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.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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. […].
Rethinking Clinical Trials
SEPTEMBER 30, 2022
The Health Care Systems Research Network (HCSRN) is accepting abstract submissions and panel presentation submissions for its 2023 Annual Conference until October 7, 2022. The conference will be held in Denver, Colorado, from February 21 to 23, 2023. The HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems.
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
The European Medicines Agency (EMA) has accepted Moderna ’s submission seeking a variation to the Conditional Marketing Authorization (CMA) for assessing a 50µg dose of the Omicron-based bivalent Covid-19 booster candidate, mRNA-1273.222, for adults aged 12 years and above. The mRNA-1273.222 vaccine comprises 25µg doses of mRNA-1273 (Spikevax) and a vaccine candidate against the BA.4/BA.5 subvariants of Omicron.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Worldwide Clinical Trials
SEPTEMBER 29, 2022
Ensuring a seamless transition from preclinical to clinical stages in large molecule bioanalysis will help you reach crucial trial milestones on time and within budget. However, optimizing pharmacokinetics (PK) assays to bridge the preclinical-to-clinical gap requires some finesse. This is because the stages differ both in scale (small vs. large) and focus (safety vs. safety and efficacy).
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 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.
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 […].
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Rethinking Clinical Trials
SEPTEMBER 29, 2022
In this Friday’s PCT Grand Rounds, Marianne Chase of Massachusetts General Hospital and Dr. Jörg Goldhahn of ETH Zurich will present “CTTI’s Digital Health Trials Hub: Multi-Stakeholder Resources to Conduct Effective Digital Health Trials.” The Grand Rounds session will be held on Friday, September 30, 2022, at 1:00 pm eastern. Chase is senior director for clinical trial operations as Mass General’s Neurological Clinical Research Institute.
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 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 […].
Advertisement
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 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 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.
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.
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.
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.
Pharmaceutical Technology
SEPTEMBER 26, 2022
The European Commission (EC) has granted approval for AstraZeneca division Alexion’s Ultomiris (ravulizumab) as an add-on to standard therapy to treat generalised myasthenia gravis (gMG) in adults. The treatment is indicated for gMG patients who are anti-acetylcholine receptor (AChR) antibody-positive. In July, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion recommending a grant of marketing authorisation for Ultomiris.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 28, 2022
The next time a fly lands on your food, you might want to consider throwing that bite away. A new review suggests the muck that flies regurgitate could very well be infected with a pathogen. When you think of a disease-carrying insect, chances are you imagine a blood-sucking mosquito or tick. But recent findings suggest […].
Advertisement
Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
STAT News
SEPTEMBER 28, 2022
HARLINGEN, Texas — Here in the Rio Grande Valley almost everyone knows, or cares for, someone with dementia. It’s not a surprise. The region has some of the nation’s highest rates of the disease. But what’s less appreciated is the enormity of the burden carried by the mostly Mexican American caregivers. In a culture where caregiving is a family affair, it’s almost unthinkable for children and spouses to place loved ones in nursing facilities or ask for outside
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.
Pharmaceutical Technology
SEPTEMBER 30, 2022
InflaRx has submitted an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its lead candidate, vilobelimab, to treat Covid-19 patients who are critically ill. The latest development comes after the company had encouraging discussions with the agency at a Type B meeting. In addition, vilobelimab received Fast Track designation from the FDA to treat critically ill, mechanically ventilated, intubated patients with the infection.
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.
Advertisement
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.
STAT News
SEPTEMBER 29, 2022
A clinical trial of one or perhaps two experimental vaccines designed to protect against the Ebola Sudan virus could soon begin in Uganda, as long as the country agrees to allow the research to take place, an official of the World Health Organization said Wednesday. The trial could get underway within a couple of weeks and definitely before the end of October, said Ana Maria Henao-Restrepo, who heads WHO’s R&D Blueprint effort to develop drugs, diagnostics, and vaccines to respon
Bio Pharma Dive
SEPTEMBER 28, 2022
A former Biogen employee sued in 2012, alleging the company paid physician fees to encourage prescribing of its drugs. Biogen did not admit wrongdoing as part of the settlement.
Pharmaceutical Technology
SEPTEMBER 30, 2022
Pheon Therapeutics has announced its launch to progress new antibody-drug conjugates (ADCs) for treating solid tumours. The launch comes after the company raised $68m in a series A financing round led by Brandon Capital, Forbion and Atlas Venture. Seed investor Research Corporation Technologies (RCT) also took part in the funding round. The latest financing will aid the company in progressing its lead ADC programme to clinical proof-of-concept (PoC) and validate the new ADC pipeline. .
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.
Advertisement
Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
Expert insights. Personalized for you.
364 
Let's personalize your content