Nabla Bio secures $26m in Series A funding round
Pharmaceutical Technology
MAY 15, 2024
Nabla Bio has secured $26m in a Series A financing round led by Radical Ventures, for generative protein designing.
Wed.May 15, 2024
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Eisai sets new revenue target for Alzheimer’s drug Leqembi
Bio Pharma Dive
MAY 15, 2024
The annual forecast, which comes as Eisai and Biogen have begun submitting a more convenient form of Leqembi for approval, looks “more realistic” than previous guidance, according to Jefferies analysts.
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FDA rejects label expansion for Dynavax’s hepatitis B vaccine
Pharmaceutical Technology
MAY 15, 2024
The US agency rejected the expanded use of Dynavax’s vaccine for adults on haemodialysis, citing insufficient efficacy and safety data.
Scientists Reveal Just How Far Plastic Can Reach Into Your Lungs
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 15, 2024
Miniscule fragments of plastic pollution invade the human body every day without our knowing it, not just from eating and drinking but from simply breathing. By some estimates, the average person inhales a credit card’s worth of plastic every week with unknown health effects.
FDA clears IND for Verismo Therapeutics’ CAR-T therapy
Pharmaceutical Technology
MAY 15, 2024
Verismo Therapeutics announced FDA clearance for a Phase I trial of its CAR-T therapy to treat non-Hodgkin lymphoma.
PCI issues guidelines for institutions prior to commencement of inspection process
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 15, 2024
The Pharmacy Council of India (PCI) has issued guidelines for the institutions related to the inspection process for the academic year 2024-25, mandating that the students and the faculties should have their smart cards and the infrastructure of the institutions should have mandatory active Quick Response (QR) code at the time of inspection.
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PCI issues guidelines for institutions prior to commencement of inspection process
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 15, 2024
The Pharmacy Council of India (PCI) has issued guidelines for the institutions related to the inspection process for the academic year 2024-25, mandating that the students and the faculties should have their smart cards and the infrastructure of the institutions should have mandatory active Quick Response (QR) code at the time of inspection.
GLP-1 receptor agonist sales expected to reach $125bn by 2033
Pharmaceutical Technology
MAY 15, 2024
Glucagon-like peptide-1 (GLP-1) receptor agonists are a class of incretin mimetic medicines for the treatment of Type 2 diabetes and obesity.
Bolt Biotherapeutics to lay off staff, abandon lead ADC candidate
Bio Pharma Dive
MAY 15, 2024
The company will cut its workforce by half and shuffle leadership as it discontinues testing of the drug trastuzumab imbotolimod.
Risk adjusted net present value: What is the current valuation of Corcept Therapeutics’s Miricorilant?
Pharmaceutical Technology
MAY 15, 2024
Miricorilant is a small molecule commercialized by Corcept Therapeutics, with a leading Phase II program in Obesity.
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
May 15, 2024: This Week’s PCT Grand Rounds to Feature the CardioHealth Alliance
Rethinking Clinical Trials
MAY 15, 2024
Dr. Ken Mahaffey, Dr. Nishant Shah, and Dr. Neha Pagidipati In this Friday’s PCT Grand Rounds, Ken Mahaffey of Stanford University and Nishant Shah and Neha Pagidipati of Duke University will present “CardioHealth Alliance: A Platform to Improve Care.” The Grand Rounds session will be held on Friday, May 17, 2024, at 1:00 pm eastern.
Circular RNA: Vaccines, therapeutics and biomarkers could be revolutionised
Pharmaceutical Technology
MAY 15, 2024
CircRNA is still in early days of development, but could be in trials as vaccines, therapeutics and biomarkers in the next few years.
May 17, 2024: This Week’s PCT Grand Rounds to Feature the CardioHealth Alliance
Rethinking Clinical Trials
MAY 15, 2024
Dr. Ken Mahaffey, Dr. Nishant Shah, and Dr. Neha Pagidipati In this Friday’s PCT Grand Rounds, Ken Mahaffey of Stanford University and Nishant Shah and Neha Pagidipati of Duke University will present “CardioHealth Alliance: A Platform to Improve Care.” The Grand Rounds session will be held on Friday, May 17, 2024, at 1:00 pm eastern.
University of Nottingham develops 3D-printed medication method
Pharmaceutical Technology
MAY 15, 2024
The University of Nottingham in the UK has announced the development of a new method enabling the creation of 3D-printed personalised pills.
With new partnership, Galapagos takes decentralized CAR-T manufacturing quest nationwide
Fierce Pharma
MAY 15, 2024
Though Galapagos has undergone plenty of staff shakeups and strategy revamps in recent years, the company is sticking strong to the CAR-T pivot first unveiled by CEO Paul Stoffels, M.D., following | Galapagos has teamed up with the largest blood supply network in the U.S. to help establish decentralized CAR-T production on a national scale.
Eisai begins rolling submission to FDA for injectable version of Leqembi
Pharmaceutical Technology
MAY 15, 2024
Eisai has initiated a rolling submission to FDA for approval of a more convenient version of its Alzheimer’s disease treatment Leqembi.
GSK, UK govt put £130m into antimicrobial resistance fight
pharmaphorum
MAY 15, 2024
GSK has become the first founding partner of the new Fleming Initiative, which aims to tackle the rising threat of antimicrobial resistance (AMR) and is also backed by the UK government.
OCT Europe: Unless everyone is benefiting, what is the point?
Pharmaceutical Technology
MAY 15, 2024
A big topic at Arena International’s Outsourcing in Clinical Trials Europe 2024 is how everyone should benefit from clinical research.
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.
In Novo pricing probe, Sanders cranks up the heat with dire warning on projected GLP-1 spending
Fierce Pharma
MAY 15, 2024
After recently placing a spotlight on Novo Nordisk’s "outrageous" U.S. | A new Senate HELP Committee report says GLP-1 drugs could "bankrupt our entire health care system" because of their high prices coupled with high uptake.
Moffitt and Fulgent Pharma partner on personalised cancer therapies
Pharmaceutical Technology
MAY 15, 2024
Moffitt Cancer Center and Fulgent Pharma have announced a partnership to enhance the development of personalised therapies for cancer.
Case Study: MHRA
pharmaphorum
MAY 15, 2024
MHRA's innovative regulatory approach enables Nuwiq's accelerated clinical trial timeline for haemophilia patients. Learn how their flexible approach is speeding access to new treatments.
Companies prepare for ADC trial readouts at ASCO 2024
Pharmaceutical Technology
MAY 15, 2024
Several companies have announced data presentations at the 2024 ASCO annual meeting for their late-stage and approved programs.
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
Eli Lilly settles with spa selling knockoff Mounjaro, Zepbound amid crackdown on fake GLP-1 meds
Fierce Pharma
MAY 15, 2024
After Eli Lilly sued several companies that were allegedly selling unauthorized versions of its tirzepatide products, the drugmaker has successfully cracked down on one of them. | Under legal pressure from Eli Lilly, a medical spa has agreed to pay an undisclosed settlement and undertake several "corrective actions," such as noting publicly that compounded versions of Lilly's tirzepatide products are not approved by the FDA.
Enveric Biosciences to out-license psilocin prodrug to MindBio
Pharmaceutical Technology
MAY 15, 2024
Enveric Biosciences has entered a non-binding term sheet with MindBio Therapeutics to out-license a class of psilocin prodrugs.
BMS CAR-T Therapy Wins FDA Approval for Expanded Use in Follicular Lymphoma
BioSpace
MAY 15, 2024
Following back-to-back approvals in lymphocytic leukemia, Bristol Myers Squibb’s CAR-T therapy Breyanzi on Wednesday won the FDA’s green light for relapsed or refractory follicular lymphoma.
Risk adjusted net present value: What is the current valuation of Ultragenyx Pharmaceutical’s Rebisufligene Etisparvovec?
Pharmaceutical Technology
MAY 15, 2024
Rebisufligene Etisparvovec is a gene therapy commercialized by Ultragenyx Pharmaceutical, with a leading Phase III program in Mucopolysaccharidosis III (MPS III) (Sanfilippo Syndrome ).
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.
Home testing devices for sleep apnoea backed for NHS use
pharmaphorum
MAY 15, 2024
Five home-testing devices to diagnose sleep apnoea, which can affect the health of around 2.5 million adults in the UK, have been recommended for NHS use by NICE.
Risk adjusted net present value: What is the current valuation of Enliven Therapeutics’s ELVN-001?
Pharmaceutical Technology
MAY 15, 2024
ELVN-001 is a small molecule commercialized by Enliven Therapeutics, with a leading Phase I program in Chronic Myelocytic Leukemia (CML, Chronic Myeloid Leukemia).
FDA clears Roche self-collection system for HPV screening
pharmaphorum
MAY 15, 2024
The FDA has approved Roche's HPV self-sampling solution that the company says can tackle unequal access to screening that can put women at risk of cervical cancer
Risk adjusted net present value: What is the current valuation of CytomX Therapeutics’s CX-2051?
Pharmaceutical Technology
MAY 15, 2024
CX-2051 is a monoclonal antibody conjugated commercialized by CytomX Therapeutics, with a leading Phase I program in Metastatic Colorectal Cancer.
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.
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