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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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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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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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.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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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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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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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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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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IFM, an unorthodox biotech startup, scores third buyout with Novartis deal

Bio Pharma Dive

With a decision by the Swiss pharma to acquire another one of its subsidiaries, IFM Therapeutics has now sold three spin-offs for $700 million upfront and the potential for billions more in future payments.

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

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AbbVie’s Produodopa approved by SMC to treat Parkinson’s disease patients in Scotland

Pharma Times

The progressive neurological disorder affects approximately 12,400 people in Scotland

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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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Merck to start trials investigating single dosing regimen of HPV vaccine

Pharmaceutical Technology

The two trials will evaluate alternative dosing regimens for Gardasil 9 vaccine compared to the currently approved three-dose regimen.

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FDA flags early deaths in CAR-T myeloma trials for J&J and Legend’s Carvykti, Bristol Myers’ Abecma

Fierce Pharma

The FDA has raised concerns about early clinical trial deaths as part of two applications that aim to move the CAR-T therapies Carvykti and Abecma into earlier lines of treatment for multiple myelo | Ahead of an important advisory committee meeting, the FDA has raised concerns about early trial deaths for multiple myeloma cell therapies. At the meeting, experts will discuss applications that aim to move the CAR-T therapies Carvykti and Abecma into earlier lines of treatment.

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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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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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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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US study reveals age-related skin changes could contribute to melanoma metastases

Pharma Times

Around 200,000 people in the US are expected to be diagnosed with the skin cancer this year

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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Takeda winds down manufacturing and R&D operations in Austria after gene therapy pivot, plots 190 layoffs

Fierce Pharma

After Takeda’s unsuccessful attempt to sell an Austrian manufacturing and development site, the Japan-based company is calling it quits on much of the operations at the facility. | After Takeda’s unsuccessful attempt to sell an Austrian manufacturing and development site, the Japan-based company is calling it quits on much of the operations at the facility.

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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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Digitalising supply chains may be the zeitgeist, but let’s not forget about the power of human partnerships

pharmaphorum

Digitalising supply chains may be the zeitgeist, but let’s not forget about the power of human partnerships Mike.

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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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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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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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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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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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BaseCamp unveils improved protein structure prediction model

pharmaphorum

Basecamp Research launches BaseFold, a deep learning model that it says surpasses benchmark tool AlphaFold2 and should accelerate AI-based drug discovery

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Recently Laid Off? Contract Work Could Be an Attractive Option

BioSpace

Staffing agencies say contract work is a great way to break into an industry and avoid a resume gap.

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Prilenia eyes 2025 launch for Huntington’s drug pridopidine

pharmaphorum

Prilenia Therapeutics is planning to file its Huntington’s disease drug pridopidine in the EU shortly, after mixed results in a phase 3 trial.

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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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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.