Bio Pharma Dive
SEPTEMBER 13, 2023
The biotech is telling investors it expects to launch as many as 15 new products in five years, a bold goal that will require a lot to go right to pull off.
Pharmaceutical Technology
SEPTEMBER 13, 2023
The FDA is also reviewing a subcutaneous formulation of Takeda’s blockbuster drug for ulcerative colitis.
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Bio Pharma Dive
SEPTEMBER 13, 2023
“There is a light wind for benefit, and no wind for risk,” said one adviser who voted with eight others to recommend the biotech’s drug Onpattro for cardiomyopathy of ATTR amyloidosis.
Pharmaceutical Technology
SEPTEMBER 13, 2023
Eli Lilly has had its therapy Mounjaro (tirzepatide) approved for patients in England with type 2 diabetes (T2D).
Bio Pharma Dive
SEPTEMBER 13, 2023
This fall will now feature vaccination campaigns for COVID-19, influenza and respiratory syncytial virus.
Pharmaceutical Technology
SEPTEMBER 13, 2023
Currently, NSCLC patients with EGFR exon 19 deletions or L858R substitution face limited therapeutic options after seeing disease progression post-front-line treatment.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 13, 2023
The patch allows for vaccine storage and transport at room temperature along with at-home administration.
Rethinking Clinical Trials
SEPTEMBER 13, 2023
Speakers Matthew Prekker, MD, MPH Associate Professor of Emergency Medicine and Pulmonary and Critical Care Medicine Hennepin County Medical Center University of Minnesota Medical School Jonathan Casey, MD, MSc Assistant Professor of Pulmonary and Critical Care Vanderbilt University Medical Center Director, Coordinating Center, Pragmatic Critical Care Research Group Slides Keywords Critical Care Medicine, Pragmatic Trial, DEVICE, Laryngoscope Key Points Emergency tracheal intubation is a c
Pharmaceutical Technology
SEPTEMBER 13, 2023
The company will divest the AVTX-800 rare disease compound series to AUG Therapeutics, with an expected completion in Q4 2023.
Rethinking Clinical Trials
SEPTEMBER 13, 2023
In this Friday’s PCT Grand Rounds, Pasquale Rummo of the NYU Grossman School of Medicine will present “Effect of Financial Incentives and Default Options on Food Choices of Adults With Low Income in Online Retail Settings.” The Grand Rounds session will be held on Friday, September 15, 2023, at 1:00 pm eastern. Rummo is an associate professor of population health in the NYU Grossman School of Medicine.
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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
Pharmaceutical Technology
SEPTEMBER 13, 2023
On August 28, the FDA approved the label expansion of Bristol Myers Squibb’s Reblozyl, which is set to improve MDS patients’ quality of life.
ACRP blog
SEPTEMBER 13, 2023
With observations of National Hispanic Heritage Month kicking off on September 15, this year’s events will have special resonance for a team of Oregon Health & Science University (OHSU) researchers who are working to bring the benefits of clinical trials to more persons in underserved communities. Eneida R. Nemecek, MD, MS, MBA, an endowed professor of pediatrics and medical oncology and Medical Director of Clinical Research at the Knight Cancer Institute of OHSU, recently received a $625,00
Pharmaceutical Technology
SEPTEMBER 13, 2023
The US Food and Drug Administration has sent letters to eight companies for unauthorised manufacturing or marketing of unapproved eye drugs.
Fierce Pharma
SEPTEMBER 13, 2023
For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. | For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. But on Tuesday, an FDA advisory committee agreed by a 16-0 vote that the ingredient does not work.
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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
Pharmaceutical Technology
SEPTEMBER 13, 2023
Dewpoint Therapeutics entered a collaboration with Chemify to expedite the discovery of molecules that target cancer and neurodegeneration.
XTalks
SEPTEMBER 13, 2023
This episode features an interview with Ram Mukunda and Claudia Grimaldi from IGC Pharma , a clinical-stage pharmaceutical company focused on improving the health and well-being of patients affected by Alzheimer’s disease and bringing therapies for it to market. The company is currently conducting a Phase II study with IGC-AD1, an investigational low-dose tetrahydrocannabinol-(THC) based formulation that reduces neuropsychiatric symptoms such as agitation in dementia due to Alzheimer’s.
Pharmaceutical Technology
SEPTEMBER 13, 2023
Diet and weight-loss drugs have entered the public consciousness, particularly for their usefulness in treating obesity-related diabetes.
Intouch Solutions
SEPTEMBER 13, 2023
As summer comes to a close, we’re recapping a few of the employee virtual events hosted through our Virtual Vibes program. Virtual Vibes is a program for ‘INTOUCHers’ developed by ‘INTOUCHers’ with the goal of bringing employees together, both in-person and virtually, to build relationships, culture, and community beyond the day-to-day. In our “Escape to Italy” Virtual Vibes series, Agency Culture Influencer, Michael Tatasciore, planned a variety of Italian summer-inspired events for employees t
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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.
Pharmaceutical Technology
SEPTEMBER 13, 2023
Moonshot incubator client Axolotl Biologix has finalised a merger with Carmell Therapeutics to bolster the regenerative medicine sector.
Pharma Times
SEPTEMBER 13, 2023
Theoria technologies aims to empower those affected by dementia - News - PharmaTimes
Pharmaceutical Technology
SEPTEMBER 13, 2023
Roche planned to launch its new subcutaneous Tecentriq formulation this year, but it will be pushed back after tweaks requested by FDA.
BioSpace
SEPTEMBER 13, 2023
During Wednesday’s annual R&D Day, Moderna said it is culling four programs from its pipeline, including two molecules that had been discontinued last year by AstraZeneca.
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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.
Pharmaceutical Technology
SEPTEMBER 13, 2023
Menarini Asia-Pacific has entered a long-term exclusive agreement to license Astellas Pharma’s Smyraf to treat rheumatoid arthritis.
Fierce Pharma
SEPTEMBER 13, 2023
While the FDA and the Centers for Disease Control and Prevention (CDC) have signed off on updated COVID vaccines for this season, Moderna is already reportedly preparing for lower demand for its sh | Moderna is speaking with its manufacturing partners to scale back production of its mRNA COVID vaccine to adapt to the endemic phase of the disease, Moderna’s president and R&D head, Stephen Hoge, said, Reuters reports.
Pharmaceutical Technology
SEPTEMBER 13, 2023
Hasten Biopharmaceutical has signed an agreement to develop and commercialise LIB Therapeutics’ lerodalcibep in Greater China.
BioSpace
SEPTEMBER 13, 2023
AlveoGene has licensed the U.K. Respiratory Gene Therapy Consortium’s InGenuiTy platform for all uses excluding the CTFR gene, which is already licensed to Boehringer Ingelheim for cystic fibrosis.
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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.
Antidote
SEPTEMBER 13, 2023
Globally, there are thousands of research studies and clinical trials conducted each year, all with the shared goal of bringing new treatment options and medical devices to the market. However, approximately 80% of clinical trials are delayed or closed because of problems with recruitment.
BioSpace
SEPTEMBER 13, 2023
In the largest biotech Series C financing so far this year, Generate:Biomedicines picked up new investors including Amgen and NVIDIA’s venture capital arm to advance its pipeline of 17 programs.
Fierce Pharma
SEPTEMBER 13, 2023
Moderna has spent the last several years riding the ups and downs of the COVID-19 pandemic. | Moderna CEO Stéphane Bancel is optimistic that the company will beat the low end of its $6 billion to $8 billion COVID vaccine sales estimate for 2023. But his optimism comes as Moderna reportedly eyes manufacturing cuts as it shifts to an endemic market response.
Pharma Times
SEPTEMBER 13, 2023
Four research innovation teams are set to receive £500,000 each - News - PharmaTimes
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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.
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