Pharmaceutical Technology
NOVEMBER 14, 2024
BioNTech has signed a definitive agreement to acquire Biotheus to obtain complete worldwide rights to BNT327/PM8002, a programmed death-ligand 1 and vascular endothelial growth factor A-targeting bispecific antibody.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 14, 2024
The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinical trials, has recommended grant of market authorisation for Telangana-based MSN Laboratories for sleep disorder drug Pitolisant tablets.
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Bio Pharma Dive
NOVEMBER 14, 2024
The company is paying China-based biotech LaNova Medicines $588 million for the type of dual-pronged antibody drug that recently bested Keytruda in a clinical trial.
Rethinking Clinical Trials
NOVEMBER 14, 2024
Speaker Sumit Agarwal, MD, MPH, PhD Assistant Professor Division of General Medicine University of Michigan Slides Keywords Income Support; Cash Benefits; Low-Income Population Key Points Low-income patients face several barriers to care and achieving better health. Co-pays prevent people from filling prescriptions; transportation barriers prevent patients from attending appointments; emergency departments take the place of primary care; and peop
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Bio Pharma Dive
NOVEMBER 14, 2024
A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.
Rethinking Clinical Trials
NOVEMBER 14, 2024
The Interagency Pain Research Coordinating Committee (IPRCC) is accepting nominati ons for new members to help advance the diagnosis, prevention, and treatment of pain and diseases and disorders associated with pain. The committee will include: health professionals and scientists who are leaders in the field of pain research patients with pain-related conditions, patient-advocates, and community organizations for individuals with pain-related conditions.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
NOVEMBER 14, 2024
The US Food and Drug Administration (FDA) has granted accelerated approval for PTC Therapeutics’ KEBILIDI, the first gene therapy in the US that is directly delivered to the brain.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 14, 2024
(Taokinesis/Canva) Because there are typically no symptoms until the first fracture occurs, osteoporosis is considered a silent disease. Some call it a silent killer. Osteoporosis is a bone disease characterized by decreased bone density and strength, leading to fragile, brittle bones that increase the risk of fractures, especially in the spine, hips and wrists.
Pharmaceutical Technology
NOVEMBER 14, 2024
Adaptimmune’s Phase II IGNYTE-ESO trial investigating experimental T cell therapy lete-cel has achieved its primary endpoint.
Bio Pharma Dive
NOVEMBER 14, 2024
Kebilidi is the first approved gene therapy that can be directly administered to the brain. Its OK secures a priority review voucher for PTC.
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
Pharmaceutical Technology
NOVEMBER 14, 2024
Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.
FDA Law Blog
NOVEMBER 14, 2024
By Jennifer D. Newberger — “An open foe may prove a curse, but a pretended friend is worse.” When the poet John Gay wrote these words in 1727, the idea of an administrative agency like the FDA was likely the furthest thing from his mind. That he is now being quoted in a blog post to discuss the relationship between medical device companies and their regulatory oversight body shows that some ideas really do have staying power.
Fierce Pharma
NOVEMBER 14, 2024
The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy has already been approved to treat AADC deficiency in Europe and the U.K., among other countries, where it's branded as Upstaza.
FDA Law Blog
NOVEMBER 14, 2024
By Ricardo Carvajal — Among the more interesting developments in the recent election was the emergency of Robert Kennedy as a prominent figure in the MAGA movement – and the collateral emergence of the MAHA movement (Make America Healthy Again). As crisply laid out in short YouTube video , MAHA aims to transform public health by zeroing in on “our nation’s biggest health challenge – chronic disease.
Pharma Times
NOVEMBER 14, 2024
Therapy shows high efficacy in initial trial phase
Pharmaceutical Technology
NOVEMBER 14, 2024
The company has discontinued the Phase I/II trial of its only clinical candidate due to a potential “unfavourable risk-benefit profile”.
Pharma Times
NOVEMBER 14, 2024
First participant vaccinated in study of ovx836 booster dose
Pharmaceutical Technology
NOVEMBER 14, 2024
Discover the top sales and marketing intelligence solutions tailored for the pharmaceutical industry. Download our guide to predictive analytics and data-driven insights.
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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
Fierce Pharma
NOVEMBER 14, 2024
GSK’s 3 billion pounds sterling peak sales goal for its multiple myeloma drug Blenrep appears increasingly attainable thanks to a key patient survival win.
Pharmaceutical Technology
NOVEMBER 14, 2024
Metsera has brought in over $500m in funding in just seven months as it looks to enter the competitive weight loss arena.
pharmaphorum
NOVEMBER 14, 2024
GSK's multiple myeloma therapy Blenrep's increase in overall survival in the DREAMM-7 trial has achieved statistical significance
Pharmaceutical Technology
NOVEMBER 14, 2024
In Shanghai, more than 300 industry leaders, experts, and partners met to discuss the latest trends in the data centre industry.
Outsourcing Pharma
NOVEMBER 14, 2024
AstraZeneca has become the latest big pharma company to devote new cash to its US manufacturing muscle this year as it unveils a $3.5 billion infusion into US sites.
Pharmaceutical Technology
NOVEMBER 14, 2024
Perceptive eClinical Launches ClinPhone 5: A ground-breaking new RTSM platform delivering a leap in clinical development technology.
BioPharma Reporter
NOVEMBER 14, 2024
The interim phase 2 trial results show a good immune response in participants and the therapy is well tolerated to date.
Pharmaceutical Technology
NOVEMBER 14, 2024
Flagship Pioneering-founded Valo Health has announced the appointment of Dr Brian Alexander as its new CEO.
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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
NOVEMBER 14, 2024
Syncona launches Slingshot Therapeutics with a mission to find promising projects in academia and translate them into development projects.
Pharmaceutical Technology
NOVEMBER 14, 2024
Adaptimmune’s Phase II IGNYTE-ESO trial investigating experimental T cell therapy lete-cel has achieved its primary endpoint.
BioPharma Reporter
NOVEMBER 14, 2024
The interim phase 2 trial results show a good immune response in participants and the therapy is well tolerated to date.
Fierce Pharma
NOVEMBER 14, 2024
Upon reexamination, the European Medicines Agency has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. | Upon reexamination, the EMA has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. But the recommendation for approval has a restriction.
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