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.
MedCity News
JUNE 23, 2023
The FDA again rejected Intercept Pharmaceuticals’ application seeking accelerated approval for its NASH drug and asked for more data. Instead, the biotech will stop all work in that fatty liver disease and focus on drugs for other serious but rare liver conditions.
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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
Psylo and Daiichi Sankyo have signed a sponsored research deal to advance the development of non-hallucinogenic psychiatric therapies.
European Pharmaceutical Review
JUNE 23, 2023
Study data from a major trial has demonstrated RNA CAR-T (rCAR-T) therapy Descartes-08 facilitated significant and long-lasting clinical improvement in generalised myasthenia gravis (gMG). This is the first clinical trial using rCAR-T to treat autoimmunity. It is also the first successful Phase II trial using an engineered cell therapy for autoimmunity.
MedCity News
JUNE 23, 2023
For employers, it’s like having to buy a different cell phone for each contact. And for the consumer, navigating all the different digital platforms, the log-ins, the various apps – it’s a nightmare.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
JUNE 23, 2023
Proof that human interaction and support works is in the numbers: nurses, benefits experts, and coaches have a definitive impact on employee health, happiness, and productivity.
European Pharmaceutical Review
JUNE 23, 2023
A report published by BioPhorum titled ‘ Minimizing the impact of bioburden and sterility testing on gene therapy batch yield ’ offers recommendations for reducing the volumes required for testing. This approach conserves product for patients, maintains compliance and delivering assay and process information on the microbiological status of gene therapy products.
MedCity News
JUNE 23, 2023
PM Pediatric Care’s funding round was led by Scopia Capital and included participation from Jefferson River Capital. In total, the company has raised more than $140 million, said Steven Katz, co-founder and co-CEO of PM Pediatric Care.
PharmaTimes
JUNE 23, 2023
The organisations will focus on the delivery of clinical trials which concentrate on rare cancers - News - PharmaTimes
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MedCity News
JUNE 23, 2023
Let’s explore the top 5 steps to promote well-being and mental health while breaking the stigma from your society.
PharmaTimes
JUNE 23, 2023
Companies’ precision medicine approach has potential to increase clinical trial success rates - News - PharmaTimes
Healthcare Success
JUNE 23, 2023
The healthcare marketplace is crowded. As patient expectations continue to evolve, the need for thoughtful environmental designs that prioritize peace, tranquility, and healing cannot be overstated—they play a vital role in patient experiences and the perception of overall quality of care. Studies have shown many positive effects of healthcare environmental design on medical outcomes.
Clarify Health
JUNE 23, 2023
As the healthcare landscape evolves, so must our strategies to optimize health outcomes and cost efficiency. Recognizing influenceable physician behaviors and harnessing the power of new payment models, including micro-incentives , to shape these behaviors to lower care costs are pivotal. Several physician behaviors directly impact health outcomes and costs and are amenable to change through appropriate incentives.
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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
PharmaTech
JUNE 23, 2023
The guidance describes the CDER formal dispute resolution (FDR) procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical issue related to a final order.
PM360
JUNE 23, 2023
Press Release Contact: Kayla Walsh Awards Coordinator, PM360 646-300-8114 kayla.walsh@pm360online.com PM360 Now Accepting Entries for 2024 Pharma Choice Awards Call for the Best Healthcare Creative from the Past Year NEW YORK, NY, June 22, 2023 : The 2024 PM360 Pharma Choice Awards are officially open for entries. For the past 15 years, PM360, a leading life sciences marketing industry trade publication, has let the industry vote on the top creative campaigns and initiatives to choose the year
Pharma Leaders
JUNE 23, 2023
US-based amyloid diseases treatment solutions developer AltPep has raised $52.9m in its Series B investment round led by Senator Investment Group. Former investors such as Matrix Capital Management Company and Alexandria Venture Investments, who took part in the firm’s Series A round, joined the latest fundraise along with new backers. The new investors in Series B include Eli Lilly and Company, Partners Investment, and Section 32.
Pharmaceutical Technology
JUNE 23, 2023
IRBM has extended its collaboration with MSD to develop peptide therapeutics, following results in coronavirus, cholesterol, and obesity.
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PharmExec
JUNE 23, 2023
Complaints filed against CMS target the unconstitutionality of the Act, while the stifling of innovation in biopharma runs a parallel argument for numerous reasons
Pharmaceutical Technology
JUNE 23, 2023
Talaris Therapeutics has entered into a definitive agreement to merge with late-stage clinical biotechnology company Tourmaline Bio.
PharmaTech
JUNE 23, 2023
Sanofi’s Open Innovation Portal is designed to promote community feedback and propose novel solutions to various problems in the healthcare landscape.
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
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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.
PharmaTech
JUNE 23, 2023
Chris Preti, CEO of Jubilant HollisterStier Contract Manufacturing Services, shares insight into the outsourcing industry.
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.
PharmaVoice
JUNE 23, 2023
Dr. Monika Vnuk, SVP of global partnering and business development, is setting her sights on out-of-the-box partnerships.
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.
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
Pharmacy Times
JUNE 23, 2023
Pharmacists can recognize evidence of successful interventions and learn how to integrate them into their own practice.
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
Pharmacy Times
JUNE 23, 2023
Dr Haumschild opens the discussion with Larry Anderson, MD, PhD, and Gabe Hinojosa, PharmD, BCOP, regarding various states of relapse in multiple myeloma.
Pharmaceutical Technology
JUNE 23, 2023
Kymera Therapeutics has announced that the FDA has granted KT-253 orphan drug designation for treating acute myeloid leukaemia.
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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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