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Neena Brizmohun

Neena Brizmohun writes and commissions news, features and analysis to meet the regulatory, business and market access information needs of the companies and regulatory agencies that operate in the pharmaceutical and medical device space worldwide.

Her areas of expertise include the cutting-edge early market access schemes that are being trialed around the world for taking drugs and medical devices to market faster. She is also interested in initiatives for harmonizing regulations at the global level as well as issues affecting clinical trials, manufacturing and post-market safety monitoring. She explores the challenges and opportunities that these issues introduce for both industry and the regulators and is on a constant look out for what might be coming next.

A scientist by training, Neena started her journalistic career at Informa in 1997. She has been the deputy editor of Scrip Regulatory Affairs since 2007. Prior to that, she worked as the science editor for Clinica Medtech Intelligence. Before becoming a journalist she worked as a biomedical scientist at St Thomas' Hospital in London for 10 years.
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Latest From Neena Brizmohun

Only One In Seven PRIME Applications Meet EMA Test

Of the 14 applications for entry onto the European Medicines Agency’s priority medicines scheme during the first two months of 2019, only two – from AstraZeneca and Freeline – made the grade.
Europe Market Access

Achilles On Getting ‘New Wave’ Immunotherapy From Concept To Clinic In Three Years

Clonal neoantigen immunotherapy developer Achilles Therapeutics tells the Pink Sheet how the regulatory landscape for advanced therapies might not be as tricky as it used to be.

Research & Development Clinical Trials

New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances now includes three new products including Lusutrombopag Shionogi for treating severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (e.g., medicine, vaccine, biologic).

Europe Approvals

‘Alarming’ Paclitaxel-Coated Device Findings Trigger UK Safety Probe

An expert advisory group set up by UK regulators has been given a few months to review the safety of paclitaxel-eluting balloons and stents in the treatment of patients with peripheral arterial disease, following a recent study that produced worrying results.

Safety United Kingdom

‘No Deal’ Brexit? Australia Will Still Accept UK Notified Body Certificates

The Therapeutic Goods Administration has released a statement on the implications of Brexit for medical devices in Australia.

Australia Brexit

Canadian Guidance Clarifies New Formats For Marketing Applications

Health Canada is planning to adopt the International Medical Device Regulators Forum’s Table of Contents formats as of April 1.

Canada Policy & Regulation
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