Wed.Mar 13, 2024

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Automation, risk management, and the manufacture of medical devices

Pharmaceutical Technology

As the demand for medical devices continues to rise, manufacturers are increasingly turning to automation during the assembly process to get their products to market faster. But how can the risks involved be mitigated?

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FDA to focus on ‘early deaths’ in meeting on broader CAR-T use in myeloma

Bio Pharma Dive

Briefing documents posted ahead of Friday’s advisory panel zeroed in on increased rates of early death in tests of cell therapies from Bristol Myers Squibb and Johnson & Johnson.

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Bright Green invests $250m to expand facility in New Mexico, US

Pharmaceutical Technology

Bright Green has announced plans to expand its controlled substances drug production facility in New Mexico, US with an investment of $250m.

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Many Dementia Cases Could Actually Be a Hidden Form of Liver Disease

AuroBlog - Aurous Healthcare Clinical Trials blog

A recent study of US veterans found that 10% of those diagnosed with dementia actually had a liver condition called hepatic encephalopathy (HE) – a treatable condition. The liver can be damaged by several things, including alcohol, fatty deposits and hepatitis viruses.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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March 13, 2024: In This Friday’s PCT Grand Rounds, a Pragmatic Trial of Antibiotic Choice on Renal Outcomes

Rethinking Clinical Trials

Dr. Edward Qian In this Friday's PCT Grand Rounds, Edward Qian of Vanderbilt University will present "The Effect of Antibiotic Choice on Renal Outcomes: The ACORN Trial." The Grand Rounds session will be held on Friday, March 15, 2024, at 1:00 pm eastern. The ACORN trial compared the effects of cefepime vs piperacillin-tazobactam on the incidence of acute kidney injury among acutely ill adults.

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NABL Kolkata spearheads cutting-edge awareness programme on calibration of medical devices

AuroBlog - Aurous Healthcare Clinical Trials blog

In order to set in pioneering progress in Eastern India’s laboratory standards, the National Accreditation Board for Testing and Calibration Laboratories (NABL) Kolkata office has orchestrated a ground-breaking virtual awareness program, revolutionizing perspectives on calibration within the Eastern India region’s laboratories.

More Trending

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Risk adjusted net present value: What is the current valuation of Novo Nordisk’s Belcesiran?

Pharmaceutical Technology

Belcesiran is an antisense rnai oligonucleotide commercialized by Novo Nordisk, with a leading Phase II program in Alpha-1 Antitrypsin Deficiency (A1AD).

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FDA Approves Madrigal’s Rezdiffra as First MASH Therapy

BioSpace

Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) is the first-ever approved therapy for metabolic dysfunction-associated steatohepatitis—a decision experts say could signal a sea change in treatment of the disease.

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Lamassu Bio secures US NIH grant for sarcoma treatment

Pharmaceutical Technology

Lamassu Bio has received a $2.05m grant from the US National Institutes of Health (NIH) and National Cancer Institute (NCI) for the development of SA53, a new therapeutic for p53 wild-type sarcomas.

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From a childhood fascination to a pull towards translational medicine, who is this week's Woman in Science?

BioPharma Reporter

Kate Broderick takes us on her intriguing journey - from being drawn to how science was applied within a medical setting, to the enormous challenge of working around the clock when the pandemic began.

Medicine 114
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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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Risk adjusted net present value: What is the current valuation of AstraZeneca’s AZD-3427?

Pharmaceutical Technology

AZD-3427 is commercialized by AstraZeneca, with a leading Phase II program in Pulmonary Hypertension.

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Biotech trade group pledges support for BIOSECURE Act, plans to boot member WuXi AppTec

Fierce Pharma

As CDMO giants Wuxi AppTec and WuXi Biologics come under mounting scrutiny for their alleged ties to Chinese government officials, they are losing a key ally in Washington, D.C. | As CDMO giants Wuxi AppTec and WuXi Biologics come under mounting scrutiny for their alleged ties to Chinese government officials, they are losing a key ally in Washington, D.C.

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Pearl Bio and Merck partner for discovery of cancer therapies

Pharmaceutical Technology

Pearl Bio has signed an agreement with Merck for the discovery of biologics that incorporate non-standard amino acids to treat cancer.

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World Glaucoma Week 2024: New Advances in Glaucoma Care

XTalks

World Glaucoma Week is an initiative that began with the collaborative efforts of the World Glaucoma Association (WGA) and the World Glaucoma Patient Association (WGPA). It evolved from World Glaucoma Day, which was first commemorated on March 6, 2008. The theme for World Glaucoma Week 2024 is “Uniting for a Glaucoma-Free World.” This year’s week-long campaign is a platform for eye care professionals, health organizations and the medical device and healthcare industry to share the latest knowled

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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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Allumiqs and Prolytix collaborate for drug discovery

Pharmaceutical Technology

Allumiqs has entered into a long-term strategic collaboration with Prolytix to expedite the discovery and development of new drugs.

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Transitioning PROs from paper to digital: Maintaining data integrity and patient experience

pharmaphorum

Transitioning patient-reported outcomes (PROs) from paper to digital (ePRO) is crucial for maintaining data integrity and improving the patient experience. Learn how to seamlessly make this transition and optimise your data collection process.

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Quality versus quantity in T-cell production: Why it doesn’t have to be a trade-off

Pharmaceutical Technology

In T-cell manufacturing, the historical issue of maintaining the quality of materials when scaling up production is changing.

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Building Cancer Awareness and Empowering Métis Youth: Featuring Jordyn Playne, President, Métis Nation of Ontario Youth Council – Xtalks Life Science Podcast Ep. 150

XTalks

In this episode, Ayesha spoke with Jordyn Playne, President of the Métis Nation of Ontario (MNO) Youth Council , a group of youth representatives from across Ontario who advocate on behalf of the concerns and interests of Métis youth at the provincial level. Jordyn is also a Clinical Consultant and Trainer at Waypoint Centre for Mental Health Care, as well as an advocate for cancer prevention.

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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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Galderma sets price range for supersized $2.6bn IPO in Europe

Pharmaceutical Technology

The dermatology-centric pharma company is likely set for one of the biggest public listings in Europe since 2022.

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SXSW 2024 Insights: Why the Greatest Risk a Brand Can Take Is Being Ordinary, Part 1

Intouch Solutions

Our team is on the ground at SXSW 2024, and as we navigate through the bustling streets of downtown Austin, Texas — where the magic of immersive brand experiences dress the streets — we can’t help but feel the pulse of innovation surrounding us. In this blog, Hattie Stearns, Senior Director, Experience Design & Innovation, delves into several key trends and insights from Day 1 of the conference, including the importance of building authentic immersive experiences that enable human connection

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Risk adjusted net present value: What is the current valuation of Kissei Pharmaceutical’s Cretostimogene Grenadenorepvec?

Pharmaceutical Technology

Cretostimogene Grenadenorepvec is an oncolytic virus commercialized by Kissei Pharmaceutical, with a leading Phase III program in Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer).

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eClinical innovations streamline clinical trial processes: Insights from Dawn Kaminski

Outsourcing Pharma

In the fast-evolving landscape of clinical trials, technological advancements play a vital role in streamlining processes, enhancing efficiency, and ultimately improving patient outcomes.

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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.

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Risk adjusted net present value: What is the current valuation of Novo Nordisk’s (Insulin icodec + Semaglutide)?

Pharmaceutical Technology

(Insulin icodec + Semaglutide) is a recombinant peptide and recombinant protein commercialized by Novo Nordisk, with a leading Phase III program in Type 2 Diabetes.

Insulin 100
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Lilly adds Amazon Pharmacy to LillyDirect DTC channel

pharmaphorum

Amazon Pharmacy will provide dispensing for Eli Lilly’s recently launched direct-to-consumer LillyDirect channel, covering obesity, diabetes, and migraine drugs.

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Risk adjusted net present value: What is the current valuation of Johnson & Johnson’s Nipocalimab?

Pharmaceutical Technology

Nipocalimab is a monoclonal antibody commercialized by Johnson & Johnson, with a leading Phase III program in Acquired (Autoimmune) Hemolytic Anemia.

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Merck to Start Trials of New HPV Vaccine and Single-Dose Gardasil Shot

BioSpace

Merck is looking to expand its offerings in the human papillomavirus space with a new vaccine and to study a single-shot variant of Gardasil 9, both of which will start trials toward the end of 2024.

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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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Risk adjusted net present value: What is the current valuation of Johnson & Johnson’s PN-235?

Pharmaceutical Technology

PN-235 is a synthetic peptide commercialized by Johnson & Johnson, with a leading Phase III program in Plaque Psoriasis (Psoriasis Vulgaris).

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Mirum Secures Livmarli’s Expansion into Familial Intrahepatic Cholestasis

BioSpace

Wednesday’s FDA approval expands Mirum’s Livmarli into the rare genetic disorder that causes progressive liver disease. The biotech has also filed a supplemental New Drug Application for a higher dose of the drug and allowing its use in younger patients.

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Risk adjusted net present value: What is the current valuation of Novo Nordisk’s Denecimig?

Pharmaceutical Technology

Denecimig is a monoclonal antibody commercialized by Novo Nordisk, with a leading Phase III program in Hemophilia A (Factor VIII Deficiency).

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J&J's Duato nets major raise to $28.4M, jumps to top of pharma CEO pay rankings

Fierce Pharma

It didn’t take long for Johnson & Johnson CEO Joaquin Duato to catch up to his predecessor. | It didn’t take long for Johnson & Johnson CEO Joaquin Duato to catch up to his predecessor. After paying Duato $13.1 million in his first year as CEO, the pharma giant more than doubled his compensation to $28.4 million last year, according to a regulatory filing.

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Accelerating Clinical Supply Through Integrated Drug Development

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.