Pfizer quits Duchenne gene therapy, lays off staff following study setback
Bio Pharma Dive
JULY 30, 2024
The company is letting go of 150 staffers alongside a decision to officially terminate the high-profile program, which was acquired in 2016.
Sat.Jul 27, 2024 - Fri.Aug 02, 2024
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One Diet Choice While Pregnant May Protect Your Child’s Heart For Life
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 31, 2024
The food consumed by a pregnant mother just got a little bit more important. According to a new study on pregnant mice, a diet rich in fiber improves the long-term heart health of developing offspring, significantly lowering their risk of cardiovascular disease later in life.
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Understanding ICH Guideline Q14
Pharmaceutical Technology
AUGUST 1, 2024
Q14 is a new guideline detailing the elements of minimal and enhanced approaches for analytical procedure development. While the traditional minimal development approach remains valid, the advanced approach employing QbD principles requires additional development data and knowledge.
Another IRA lawsuit bites the dust with ruling on Novo Nordisk case; company pledges to appeal
Fierce Pharma
AUGUST 1, 2024
Like clockwork, another lawsuit challenging the constitutionality of the Inflation Reduction Act's (IRA's) price-setting measures has been shot down in the courts. | The ruling from the New Jersey federal court marks the latest in a string of rejections as various drugmakers have taken to the courts to fight the drug pricing legislation.
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
Bateman Horne Center leads the way in ME/CFS and long COVID education
BioPharma Reporter
AUGUST 1, 2024
The Bateman Horne Center of Excellence (BHC) has established itself as a trusted leader in the clinical care, provider education, patient advocacy, and research of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and long COVID.
First-of-its-kind cell therapy approved by FDA for rare soft tissue cancer
Bio Pharma Dive
AUGUST 2, 2024
Adaptimmune’s Tecelra is the first TCR cell therapy to reach market and, at $727,000, is also the priciest cellular medicine for cancer in the U.S.
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Here’s What ‘Diet’ Soft Drink Could Be Doing to Your Health in The Long Term
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 1, 2024
Many people are drinking less sugary soft drink than in the past. This is a great win for public health, given the recognised risks of diets high in sugar-sweetened drinks. But over time, intake of diet soft drinks has grown. In fact, it’s so high that these products are now regularly detected in wastewater.
July 31, 2024: Gene Editing Therapies and Population Health, in This Week’s PCT Grand Rounds
Rethinking Clinical Trials
JULY 31, 2024
Dr. Adrian Hernandez In this Friday’s PCT Grand Rounds, Adrian Hernandez of Duke University will present “Precision Health to Population Health: Opportunities and Challenges for Gene Editing Therapies.” The Grand Rounds session will be held on Friday, August 2, 2024, at 1:00 pm eastern. Hernandez is a professor of medicine and vice dean in the Duke University School of Medicine and the executive director of the Duke Clinical Research Institute.
Lilly obesity drug shows heart benefit in late-stage trial
Bio Pharma Dive
AUGUST 1, 2024
The drug led to a 38% reduction in the risk of death or complications from a type of heart failure, a finding that compared favorably to available treatments.
AbbVie acquires Cerevel Therapeutics for $8.7bn
Pharmaceutical Technology
AUGUST 2, 2024
AbbVie has completed its acquisition of all outstanding shares of Cerevel Therapeutics in a deal valued at $8.7bn.
Ancient Genes of Zombie Viruses Revealed as Hidden Drivers of Cancer
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 30, 2024
When viruses pay us a visit, they sometimes leave parts of themselves behind. Silently tucked away in our genomes, some of these bits of foreign DNA can get passed down through the generations.
Study finds 3D-printed blood vessels could improve heart bypass outcomes
Pharma Times
JULY 29, 2024
Coronary heart disease is the most common form of heart and circulatory disease
Moderna shares fall amid lower sales outlook for RSV, COVID shots
Bio Pharma Dive
AUGUST 1, 2024
The biotech cited competitive pressure and “very low” expected sales in Europe for its latest guidance cut, which sent shares down by nearly 20%.
Otsuka snaps up Jnana with its phenylketonuria drug for $800m
Pharmaceutical Technology
AUGUST 1, 2024
The acquisition is expected to conclude in Q3 this year and will see Otsuka adding Jnana’s phenylketonuria therapy to its portfolio.
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
Blue Light From Your Phone Really Can Affect Your Skin. Here’s How.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 29, 2024
Social media is full of claims that everyday habits can harm your skin. It’s also full of recommendations or advertisements for products that can protect you. Now social media has blue light from our devices in its sights. So can scrolling on our phones really damage your skin? And will applying creams or lotions help?
Vertex lifts sales guidance as launch of gene therapy Casgevy picks up steam
Fierce Pharma
AUGUST 2, 2024
As growth in Vertex's cystic fibrosis portfolio buoys the company amid the launch of gene therapy Casgevy, the company is feeling confident enough to boost its revenue outlook for the year. | As of mid-July, around 20 patients completed the first step of Casgevy treatment by having their cells collected, up from five patients during the first quarter.
Biotech startup Airna raises $60M for RNA editing medicines
Bio Pharma Dive
JULY 31, 2024
Launched last September, the company is working on a treatment for alpha-1 antitrypsin deficiency, which it said could enter the clinic in 2025.
Takeda’s revenue climbs by 14.1% in Q1 FY2024
Pharmaceutical Technology
AUGUST 1, 2024
Takeda has reported a revenue of Y1,208bn for Q1 FY2024, a 14.1% increase from Y1,058bn in the corresponding period of FY2023.
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.
ICMR calls for proposals to commercialize CRISPR Cas-Based TB detection system
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 31, 2024
The Indian Council of Medical Research (ICMR) has announced an Expression of Interest (EoI) inviting eligible organizations, companies, and manufacturers to participate in the ‘Transfer of Technology’ for a CRISPR Cas-based TB detection system.
Study finds ovarian cancer-treated women less likely to develop breast cancer
Pharma Times
AUGUST 1, 2024
Combined, ovarian and breast cancer affect over 60,000 women in the UK every year
UniQure restructuring to claim 300 jobs
Bio Pharma Dive
AUGUST 1, 2024
The job cuts affects 65% of UniQure’s workforce and include the gene therapy developer’s recent sale of a manufacturing plant to Genezen.
Valneva and LimmaTech partner for shigellosis vaccine development
Pharmaceutical Technology
AUGUST 1, 2024
Valneva and LimmaTech have signed a deal to potentially develop the first marketed shigellosis vaccine.
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.
Indian life sciences sector integrating technologies in R&D efforts
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 1, 2024
The Indian life sciences sector is making strides by integrating quantum computing, artificial intelligence (AI), machine learning (ML), advanced analytics, big data, internet of things (IoT) and blockchain into their research and development efforts.
FDA signs off on Adaptimmune's Tecelra as the first engineered cell therapy for a solid tumor
Fierce Pharma
AUGUST 2, 2024
Adaptimmune has won accelerated FDA approval | Adaptimmune has won accelerated FDA approval for Tecelra (afami-cel), a treatment for metastatic or unresectable synovial sarcoma which becomes the first engineered cell therapy for a solid tumor and the first new treatment in the indication in more than a decade.
GSK cuts vaccine forecasts, while predicting faster overall growth
Bio Pharma Dive
JULY 31, 2024
Several factors are slowing U.S. sales of Shingrix, the shingles vaccine that's become one of the British pharma's top sellers.
Pfizer’s Q2 2024 net income attributable to shareholders down 98%
Pharmaceutical Technology
JULY 31, 2024
Pfizer has posted a 98% decrease in net income attributable to shareholders of $41m for Q2 2024, compared to $2.3bn in Q2 2023.
Indian pharma to take advantage of GenAI potential to streamline drug discovery, reduce cost & time-to-market
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 28, 2024
The Indian pharmaceutical industry is working to take advantage of Generative AI potential to transform drug discovery. Functions such as establishing connections between the causative pathways and showing the genetic predispositions have the potential to enable successful interventions and revert disease progression.
Researchers reveal CAR-enhancer therapy could help overcome cancer relapse
Pharma Times
AUGUST 2, 2024
Cancer is estimated to affect more than three million people living in the UK, according to Macmillan Cancer Support
Cigna CEO promises ‘aggressive’ defense of pharmacy benefit managers
Bio Pharma Dive
AUGUST 1, 2024
David Cordani’s comments to investors Thursday come as the payer blew past Wall Street’s expectations for the second quarter, helped by significant growth in its health services division — including PBM Express Scripts.
Attralus set for amyloidosis asset’s European orphan designations
Pharmaceutical Technology
JULY 29, 2024
EMA’s COMP has adopted positive opinions for two orphan medicinal product designations for Attralus’s AT-02.
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.
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