Continuous manufacturing: Changing the paradigm in the pharmaceutical manufacturing sector
The author explains how continuous manufacturing is reshaping pharmaceutical production
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Browsing Tag
EMA
Indian biotech start-ups: Need for pragmatic, pro-active, progressive regulatory milieu
Dr Arun Bhatt, Consultant – Clinical Research and Drug Development highlights that the Indian biotech startup sector has surged in…
Lupin completes Phase 3 Trials for Lucentis Biosimilar
The study has achieved its primary endpoint of therapeutic equivalence in visual acuity improvement for wet AMD patients,…
Nidlegy Marketing Authorization Application Submitted to EMA
First marketing authorisation submission for Nidlegy for the treatment of locally advanced, fully resectable melanoma in the…
Nezglyal remains promising therapy despite EMA’s market authorisation refusal: GlobalData
Nezglyal is a novel orally bioavailable and selective peroxisome proliferator-activated receptor (PPAR) gamma agonist that is…
US FDA approves GSK’s Arexvy, world’s first RSV vaccine for older adults
Older adults, including those with underlying medical conditions such as diabetes and chronic heart and lung disease, are at…
EMA seeks to issue guidance on liver damage from Novartis’s gene therapy
The statement follows recent deaths due to liver failure after treatment with the gene therapy, the EMA said
Sanofi and AstraZeneca win EU approval for prevention of infant RSV
The long-acting therapy, also known as nirsevimab, was given the European Union (EU) marketing authorisation for the prevention of…
EMA recommends Moderna’s updated Omicron-tailored vaccine
The agency also authorised Pfizer-BioNTech's and Moderna's vaccines for children as young six months
Pfizer announces positive results from phase-III study in 20-valent Pneumococcal Conjugate Vaccine…
The company intends to file for regulatory approval in the EU in the next few months