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
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
Shots: The companies launch Nepexto, a biosimilar referencing Amgen’s Enbrel, and is indicated for the mod. to sev. RA, JIA from the age of 2yrs., active and progressive PsA, severe axSpA, mod. to sev. PsO and chronic severe PsO in children and adolescents from the age of 6yrs. Nepexto is available as a solution for […]Read More
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
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
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
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
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
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
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
Copyright ©2020 PharmaShots | Powered by Octavus Consulting
