Signal: Medtech’s Covid boom is well and truly over as Avail, Olive shutter
Pharmaceutical Technology
NOVEMBER 5, 2023
Two more medtech darlings have closed their doors this week, signalling an end to the funding rush of Covid.
Sun.Nov 05, 2023
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Study Highlights Standout Clinical Success of Certain Cell and Gene Therapies
BioSpace
NOVEMBER 5, 2023
A recent report by Tufts Medical Center reveals impressive approval rates for durable cell and gene therapies, but experts urge caution over persistent safety and accessibility concerns.
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ABP-671 by Jiangsu Atom Bioscience and Pharmaceutical for Hyperuricemia: Likelihood of Approval
Pharmaceutical Technology
NOVEMBER 5, 2023
ABP-671 is under clinical development by Jiangsu Atom Bioscience and Pharmaceutical and currently in Phase II for Hyperuricemia.
New patent expiration for APIL drug ACTONEL
Drug Patent Watch
NOVEMBER 5, 2023
Annual Drug Patent Expirations for ACTONEL Actonel is a drug marketed by Apil and Warner Chilcott and is included in two NDAs. It is available from two suppliers. There are… The post New patent expiration for APIL drug ACTONEL appeared first on DrugPatentWatch - Make Better Decisions.
KT-253 by Kymera Therapeutics for Myeloproliferative Disorders: Likelihood of Approval
Pharmaceutical Technology
NOVEMBER 5, 2023
KT-253 is under clinical development by Kymera Therapeutics and currently in Phase I for Myeloproliferative Disorders.
Pfizer’s $3.5B Cost-Cutting Program Claims 200 Jobs at Michigan Site
BioSpace
NOVEMBER 5, 2023
Seeking to weather declining sales from its COVID-19 business in the third quarter, Pfizer is laying off approximately 200 employees at its manufacturing facility in Kalamazoo, Michigan.
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Overnight Stay in the Emergency Department and Mortality in Older Patients
JAMA Internal Medicine
NOVEMBER 5, 2023
This French cohort study evaluates in-hospital mortality and adverse effects among older adults (≥75 years) who waited overnight in the emergency department for a bed in a hospital ward.
KT-253 by Kymera Therapeutics for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia): Likelihood of Approval
Pharmaceutical Technology
NOVEMBER 5, 2023
KT-253 is under clinical development by Kymera Therapeutics and currently in Phase I for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia).
BMS Pays $100M Upfront for ADC from Korean Biotech Orum Therapeutics
BioSpace
NOVEMBER 5, 2023
After its deal with Tubulis in April 2023, Bristol Myers Squibb is continuing its antibody-drug conjugate buying spree by acquiring an asset from South Korea’s Orum Therapeutics.
KT-253 by Kymera Therapeutics for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia): Likelihood of Approval
Pharmaceutical Technology
NOVEMBER 5, 2023
KT-253 is under clinical development by Kymera Therapeutics and currently in Phase I for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia).
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
Kodiak Breathes New Life into Failed Eye Drug with Phase III Victory
BioSpace
NOVEMBER 5, 2023
Although Kodiak Sciences initially scrapped its development of tarcocimab tedromer after late-stage failures, new data has convinced the company to give the eye drug another shot.
BGB-16673 by BeiGene for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma): Likelihood of Approval
Pharmaceutical Technology
NOVEMBER 5, 2023
BGB-16673 is under clinical development by BeiGene and currently in Phase II for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma).
Travere Touts Phase III Kidney Disease Data for Filspari After Trial Failures
BioSpace
NOVEMBER 5, 2023
Following two late-stage failures, Travere Therapeutics has unveiled the results of two Phase III studies, attempting to regain Filspari’s footing in IgA nephropathy and focal segmental glomerulosclerosis.
ALTO-100 by Alto Neuroscience for Post-Traumatic Stress Disorder (PTSD): Likelihood of Approval
Pharmaceutical Technology
NOVEMBER 5, 2023
ALTO-100 is under clinical development by Alto Neuroscience and currently in Phase II for Post-Traumatic Stress Disorder (PTSD).
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
Navigating the Challenges of Clinical Trial Design
BioSpace
NOVEMBER 5, 2023
Navigating the Challenges of Clinical Trial Design - read this article along with other careers information, tips and advice on BioSpace
ALTO-100 by Alto Neuroscience for Post-Traumatic Stress Disorder (PTSD): Likelihood of Approval
Pharmaceutical Technology
NOVEMBER 5, 2023
ALTO-100 is under clinical development by Alto Neuroscience and currently in Phase II for Post-Traumatic Stress Disorder (PTSD).
Talking About Dying
JAMA Internal Medicine
NOVEMBER 5, 2023
This essay describes a palliative medicine physician’s experience with a dying patient and reflections on life.
KT-253 by Kymera Therapeutics for Refractory Acute Myeloid Leukemia: Likelihood of Approval
Pharmaceutical Technology
NOVEMBER 5, 2023
KT-253 is under clinical development by Kymera Therapeutics and currently in Phase I for Refractory Acute Myeloid Leukemia.
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.
New patent expiration for Teva Pharm drug ARMONAIR RESPICLICK
Drug Patent Watch
NOVEMBER 5, 2023
Annual Drug Patent Expirations for ARMONAIR+RESPICLICK Armonair Respiclick is a drug marketed by Teva Pharm and is included in one NDA. It is available from one supplier. There are thirteen… The post New patent expiration for Teva Pharm drug ARMONAIR RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.
Birociclib by Sihuan Pharmaceutical Holdings Group for Solid Tumor: Likelihood of Approval
Pharmaceutical Technology
NOVEMBER 5, 2023
Birociclib is under clinical development by Sihuan Pharmaceutical Holdings Group and currently in Phase I for Solid Tumor.
New patent expiration for Teva Pharm drug AIRDUO DIGIHALER
Drug Patent Watch
NOVEMBER 5, 2023
Annual Drug Patent Expirations for AIRDUO+DIGIHALER Airduo Digihaler is a drug marketed by Teva Pharm and is included in one NDA. It is available from four suppliers. There are twenty-eight… The post New patent expiration for Teva Pharm drug AIRDUO DIGIHALER appeared first on DrugPatentWatch - Make Better Decisions.
KT-253 by Kymera Therapeutics for Myeloproliferative Disorders: Likelihood of Approval
Pharmaceutical Technology
NOVEMBER 5, 2023
KT-253 is under clinical development by Kymera Therapeutics and currently in Phase I for Myeloproliferative Disorders.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
New patent expiration for Teva Pharm drug AIRDUO RESPICLICK
Drug Patent Watch
NOVEMBER 5, 2023
Annual Drug Patent Expirations for AIRDUO+RESPICLICK Airduo Respiclick is a drug marketed by Teva Pharm and is included in one NDA. It is available from four suppliers. There are sixteen… The post New patent expiration for Teva Pharm drug AIRDUO RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.
ALTO-300 by Alto Neuroscience for Major Depressive Disorder: Likelihood of Approval
Pharmaceutical Technology
NOVEMBER 5, 2023
ALTO-300 is under clinical development by Alto Neuroscience and currently in Phase II for Major Depressive Disorder.
New patent expiration for Teva Pharm drug ARMONAIR DIGIHALER
Drug Patent Watch
NOVEMBER 5, 2023
Annual Drug Patent Expirations for ARMONAIR+DIGIHALER Armonair Digihaler is a drug marketed by Teva Pharm and is included in one NDA. It is available from one supplier. There are twenty-five… The post New patent expiration for Teva Pharm drug ARMONAIR DIGIHALER appeared first on DrugPatentWatch - Make Better Decisions.
ABSK-021 by Abbisko Therapeutics for Small-Cell Lung Cancer: Likelihood of Approval
Pharmaceutical Technology
NOVEMBER 5, 2023
ABSK-021 is under clinical development by Abbisko Therapeutics and currently in Phase I for Small-Cell Lung 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.
Innoviva’s ‘game changer’ antibiotic tackles gonorrhoea
pharmaphorum
NOVEMBER 5, 2023
Innoviva’s ‘game changer’ antibiotic tackles gonorrhoea Phil.
(Favezelimab + pembrolizumab) by Merck for Bladder Cancer: Likelihood of Approval
Pharmaceutical Technology
NOVEMBER 5, 2023
(Favezelimab + pembrolizumab) is under clinical development by Merck and currently in Phase II for Bladder Cancer.
14th Asia Pacific Symposium on Cochlear Implant and Related Sciences Set to Convene in Seoul — Featuring HP&M’s Dr. Philip Won
FDA Law Blog
NOVEMBER 5, 2023
The 14th Asia Pacific Symposium on Cochlear Implant and Related Sciences is poised to captivate the global scientific community from November 8-11, 2023, as it convenes in Seoul, Korea. This prestigious four-day conference promises to deliver a wealth of cutting-edge insights, featuring presentations by eminent scientists and clinicians, all unified under the thought-provoking theme, “Towards Better Speech Perception and Beyond.
KT-253 by Kymera Therapeutics for Myelodysplastic Syndrome: Likelihood of Approval
Pharmaceutical Technology
NOVEMBER 5, 2023
KT-253 is under clinical development by Kymera Therapeutics and currently in Phase I for Myelodysplastic Syndrome.
Accelerating Clinical Supply Through Integrated Drug Development
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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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