Wed.May 15, 2024

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Nabla Bio secures $26m in Series A funding round

Pharmaceutical Technology

Nabla Bio has secured $26m in a Series A financing round led by Radical Ventures, for generative protein designing.

Protein 245
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Eisai sets new revenue target for Alzheimer’s drug Leqembi

Bio Pharma Dive

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.

Drugs 293
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FDA rejects label expansion for Dynavax’s hepatitis B vaccine

Pharmaceutical Technology

The US agency rejected the expanded use of Dynavax’s vaccine for adults on haemodialysis, citing insufficient efficacy and safety data.

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Scientists Reveal Just How Far Plastic Can Reach Into Your Lungs

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Scientist 182
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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FDA clears IND for Verismo Therapeutics’ CAR-T therapy 

Pharmaceutical Technology

Verismo Therapeutics announced FDA clearance for a Phase I trial of its CAR-T therapy to treat non-Hodgkin lymphoma.

Trials 263
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Blackstone-backed biotech launches with up to $300M for immune drug

Bio Pharma Dive

Uniquity Bio emerged from stealth mode ready to begin Phase 2 trials of an antibody targeting the protein TSLP in asthma and COPD.

Protein 177

More Trending

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GLP-1 receptor agonist sales expected to reach $125bn by 2033

Pharmaceutical Technology

Glucagon-like peptide-1 (GLP-1) receptor agonists are a class of incretin mimetic medicines for the treatment of Type 2 diabetes and obesity.

Sales 162
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Bolt Biotherapeutics to lay off staff, abandon lead ADC candidate

Bio Pharma Dive

The company will cut its workforce by half and shuffle leadership as it discontinues testing of the drug trastuzumab imbotolimod.

Drugs 169
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Risk adjusted net present value: What is the current valuation of Corcept Therapeutics’s Miricorilant?

Pharmaceutical Technology

Miricorilant is a small molecule commercialized by Corcept Therapeutics, with a leading Phase II program in Obesity.

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PCI issues guidelines for institutions prior to commencement of inspection process

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Pharmacy 141
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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May 15, 2024: This Week’s PCT Grand Rounds to Feature the CardioHealth Alliance

Rethinking Clinical Trials

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.

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Circular RNA: Vaccines, therapeutics and biomarkers could be revolutionised

Pharmaceutical Technology

CircRNA is still in early days of development, but could be in trials as vaccines, therapeutics and biomarkers in the next few years.

RNA 147
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May 17, 2024: This Week’s PCT Grand Rounds to Feature the CardioHealth Alliance

Rethinking Clinical Trials

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.

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University of Nottingham develops 3D-printed medication method

Pharmaceutical Technology

The University of Nottingham in the UK has announced the development of a new method enabling the creation of 3D-printed personalised pills.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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GSK, UK govt put £130m into antimicrobial resistance fight

pharmaphorum

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.

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Eisai begins rolling submission to FDA for injectable version of Leqembi

Pharmaceutical Technology

Eisai has initiated a rolling submission to FDA for approval of a more convenient version of its Alzheimer’s disease treatment Leqembi.

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BMS CAR-T Therapy Wins FDA Approval for Expanded Use in Follicular Lymphoma

BioSpace

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.

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OCT Europe: Unless everyone is benefiting, what is the point?

Pharmaceutical Technology

A big topic at Arena International’s Outsourcing in Clinical Trials Europe 2024 is how everyone should benefit from clinical research.

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The New Age of Decentralized Clinical Trials

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.

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Case Study: MHRA

pharmaphorum

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.

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Moffitt and Fulgent Pharma partner on personalised cancer therapies

Pharmaceutical Technology

Moffitt Cancer Center and Fulgent Pharma have announced a partnership to enhance the development of personalised therapies for cancer.

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Home testing devices for sleep apnoea backed for NHS use

pharmaphorum

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.

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Companies prepare for ADC trial readouts at ASCO 2024

Pharmaceutical Technology

Several companies have announced data presentations at the 2024 ASCO annual meeting for their late-stage and approved programs.

Trials 130
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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FDA clears Roche self-collection system for HPV screening

pharmaphorum

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

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Enveric Biosciences to out-license psilocin prodrug to MindBio

Pharmaceutical Technology

Enveric Biosciences has entered a non-binding term sheet with MindBio Therapeutics to out-license a class of psilocin prodrugs.

Licensing 130
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Galapagos Partners with Blood Centers of America to Decentralize CAR-T Production

BioSpace

Belgian biotech Galapagos is teaming with Blood Centers of America to help deploy its decentralized CAR-T therapy manufacturing platform closer to treatment centers across the U.S.

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Risk adjusted net present value: What is the current valuation of Ultragenyx Pharmaceutical’s Rebisufligene Etisparvovec?

Pharmaceutical Technology

Rebisufligene Etisparvovec is a gene therapy commercialized by Ultragenyx Pharmaceutical, with a leading Phase III program in Mucopolysaccharidosis III (MPS III) (Sanfilippo Syndrome ).

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How Machine Learning Drives Clinical Trial Efficiency

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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With new partnership, Galapagos takes decentralized CAR-T manufacturing quest nationwide

Fierce Pharma

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.

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Risk adjusted net present value: What is the current valuation of Enliven Therapeutics’s ELVN-001?

Pharmaceutical Technology

ELVN-001 is a small molecule commercialized by Enliven Therapeutics, with a leading Phase I program in Chronic Myelocytic Leukemia (CML, Chronic Myeloid Leukemia).

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Eisai, Biogen start delayed subcutaneous Leqembi filing

pharmaphorum

Eisai and Biogen have filed a rolling biologics license application in the US for a subcutaneous formulation of Alzheimer’s disease therapy Leqembi that was delayed by the FDA on procedural grounds.

Licensing 105
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Risk adjusted net present value: What is the current valuation of CytomX Therapeutics’s CX-2051?

Pharmaceutical Technology

CX-2051 is a monoclonal antibody conjugated commercialized by CytomX Therapeutics, with a leading Phase I program in Metastatic Colorectal Cancer.

Antibody 100
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Roles and Responsibilities of Specialized Clinical Supply Experts

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.