FDA Law Blog: Biosimilars

JUNE 12, 2024

We are looking forward to seeing the START pilot program chart a path for a broader application of this more enhanced communication approach and FDA’s continued collaboration to facilitate development of new drugs for rare diseases, as we know there are many programs that would benefit from this approach, not just those included in the pilot.

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Communication Vaccines Drug Development 59

Express Pharma

JULY 10, 2024

India has traced a journey of grit and glory to emerge as a major supplier of generic drugs and vaccines globally. IBER Report 2023 divulges, “The biopharma vaccines (non-COVID alone) market makes a significant daily contribution of approximately $38 million. Today, it is a key player in the global pharma landscape.

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Vaccines Drug Development Process Improvement Biosimilars 96

FDA Law Blog: Biosimilars

SEPTEMBER 10, 2023

The COVID-19 vaccines were initially authorized under EUAs, but their approvals do not appear to have been based on RWE. EUAs can, of course, be issued for new uses of approved products, but they do not have to be. Does this offer the potential to use RWE for an initial approval?

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Documentation Vaccines Drug Development 108

FDA Law Blog: Biosimilars

JANUARY 7, 2024

To better understand FDA’s approach in classifying postmarketing pregnancy studies as PMRs or PMCs, we reviewed all postmarketing requirements (PMRs) and postmarketing commitments (PMCs) related to maternal and fetal outcomes in FDA’s PMR/PMC database for drugs approved in the ten-year period from January 2014 through December 2023.

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Documentation Vaccines Drug Development 59

Pharmaceutical Technology

JULY 23, 2008

Despite the enormous growth being enjoyed by the global oncology market, potential cancer cures are left on laboratory shelves on a regular basis, according to Dr Victoria John, head of clinical partnerships at Cancer Research UK’s Drug Development Office. That will affect the intellectual property of oncology drug manufacturers.

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Pharmaceutical Companies Pharmaceutical Companies Compounding Biosimilars 40

Pharmaceutical Technology

SEPTEMBER 26, 2022

The company told GlobalData PharmSource: “The biosimilar facilities in Austria and Slovenia would continue to manufacture biosimilars for Sandoz under a contractual agreement with Novartis. These highlight the parent company’s focus on innovative and high-value drug development.

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Biosimilars Drug Development Vaccines Dosage 64

European Pharmaceutical Review

OCTOBER 27, 2022

For a market dominated by biosimilars and biobetters this means a cooling of valuations and gradual structural changes. Vicky Xia, suggested that “ Despite all the excitement, China still lags behind US, EU and Japan in innovative drug development.

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Biosimilars Vaccines Drug Development 98

Pharmaceutical Technology

DECEMBER 22, 2022

The company is a clinical-stage biopharmaceutical startup that uses its artificial intelligence (AI)-enabled platform to measure brain biomarkers, including electroencephalogram (EEG) activity and behavioural patterns, wearable data, genetics and other factors, to drive targeted drug development in mental health. Civica JAAQ Sanofi.

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Diabetes Biosimilars Pharmaceutical Companies Pharmaceutical Companies 52

PharmaShots

APRIL 3, 2023

of the newly combined company The combined companies’ focus is to advance Elicio’s lymph node-targeting amphiphile technology to develop immunotherapies & also focus on ELI-002, a therapeutic cancer vaccine targeting mKRAS-driven tumors is currently being evaluated in the P-I trial (AMPLIFY-201) for PDAC and CRC.

Biosimilars 40

Biosimilars Diabetes Compounding Hospitals 40

Express Pharma

FEBRUARY 5, 2025

Looming patent expiries Patent expirations have been a significant opportunity for the Indian pharma space that is dominated by generics and biosimilars manufacturing. This trend is likely to continue as these companies continue to build a portfolio of branded specialty products and biosimilars.

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Biosimilars Vaccines Drug Development 90

Pharmaceutical Technology

APRIL 12, 2023

The Association of the British Pharmaceutical Industry (ABPI) also states that “the use of animals in medical research has played and continues to play an essential role in the development of new medicines and vaccines”. The topic of animal testing remains a fiercely contentious topic in the public eye. The FDA’s Modernization Act 2.0

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Vaccines Biosimilars Communication Pharmaceutical Companies 98

Safe Biologics

SEPTEMBER 11, 2023

On July 26 th , ASBM hosted a webinar with the Generics and Biosimilars Initiative (GaBI) to examine the price-setting policy’s impact on drug development and reduced patient access to new medicines. 3] “ Democrat plan on drug costs will stifle innovation”, San Antonio Express-News, May 12, 2021 [1] [link]

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Drug Pricing Biosimilars Vaccines Drug Development 150

Safe Biologics

MARCH 10, 2025

Small molecule drugs make up over 90% of prescriptions filled in the U.S. Yet, since the IRAs implementation in 2021, investment in small molecule drug development has dropped by 70% as manufacturers shift resources toward biologics, which have more favorable financial incentives under the law. Read the full statement here.

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Biosimilars Independent Pharmacies Drug Pricing Vaccines 130