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Neena Brizmohun

Executive Editor

Neena has been covering regulatory, business and market access developments that impact pharmaceutical and medical device companies since 1997. She explores the challenges and opportunities that developments worldwide introduce for industry and regulators. Her areas of expertise include regulatory schemes for getting products to market faster. Neena's other specialist areas include new medicines coming to market in the EU, pricing and reimbursement, clinical trials, real-world evidence, post-marketing safety monitoring, transparency policies relating to the publication of trial data, and global harmonization initiatives for pharma and medtech.

Latest From Neena Brizmohun

New EU Filings

Zanidatamab, Jazz and BeiGene’s investigational treatment for biliary tract cancer, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Drug Review Europe

Eleven New Drugs Filed In EU; Sipavibart & Dorocubicel Win Fast-Track Status

AstraZeneca’s sipavibart for preventing COVID-19 in the highly vulnerable population of immunocompromised patients is among the latest drugs that the European Medicines Agency has started to review for potential pan-EU marketing authorization.

Europe Approvals

New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, including Ixchiq, Valneva's chikungunya virus vaccine

Europe Approvals

In Vitro Triumph: European Pharmacopoeia Abolishes Rabbit Pyrogen Test

The use of the RPT is to no longer be required in any text of the European Pharmacopoeia and medicine developers will have to select a suitable in vitro test to control the pyrogenicity of their product.

Europe Animal Testing

Hong Kong Enhances Expedited Drug Licensing Process; Adopts Refuse-To-File Tool

Two announcements by the Pharmacy and Poisons Board have implications for drug companies looking to register their products in Hong Kong.

Hong Kong Drug Review

Swissmedic Cracks Down on Vague Drug Indications & Tightens Assessments of CCI Claims

The Swiss drug regulator makes public the indications in drug marketing applications within 60 days of receiving them, but says the level of detail that companies provide on this front is inconsistent. It also promises to be more stringent when it comes to assessing claims by companies who are worried that their commercially confidential information will be disclosed.

Switzerland Packaging
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