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.
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.
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.
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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.
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.
FDA approves J&J’s multiple myeloma therapy
Pharmaceutical Technology
JULY 31, 2024
The US FDA has granted approval for Johnson & Johnson’s (J&J) DARZALEX FASPRO for treating newly diagnosed multiple myeloma (NDMM).
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
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.
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.
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.
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.
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?
Talk of the Towne episode 11: American Kidney Fund
Antidote
JULY 30, 2024
In the latest installment of Talk of the Towne, we sat down with Melanie Paris, M.A., MPH, the Senior Director of Strategic Partnerships and Kidney Disease Education at the American Kidney Fund (AKF). In the discussion, we got her insights into the types of kidney disease, treatment disparities, and the importance of clinical research in the field. She also shared many valuable resources for individuals and their loved ones living with kidney disease, which are linked here.
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.
Bristol Myers Squibb reports dip in net income for Q2 2024
Pharmaceutical Technology
JULY 29, 2024
Bristol Myers Squibb (BMS) has posted net income attributable to the company of $1.7bn during Q2 2024, a 19% drop versus $2.1bn in Q2 2023.
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.
The Neural Signature of OCD Has Been Identified in The Human Brain
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 28, 2024
Researchers have discovered patterns in the brain that reflect the effectiveness of deep brain stimulation therapy for obsessive–compulsive disorder (OCD), potentially leading to improvements in the way that the condition is handled individually for each case.
Bayer lops off 70 more employees at New Jersey headquarters
Fierce Pharma
JULY 31, 2024
Four months after Bayer handed pink slips to 90 staffers at its U.S. headquarters in Whippany, New Jersey, the company is laying off 70 more workers at the site. | Four months after Bayer handed pink slips to 90 staffers at its U.S. headquarters in Whippany, New Jersey, the company is laying off 70 more at the site, according to a state Worker Adjustment and Retraining Notification.
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.
MSD reports net income of $5.4bn in Q2 2024
Pharmaceutical Technology
JULY 31, 2024
MSD has reported a net income on a GAAP basis of $5.4bn for Q2 2024 compared to the net loss of $5.9bn in the same quarter of 2023.
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.
Lilly gets first heart outcomes readout with tirzepatide
pharmaphorum
AUGUST 2, 2024
Eli Lilly's dual GLP-1/GIP agonist tirzepatide has been shown to reduce the risk of worsening disease in people with heart failure and obesity in a phase 3 trial, the first to show a benefit on cardiovascular outcomes with the drug.
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.
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.
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.
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.
Frontiers Health 2024: Connecting changemakers, cultivating health system change
pharmaphorum
JULY 31, 2024
Frontiers Health 2024 is a platform connecting innovators and changemakers in the life sciences industry to cultivate positive changes in health systems. Discover the latest trends and insights in healthcare innovation.
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.
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.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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