DCGI approved Itolizumab to treat COVID-19 patients with moderate to severe acute respiratory distress
India’s drug regulator has approved Itolizumab, a drug used to cure skin ailment psoriasis for “restricted emergency use” to treat COVID-19 patients... Read More
Roche’s Elecsys IL-6 test received USFDA EUA
Roche announced that the US Food and Drug Administration (FDA) has issued an Emergency Use Authorisation (EUA) for the Elecsys IL-6 test.... Read More
Market Exclusivity Case Study: XIFAXAN (rifaximin)
Posted on07 May 2020
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Bausch Health Companies Inc. along with its wholly owned subsidiary, Salix Pharmaceuticals, which is one of the largest specialty pharmaceutical companies in... Read More
Aleor Dermaceuticals receives EIR from US FDA for Karakhadi formulation facility
Aleor Dermaceuticals Ltd. (Aleor), a 60:40 joint venture between Alembic Pharmaceuticals Ltd. (Alembic) and Orbicular Pharmaceutical Technologies Pvt. Ltd. (Orbicular), has received... Read More
Bausch + Lomb – Stada Arzneimittel – Xbrane Biopharma – licensing deal for Lucentis biosimilar
Bausch + Lomb announced an exclusive licensing agreement with Stada Arzneimittel and its development partner Xbrane Biopharma to develop and commercialize a... Read More
Who determines when a prescription medicine should be switched to OTC status?
Posted on07 Apr 2020
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Technically, anyone could submit a Citizen’s Petition to FDA to switch a product from Rx to OTC status. However, the holder of... Read More
Case Study: US FDA approves erythroid maturation agent, Reblozyl
Bristol Myers Squibb and Acceleron Pharma Inc, a biopharmaceutical company, announced the US Food and Drug Administration (FDA) has approved Reblozyl (luspatercept-aamt),... Read More
Case Study: Compassionate use of remdesivir of Gilead for COVID-19
Posted on06 Apr 2020
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During an extraordinary virtual meeting held on April 2, 2020, EMA’s human medicines committee (CHMP) gave recommendations on how the investigational antiviral... Read More
What are the difference between FDA 483 and Warning Letter?
Posted on27 Mar 2020
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483 observation or FDA 483 and warning letter seems to be same, nut there is difference between the FDA form 483 and... Read More
New Drug Approval Case Study: USFDA approval of Zeposia, delayed market launch likely due to COVID-19
U.S. Food and Drug Administration (FDA) has approved ZEPOSIA® (ozanimod) 0.92 mg for the treatment of adults with relapsing forms of multiple... Read More