Tags : Lupin

Weekly Snapshot

PharmaShots Weekly Snapshots (May 31 – June 4, 2021)

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

Top 20

Top 20 Generics Pharma Companies Based On 2019 Revenue

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

Insights+

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 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

Weekly Snapshot

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

Biosimilars Insights+

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 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

Weekly Snapshot

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

Biosimilars

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

Biosimilars Insights+

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 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