Jazz’ Sunosi (solriamfetol) Receives NICE Recommendation for the Treatment of Excessive Daytime Sleepiness Caused by Narcolepsy Published: Nov 19, 2021 | Tags: Jazz, Sunosi, solriamfetol, NICE, Recommendation, Excessive Daytime Sleepiness, […]readmore
Tags : Biogen
Shots: The approval is based on the data from PK bridging studies and P-III EVOLVE-MS-2 study to evaluate the GI tolerability of Vumerity vs Tecfidera in patients with relapsing-remitting MS […]readmore
AbbVie’s Rinvoq (upadacitinib) Receives the Health Canada Approval for the Treatment of Moderate to Severe Atopic Dermatitis Published: Oct 8, 2021 | Tags: AbbVie, Rinvoq, upadacitinib, Health Canada, Approval, Atopic […]readmore
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 […]readmore
Shots: The LANDSCAPE and NEST clinical development program evaluates the efficacy and safety of zuranolone in patients with MDD and PPD. The presentations also include data from the P-III WATERFALL […]readmore
The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular merger agreement to acquired First […]readmore
Everest’s SPR206 Receives the NMPA’s IND Approval for the Treatment of MDR Gram-Negative Bacterial Infections Published: Sept 24, 2021 | Tags: Everest, SPR206, NMPA, IND, Approval, MDR Gram-Negative Bacterial Infections […]readmore
Samsung Bioepis and Biogen’s Byooviz (biosimilar, ranibizumab) Receives the US
Shots: The approval is based on a totality of evidence including analytical, non-clinical/clinical data from the P-III study evaluates the efficacy, safety, PK & immunogenicity of SB11 (0.5mg) vs Lucentis […]readmore
In an interview with PharmaShots, Ron Elwell, President, and Founder of Swoop and IPM.ai shared his views on the Real Chemistry Clinical Trial Recruitment System that is designed to accelerate […]readmore
Shots: The P-II CONVEY withdrawal study evaluates efficacy & safety of vixotrigine (200/350 mg, bid) vs PBO in 265 patients with SFN for 12wks. The study met its 1EPs i.e., […]readmore