Drug Discovery World

AUGUST 8, 2023

In the global pharmaceuticals market, India ranks third worldwide for production by volume and the domestic pharmaceutical market is expected to reach US$120-130 billion by 2030 1. A report by PWC shared that the pharmaceutical industry’s main markets are under ‘serious pressure’ 7.

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Drug Discovery World

AUGUST 10, 2022

By Mark White, Associate Director of Biopharma Product Marketing at Bio-Rad and Marwan Alsarraj, Biopharma Segment Manager, Digital Biology Group. Exactly three decades later, the first CAR T cell therapy hit the market. As new CAR T cell therapies reach the market, quality control will become even more important.

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Drug Discovery World

FEBRUARY 21, 2023

Trodelvy has been marketed for triple-negative breast cancer since 2021. billion by 2028. Israel Stern, Oncology & Hematology Analyst at GlobalData, commented: “Patients with HR+/HER2- metastatic breast cancer who are treated with hormone therapy and chemotherapy often develop resistance to these treatments.

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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

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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Agency IQ

MAY 28, 2024

This draft framework – which will come into force alongside the future medical device regulations – proposes four market access routes that have the potential to recognize the decision-making of four “comparable regulator countries,” but only for certain device and diagnostics types. law as the Medical Devices Regulation 2002 (UK MDR 2002).

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The Pharma Data

NOVEMBER 8, 2020

Additionally, our pipeline and our recent transactions have significant mid-term value still to be unlocked that reinforces our potential in the market. Although the area of dermatology has been severely disrupted since the COVID-19 pandemic began, the EU market shows resilience and the US market is starting to show signs of recovery in Q3.

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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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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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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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