Viseven

JANUARY 4, 2023

This article will cover the most important areas of AI influence on the pharma industry and new drugs development. From life-saving drugs discovery, development, and production to clinical trials, communication, and drug target identification — AI pharmaceutical is a definite game-changer.

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Putting Patients First Blog

JULY 10, 2023

MACC Commissioner United States Food and Drug Administration 5 630 Fishers Lane, Rm. MACC Commissioner United States Food and Drug Administration 5 630 Fishers Lane, Rm. The NHC was a strong supporter of the inclusion of these guidances in the Prescription Drug User Fee Act (PDUFA) VI agreement. Califf M.D., Califf M.D.,

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FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

The guidance describes the following as potentially being suitable for the VCS recognition program: Common rules, conditions, guidelines, or characteristics for products or related processes and production methods; Definition of terms; classification of components; delineation of procedures; specification of dimensions, materials, performance, designs, (..)

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Putting Patients First Blog

APRIL 7, 2025

14 In addition, sponsors should ensure that the datasets used to develop AI models reflect the intended patient population and disease variations. 15 ,16 Failure to do so risks overlooking meaningful variability and could reinforce historical limitations in drug development.

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Pharmaceutical Technology

MARCH 23, 2023

Scientific research and a better understanding of the condition is driving new developments in medications. The condition’s symptoms are not homogeneous, and that makes drug development complicated,” Javier Szwarcberg, CEO of Spruce Biosciences, a rare disease company researching endocrine disorders, says.

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Putting Patients First Blog

APRIL 14, 2023

10: External Data Submission Timing The NHC understands the tight timeline for the drug selection and price negotiation processes. Conversely, it is crucial CMS continuously work to ensure access and remove barriers to both negotiated and non-negotiated drugs that providers and patients agree are necessary and appropriate.

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pharmaphorum

MARCH 30, 2021

“There’s a lot that drug development for more common diseases could learn from rare disease R&D”. I think there’s a lot that drug development for more common diseases could learn from rare disease R&D.”. We have to be innovative to get around those challenges. Rare diseases during COVID.

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Hospitals Communication Drug Development Pharmaceutical Companies 111

pharmaphorum

APRIL 11, 2022

Innovative ‘next-generation’ medicines are met with a series of hurdles such as increased cost of development, regulatory challenges and delays, and longer and more complex clinical trials. The answer to this question comes back to our definition of value. And it all fuels the debate: are medicines a cost or an investment?

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pharmaphorum

JANUARY 27, 2023

Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. What I’ve seen with patient centricity over the last few years is really a broadening of the definition,” Dr Mullen explained. But who is benefitting?

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PharmaShots

APRIL 3, 2023

It now offers DPN patients relief from chronic pain through low doses of stimulation & the battery lasts up to 10 years at low-dose settings The system also pairs with Abbott’s NeuroSphere Virtual Clinic, a connected care app for people to communicate with a physician and receive remote treatment adjustments.

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Express Pharma

OCTOBER 31, 2024

She highlighted that while the GCC was initially set up for cost savings in drug development, the focus has shifted to harnessing India’s vast talent pool, particularly in the scientific and medical fields, in an interview with Viveka Roychowdhury India seems to have become a hub for pharma GCCs. With a long gestation period.

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FDA Law Blog: Biosimilars

OCTOBER 28, 2024

To this end, FDA recently announced the publication of a guidance titled “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development,” (the “Guidance”). The Guidance is written carefully to communicate that these determinations are all very case-specific. What does it all mean?

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