Regulatory

Breaking News

NICE recommends Lilly’s mirikizumab for the treatment of Ulcerative Colitis

Eli Lilly has received the "go ahead" from NICE, the organisation that has recommended its mirikizumab for the treatment of adults with moderately...

Moderna receives positive opinion from the EMA for Spikevax

Moderna has revealed the European Medicine's Agency (EMA) has provided positive opinion on its COVID-19 vaccine Spikevax's marketing authorisation

Rentschler receives MHRA approval for AAV vector facility

The CDMO has received a cGMP following an MHRA visit to its UK site, now set for clinical production of adeno-associated virus (AAV) vectors for ge...

Unlocking opportunities: entering the UK medical device market successfully

In the changing landscape of European medical device regulations, the UK remains an attractive destination for US and foreign businesses. Unlike th...

uniQure gets FDA clearance for AAV9 vector gene therapy

The company has received clearance from the FDA for an investigational new drug application for AMT-260, a gene therapy candidate for uniQure

Innovate UK awards Stablepharma grant to advance fridge-free vaccine

Innovate UK has awarded Stablepharma a grant to advance its lead candidate SPVX02, a fridge-free vaccine for the prevention of Tetanus and Diphtheria

What's in an FDA approval? How a start-up company gets its drug to market

The FDA wields a supreme amount of power in the regulatory realm of the pharmaceutical industry. For smaller start-ups or those newer to the indust...

How to proactively address EU HTAR implementation challenges before 2025

Data landscape challenges within the European Union (EU) have historically been driven by the different laws, processes and regulatory standards of...

SOMAi receives manufacturing license for medicinal cannabis

The European company has received authorisation to manufacture, import and export medicinal cannabis proudcts from its facility in Lisbon, Portugal

LighthouseAI receives $2.25m for AI regulatory surveillance

The funding, part of an ongoing $3.25 million seed round, is set to support LighthouseAI's flagship product suite and the company's artificial inte...

Changes ahead as the US FDA proposes longer national drug codes

The national drug code (NDC) is a unique number used by the US Food and Drug Administration (FDA) to identify and report drugs

What to consider for successful GMP Annex 1 implementation

In advance of her presentation at Manufacturing Chemist Live, Dr Nicole Hunter (NH), Head of Global Regulatory and Validation Services at Watson-Ma...

AstraZeneca's Forxiga approved in China to reduce cardiovascular death

Forxiga has just been approved by China's National Medical Products Administration. The drug is also approved for the treatment of patients with ch...

European Commission adopts proposal to delay MDR deadlines

With thousands of outstanding conformity assessments for medical device certification under the Medical Device Regulation and limited capacity to m...

Bürkert delivers gas control system for aseptic spray dryer

Nova Laboratories worked with Bürkert on the development of its latest aseptic spray drying process and explained the process

Investment, outsourcing and globalisation: key trends for 2023

The start of 2023 has been challenging for the pharmaceutical industry. Economic constraints in Europe and the United States, staffing shortages, a...