Bio Pharma Dive
AUGUST 7, 2023
The need for more research into rare diseases is clear, but researchers face significant challenges. Fortunately, technology has created opportunities to innovate in clinical trials for rare diseases.
Pharmaceutical Technology
AUGUST 7, 2023
Health Canada has granted approval for GSK’s Arexvy vaccine to prevent RSV-caused lower respiratory tract disease in older adults.
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Bio Pharma Dive
AUGUST 7, 2023
The investment bank estimates that, while many smaller biotechs are laying off staff, larger companies are still growing from early 2021 levels.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 7, 2023
Fitness trackers help you stay healthy by keeping count of your steps and monitoring your heart rate, driving you on to hit those cardio goals. New research from ETH Zürich in Switzerland could see future wearable devices (with perhaps a few implants and a touch of genetic engineering) boost our health directly.
Pharmaceutical Technology
AUGUST 7, 2023
Iveric Bio, an Astellas company, has received clearance from the US Food and Drug Administration (FDA) for IZERVAY.
Bio Pharma Dive
AUGUST 7, 2023
Analysts are now questioning whether Sage’s partner Biogen will hand back rights to the drug, which was approved for postpartum depression but not major depressive disorder.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
AUGUST 7, 2023
Keynote: Can the COVID-19 Crisis Lead to Reformation of the Evidence Generation Ecosystem? Description Dr. Robert Califf leads a discussion about opportunities to reform and rebuild the evidence generation ecosystem after the COVID-19 public health crisis Biography Robert Califf, MD Comissioner of Food and Drugs, U.S. Food and Drug Administration The post Keynote: Can the COVID-19 Crisis Lead to Reformation of the Evidence Generation Ecosystem?
Pharmaceutical Technology
AUGUST 7, 2023
HuidaGene claims its gene therapy candidate was superior to FDA-approved Luxturna in preclinical studies.
Rethinking Clinical Trials
AUGUST 7, 2023
From left: Devon Check and Hayden Bosworth In an interview at the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting, Implementation Science Core cochairs Hayden Bosworth and Devon Check reflected on the Core’s goals and factors for implementation success. The Implementation Science Core, which launched in 2022, supports implementation-related research aims in pragmatic clinical trials to promote the uptake and sustainability of effective interventions in routine practice
Bio Pharma Dive
AUGUST 7, 2023
As research evolves for new oncology treatments, companies including Context Therapeutics are developing potential therapies focused on the emerging novel oncology target Claudin 6 (CLDN6).
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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
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 7, 2023
The Union health ministry has issued a notification prohibiting the manufacture, sale and distribution of pain killers, ketoprofen and aceclofenac and their formulations for animal use with immediate effect, as they are likely to involve risk to animals.
Pharmaceutical Technology
AUGUST 7, 2023
The UK Health Security Agency (UKHSA) has opened a vaccine development and evaluation centre (VDEC) to globally bolster pandemic preparedness.
Bio Pharma Dive
AUGUST 7, 2023
The all-stock deal comes months after Gilead waived an option to buy Pionyr, and gives Ikena some needed breathing room in a tough market.
Pharmaceutical Technology
AUGUST 7, 2023
Basilea Pharmaceutica has announced the submission of a new NDA seeking approval from the US FDA for its antibiotic ceftobiprole.
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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
Rethinking Clinical Trials
AUGUST 7, 2023
Keynote: Diverse Representation Among Clinical Trial Participants: Why It’s Important and How Can We Improve Description Dr. Clyde Yancy presents the keynote session for the Diversity Workshop Grand Rounds series. Biography Clyde W. Yancy, MD, MSc, MACC, FAHA, MACP, FHFSA Vice Dean, Diversity and Inclusion, Northwestern University, Feinberg School of Medicine The post Keynote: Diverse Representation Among Clinical Trial Participants: Why It’s Important and How Can We Improve appeared
Pharmaceutical Technology
AUGUST 7, 2023
Following the publication of Phase II trial results and marketing approval in China, Akeso has started five Phase III trials.
Pharmaceutical Commerce
AUGUST 7, 2023
Creating a user-centric approach that harnesses both digital tools and behavioral science is key to getting—and maintaining—patients on therapy, and improving clinical, financial, and, ultimately, brand-success outcomes for pharma manufacturers.
Pharmaceutical Technology
AUGUST 7, 2023
BioNTech will hold marketing global rights for Duality Bio’s antibody-drug conjugates, except in China, Hong Kong, and Macau.
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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.
XTalks
AUGUST 7, 2023
Netflix, known for its thrilling documentaries, stirred the pot once again with another insightful exposé. This time, the streaming service plunged into the world of food safety with its newest Netflix food documentary, “Poisoned: The Dirty Truth About Your Food,” which promises to question viewers’ perception about everyday foods and their origins.
Pharmaceutical Technology
AUGUST 7, 2023
The July slump in healthtech jobs shouldn't be read as an indictment of the sector but as proof of its longevity.
Drug Patent Watch
AUGUST 7, 2023
A recent update from Foley & Lardner attorney Courtenay C. Brinckerhoff discusses trends in Inter Partes Review (IPR) and Post Grant Review (PGR) proceedings involving Orange Book and biologic patents, based… The post Insights into Shifting Dynamics: Orange Book and Biologic PTAB Trends appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
AUGUST 7, 2023
A new FDA guideline gives manufacturers suggestions to identify carcinogenic drug compounds through clinical study.
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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.
BioPharma Reporter
AUGUST 7, 2023
Evox Therapeutics, an exosome therapeutics company, has announced a research collaboration and option agreement with the Icahn School of Medicine at Mount Sinai in New York, US.
Outsourcing Pharma
AUGUST 7, 2023
The first oral pill in the United States specifically for postpartum depression, a serious mental illness, has been approved by the US Food and Drug Administration (FDA).
Fierce Pharma
AUGUST 7, 2023
Less than four months after Astellas’ $5.9 billion buyout of eye disease specialist Iveric Bio, the deal is already making the Tokyo-based company look visionary. | Less than four months after Astellas’ $5.9 billion buyout of Iveric Bio, the FDA has signed off on the main asset acquired in the deal, the geographic atrophy treatment Izervay.
Outsourcing Pharma
AUGUST 7, 2023
OSP was fortunate enough to have an interesting discussion with Stephen Corson, who is a statistics manager at Phastar, a specialist biometrics CRO headquartered in the UK.
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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.
Fierce Pharma
AUGUST 7, 2023
As Pfizer eyes possible cost cuts, its COVID vaccine partner BioNTech is “carefully watching” its spending, the German company’s finance chief Jens Holstein
BioSpace
AUGUST 7, 2023
Data from a Phase III study released Tuesday found that Novo Nordisk’s Wegovy lowered the risk of cardiovascular complications and death by 20% versus placebo in overweight and obese adults.
Fierce Pharma
AUGUST 7, 2023
While an FDA approval is typically cause for celebration, Sage Therapeutics and Biogen have a tough road ahead to market their new postpartum depression (PPD) drug. | Friday, the U.S. FDA gave the green light to zuranolone. Now going by the commercial moniker Zurzuvae, the partners’ drug represents the first and only oral treatment for women with PPD, which affects some 500,000 patients in the U.S. each year, according to Biogen and Sage.
Pharma Times
AUGUST 7, 2023
Partnership with Icahn School of Medicine will involve developing exoAAV vectors for heart disease patients - 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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