Bio Pharma Dive
JULY 5, 2023
Phase 2 results show a pill the company is developing is competitive with other oral medicines in testing against psoriasis, among them the TYK2 inhibitors that have drawn significant industry interest.
Pharmaceutical Technology
JULY 5, 2023
Following FDA approival and CE marking for Incyte’s JAK-inhibiting cream Opzelura (ruxolitinib), the MHRA has followed suit in the UK.
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Bio Pharma Dive
JULY 5, 2023
The deal enables Sarepta to quickly cash in on the clearance of Elevidys, with $102 million in new funds to help bankroll its drug research.
Pharmaceutical Technology
JULY 5, 2023
The corporate strategy aims to introduce new legislation for faster regulations, new international collaborations, and digitisation.
Bio Pharma Dive
JULY 5, 2023
The medicine delayed disease progression compared to chemotherapy in a closely watched lung cancer trial. But analysts questioned its effect size and safety, and AstraZeneca shares fell more than 8%.
Rethinking Clinical Trials
JULY 5, 2023
June 23-24, 2023 : The NIH Pragmatic Trials Collaboratory hosted a Pre-Conference Workshop, “Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials Workshop,” at the Health Care Systems Research Network 2023 Annual Conference. This training workshop introduces concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs) and provides firsthand ePCT experiences and case studies from the NIH Pragmatic Trials Collaboratory Demonstrat
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 5, 2023
The EC approved extending the label for Vertex Pharmaceuticals’ Orkambi to treat cystic fibrosis in children aged one to two years.
Rethinking Clinical Trials
JULY 5, 2023
Dr. Ankeet Bhatt In this Friday’s PCT Grand Rounds, Ankeet Bhatt of the Kaiser Permanente Northern California Division of Research will present “Implementing Virtual Strategies Across an Integrated Healthcare System: The IMPLEMENT-HF Study.” The Grand Rounds session will be held on Friday, July 7, 2023, at 1:00 pm eastern. Dr. Bhatt is an associate physician at the Kaiser Permanente San Francisco Medical Center and a research scientist at the Kaiser Permanente Northern Californ
Pharmaceutical Technology
JULY 5, 2023
ChatGPT's release to the public in November 2022 started a wave of global interest and funding, but has the hype outrun AI development?
BioPharma Reporter
JULY 5, 2023
Lucy Jung is the CEO and founder at Charco Neurotech, a medtech start-up which has developed the CEU1, a non-invasive wearable device for Parkinson's, that uses vibrotactile stimulation to reduce symptoms of slowness and stiffness resulting in improved movement. We spoke to her about her background, how she got involved in the Parkinson's space and her fascination for problem-solving.
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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
JULY 5, 2023
The UK NHS has announced plans to provide ranibizumab for preventing blindness in preterm babies with retinopathy of prematurity.
Fierce Pharma
JULY 5, 2023
Despite political tensions between Washington and Beijing, foreign pharmaceutical investments are progressing in China. | In a deal that could be worth up to $1 billion, Massachusetts-based Moderna inked a memorandum of understanding, plus a land collaboration agreement, to research, develop and manufacture mRNA medicines in China.
Pharmaceutical Technology
JULY 5, 2023
The United States Patent and Trademark Office has provided a new patent for OSE Immunotherapeutics’ Tedopi, a vaccine for cancer.
Drug Discovery World
JULY 5, 2023
Mark Garner, PhD., Global Cancer Segment Market Manager at Agilent Technologies, recently sat down with DDW Editor Reece Armstrong to tell us about the developments in the ‘golden age’ of cancer research. RA: Please can you tell us a bit more about your role at Agilent? MG: I am responsible for Agilent’s cancer segment. You could describe my role as being a convener across all our cancer research-related product lines, our Medical Affairs team, and the rest of the organisation.
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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
JULY 5, 2023
The Chinese NMPA has granted approval for RareStone Group’s pitolisant to treat cataplexy in adult narcolepsy patients.
Antidote
JULY 5, 2023
Breast cancer as defined by the Centers for Disease Control and Prevention (CDC) is “a disease in which cells in the breast grow out of control.” It is the second leading cause of cancer-related death in women, and approximately 264,000 new cases are diagnosed in the United States each year.
Pharmaceutical Technology
JULY 5, 2023
FSD Pharma has named Zeeshan Saeed as the new chief executive officer (CEO) of the firm through a unanimous vote
XTalks
JULY 5, 2023
In this episode, Vera interviews two experts from CytoMed Therapeutics: Mr. Choo Chee Kong, Chairman and Director; and Dr. Tan Wee Kiat, PhD, Chief Operating Officer. Established in 2018, CytoMed is a biotechnology firm that originated from the Agency for Science, Technology and Research (A*STAR), Singapore’s premier public sector research and development agency.
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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.
Drug Discovery World
JULY 5, 2023
The Summer 2023 issue of Drug Discovery World Magazine is out now and includes an exclusive guide on Therapeutic Antibodies. Featuring a Therapeutic Spotlight on Immuno-oncology , the magazine is available to download free here and read for free on the DDW App. You can also request to receive a copy of the printed magazine here. Key features of the Summer issue include a market report on India’s drug discovery sector, advancing treatments in Alzheimer’s, and whether big data can chart
XTalks
JULY 5, 2023
Healthcare price transparency has become an increasingly important issue as the cost of healthcare services in the US continues to rise. Total healthcare spending in the country hit $4.3 trillion in 2021, with private health insurers shouldering the bulk at 28 percent of this cost, according to data from the Centers for Medicare and Medicaid Services (CMS).
Fierce Pharma
JULY 5, 2023
While the price of just about everything has increased over the last six years in the U.S., the same can’t be said for the cost of an FDA priority review voucher. Just ask Sarepta Therapeutics. | The price of priority review vouchers is falling. Just ask Sarepta Therapeutics. Since 2017, the company has sold off three PRVs—getting less in return for each successive sale.
Pharma Times
JULY 5, 2023
Orkambi is an oral treatment for very young children that combines both lumacaftor and ivacaftor - News - PharmaTimes
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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.
Fierce Pharma
JULY 5, 2023
Go for the Gulf: Sanofi partners with local drugmakers to crank out vaccines at new manufacturing plant in Saudi Arabia fkansteiner Wed, 07/05/2023 - 15:19
Pharma Times
JULY 5, 2023
SENS-401 has been developed for hearing preservation among adult patients following cochlear implantation - News - PharmaTimes
Fierce Pharma
JULY 5, 2023
Amneal Pharmaceuticals’ hopes for a midyear launch of its extended-release Parkinson’s disease prospect—and a shot at a potential $500 million peak sales opportunity in the U.S.—have been put on ic | The FDA has rebuffed Amneal’s application for IPX203, an oral formulation of carbidopa/levodopa, which leverages a unique delivery formula in a bid to increase “on” time without troublesome dyskinesia.
pharmaphorum
JULY 5, 2023
Why the ‘80/20 Rule’ does NOT rule the specialty pharmaceutical industry Mike.
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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
JULY 5, 2023
Another FDA accelerated approval has run its course, with Roche giving up on a niche indication for cancer drug Gavreto. | Another accelerated approval has run its course, with Roche giving up on a niche indication for cancer drug Gavreto. The move comes as the Swiss pharma giant prepares to terminate a collaboration with Blueprint Medicines.
pharmaphorum
JULY 5, 2023
Collaboration with industry will help NHS face next 75 years, says ABPI Mike.
Fierce Pharma
JULY 5, 2023
Gilead and Teva have chalked up an important legal victory in a California court, defeating allegations that they created an anticompetitive scheme to delay generic competition to lucrative HIV tre | Gilead and Teva were accused of conspiring to keep HIV generics off the market in a 2019 lawsuit seeking $3.6 billion in damages. The two companies already settled part of the case in May.
pharmaphorum
JULY 5, 2023
Positive new phase 3 MRI data from UPLIZNA trial for NMOSD Nicole.
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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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