GaBI - Generics and Biosimilars Initiative

01/09/2025

GMP/GDP Inspectors Working Group (GMP/GDP IWG) Concept paper on the revision of Part IV Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products)

29/08/2025

Guidelines on the replacement or removal of animal tests for the quality control of biological products
2nd round public consultation: comments to be received not later than 19 September 2025.
https://www.who.int/groups/expert-committee-on-biological-standardization

27/08/2025

Hulio granted US interchangeability status

In May 2025, the US Food and Drug Administration (FDA) announced the decision to grant interchangeability status to&...

25/08/2025

NATO Innovation Fund makes first investments to secure the future of the Alliance’s 1 billion citizens

The NATO Innovation Fund announced today its first deep tech investments to address challenges in defence, security and resilience. These initial equity investments made by the €1 billion Fund will help advance innovation in novel materials and manufacturing, AI, space and robotics. The Fund is al...

22/08/2025

Frequency of first generic drugs approved through ‘skinny labeling’, 2021 to 2023

Previous literature found 43% of brand-name drugs experienced skinny labeling generic prescription competition in a 2015-2019 sample, which is consistent with the rate of skinny labeled generic prescription entry early in our sample. Then, the proportion of first generic prescriptions approved with....

20/08/2025

EMA recommends approval of HIV and lung disease generics

13 new medicines recommended for approval; another six medicines recommended for extension of their therapeutic indications

18/08/2025

El ‘One Big Beautiful Bill’ de Trump: implicaciones para la sanidad estadounidense

El 4 de julio de 2025, el presidente de Estados Unidos, Donald Trump, promulgó un paquete de medidas fiscales y de gasto destinado a cumplir varias...

14/08/2025

Trump’s ‘One Big Beautiful Bill’: implications for US health care

On 4 July 2025, US President Donald Trump signed into law a tax and spending package designed to fulfil several of his electoral campaign promises....

11/08/2025

Generics, Biosimilars and Follow-­ On Non-­ Biologic Complex Drugs for Multiple Sclerosis: A Narrative Review of the Regulatory and Clinical Implications for European Neurologists

08/08/2025

Medicines For No-One

ASBM Steering Committee Members Andrew Spiegel, Executive Director of the Global Colon Cancer Association (GCCA); and Marcia Horn, CEO of the International C...

06/08/2025

MHRA issues guidance for decentralized manufacturing

These Regulations amend the Human Medicines Regulations 2012 (S.I. 2012/1916) (“HMRs”) and the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031) (“CTRs”). These Regulations make provision for medicinal products that are manufactured in a modular unit, to enable depl...

04/08/2025

Senate HELP Committee Recommendations for 340B Reforms

WASHINGTON – Today, U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a...