Bio Pharma Dive
JUNE 23, 2023
In a memo made public Friday, Peter Marks, head of the agency office that oversees gene therapies, wrote that he disagreed with other reviewers and saw “compelling” evidence to clear Elevidys.
Pharmaceutical Technology
JUNE 23, 2023
Psylo and Daiichi Sankyo have signed a sponsored research deal to advance the development of non-hallucinogenic psychiatric therapies.
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Bio Pharma Dive
JUNE 23, 2023
Ahead of Leqembi’s possible full approval next month, the agency released details emphasizing how the required registry to track patient outcomes will be free and easy to use.
Pharma Mirror
JUNE 23, 2023
LAUSANNE, Switzerland – Viseven, a leading global MarTech services provider for the Pharma and Life Sciences industries, is thrilled to announce its partnership with SpotMe, an enterprise event platform tailored to high-touch industries. This collaboration marks a significant milestone in digital communication within the healthcare industry. Driving Success in Pharma Communication The partnership between Viseven and SpotMe creates a unique point of view on the HCP engagement and B2B event organi
Bio Pharma Dive
JUNE 23, 2023
An EMA committee expressed concern with the main study meant to show Amylyx’s drug is safe and effective. The company now plans to ask for a re-examination of its approval application.
Pharma Mirror
JUNE 23, 2023
In the fast-paced, highly competitive pharmaceutical industry, sales reps must adapt to new ways of engaging with customers and healthcare professionals (HCPs). Two such approaches are through the use of omnichannel and sales enablement technologies, which can revolutionize the way pharmaceutical companies develop their sales force and interact with their stakeholders.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 23, 2023
IRBM has extended its collaboration with MSD to develop peptide therapeutics, following results in coronavirus, cholesterol, and obesity.
Drug Discovery World
JUNE 23, 2023
Sarepta Therapeutics’ Elevidys has become the first gene therapy for Duchenne muscular dystrophy (DMD) to gain marketing authorisation in the US. The Food and Drug Administration (FDA) has granted accelerated approval to Elevidys (delandistrogene moxeparvovec-rokl), an adeno-associated virus (AAV) based gene therapy for the treatment of DMD. It is approved in ambulatory paediatric patients aged four through five years with DMD with a confirmed mutation in the DMD gene based on expression of Elev
Pharmaceutical Technology
JUNE 23, 2023
Talaris Therapeutics has entered into a definitive agreement to merge with late-stage clinical biotechnology company Tourmaline Bio.
Pharma Times
JUNE 23, 2023
The organisations will focus on the delivery of clinical trials which concentrate on rare cancers - News - PharmaTimes
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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
JUNE 23, 2023
NephroDI Therapeutics has signed a deal with the McQuade Center for Strategic Research and Development (MSRD) for the development of NDI-5001
XTalks
JUNE 23, 2023
The American Medical Association (AMA) recently announced the recipients of the 2023 Electronic Health Record (EHR) Use Research Grant Program. Nine organizations will receive a total of $589,000 for research focused on studying the use of EHR systems. The aim of this research is to find solutions for preventing clinician burnout, enhancing patient care and improving workflows in medical practices.
Pharmaceutical Technology
JUNE 23, 2023
Facilities in Andhra Pradesh and Telangana accounted for 23% of all sites in India, confirming the area as a key pharma manufacturing hub.
Fierce Pharma
JUNE 23, 2023
After years of using the patent system to delay competition from a rival company and then exhausting that ploy early this year, Jazz Pharmaceuticals is taking a new route—suing the FDA. | After years of using the patent system to delay competition to its key Xyrem/Xywav franchise from a rival company, Jazz Pharmaceuticals is taking a new route—suing the FDA.
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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
JUNE 23, 2023
The regulatory framework governing medicine development is in flux. CDMOs face growing challenges to keep up with QA and compliance.
Pharma Times
JUNE 23, 2023
Companies’ precision medicine approach has potential to increase clinical trial success rates - News - PharmaTimes
Pharmaceutical Technology
JUNE 23, 2023
Erasca has obtained orphan drug designation (ODD) from the US FDA for ERAS-801 to treat malignant glioma, including glioblastoma
Drug Channels
JUNE 23, 2023
This week, I’m rerunning some popular posts while I prepare for today’s live video webinar: PBMs and the Battle Over Patient Support Funds: Accumulators, Maximizers, and Alternative Funding. Click here to see the original post from January 2023. Now that 2023 is underway, let’s review employer-sponsored coverage for prescription drugs and speculate on what’s ahead.
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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
JUNE 23, 2023
Kymera Therapeutics has announced that the FDA has granted KT-253 orphan drug designation for treating acute myeloid leukaemia.
Fierce Pharma
JUNE 23, 2023
A month before it was set to take the stand in the highly anticipated first Zantac-related trial, GSK scratched the case with a settlement. | GSK can now wipe an upcoming California Zantac trial off its plate with a confidential settlement a month before what would have been the first state-level trial.
Pharmaceutical Technology
JUNE 23, 2023
The FDA has blocked the approval of Intercept’s NASH therapy, pushing the company to restructure its investment strategy.
pharmaphorum
JUNE 23, 2023
Gaps in breast cancer care in Europe and the importance of genomic testing Mike.
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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
JUNE 23, 2023
ASLAN Pharmaceuticals and Zenyaku Kogyo have entered a strategic licensing deal for the former’s eblasakimab in Japan.
pharmaphorum
JUNE 23, 2023
Generative Health: A new standard of care Mike.
Pharmaceutical Technology
JUNE 23, 2023
Sarepta will now need to complete a confirmatory trial to prove the therapy improves physical function and mobility.
Drug Patent Watch
JUNE 23, 2023
Annual Drug Patent Expirations for JUBLIA Jublia is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. There are sixteen patents protecting… The post New patent for Bausch drug JUBLIA appeared first on DrugPatentWatch - Make Better Decisions.
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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.
Pharmaceutical Technology
JUNE 23, 2023
The medication could be a strong contender in the EU migraine market as a daily CGRP antagonist for migraines.
Drug Patent Watch
JUNE 23, 2023
Annual Drug Patent Expirations for DUOBRII Duobrii is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. There are four patents protecting… The post New patent for Bausch drug DUOBRII appeared first on DrugPatentWatch - Make Better Decisions.
Antidote
JUNE 23, 2023
Osteoarthritis (OA) is a condition associated with the gradual denigration of cartilage in the joints — and while it can occur anywhere in the body, the knee is one of the most common areas impacted. Current research estimates that 46% of people will develop knee OA in their lifetime.
Drug Patent Watch
JUNE 23, 2023
Annual Drug Patent Expirations for EMPAVELI Empaveli is a drug marketed by Apellis Pharms and is included in one NDA. It is available from one supplier. There are eight patents… The post New patent for Apellis Pharms drug EMPAVELI appeared first on DrugPatentWatch - Make Better Decisions.
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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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