Tonix Pharmaceuticals Presents Results of TNX-102 SL in P-III RELIEF study for the Management of Fibromyalgia at ASCP 2021 Published: June 4, 2021 | Tags: Tonix Pharmaceuticals, TNX-102 SL, P-III, RELIEF Study, Fibromyalgia, ASCP 2021 Dermavant Submits NDA to the US FDA for Tapinarof Cream to Treat Plaque Psoriasis Published: June 4, 2021 | Tags: […]Read More
The global generics pharmaceutical market has become an intimidating segment of the pharmaceutical drug market which continuously growing and increasing with its accessibility & benefits offered as efficient and economical drugs. Generics are approved copies of small molecule drugs that contain the same amount of active ingredients, dosage form, safety, strength, route of administration, quality, […]Read More
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Mylan with its partner Lupin and Biocon launched Nepexto (biosimilar, etanercept) and Semglee (insulin glargine injection) in Germany & in the US, respectively. Additionally, Formycon and Bioeq planned to initiate P-III MAGELLAN-AMD Trial for its FYB203 (biosimilar, […]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 Mylan with its partners Lupin and Biocon received MAA for Nepexto (biosimilar, etanercept) in EU and the US FDA’s Approval for Semglee (biosimilar, insulin glargine) respectively Our team at PharmaShots has summarized 15 key events of the […]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 Hence, the providers are more likely to adopt biosimilars as a “reference product to biologics” possessing similar therapeutic properties The US FDA took an initiative to develop new pathways for Insulin biosimilars. Our team at PharmaShots has […]Read More
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