Bluebird preps for first commercial use of sickle cell gene therapy
Bio Pharma Dive
MAY 6, 2024
A 12-year-old boy in the Washington, D.C., area is set become the first patient treated with Lyfgenia since its U.S. approval last December.
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Angle signs AstraZeneca deal to develop prostate cancer assay
Pharmaceutical Technology
MAY 3, 2024
UK liquid biopsy company, Angle, has agreed a supplier agreement with AstraZeneca to develop a Parsotix-based Androgen Receptor (AR) assay for use in prostate cancer studies.
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AstraZeneca admits Covid-19 vaccine may cause blood clots in “very rare” cases
Pharmaceutical Technology
MAY 1, 2024
AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.
Breakthrough Vaccine Shows High Protection Against Drug-Resistant Superbug in Mice
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 1, 2024
Scientists have developed a vaccine against a notorious drug-resistant superbug, targeting molecules on its surface that are also found on other bacteria and fungi.
May 1, 2024: PKIDS Pragmatic Trial to Be Featured in PCT Grand Rounds
Rethinking Clinical Trials
MAY 1, 2024
Dr. Gregory Tasian In this Friday’s PCT Grand Rounds, Gregory Tasian of the Children’s Hospital of Philadelphia will present “Comparative Effectiveness of Kidney Stone Surgery in Pediatric Patients: The PKIDS Trial.” The Grand Rounds session will be held on Friday, May 3, 2024, at 1:00 pm eastern. The Pediatric Kidney Stone (PKIDS) Care Improvement Network Trial is a patient-centered, pragmatic clinical trial comparing the effectiveness of stone clearance for 3 surgical m
ASGCT 2024 Comes at Pivotal Time for Gene and Cell Therapy Sector
BioSpace
MAY 6, 2024
Jeffrey Chamberlain, president of the American Society of Gene & Cell Therapy, spoke with BioSpace about what we can expect to learn about in Baltimore this week.
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Common Blood Pressure Drug Increases Lifespan And Slows Aging in Animals
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 2, 2024
The hypertension drug rilmenidine has been shown to slow down aging in worms, an effect that in humans could hypothetically help us live longer and keep us healthier in our latter years. Previous research has shown rilmenidine mimics the effects of caloric restriction on a cellular level.
BioNTech plots first wave of cancer launches in 2026 as COVID vaccine sales continue to disappoint
Fierce Pharma
MAY 6, 2024
As BioNTech continues to endure a sharp decline in COVID-19 vaccine sales, the German mRNA specialist is looking ahead to the next leg of its commercial journey. | With plans to have at least 10 potentially registrational trials underway by the end of 2024, BioNTech is plotting the first wave of its market debut in oncology from 2026 onward.
AAVs in Focus at ASGCT: Improved Precision, Targeting Common Diseases
BioSpace
MAY 6, 2024
Adeno-associated viruses have long been go-to vectors for gene therapies. How AAVs are improving will be among the cell and gene therapy topics to be covered in Baltimore this week.
The top pharmaceutical companies by R&D expenditure
Pharmaceutical Technology
MAY 2, 2024
From Merck & Co to Sanofi, Pharmaceutical Technology lists the leading pharmaceutical companies spending the most on R&D in 2023.
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
Amgen shares soar as executives outline obesity drug push
Bio Pharma Dive
MAY 3, 2024
The company said data for its Wegovy competitor was promising enough to move the drug into late-stage testing, triggering a stock jump that added billions to Amgen’s market value.
Exercising in Midlife May ‘Reverse’ Years of Inactivity, Large Study Finds
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 5, 2024
As the world’s aging population grows, and dementia, cardiovascular disease, and osteoporosis reach epidemic levels, people of all ages want to know how they can live healthier, not just longer, lives. For women in their 40s and 50s, it’s not too late to take action.
Amneal agrees to $272.5M settlement to resolve opioid lawsuits
Fierce Pharma
MAY 6, 2024
Amneal Pharmaceuticals has agreed to pay $272.5 million to settle approximately 900 lawsuits brought by state, local and Native American jurisdictions claiming that the New Jersey generics producer | Amneal Pharmaceuticals has agreed to pay $272.5 million to settle approximately 900 lawsuits brought by state, local and Native American jurisdictions claiming that the New Jersey generics producer fueled the opioid crisis by failing to act on suspicious opioid orders.
Can a Device Be Found Not Substantially Equivalent Because of Cybersecurity Risks? A Review of FDA’s Draft Guidance on Cybersecurity in Medical Devices
FDA Law Blog
MAY 6, 2024
By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. The draft guidance provides recommendations on what is required to meet cybersecurity obligations under section 524B of the Food, Drug and Cosmetic Act (FD&C).
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.
FDA grants RMAT designation to Taysha’s Rett syndrome gene therapy
Pharmaceutical Technology
MAY 3, 2024
The FDA has awarded the designation following a review of initial safety and efficacy data from two Phase I/II clinical trials.
GSK raises forecasts on strong vaccine, HIV drug sales
Bio Pharma Dive
MAY 1, 2024
Sales of the shingles vaccine Shingrix and the RSV shot Arexvy helped fuel quarterly revenue totals that surpassed analyst expectations, though the company warned momentum could slow in the months ahead.
IPC and CSIR-IMTech forge strategic partnership to advance research in microbiology
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 6, 2024
Aimed at driving innovation and progress in the field of microbiology, the Indian Pharmacopoeia Commission (IPC) and the CSIR-Institute of Microbial Technology (IMTech), Chandigarh, have joined forces towards advancing microbiological research and development for the betterment of public health.
Prevention revolution: How digital tools can help us get ahead of health problems
pharmaphorum
MAY 1, 2024
Discover how digital tools can provide insights to help us. Digital technology could be a game-changer that offers the elusive promise of tackling the root cause, not just the conditions themselves, when it comes to human health.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Eli Lilly Gears Up for Donanemab Adcomm as FDA Ponders Changes to Format
BioSpace
MAY 6, 2024
FDA Commissioner Robert Califf has said that advisory committee meetings should focus more on discussion and be “less about the outcome,” but other agency officials recently advocated for retaining the vote on whether to approve a product under review.
Moderna reports $1.2bn net loss in Q1 2024
Pharmaceutical Technology
MAY 3, 2024
Moderna reported a net loss of $1.2bn in the first quarter (Q1) of 2024, a stark contrast to its net income of $79m in Q1 2023.
Pfizer’s strong Vyndaqel sales draw attention to rare disease drug’s patent life
Bio Pharma Dive
MAY 1, 2024
Sales of the transthyretin amyloidosis treatment widely beat Wall Street forecasts in the first quarter. The company aims to extend its patent exclusivity.
India puts in place mechanisms to combat malaria as drug resistance poses serious challenge
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 1, 2024
India is now putting in place a mechanism to combat malaria as drug resistance poses a serious challenge. The treatment of malaria depends on timely diagnosis and efficient medication, especially artemisinin-based combination therapies (ACTs) that help in getting rid of parasites and relieve symptoms.
2022 Research: The Rapid Rise of Ocean Freight Visibility
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Pfizer hires Citi analyst Andrew Baum to manage portfolio strategy, business development
Fierce Pharma
MAY 6, 2024
“Our next question will come from Andrew Baum with Citi.” | Citi analyst Andrew Baum, after covering Pfizer for more than a decade, will join the Big Pharma company as chief strategy and innovation officer. In the role, he'll oversee the drugmaker's portfolio management and business development activities.
BioNTech Misses Q1 Earnings, Revenue on Lower COVID-19 Sales
BioSpace
MAY 6, 2024
Reeling from “endemic-level demand” for its COVID-19 vaccine, BioNTech on Monday reported a steep decline in revenues and a loss per share that fell short of analysts’ consensus estimates for the first quarter of 2024.
NHS to provide Pfizer’s Voxelotor to treat sickle cell disease
Pharmaceutical Technology
MAY 3, 2024
The NHS in the UK has announced plans to offer Pfizer's Voxelotor (Oxbryta), a new treatment option for sickle cell disease.
Novartis to buy Mariana Oncology in radiopharmaceutical expansion
Bio Pharma Dive
MAY 2, 2024
The $1 billion dollar acquisition will add to Novartis’ pipeline of the targeted radiation drugs, giving it a potential lung cancer treatment.
An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
CDSCO empowers regulators & boosts exports through comprehensive training programmes
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 2, 2024
In a concerted effort to fortify regulatory capabilities and enhance pharmaceutical exports, the Central Drugs Standard Control Organisation (CDSCO) has orchestrated a series of impactful training initiatives in the fiscal year 2023-24.
Boehringer will use Walgreens trials unit for obesity trial
pharmaphorum
MAY 3, 2024
Walgreens’ plans to disrupt the clinical trials sector have taken a step forward with a high-profile partnership with Boehringer Ingelheim
The Next Frontier: Industrializing Cell Therapy Manufacturing
BioSpace
MAY 6, 2024
Q&A: Development Scientist at AGC Biologics Sara Morlacchi analyzes the growth of the cell therapy industry and barriers for cost and accessibility.
Eli Lilly reports 67% increase in Q1 2024 net income
Pharmaceutical Technology
MAY 1, 2024
Eli Lilly has announced that its net income rose to $2.24bn in Q1 2024, a 67% increase from $1.34bn in the same period of 2023.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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