Fierce Pharma
AUGUST 25, 2023
With one week to go until the Centers for Medicare and Medicaid Services (CMS) releases its list of ten drugs up for the first round of pricing negotiations, AstraZeneca is jumping into the legal b | The company cited concerns with the law's consequences for orphan drug development. AstraZeneca becomes the sixth drugmaker to file suit against the IRA.
Pharmaceutical Technology
AUGUST 25, 2023
The US Food and Drug Administration's recent accelerated approval of Pfizer's Elrexfio for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) has made a significant impact in the oncology community.
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Fierce Pharma
AUGUST 25, 2023
Add another failed trial to the list of setbacks for Merck and Eisai’s combination of Keytruda and Lenvima. | Add another failed trial to the list of setbacks for Merck and Eisai’s combination of Keytruda and Lenvima. The companies have decided to shut down a phase 3 study testing the PD-1/TKI combo in first-line head and neck cancer.
PharmExec
AUGUST 25, 2023
The Generic Drug User Fee Amendments, designed to facilitate the delivery of safe and effective generic drugs to the public and improve the predictability of the ANDA assessment process, has undergone changes that will impact the pre-ANDA and ANDA approval process—and ultimately the path for generic drugs to approval.
Fierce Pharma
AUGUST 25, 2023
Two months after a federal court in Delaware rejected Biogen’s patent infringement c | The FDA has endorsed Novartis' Tyruco as the first U.S. biosimilar to treat multiple sclerosis. The copycat will compete with Biogen's Tysabri, covering all of the original drug's indications for relapsing MS in addition to Crohn’s disease.
MedCity News
AUGUST 25, 2023
Future research should focus on identifying the interactions between the immune system, microbes, and allergic responses; and exploring potential therapeutic strategies targeting the skin microbiome for allergy management.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
AUGUST 25, 2023
Next year REACH ACOs will have to show success in developing and maintaining comprehensive health equity plans, and by kicking the can down the road they risk not knowing enough about their patient population in terms of what works better and what doesn’t. ACOs can pay in the effort of continuous iteration now or they can pay in poor health outcomes for their patients and the resulting increased costs.
European Pharmaceutical Review
AUGUST 25, 2023
A paper published in Molecules has detailed a strategy and evaluation approach for acceptable classification of species usually detected in migration studies. This can therefore support extractable and leachable (E&L) studies. Migration studies are one of the few domains of QA/QC pharmaceutical analysis employing wide-scope screening methodologies, the paper noted.
MedCity News
AUGUST 25, 2023
By leveraging sophisticated patient intake forms, robust patient-provider matching algorithms, self-scheduling features, calendar management tools, and telehealth capabilities, healthcare providers can bridge the gap between consumer expectations and the current state of healthcare access.
European Pharmaceutical Review
AUGUST 25, 2023
The European Commission (EC)’s revised Annex 1 – Manufacture of Sterile Medicinal Products is now effective in the EU. As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. What is included in the new revision? According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments.
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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.
MedCity News
AUGUST 25, 2023
Rapport Therapeutics, a clinical-stage biotech that was founded last year, raised $150 million in Series B financing, bringing its total funding to date to $250 million. The company’s platform leverages receptor-associated proteins to create neurology drugs that have more focused activity in the brain, going after disease-driving circuits and cell types.
Medgadget
AUGUST 25, 2023
Researchers at the Mount Sinai Hospital have developed an mRNA-based treatment for cancer. The approach combines the delivery of mRNA therapy in lipid nanoparticles and also involves co-delivering dendritic cells that have also been primed through treatment with lipid-encased mRNA. The technology aims to overcome some of the immune evasive tricks that tumors use to circumvent the immune system, some of which can hamper more traditional immunotherapies.
MedCity News
AUGUST 25, 2023
Cigna removed 25% of medical services from prior authorization requirements. This represents more than 600 codes, and includes 100 surgical codes, nearly 200 genetic testing codes, durable medical equipment, orthoses and prosthetics and other services, said Dr. Scott Josephs, chief medical officer of Cigna Healthcare.
PharmaVoice
AUGUST 25, 2023
FDA Commissioner Robert Califf suggested larger reforms are needed to bolster the generic drug industry and prevent future medication shortages.
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Medgadget
AUGUST 25, 2023
Scientists at New York University have developed a gene therapy for chronic pain. The technology works by targeting the NaV1.7 sodium ion channel present on neurons, which is an important component of the pain response. The researchers encoded a version of a peptide that allows a modulatory protein, called CRMP2, to bind to NaV1.7 sodium ion channels and modulate their activity.
Eversana Intouch
AUGUST 25, 2023
“Aside from the smashing success of ‘Barbie’ setting box office records, topping more than [$1 billion] and counting, the movie is also doing something much more important than sales – shining a spotlight on women’s health. In a time where there seems to be a war waged on women’s reproductive health and autonomy, Barbie (of all symbols!
Medgadget
AUGUST 25, 2023
LumaFlo , a medtech company based in Israel, has developed a decontamination technology that does not require UV light, something that can be dangerous for people nearby. The COVID-19 pandemic highlighted the need for safe and effective decontamination technologies for both public spaces and healthcare facilities. However, many such technologies rely on UV light to kill pathogens, but this can also have negative effects on those exposed.
Pharmaceutical Technology
AUGUST 25, 2023
Soliris is already approved to treat refractory generalised myasthenia gravis in adults in different regions.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
PharmaTimes
AUGUST 25, 2023
The decision follows a recent recommendation from the European Medicines Agency’s human medicines committee - News - PharmaTimes
Copyright Clearance Center
AUGUST 25, 2023
In July, according to BookScan, sales for roughly 180 BookTok authors fell 4.5 percent over 2022.
Referral MD
AUGUST 25, 2023
Photo by JoshuaWoroniecki on Pixabay Artificial Intelligence (AI) has enormous potential to revolutionize the medical industry, leading to better patient outcomes, more efficient diagnoses, and improved workflows. One area where AI can make an impactful difference is streamlining the referral process for doctors and patients, reducing wait times, and improving the overall quality of healthcare.
Legacy MEDSearch
AUGUST 25, 2023
Paragonix Technologies , a leading organ transplant company, received US Food and Drug Administration (“FDA”) clearance for its next-generation donor lung preservation system, BAROguard. The BAROguard System combines Paragonix’s existing advanced hypothermic preservation technology with automated continuous and active airway pressure control, ensuring that an optimal temperature range and a clinically recommended inflation pressure range for donor lungs are maintained throughout the journey from
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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
AUGUST 25, 2023
Patient data sharing among various stakeholders for research purposes forms the baseline for innovative new healthcare solutions pertinent to diagnosis, treatment, preventive measures, etc.
PharmaTimes
AUGUST 25, 2023
The disease-modifying therapy is approved to treat all indications covered by Tysabri - News - PharmaTimes
Pharmaceutical Technology
AUGUST 25, 2023
Novo Nordisk is eyeing the cardiology treatment space for its highly sought-after drug that is dominating the weight loss and diabetes drug landscape.
Copyright Clearance Center
AUGUST 25, 2023
Speaking at a client’s board meeting earlier this summer, one of the topics that came up was the scholarly communications arena and what’s…
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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
Pharmaceutical Technology
AUGUST 25, 2023
Merck (MSD) and AstraZeneca have received approval in Japan for Lynparza to treat BRCA-mutated (BRCAm) castration-resistant prostate cancer.
Pharmaceutical Commerce
AUGUST 25, 2023
In this PC Podcast episode, Susanne Katus discusses the increasing number of regulations impacting both pharma and biotech companies.
Pharmaceutical Technology
AUGUST 25, 2023
Novo Nordisk has engaged Thermo Fisher as a contract manufacturer to produce the weight-loss drug, Wegovy (semaglutide), Reuters reported.
Pharmacy Times
AUGUST 25, 2023
Investigators determined that there needs to be an evaluation of harm caused by pharmacy professionals who are in unique positions on social media, propagating misinformation about COVID-19, vaccines, treatment, masks, and other conspiracy theories.
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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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