Tags : Marketing Authorization

Biosimilars

Enzene Receives Marketing Authorization for Teriparatide (biosimilar) in India

Shots: The company received DCGI’s MA for Teriparatide (biosimilar) for the treatment of Osteoporosis vs anti-resorptive therapies such as bisphosphates and SERMs The approved product will be marketed through Alkem Laboratories as well as it explore other potential partnering opportunities Teriparatide will be launched in a fully compliant pen device Click here ­to­ read full press […]Read More

Regulatory

Biogen’s Plegridy (peginterferon beta-1a, IM) Receives EC’s Approval for Relapsing-Remitting

Shots: The approval is based on data assessing bioequivalence and AEs associated with IM administration vs SC administration of Plegridy in healthy volunteers Result: The data showed that participants receiving therapy through IM experienced fewer injection site reactions (14.4 vs 32.1 %), safety profiles were similar. The frequency of injection site reactions and AEs were […]Read More

Biotech Regulatory

Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval

Shots: The approval is based on two P-III studies assessing the safety and efficacy of Supemtek (quadrivalent recombinant influenza vaccine) in 10,000 patients with influenza aged > 18yrs. Supemtek is 1st and only recombinant influenza vaccine approved in the EU The P-III efficacy study demonstrated improved protection against influenza compared to standard-dose influenza vaccine and […]Read More

Regulatory

AbbVie’s Maviret (glecaprevir/pibrentasvir) Receives EC’s Marketing Authorization as Eight-Week Regimen

Shots: The approval is based on P-IIIb EXPEDITION-8 study assessing Maviret in 343 treatment naïve chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6) for 8wks. The P-IIIb EXPEDITION-8 study results: GT1- 6 patients achieving SVR12 (97.7%); GT3 patients achieving SVR12 (95.2%); one case of virologic failure and no case of discontinuation was […]Read More

Pharma

ViiV Healthcare’s Dovato (dolutegravir/lamivudine) Receives European Commission Marketing Authorization for

Shots: The marketing authorization is based on GEMINI 1 & 2 studies result assessing Dovato vs dolutegravir + tenofovir disoproxil fumarate/emtricitabine in 1400+ patients with HIV-1 infection for 48wks. The GEMINI 1 & 2 studies result demonstrated that two drug regimen showed non-inferior efficacy based on plasma HIV-1 RNA <50 copies/ml compared three-drug regimen in […]Read More