Avacta doses first patient in pivotal phase 1a trial
Pharma Times
APRIL 5, 2023
Individual receives AVA6000 treatment as part of additional dose escalating study
Sat.Apr 01, 2023 - Fri.Apr 07, 2023
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5 FDA decisions to watch in the second quarter
Bio Pharma Dive
APRIL 3, 2023
By the end of June, the agency could clear a gene therapy for Duchenne muscular dystrophy and two vaccines for RSV, as well as issue a precedent-setting decision on a closely watched ALS drug.
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Latest WHO Covid-19 vaccine guidance may decrease future demand
Pharmaceutical Technology
APRIL 3, 2023
The World Health Organisation (WHO) has revised its recommendations regarding the use of Covid-19 vaccines following a meeting of the agency’s Strategic Advisory Group of Experts on Immunisation (SAGE). The latest guidance applies to the current phase of the pandemic and reflects the impact of the Omicron variant, which has led to high levels of immunity in all age groups through both vaccination efforts and infections across the globe.
There’s Something Different in The Brains of Teens With Sleep Apnea
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 5, 2023
Interruptions to breathing during sleep may cause parts of the adolescent brain critical to learning and memory to become thin or inflamed, according to a record-sized study carried out on US teenagers.
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
Broccoli consumption protects gut lining, reduces disease in mice, study shows
Medical Xpress
APRIL 6, 2023
Broccoli is known to be beneficial to our health. For example, research has shown that increased consumption of the cruciferous vegetable decreases incidences of cancer and type 2 diabetes. In a recent study, researchers at Penn State found that broccoli contains certain molecules that bind to a receptor within mice and help to protect the lining of the small intestine, thereby inhibiting the development of disease.
Gene therapy startup Vedere to close two years after launch
Bio Pharma Dive
APRIL 2, 2023
The startup, a successor to an eye gene therapy biotech that Novartis bought in 2020, will wind down after preclinical experiments didn’t meet the bar set by its leaders.
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PCIM&H soon to develop pharmacopoeia standards for Ayurveda, Siddha, Unani & Homoeopathy drugs
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 4, 2023
The Pharmacopoeia Commission of Indian Medicine and Homoeopathy (PCIM&H) may soon undertake development of pharmacopoeia standards for the Ayurveda, Siddha, Unani and Homoeopathy drugs under the ‘One Herb One Standard’ (OHOS) among other initiatives during the financial year 2023-24.
New study shows SARS-CoV-2 infection accelerates the progression of dementia
Medical Xpress
APRIL 4, 2023
Infection with SARS-CoV-2 has a significant impact on cognitive function in patients with preexisting dementia, according to new research published in the Journal of Alzheimer's Disease Reports. Patients with all subtypes of dementia included in the study experienced rapidly progressive dementia following infection with SARS-CoV-2.
Seagen, Astellas win expanded FDA approval for bladder cancer drug
Bio Pharma Dive
APRIL 4, 2023
The first-line approval of Padcev together with Keytruda is viewed as important to expanding the drug’s market, and comes weeks after Pfizer agreed to buy Seagen for $43 billion.
MHRA fast tracks ADvantage’s immunomodulator for Alzheimer’s disease
Pharmaceutical Technology
APRIL 6, 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted ADvantage Therapeutics’ immunotherapy AD04 an Innovation Passport for the treatment of Alzheimer’s disease. The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE).
Delhi HC refuses interim injunction to Boehringer Ingelheim, permits generic manufacturers to produce linagliptin
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 6, 2023
A Single Bench of the Delhi High Court has refused to grant interim injunction in favour of German pharma major Boehringer Ingelheim against the Indian generic manufacturers in a patent litigation on the former’s diabetes drug linagliptin, noting that prima facie the patent is vulnerable to revocation and the company has made an attempt towards […]
Researchers reveal why viruses like SARS-CoV-2 can reinfect hosts, evade the immune response
Medical Xpress
APRIL 6, 2023
The human body is capable of creating a vast, diverse repertoire of antibodies—the Y-shaped sniffer dogs of the immune system that can find and flag foreign invaders. Despite our ability to create a range of antibodies to target viruses, humans create antibodies that target the same viral regions again and again, according to a new study led by investigators from Brigham and Women's Hospital, a founding member of the Mass General Brigham healthcare system, and Harvard Medical School.
Vertex, CRISPR finish US filing for gene editing drug approval
Bio Pharma Dive
APRIL 3, 2023
The approval application is the first in the U.S. for a CRISPR-based medicine and puts the partners ahead of a rival therapy from Bluebird bio.
EC grants marketing authorisation for Sandoz’s biosimilar Hyrimoz
Pharmaceutical Technology
APRIL 3, 2023
The European Commission (EC) has granted marketing authorisation for Sandoz’s biosimilar Hyrimoz (adalimumab) citrate-free high-concentration formulation (HCF). Hyrimoz has been approved for use in all the indications covered by the reference medicine Humira, including plaque psoriasis, rheumatic diseases, ulcerative colitis, Crohn’s disease, uveitis and hidradenitis suppurativa.
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
ICMR issues Guidelines for ICMR network of institutions for joint ethics review of multicentre research
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 3, 2023
The Indian Council of Medical Research (ICMR) has issued Guidelines for ICMR network of institutions for joint ethics review of multicentre research.
Hospitals pledge to protect patient privacy. Almost all their websites leak visitor data like a sieve
STAT News
APRIL 3, 2023
Every hospital in America promises to protect the privacy of its patients and the details of their medical care. And almost every one of them uses sophisticated data tools to track and share the personal information of visitors as soon as they start clicking on their websites. A new study found that 99% of U.S. hospitals employed online data trackers in 2021 that transmitted visitors’ information to a broad network of outside parties, including major technology companies, data brokers, an
AbbVie removes two approvals for blood cancer drug Imbruvica
Bio Pharma Dive
APRIL 7, 2023
In paring back use of Imbruvica, the drugmaker has become the latest developer to voluntarily withdraw indications for a cancer medicine following a setback in confirmatory testing.
Vertex and CRISPR Therapeutics submit BLAs to FDA for exa-cel
Pharmaceutical Technology
APRIL 4, 2023
Vertex Pharmaceuticals and CRISPR Therapeutics have completed the rolling submission of biologics licence applications (BLAs) to the US Food and Drug Administration (FDA) for exagamglogene autotemcel (exa-cel) to treat sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). The applications include requests for priority review. If granted, these would shorten the time taken for application review to eight months.
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 introduces training course to create a pool of talented health research professionals
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 5, 2023
In order to create a pool of talented health research professionals in the country, the Indian Council of Medical Research (ICMR) has introduced a training course on “Harnessing the Power of Immunology in Medicine: Tools, Translation and Therapy”.
A deadly disease so neglected it's not even on the list of neglected tropical diseases
NPR Health - Shots
APRIL 1, 2023
It's called noma and is a disease of poverty, striking mainly children. Most patients die. Survivors are badly disfigured.
BioNTech moves into ADCs with Duality deal
Bio Pharma Dive
APRIL 3, 2023
The biotech is expanding its cancer medicine pipeline by licensing two experimental antibody drug conjugates from Shanghai-based Duality.
Sartorius upscales gene therapy prowess with $2.6bn Polyplus acquisition
Pharmaceutical Technology
APRIL 3, 2023
Sartorius , through its French listed sub-group Sartorius Stedim Biotech , has signed an agreement to acquire Polyplus for €2.4bn ($2.6bn). The deal will see Polyplus join the German life science group’s portfolio allowing the latter to leverage expertise in transfection reagents and plasmid DNA for gene therapy. Polyplus, based in Strasbourg, France, produces key components in the production of viral vectors used in cell and gene therapies.
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.
STAT+: ‘True disruption’: Mark Cuban’s company will sell brand-name diabetes medicines from J&J
STAT News
APRIL 4, 2023
For the first time, Mark Cuban’s Cost Plus Drug Company is selling medicines made by a large drug manufacturer directly to consumers at a greatly reduced price, the latest sign that the billionaire is trying to make good on his vow to disrupt the opaque pharmaceutical supply chain. Until now, the company has focused on selling generic versions of brand-name medicines.
Building a better brain through music, dance and poetry
NPR Health - Shots
APRIL 3, 2023
Art can make the brain's wiring stronger, more flexible, and ready to learn, say the authors of the new book, Your Brain on Art: How the Arts Transform Us.
Freeline cuts more jobs and halts Fabry gene therapy work
Bio Pharma Dive
APRIL 4, 2023
The U.K. biotech will lay off 30% of its workforce and focus on an experimental Gaucher disease treatment, five months after an initial restructuring that cut a hemophilia gene therapy.
Alzheimer’s disease not forgotten as FDA oversees record number of designations awarded
Pharmaceutical Technology
APRIL 4, 2023
The FDA has seen a record surge in review designations being awarded over the last two years for Alzheimer’s indications, with 12 review designations being awarded to drugs between 2020 and 2022. This coincided with the much-anticipated wave of monoclonal antibody drugs for Alzheimer’s disease (AD) such as Eisai/Biogen’s Leqembi (lecanemab-irmb) and Eli Lilly’s donanemab, which are predicted to provide significant improvement on previous AD therapies.
After Johnson & Johnson loses again in bankruptcy case, it's game on for talc lawsuits
Fierce Pharma
APRIL 3, 2023
After Johnson & Johnson loses again in bankruptcy case, it's game on for talc lawsuits kdunleavy Mon, 04/03/2023 - 06:44
Doctors are drowning in paperwork. Some companies claim AI can help
NPR Health - Shots
APRIL 5, 2023
New startups believe chatbot technology could help reduce the burden on physicians. But some academics warn bias and errors could hurt patients.
In NEJM, full Pfizer data show RSV vaccine’s protection
Bio Pharma Dive
APRIL 5, 2023
Results from two large clinical trials, published in the high-profile medical journal Wednesday, detail the shot’s safety and efficacy against the common respiratory infection.
BioNTech and DualityBio team up to develop ADC therapeutics for cancer
Pharmaceutical Technology
APRIL 3, 2023
BioNTech has signed exclusive licence and collaboration agreements with Duality Biologics (DualityBio) for the development of two antibody-drug conjugate (ADC) assets for solid tumours. The agreements also include the manufacturing and commercialisation of the two assets, including DB-1303 and DB-1311, across the globe. As part of the new deals, BioNTech will have commercial rights to the ADCs worldwide, excluding mainland China, the Hong Kong special administrative region and the Macau special
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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