Vibha Sharma
Her fields of interest include the EU Pharmacovigilance legislation and the EU Paediatrics Regulation on which she has written several exclusive articles from various industry conferences. She has also commissioned some pieces of expert analysis on major developments in the pharma and medtech regulatory arenas.
Before joining Informa, she was principal correspondent with India's national newspaper Hindustan Times, where she reported on health and medical issues, besides several other topics. She has also worked with two other Indian national dailies, The Indian Express and The Asian Age.
Latest From Vibha Sharma
Misinformation Prompted Six Court Cases Against EU COVID-19 Vaccine Approvals In 2021
The EU’s conditional approval of four COVID-19 vaccines and its decision to extend the use of Pfizer/BioNTech’s Comirnaty to a younger age group were challenged in the court last year but the cases were declared inadmissible.
BioMarin’s Hemophilia Gene Therapy Among Nine Products On Track For EU-Wide Approval
Four orphan drugs and a new COVID-19 vaccine are among the latest products that the European Medicines Agency says should be approved.
EMA Gives Oncopeptides’ Multiple Myeloma Drug The Thumbs Up; Keeps US FDA In Loop
With Pepaxti now on track for pan-EU marketing approval to treat patients with triple class refractory multiple myeloma, Oncopeptides is in talks with the Food and Drug Administration to achieve a clear path forward for the drug in the US where it has experienced difficulties despite being granted an accelerated approval.
Gilead’s Lenacapavir, Takeda’s Maribavir Due For Oral Explanations At EMA
The sponsors of four drugs were due or possibly due to appear before the European Medicines Agency to explain why their respective products merit EU-wide approval.
BioMarin’s Roctavian & Argenx’s Efgartigimod Among Eight Hopefuls Awaiting EU Verdict
Will BioMarin be second time lucky with its hemophilia gene therapy Roctavian in the EU? The European Medicines Agency could soon decide whether the product should be approved.
EU Proposes Changes To Labeling Of Investigational Drugs Under Clinical Trial Regulation
The European Commission is inviting stakeholder feedback on proposals to do away with the need to display the expiry date on the primary packaging of investigational drugs in certain situations.