Case Study : US FDA approval of Marinus Pharma’s Ztalmy
Marinus Pharmaceuticals, Inc., a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, announced that the US Food... Read More
What if Design of experiments (DoE) approach?
Posted on21 Mar 2022
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Design of experiments (DoE) is a systematic approach aiming to maximize information content from an experimental study, while keeping the number of... Read More
Zydus gets orphan drug designation from USFDA for antimalarial compound
Zydus Cadila said its antimalarial compound ZY19489′, which is currently under development with Medicines for Malaria Venture (MMV), has received ‘orphan drug... Read More
What is Scale-Up and Post Approval Changes (SUPAC) report?
The scale-up process and the changes made after approval in the composition, manufacturing process, manufacturing equipment, and change of site have become... Read More
Nucala received USFDA approval to treat chronic rhinosinusitis with nasal polyps
GlaxoSmithKline (GSK) announced that the US Food and Drug Administration (FDA) have approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5),... Read More
Lupin’s Somerset plant received US FDA warning letter for
Lupin has received a warning letter from the US Food and Drug Administration relating to its US-based manufacturing plant located in Somerset,... Read More
FDA Grants Accelerated Approval for Alzheimer’s drug Aduhelm
Posted on10 Jun 2021
Tagsaducanumab, Aduhelm, Biogen, Eisai, global pharma licensing deal, monoclonal antibody, Neurimmune, pharma deal
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USFDA approved Aduhelm (aducanumab) for the treatment of Alzheimer disease. Alzheimer’s drug Aduhelm is research molecule of Neurimmune. Neurimmune licensed its antibody... Read More
Amryt’s filed Oleogel-S10 NDA for the treatment of Epidermolysis Bullosa
Amryt, a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today announces that the U.S.... Read More
Insight on Sun Pharma’s Licensing Agreement with Ferring Pharmaceutical for Caritec in India
Sun Pharmaceutical Industries entered into a licensing agreement with Ferring Pharmaceuticals to commercialise innovative obstetric drug Caritec in India. One of the... Read More
EMA authorises Pfizer covid vaccine “Comirnaty” for 12-15 yrs
EMA has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 12 to 15.... Read More