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
Insight on US FDA approval of Myfembree OD treatment for management of heavy menstrual bleeding associated with uterine fibroids
Myovant Sciences and Pfizer announced that the US Food and Drug Administration (FDA) has approved Myfembree (relugolix 40 mg, estradiol 1 mg,... Read More
DCGI – India approved anti-Covid drug 2-DG developed by DRDO for emergency use
The Drugs Controller General of India has approved an anti-COVID-19 drug developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS)... Read More
Eli Lilly to partner with Cipla, Lupin, Sun Pharma to manufacture, distribute Baricitinib in India
US drug-maker Eli Lilly, on May 10, announced that it had issued royalty-free, non-exclusive voluntary licenses to established Indian pharmaceutical manufacturers of... Read More