5 FDA decisions to watch in the third quarter
Bio Pharma Dive
JUNE 26, 2023
By the end of September, the FDA will hold two anticipated advisory meetings and issue important decisions on drugs for Alzheimer’s, depression and a type of vision loss.
Sat.Jun 24, 2023 - Fri.Jun 30, 2023
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Lantidra wins FDA approval as first-ever type 1 diabetes cell therapy
Pharmaceutical Technology
JUNE 29, 2023
The FDA has announced that Lantidra, a cellular therapy for type 1 diabetes, has become the first treatment of its kind to be approved.
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Scientists Just Figured Out How This Deadly Superbug Hides Inside Us
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 28, 2023
Golden staph are ubiquitous bacteria, living harmlessly on the skin or inside the nose of nearly one in three people worldwide. Yet they are duplicitous, too. In some situations, golden staph (Staphylococcus aureus) can become monsters, causing dangerous infections in the skin, blood, bones, or elsewhere.
Vertex and Lonza to establish T1D cell therapy manufacturing facility
Pharmaceutical Technology
JUNE 27, 2023
Vertex and Lonza have entered a partnership to establish a facility in Portsmouth, US, to manufacture cell therapies for type 1 diabetes.
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
BioMarin finally secures FDA approval of hemophilia gene therapy
Bio Pharma Dive
JUNE 29, 2023
After a prolonged journey, the medicine, known as Roctavian, is now cleared for certain patients with hemophilia A, the more common form of the rare bleeding disorder.
10 clinical trials to watch in the second half of 2023
Bio Pharma Dive
JUNE 27, 2023
A Duchenne gene therapy faces a crucial test, while highly anticipated study results are expected in lung cancer, obesity and heart disease.
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Sanofi chalks up another win for its immune system research
Bio Pharma Dive
JUNE 27, 2023
A drug called amlitelimab, which Sanofi acquired through a $1.1 billion acquisition, met the main goal of a mid-stage study testing it in patients with moderate-to-severe eczema.
Regular Short Naps Could Be The Easiest Way to Reduce The Risk of Dementia
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 25, 2023
Regular, short snoozes keep our brains young by preserving volume, a quality linked with healthy cognitive functions and a lower risk of dementia and other diseases.
Lilly to acquire cancer antibody drug startup Emergence
Bio Pharma Dive
JUNE 29, 2023
The yet-to-be-announced deal for the German biotech is the latest move by Lilly to bulk up its oncology business, adding a drug in early development for solid tumors.
NASH drugs race to cross the finish line
Pharmaceutical Technology
JUNE 26, 2023
After Intercept’s Ocaliva rejection, multiple companies are taking aim at becoming the first US-approved NASH therapy.
AbbVie's Imbruvica-Brukinsa patent suit may have merit, and BeiGene will likely settle: expert
Fierce Pharma
JUNE 27, 2023
AbbVie recently filed a patent infring | AbbVie recently filed a patent infringement lawsuit against BeiGene over their blockbuster BTK franchises. Although the litigation was launched right after a patent’s issuance, AbbVie may actually have a case here, according to one expert.
Why Figuring Out if It’s Anxiety, ADHD, or Both Matters
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 26, 2023
“Cassie” is an anxious adult. She stresses and puts off tasks that should be simple. Seeing others succeed makes her feel inadequate. It’s easier to avoid challenges than risk failing again. She has taken anxiety medication, but it didn’t help much. This hypothetical example illustrates a situation many people have faced.
Pfizer’s hemophilia B gene therapy inches closer to regulatory approval
Bio Pharma Dive
JUNE 27, 2023
The treatment could become Pfizer’s first marketed gene therapy, an area the pharma has poured significant resources into in recent years.
Health Canada approves Endo’s anti-seizure pills
Pharmaceutical Technology
JUNE 30, 2023
Health Canada has approved Endo International’s Xcopri as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy.
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
BioMarin's hemophilia gene therapy Roctavian lands FDA nod with 'glimmers' of enthusiasm among doctors
Fierce Pharma
JUNE 29, 2023
After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder. | After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder.
A Daily Multivitamin May Help Your Memory, But Only if You’re in This Age Group
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 27, 2023
Research Checks interrogate newly published studies and how they’re reported in the media. The analysis is undertaken by one or more academics not involved with the study, and reviewed by another, to make sure it’s accurate. Don’t we all want to do what we can to reduce the impact of age-related decline on our memory?
F-Prime’s Ketan Patel on ‘reverse ageism’ in biotech and investing in a downturn
Bio Pharma Dive
JUNE 30, 2023
The life sciences investor spoke with BioPharma Dive about emerging life sciences markets around the globe and why the firm invests in first-time biotech founders.
Genprex’s Reqorsa gene therapy secures another FDA fast-track designation
Pharmaceutical Technology
JUNE 29, 2023
Genprex has announced that the FDA has granted fast-track designation for Reqorsa, its small cell lung cancer (SCLC) therapy.
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.
Former Pfizer employee charged with insider trading, using advance information on Paxlovid trial
Fierce Pharma
JUNE 30, 2023
A former statistician at Pfizer and his associate have been charged (PDF) with insider trading, using advance inform | A former statistician at Pfizer and his associate have been charged with insider trading, using advance information to make more than $350,000 from stock purchases that they executed one day before the company made trial results public for COVID-19 blockbuster Paxlovid.
Can These 7 Things Keep Mosquitoes Away From You? Here’s What The Science Says.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 29, 2023
There’s one animal that ruins summer evenings: the mosquito. While mosquitoes don’t carry any diseases in the UK, their itchy bites are far from fun. Everyone has a friend who gets covered in mosquito bites and a friend who doesn’t get a single one.
With FDA approval in hand, BioMarin lays out plan to sell $2.9M gene therapy
Bio Pharma Dive
JUNE 30, 2023
The agency granted a long-awaited clearance on Thursday, but unexpected aspects of the hemophilia treatment’s label had some investors worried about its commercial prospects.
Q&A: How can the US maintain access to essential drugs?
Pharmaceutical Technology
JUNE 29, 2023
Carrie Harney, the vice president of government and regulatory Affairs at US Pharmacopeia (USP) explains US drug shortages.
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.
June 29, 2023: Workshop Materials and Videocast Now Available From ‘Getting the Right Evidence to Decision-Makers Faster’
Rethinking Clinical Trials
JUNE 29, 2023
Materials and videocast recordings are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Getting the Right Evidence to Decision-Makers Faster. ” The 2-day workshop explored the critical cycle of evidence generation by researchers to decision-making by healthcare system leaders to implement the findings of pragmatic clinical trials conducted within healthcare systems.
NABL now accepts LLP as legal entity of CAB under the Limited Liability Partnership Act 2008
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 28, 2023
The National Accreditation Board for Testing and Calibration Laboratories (NABL) now accepts the “Limited Liability Partnership” as a legal entity of Conformity Assessment Body (CAB) under the Limited Liability Partnership Act 2008.
Lilly takes over partner working on cell therapies for diabetes
Bio Pharma Dive
JUNE 29, 2023
Sigilon Therapeutics, a biotech that’s been collaborating with Lilly since 2018, has agreed to be bought for up to $310 million in the pharma’s second announced buyout this month.
CRISPR gene editing on human embryos may have dangerous consequences, says new study
Pharmaceutical Technology
JUNE 29, 2023
Experts warn caution around CRISPR gene editing technology on human embryos as it may have dangerous consequences.
June 29, 2023: Grand Rounds Podcast with Dr. Joshua Denny on All of Us Research Program is Available
Rethinking Clinical Trials
JUNE 29, 2023
In the latest episode of the NIH Collaboratory Grand Rounds podcast , Dr. Joshua Denny continues his discussion about All of Us Research Program: Improving Health Through Diverse Technology, Huge Cohorts, and Precision Medicine. The full May 5 Grand Rounds webinar with Dr. Denny is also available. The post June 29, 2023: Grand Rounds Podcast with Dr.
NABH launches Best Practices Club platform to encourage sustainable quality in healthcare
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 26, 2023
In order to encourage the sustainable quality in healthcare and patient safety, innovative ideas and implemented practices, the National Accreditation Board for Hospitals and Healthcare Providers (NABH) launched a platform named “NABH Best practices Club” where the NABH accredited/ certified/ applicant hospitals can present and pitch their best practices in their organizations.
Novartis, continuing revamp, sells eye drugs to Bausch + Lomb for up to $2.5B
Bio Pharma Dive
JUNE 30, 2023
An agreement to divest the dry eye disease treatment Xiidra and a few other medicines adds to the Swiss pharma's yearslong push to slim down from the healthcare conglomerate it once was.
The promising role of GLP-1RAs in NASH
Pharmaceutical Technology
JUNE 28, 2023
Research has shown that GLP-1RAs may have the potential to treat chronic metabolic diseases such as non-alcoholic steatohepatitis (NASH).
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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