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.
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.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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.
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.
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.
Pharmaceutical Technology
JUNE 29, 2023
Carrie Harney, the vice president of government and regulatory Affairs at US Pharmacopeia (USP) explains US drug shortages.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 29, 2023
Experts warn caution around CRISPR gene editing technology on human embryos as it may have dangerous consequences.
Bio Pharma Dive
JUNE 29, 2023
Despite hesitations, an advisory committee recommended use of the drug — a medicine Roche once developed for lung diseases — to treat the rare condition fibrodysplasia ossificans progressiva.
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.
Pharma Mirror
JUNE 29, 2023
A bright smile is said to be the best compliment one can hear from others, and the heart of preserving and sweetening those smiles lies in a dentist’s hand. Dentistry, the art, and science of oral health, confines a diverse range of practices and professionals committed to maintaining the well-being of your teeth, gums, and overall oral health.
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
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.
Pharmaceutical Technology
JUNE 29, 2023
AstraZeneca has announced impressive results for its STRIDE regimen, significantly boosting survival rates for advanced HCC patients.
Rethinking Clinical Trials
JUNE 29, 2023
Rosa Gonzalez-Guarda and Cherise Harrington In an interview during the Annual Steering Committee Meeting, Drs. Rosa Gonzalez-Guarda and Cherise Harrington, cochairs of the Health Equity Core Working Group , shared insights and next steps for health equity in the NIH Pragmatic Trials Collaboratory. One question discussed at the meeting was how to embed health equity in pragmatic clinical trials.
Pharmaceutical Technology
JUNE 29, 2023
While Alvotech aims to file a new application, the FDA's rejection delays the drug’s US launch in a landmark year for Humira biosimilars.
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
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 29, 2023
The Drugs Technical Advisory Board (DTAB) has recommended to get comments and inputs from Indian Council of Medical Research (ICMR) for further action on restricting Nicotine Replacement Therapies (NRTs) containing upto 2 mg or 4 mg only through prescription of authorised medical practitioners, as proposed by the Tobacco Control Division (TCD).
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.
Pharmaceutical Technology
JUNE 29, 2023
The T-cell therapeutics company expects to be listed on the NYSE after deal completion in Q4 2023.
Rethinking Clinical Trials
JUNE 29, 2023
This podcast continues the discussion with Dr. Joshua Denny as he discusses improving health through the All of Us research program. Click on the recording below to listen to the podcast. NIH Pragmatic Trials Collaboratory · Podcast 46: All of Us Research Program NIH Pragmatic Trials Collaboratory · Podcast 45: From Observational Studies to Pragmatic Clinical Trials: Research in PCORnet® NIH Pragmatic Trials Collaboratory · Podcast 44: The Heartline Trial: A New Paradigm in Conducting Virtual Cl
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.
Fierce Pharma
JUNE 29, 2023
Much attention has been paid to Vertex’s efforts to develop a stem cell therapy for Type 1 diabetes. | Much attention has been paid to Vertex’s efforts to develop a stem-cell therapy for Type 1 diabetes. But flying under the radar with an allogenic (donor) gene therapy for the disorder has been Chicago startup CellTrans. Thursday, the FDA signed off on CellTrans’ Lantidra (donislecel), the first cell therapy for type 1 diabetes.
Outsourcing Pharma
JUNE 29, 2023
Anebulo Pharmaceuticals is currently developing a new, first-of-its-kind drug, ANEB-001, intended to rapidly reverse the negative effects of ACI within one hour of administration. The treatment is a cannabinoid receptor antagonist, which blocks THC, the substance which gives cannabis its psychotropic effects, from binding in a personâs CB1 receptor.
Antidote
JUNE 29, 2023
In order to connect people with medical research opportunities, it is important to understand what motivates patients to participate in clinical trials. We asked 4,000 volunteers and caregivers to gain insight into their motivation for clinical trial participation. Here’s what we learned.
Intouch Solutions
JUNE 29, 2023
The Cannes Lions Festival of Creativity just clocked its 70 th anniversary, signaling a big milestone for this legendary event — and another one for EVERSANA INTOUCH: A Gold Lion for “Inequality You Can’t Ignore” with The Chrysalis Initiative ! Gold on day one was quite a start to a week of inspiration. But the following days delivered with a gallery of stunning work and insightful sessions.
Advertisement
When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Drug Discovery World
JUNE 29, 2023
AstraZeneca has announced a $400 million investment in its global AZ Forest programme, raising its commitment to plant 200 million trees by 2030. This includes new or expanded projects in Brazil, India, Vietnam, Ghana and Rwanda that will contribute to the company’s climate action, restore nature, promote biodiversity and build ecological and community resilience, spanning over 100,000 hectares worldwide.
Fierce Pharma
JUNE 29, 2023
A new treatment for Alzheimer’s disease agitation episodes might be on the horizon, but a principal trial investigator skirting protocol could muddy the waters. | After a December FDA inspection revealed a principal trial investigator skirted several study protocols, BioXCel found forged emails making it out that the site had properly adhered to reporting requirements for adverse events.
Drug Discovery World
JUNE 29, 2023
Poolbeg Pharma, a clinical-stage biopharmaceutical company focusing on infectious and other prevalent diseases with a high unmet medical need, has announced a breakthrough in its influenza AI Programme with CytoReason. Poolbeg has been working with CytoReason since March 2022. Poolbeg’s disease progression data from influenza human challenge trials combined with CytoReason’s broad repositories of curated disease data were analysed using CytoReason’s AI-led platform.
Pharma Times
JUNE 29, 2023
Partnership establishes several influenza therapy targets using artificial intelligence - News - PharmaTimes
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.
Outsourcing Pharma
JUNE 29, 2023
uMotif is starting to reap the rewards of its patient first technology â that really does what it says on the tin, says the companyâs CEO, Steve Rosenberg.
Fierce Pharma
JUNE 29, 2023
After growing the Institute for Clinical and Economic Review (ICER) into an influential drug pricing watchdog, Steve Pearson, M.D., is stepping down. | After growing the Institute for Clinical and Economic Review into an influential drug pricing watchdog, Steve Pearson is stepping down.
BioPharma Reporter
JUNE 29, 2023
Astraveus, the creator of modular, microfluidic cell foundries for cell and gene therapy (CGT) manufacturing, has raised â16.5 million in series seed financing.
Fierce Pharma
JUNE 29, 2023
While Dupixent often steals the show, Sanofi isn’t sleeping on its vaccine franchise. | By 2030, Sanofi figures its immunizations could generate more than €10 billion in annual sales, the company said during a vaccines R&D event Thursday. Much of that momentum hinges on Sanofi’s pipeline, where the company is targeting an “accelerated pace of innovation” in a bid to launch at least five phase 3 vaccine programs by 2025.
Advertisement
As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
Expert insights. Personalized for you.
330 
Let's personalize your content