Bio Pharma Dive
MAY 1, 2023
Founded by Sam Waksal, Graviton Biosciences is developing drugs that block an enzyme called ROCK2, which drew the interest of neurology-focused Ovid.
Pharmaceutical Technology
MAY 1, 2023
Astellas Pharma has entered into a definitive agreement to buy US-based biopharmaceutical company Iveric bio, in a deal valued at nearly $5.9bn. Under the deal terms, the company, through Astellas US Holding’s wholly owned subsidiary Berry Merger Sub, will acquire all the outstanding Iveric Bio shares for $40.00 in cash for each share. Both the companies’ Boards of Directors have unanimously approved the deal.
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AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 4, 2023
Scientists from the University of Michigan in the US have detected a surge of activity in the brains of two people as they transitioned into death, with the phenomenon similar to spikes of brain activity seen previously in animals whose hearts had stopped beating.
Medical Xpress
MAY 4, 2023
Secondary bacterial infection of the lung (pneumonia) was extremely common in patients with COVID-19, affecting almost half the patients who required support from mechanical ventilation. By applying machine learning to medical record data, scientists at Northwestern University Feinberg School of Medicine found that secondary bacterial pneumonia that does not resolve was a key driver of death in patients with COVID-19.
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Bio Pharma Dive
MAY 3, 2023
The decision represents the first fruits of a scientific breakthrough a decade ago that gave drugmakers, among them GSK, Pfizer and Moderna, a blueprint for an effective shot against the virus.
Pharmaceutical Technology
MAY 2, 2023
The FDA recently announced the expansion of the emergency use authorizations (EUAs) of both Pfizer/BioNTech’s and Moderna’s bivalent original/Omicron BA.4/5 Covid-19 messenger RNA (mRNA) vaccines. The expanded EUAs state that these current bivalent vaccines are now to be used for all primary and booster doses administered to individuals ages six months of age and older.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Medical Xpress
MAY 1, 2023
Reports of near-death experiences—with tales of white light, visits from departed loved ones, hearing voices, among other attributes—capture our imagination and are deeply engrained in our cultural landscape.
Bio Pharma Dive
MAY 1, 2023
The cash influx extends Maze’s financial runway into 2025, giving the South San Francisco company time to advance other drug candidates into testing.
Pharmaceutical Technology
MAY 4, 2023
Forge Biologics and global life sciences company Labcorp have announced a strategic adeno-associated virus (AAV) gene therapy development and manufacturing collaboration. Gene therapy clients will gain access to coordinated scientific expertise, drug development services and AAV manufacturing capabilities, advancing the development of new gene therapies.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 1, 2023
Microscopic backpacks full of drugs designed to stick to troublesome immune cells have been shown to improve the health of mice with a condition similar to multiple sclerosis in humans.
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
Medical Xpress
MAY 2, 2023
Rumors of artificial intelligence becoming sentient abound. In July of 2022, a Google engineer claimed that an AI chatbot he was working with had become self-aware. The same AI recently passed the Turing Test, once considered the gold standard for determining if something was human.
Bio Pharma Dive
MAY 2, 2023
Fresh off its success with the multiple myeloma treatment Carvykti, J&J is paying Cellular Biomedicine Group $245 million upfront for rights to two experimental cell therapies for blood cancer.
Pharmaceutical Technology
MAY 2, 2023
The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS). The regulatory body has also granted priority review to the application and set 28 August 2023 as a target date for the prescription drug user fee act (PDUFA).
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 3, 2023
Pharmaceutical giant Eli Lilly said Thursday it will seek approval to add its diabetes drug to the buzzy US weight loss market after achieving promising results in a new clinical trial. Tirzepatide, currently approved to treat type 2 diabetes under the name Mounjaro, is taken once a week as an injection.
Medical Xpress
MAY 3, 2023
Scientists of the Princess Máxima Center for pediatric oncology and Hubrecht Institute in the Netherlands have revealed new scientific insights into the features of fibrolamellar carcinoma (FLC), a rare type of childhood liver cancer.
Bio Pharma Dive
MAY 2, 2023
The drugmaker beat Wall Street’s first quarter forecasts despite a sales drop that puts pressure on it to succeed with upcoming market launches.
Pharmaceutical Technology
MAY 4, 2023
Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for KALYDECO (ivacaftor) to treat children with cystic fibrosis (CF) aged between one and four months. The approval allows KALYDECO to be used in infants who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to the therapy, on the basis of clinical and/or in vitro assay results.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 4, 2023
Indian pharma & healthcare faces numerous challenges in the supply chain, such as lack of visibility to the recipients and the shippers, maintaining the integrity and safety of temperature-sensitive products, meeting regulatory compliance requirements, and managing logistics costs while ensuring timely delivery.
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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
Pharma Times
MAY 5, 2023
Systems will support millions of patients with chronic respiratory conditions throughout Europe
Bio Pharma Dive
MAY 3, 2023
The company plans to quickly submit an application for U.S. approval based on the trial results, which showed a consistent benefit to treatment with the drug, called donanemab.
Pharmaceutical Technology
MAY 1, 2023
Teva Pharmaceuticals and MedinCell have received approval from the US Food and Drug Administration (FDA) for Uzedy (risperidone) extended-release injectable suspension to treat adult patients with schizophrenia, a chronic, progressive, and severely debilitating mental health disorder. Developed using MedinCell’s SteadyTeq copolymer technology, Uzedy is the first subcutaneous, long-acting formulation of risperidone.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 2, 2023
Experts have advocated for immunizing both young boys and girls against human papillomavirus (HPV) with latest generation vaccines like Gardasil-9 to address the increasing incidences of cancer cases in India. Gardasil-9 is India’s first gender-neutral HPV vaccine.
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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.
Medical Xpress
MAY 1, 2023
The exercise was simple: inhale for a count of five, then exhale for a count of five. Do that for 20 minutes, twice a day, for four weeks.
Bio Pharma Dive
MAY 5, 2023
The biotech is the latest startup to capitalize on rising investor interest in targeted drugs that use radioisotopes to destroy tumors.
Pharmaceutical Technology
MAY 5, 2023
TFF Pharmaceuticals and the National Institute of Environmental Health Sciences (NIEHS) have signed an agreement for the development of dry powder formulations of high molecular weight hyaluronan (HMW-HA) for respiratory diseases. Under the collaborative research and development agreement (CRADA), respirable dry powder formulations of HMW-HA will be developed for prevention and treatment.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 3, 2023
The Department of Pharmaceuticals (DoP) has approved the applications of five medical devices companies under the production linked incentive (PLI) scheme for promoting domestic manufacturing of medical devices, in the category it has added through an amendment of guidelines in August, 2022.
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.
Medical Xpress
MAY 3, 2023
A new study shows that sleep spindles, brief bursts of brain activity occurring during one phase of sleep and captured by EEG, may regulate anxiety in people with post-traumatic stress disorder (PTSD).
Bio Pharma Dive
MAY 4, 2023
After issues with a contract research group, the partners now expect to file an approval application for their shot in 2026, one year later than initially anticipated.
Pharmaceutical Technology
MAY 1, 2023
Nicox’s Chinese partner Ocumension Therapeutics has secured priority review status for the New Drug Application (NDA) for Zerviate (cetirizine ophthalmic solution), 0.24%, from China’s National Medical Products Administration (NMPA). This will expedite the regulatory approval process as well as the launch of Zerviate in the country, expected next year.
Pharma Times
MAY 4, 2023
The treatment is a small molecule that activates endogenous retinal stem and progenitor cells
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