Tags : Lupin

Insights+ Key Biosimilars Events of August 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference […]Read More

PharmaShots Weekly Snapshot (Aug 24 -28, 2020)

1. Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis Published: Aug 27, 2020 | Tags:  Taysha Gene Therapies, TSHA-101, Receives, US, FDA, Orphan Drug Designation, Rare Pediatric Disease Designation, GM2 Gangliosidosis 2. Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic […]Read More

Lupin and SunPharma Launch Generic Favipiravir to Treat Mild to

Shots: Lupin has launched favipiravir in India under the brand name ‘Covihalt’ for the treatment of mild to moderate COVID-19 Covihalt will be available as 200mg tablets in the form of a strip of 10 tablets, priced at $0.65 (₹49/tablet) and has received DCGI authorization for emergency use Additionally, SunPharma has launched antiviral drug favipiravir […]Read More

Insights+ Key Biosimilars Events of June 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference […]Read More

PharmaShots Weekly Snapshot (Jun 01-05, 2020)

1. Novartis Reports Results of Enerzair Breezhaler (QVM149) in P-IIIb ARGON Study to Treat Uncontrolled Asthma Published: Jun 04, 2020 | Tags: Novartis, Reports, Enerzair Breezhaler, QVM149, P-IIIb, ARGON Study, Treat, Uncontrolled Asthma 2. Melinta Therapeutics to Acquire Tetraphase Pharmaceuticals Published: Jun 04, 2020 | Tags: Melinta Therapeutics, Acquire, Tetraphase Pharmaceuticals 3. AstraZeneca Signs an Agreement with […]Read More

Mylan and Lupin Receive EC’s MAA for Nepexto (biosimilar, etanercept)

Shots: The EC has granted MAA for Nepexto, a biosimilar referencing Enbrel (etanercept), for all indications of the reference product including RA, JIA, PsA, axSpA (including axSpA and nr-axSpA), plaque psoriasis and pediatric plaque psoriasis The EC’s approval follows the CHMP’s positive opinion which is based on a biosimilarity assessment including preclinical and clinical studies […]Read More

Insights+ Key Biosimilars Events of March 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference […]Read More

Mylan and Lupin Receive CHMP’s Positive Opinion for Nepexton (biosimilar,

Shots: The EMA’s CHMP has adopted a positive opinion recommending the approval of Nepexto, a biosimilar referencing Enbrel (etanercept), for all indications of the reference product including RA, JIA, PsA, axSpA (including AS and nr-axSpA), PsO and pediatric PsO The positive opinion is based on bio similarity assessment which included pre/ clinical studies demonstrating bioequivalence […]Read More

PharmaShots’ Most Read News of 2019

The year 2019 has been a busy year for global pharma and biotech companies involved in M&A, option & licensing agreements and gaining approvals. Our team has compiled a list of 20 most read life sciences news on PharmaShots in 2019. 1. Celltrion Signed an Exclusive Co-Marketing Agreement with Juno in Australia Juno provided sales […]Read More