be chatting with BMS’ head of development about the launch of their new schizophrenia drug Cobenfy.
Say hi if you’re attending our STAT event on Friday night! Sign up to get our biotech newsletter in your inbox. Good morning. A big welcome to everyone coming to Chicago for ASCO this weekend. Read the rest…
The Mitochondria-Targeted DrugDevelopment Digital Summit (April 27-29) is the only industry-led meeting focused on end-to-end mitochondria-targeting. Join your peers this spring to collaborate and share learnings, whilst evaluating your clinical development landscape.
Today, we look at the biggest biotech events to watch this quarter. Sign up for The Readout and receive STAT’s award-winning biotech news delivered straight to your inbox. Good morning. And as my editor had to remind me (since I’m still in denial), we are indeed in the fourth quarter now.
Rare disease drugdevelopment poses unique challenges that can be overcome by using real-world evidence (RWE). Two different methodologies are used in the application of HC information in clinical development. RWE from rare diseases is available from a wide variety of sources for use as an HC in rare disease drugdevelopment.
Well, this wraps up one of the most eventful weeks of the biotech year — ASCO, followed by BIO. Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Anyone else as zonked as I am?
Using real-world data to monitor drug safety and effectiveness adds an important capability to identify ways to improve patient and clinician experiences with a drug, based on side effects, adverse events, prescribing patterns, and patients’ subsequent care needs following their use of a drug.
They offer various programs, from undergraduate degrees in pharmaceutical sciences to specialised graduate courses focusing on drugdevelopment, regulatory affairs, and market access. Moreover, hands-on experience through internships and networking events is invaluable for students.
European Medicines Agency (EMA) has published a draft reflection paper on using artificial intelligence (AI) to support the safe and effective development, regulation and use of medicines. How can AI be best harnessed for pharmacovigilance data?
They can help ensure that these submissions are complete, accurate, and timely, which is critical for advancing drugdevelopment programs. They can assist with analytical method development and validation, stability testing, and characterization of drug substances and products.
The company reported that its small molecule drug, VX-548, outperformed placebo in a pair of pain relief trials that recruited patients who had gotten an abdominoplasty (tummy tuck) or bunion surgery. But there was a catch: VX-548 didn’t outperform a combination of acetaminophen and the opioid hydrocodone, a key secondary endpoint.
Regulators are increasingly asking drugdevelopers to include the patient voice in submissions, but the best way to go about this is less clear-cut. In the United States, learning how to navigate forums such as the FDA’s listening sessions and patient-focused drugdevelopment (PFDD) meetings could be the key to “truly moving the dial”.
Of course,” Hudson said at a Financial Times event in London. “Would I have liked the stock market reaction to be more generous? “But this is a long-term game, and if you’re trying to deliver long-term value, you try not to make too many short-term decisions.”
Damian here with a special thanks to everyone who joined us for STAT’s live event in New York City last night. Sign up to get our biotech newsletter in your inbox. Good morning, everyone.
LONDON — At an event here last week, the German pharmaceutical firm Boehringer Ingelheim outlined the projects in its pipeline. There was obesity and liver disease, and computational biology and oncology. Then respiratory and inflammatory diseases. And don’t forget mental illness and retinal health.
The 7th Neuroimmunology DrugDevelopment Summit, organised by Hanson Wade, is a premier event bringing together experts in the field to discuss the latest advancements and challenges in neuroimmunology drugdevelopment. Find out more about this must-attend event.
NEW YORK — A consensus may be emerging about how to prescribe the new Alzheimer’s drug lecanemab , according to remarks made by both a critic of other Alzheimer’s medicines and the CEO of the company that developed it.
In June, Viatris filed a citizen petition with the FDA, saying that the available evidence left doubts about how neffy would actually perform in a real-life anaphylactic event compared to auto-injectable epinephrine. (A generic version is also available, made by Teva). Continue to STAT+ to read the full story…
Researchers reported that the treatment was also generally safe, with fewer adverse events among those on olezarsen than among the placebo group. Continue to STAT+ to read the full story…
Baudry is also the chief scientific advisor at NeurAegis, a preclinical-stage company developing a concussion drug. There can be serious downstream events after a concussion, like dementia , particularly with multiple concussions, explains Oxeia CEO Michael Wyand. Development bogged down by complexity.
Researchers also reported that the most common adverse events, diarrhea and headache, were mild. The study’s authors found that, when patients were on Chenodal, their level of bile alcohols was more than 20-fold lower than when they were on placebo, which was both the desired result and statistically significant.
Many compounds present sub-optimal pharmacokinetic (PK) data (either predicted from in-vitro and pre-clinical data or measured in the clinic), such as poor exposure (leading to high doses), large variability, short half-life requiring more than once-a-day dosing, or C max -related adverse events (AEs). S54 – S61 (2001).
The 8th Antigen-Specific Immune Tolerance DrugDevelopment Summit is an event organised by Hanson Wade. Discover the latest developments and networking opportunities at this leading industry conference.
The results, which also showed no serious adverse events tied to the therapy, Edit-301, were announced coinciding with the European Hematology Association’s annual meeting in Frankfurt. Continue to STAT+ to read the full story…
Odylia Therapeutics event brings together leaders across biotech, pharma, venture capital, patient advocacy, and research sectors to address the financial and structural barriers that impede rare disease drugdevelopment.
the curious story of the latest FDA drug approval, and a twist on the year’s biggest biotech event. Damian here with a look at pharma’s struggle to make inroads in D.C., Read the rest…
The Gastrointestinal Cancer DrugDevelopment Summit is the only biopharma-led conference dedicated to identifying and progressing therapeutic opportunities in targeted and immunotherapies, ADCs, and precision oncology to address the large unmet clinical need in GI cancers. Explore the full event guide here: [link]. **A
Neuroscience is arguably the next great frontier in medicine and 2022 dawned with a wave of exhilarating progress for the neurodegenerative drugdevelopment community. Download the full event guide for the speaker faculty and session details. Download the full event guide for the speaker faculty and session details.
In the second quarter of 2024, the Viseven team embarked on a global journey, traversing continents to attend and participate in the world’s most prominent pharmaceutical events. Reuters Pharma EU 2024 April was a whirlwind for us, kicking off with the Reuters event in Barcelona where we went all out.
It’s true that the FDA has no obligation to follow what the advisory committee recommends, but the votes help, Pazdur said at STAT@ASCO, STAT’s event at the American Society of Clinical Oncology annual meeting. On Sunday, Richard Pazdur, director of the FDA’s Oncology Center of Excellence, took issue with his boss.
The Non-Small Cell Lung Cancer (NSCLC) DrugDevelopment Summit is the definitive industry-led forum for drugdevelopment in the largest solid tumor indication. View the event guide now for the full agenda details and expert speaker faculty. View the event guide now for more details!
As we continue enriching the design and development of molecular glues, network with 80+ leading Chemists, Biologists, Bioinformaticians, Structural Scientists & Computational Chemists at the world’s first-of-a-kind meeting to successfully accelerate the first wave of molecular glues into the clinic. View the full event guide Here.
As the only industry-led forum providing biopharma with the insights necessary to make strategic and scientific decisions on their fibrosis pipeline, the 6th Antifibrotic DrugDevelopment Summit returns to host the unmissable conversations transforming antifibrotic drugdevelopment research. View the official agenda here.
Download the full event guide for the speaker faculty and session details. areas for 2022 include: Understanding the Pre- Clinical & Clinical Developments of Microbiome-based Therapeutics – INCLUDING a Range of Disease-Specific Case Studies. With over 50 speakers each sharing brand new sessions, the main focus?areas
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