Bio Pharma Dive
SEPTEMBER 30, 2022
The drug, which will be sold as Relyvrio, showed modest benefits in function and survival in testing. It also became the latest test of the FDA's flexibility toward new therapies for neurological disorders.
Pharmaceutical Technology
SEPTEMBER 30, 2022
After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Last month, Zynteglo (betibeglogene autotemcel), or beti-cel, was approved as a one-time potentially curative gene therapy for patients with beta-thalassaemia who require regular blood transfusions. Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September.
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AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 27, 2022
The US Food and Drug Administration (FDA) is now warning that breast implants filled with either silicone or saline may, on rare occasions, give rise to cancer in the scar tissue around breast implants. The safety notice was published this month and is based on an extensive review of the emerging literature on breast implants. […].
Pharma Times
SEPTEMBER 29, 2022
Results show reduction of clinical decline in global study of people with Alzheimer's Disease
Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health
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
SEPTEMBER 28, 2022
The companies said the drug, called lecanemab, met all of its goals in the Phase 3 study. The data are a significant finding and provide stronger support for a much-debated hypothesis for treating Alzheimer’s.
Pharmaceutical Technology
SEPTEMBER 29, 2022
Indian company Torrent Pharmaceuticals has signed a definitive agreement for the complete acquisition of Curatio Healthcare for $245.16m (Rs20bn). The deal comprises cash and cash equivalents worth $14m (Rs1.15bn) in the acquired business representing an enterprise value of $231m (Rs18.85bn). The latest takeover is anticipated to boost the presence of Torrent in the dermatology segment.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
SEPTEMBER 28, 2022
Phase 1b study evaluates effects of sevuparin on the symptoms of volunteer participants
Bio Pharma Dive
SEPTEMBER 30, 2022
The application comes a year earlier than previously had been expected, as company says drug reviewers are open to accelerated review based on data from early-stage trials.
Pharmaceutical Technology
SEPTEMBER 28, 2022
Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted four new approvals for Merck ’s (MSD outside North America) humanised monoclonal antibody, Keytruda (pembrolizumab), to treat various types of cancers. The approvals include Keytruda plus chemotherapy as neoadjuvant treatment and then continued as a single agent for adjuvant treatment post-surgery in hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative breast cancer patients.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 29, 2022
Monitoring the status of critically-ill patients in hospital is an essential task often complicated by the need to make tough, high-stake decisions under pressure. In intensive care especially, seconds count. According to a new study, algorithms could soon fill the role instead. Researchers propose software could be trained to accurately and reliably spot changes in […].
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
Pharma Times
SEPTEMBER 26, 2022
The study will focus on checkpoint inhibitor refractory non-small cell lung cancer
Bio Pharma Dive
SEPTEMBER 30, 2022
The biotechnology startup will part with its lead drug candidate, an anti-inflammatory small molecule, in Novo Nordisk’s bet on inflammasome treatments.
Pharmaceutical Technology
SEPTEMBER 28, 2022
Emergent BioSolutions has acquired exclusive global rights for oral smallpox antiviral, Tembexa (brincidofovir), from Chimerix. Tembexa has two formulations, a 100mg tablet form and 10mg/mL oral suspension, indicated to be administered once a week for two weeks. In June last year, the US Food and Drug Administration (FDA) granted approval for the antiviral therapy to treat human smallpox disease in adult as well as paediatric patients, including neonates.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 30, 2022
The Department of Commerce (DoC) has approved setting up a separate Export Promotion Council (EPC) for the medical devices sector under the administrative control of the Department of Pharmaceuticals to help exporters in promoting their products in international markets. The medical devices industry welcomed the move and the strategic step will go a long way […].
Pharma Times
SEPTEMBER 29, 2022
Positive results in COVID-19 therapy phase 3 trials show effectiveness against five symptoms
Bio Pharma Dive
SEPTEMBER 28, 2022
The company and its development partner, CRISPR Therapeutics, will begin submitting a rolling application in November. The blood disease treatment is the first of its kind to near an FDA review.
Pharmaceutical Technology
SEPTEMBER 27, 2022
Pfizer and BioNTech have submitted an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a 10µg booster of their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine in children. The companies sought authorisation for booster vaccine usage in children aged five to 11 years. Their application is based on bivalent Omicron BA.1-adapted vaccine’s safety and immunogenicity findings, non-clinical and manufacturing data of 10µg bivalent Omicron BA.4/
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 26, 2022
The National Medical Commission (NMC), the apex medical education regulatory body, has come out with draft Establishment of Medical College Regulations, (Amendment), 2022 ushering changes in rules for setting up medical institutes. The draft amendment regulations introduced changes in qualifying criteria for establishing medical colleges mentioned in ‘Establishment of Medical College Regulations, 1999.
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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
STAT News
SEPTEMBER 30, 2022
For a while, scientists thought the trillions of microbes on our bodies lived in landscapes connected to the outside world — our skin, hair, and gut — but research in the last few years has shown that’s not so. When Ravid Straussman, a cancer biologist at the Weizmann Institute of Science in Israel, looked deeper, he and several other research groups around the world found bacteria in the milieu of tumors.
Bio Pharma Dive
SEPTEMBER 26, 2022
The request, if cleared, would make U.S. kids between 5 through 11 eligible to receive a "bivalent" shot targeting components of the omicron variants currently circulating.
NPR Health - Shots
SEPTEMBER 30, 2022
California Rep. Ami Bera was bitten by a rabid fox on Capitol Hill in April. He's OK, but now, he wants to make sure the cost of the lifesaving treatment isn't a burden for those who need it.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 26, 2022
Eczema (or atopic dermatitis) affects millions of people, particularly children under the age of six. The chronic inflammatory skin disorder causes the skin to go red and dry and to start oozing and itching, making life very uncomfortable. There’s currently no cure for the condition, just ways of managing it – but an existing drug […].
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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.
STAT News
SEPTEMBER 27, 2022
The California State Legislature has sent a bill to Gov. Gavin Newsom that strengthens discipline for doctors who knowingly spread Covid-19 misinformation. Legislation like this is sorely needed across the country. More than two years into the pandemic, Covid-19 misinformation still runs rampant. Some comes from doctors spreading lies about unproven — and actually harmful — “treatments” for Covid-19 and promoting anti-vaccine conspiracy theories.
Bio Pharma Dive
SEPTEMBER 26, 2022
Over the last 2 years, a greater spotlight has shone on inequalities in health care, and the greater need to improve health equity.
NPR Health - Shots
SEPTEMBER 29, 2022
Researchers say diseases that spread between humans and animals will become increasingly commonplace as human expansion into previously uninhabited areas intensifies.
Pharma Times
SEPTEMBER 26, 2022
Precision X affinity ligand will enable the efficient purification of the non-Fc fusion protein
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 News
SEPTEMBER 28, 2022
BROWNSVILLE, Texas — Gladys Maestre is on a scouting mission. The Alzheimer’s disease researcher is driving through Southmost, a Mexican American neighborhood just north of looming sections of the border wall and a checkpoint that leads to Mexico. She passes barking dogs and “no trespassing” signs, but doesn’t see a single person outside, despite the comfortable stuffed recliners, refrigerators, and shade canopies that furnish many yards.
Bio Pharma Dive
SEPTEMBER 26, 2022
The startup, which launched last year with $315 million in funding and plans to advance a new form of gene editing, is one of the first big venture-backed biotechs in several months to seek an IPO.
NPR Health - Shots
SEPTEMBER 28, 2022
These Black men saved lives a half-century ago. A new book highlights their successes and the challenges they had to face. Some now want to make sure that memory is not forgotten.
pharmaphorum
SEPTEMBER 28, 2022
The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report. The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.
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