The Premier Consulting Blog

NOVEMBER 20, 2023

Clinical development experts would need to navigate the potential complexities arising from this regulatory shift, particularly in terms of trial design and evidence generation. Our expertise gives us the ability to develop customized and tailored strategic plans, mitigate regulatory risks, and optimize marketing success.

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The Pharma Data

JANUARY 25, 2021

Prior to November 1, 2028, the notes will be convertible only upon satisfaction of certain conditions and during certain periods. This activity could increase (or reduce the size of any decrease in) the market price of the Company’s common stock, the notes or the Company’s 2.50% Convertible Senior Notes due 2027 at that time.

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Agency IQ

AUGUST 16, 2024

SPA allows sponsors to gain regulatory perspective on whether a proposed trial design is adequate to support a marketing application, though the ultimate approval decision is based on the data submitted for review. FDA accepted the Lykos NDA in February 2024, and the submission received priority review.

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Agency IQ

JANUARY 26, 2024

EMA regulators themselves published an article discussing the review process for companion diagnostics and the lack of opportunity to use a single submission for the drug clinical trial under the Clinical Trial Regulation and the performance study application according to the IVDR.

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Agency IQ

FEBRUARY 2, 2024

This means that the medical device frameworks – including the pre-market pathways and evidentiary requirements, as well as post-market quality system frameworks and reporting requirements – are applied to the vast majority of all (CDRH-regulated) IVD products. IVDs used in blood donation screening/processing). In the E.U.,

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DrugBank

AUGUST 9, 2024

  The average cost of bringing a new drug to market is about $2.6 Moreover, the probability of success for a drug candidate entering clinical trials is only around 10%, highlighting the substantial risks involved. Pharmaceutical Market Analysis The global pharmaceutical market revenue in 2024 is projected to be 1.15

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The Pharma Data

NOVEMBER 4, 2020

Amarin’s decision to continue to invest in expanding the market for VASCEPA also reflects its confidence in its manufacturing processes, which the company has built over a decade to achieve consistent, high-quality, stable supply to support anticipated global demand. commercial team.

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Codon

SEPTEMBER 29, 2024

2028 Over the next year, the scientific community ferociously interrogated the model. The average pass rate of phase I trials went up by 5 percent. Marketed as a gesture of scientific goodwill, it also gave the companies the benefit of further academic research into their models free of charge. Subscribe to Asimov Press.

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The Pharma Data

JANUARY 9, 2021

We are proud to be a leader in the growing public health threat market, enabled by our development and manufacturing expertise, successful public-private partnerships, and broad portfolio of products and CDMO services. “Operationally, we rapidly responded to our customers’ needs, and financially, we delivered record revenue and earnings.

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The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1. A Phase 3 trial is ongoing.

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