Generalized Myasthenia Gravis
Mar 07, 2023
Incyte’s Clinical Trial for Myelofibrosis; Eisai and Bioge’s Leqembi; FDA Approves Reata Pharmaceuticals’ SKYCLARYS; Temferon Lands FDA Orphan Drug Status for Glioblastoma; Harbour BioMed Announces Results from Phase III Trial of Batoclimab; FDA Fast Track Designation to Ikena’s AHR Antagonist IK-175
Incyte Halts Phase III Clinical Trial for Myelofibrosis Incyte announced the termination of Phase III LIMBER-304 trial after the results of a pre-planned interim analysis conducted by an independent data monitoring committee (IDMC) revealed that the study is unlikely to meet the primary endpoint in the int...
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Aug 01, 2022
Can FcRn Antagonists Be The Game-Changer in the Generalized Myasthenia Gravis (gMG) Treatment Market?
Though a rare disease, generalized myasthenia gravis (gMG) still affects around 60,000 people in the US and another 100,000 in EU-5 and Japan. As per our analysis, the total diagnosed prevalent cases of gMG were approx 116K in the 7MM in 2021. These numbers are further estimated to increase by 2032. Moreover, t...
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May 03, 2022
VBL Therapeutics’ VB-111 (ofranergene obadenovec); BMS’s mavacamten (Camzyos); Merck’s KEYTRUDA; AstraZeneca and Daiichi’s Enhertu; Pfizer/Biohaven’s VYDURA (rimegepant); AstraZeneca’s Ultomiris; Supernus’s Viloxazine (Qlebree); AbbVie’s Rinvoq
FDA Grants Fast Track Designation to VB-111 for Platinium-resistant Ovarian Cancer The FDA has given VBL Therapeutics’ VB-111 (ofranergene obadenovec), a targeted anticancer viral gene therapy, fast track designation for use as a viable therapeutic option in patients with platinum-resistant Ovarian Cancer. VB...
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Feb 08, 2022
Biogen’s Aduhelm; FDA Approves Sanofi’s Enjaymo; NHS & Orchard Signs a Deal; Bristol’s Breyanzi & Abecma; Pharming’s Leniolisib; Eli Lilly’s Verzenio Trial; UCB’ Zilucoplan Trials Result; Eli Lilly’s Alzheimer’s Drug Donanemab
Biogen's Aduhelm Marketing and Approval are Under Scrutiny in New FTC and SEC Investigations Biogen can't seem to get a break when it comes to the Alzheimer's disease drug Aduhelm. Along with limited sales and a constraining Medicare coverage plan, the medicine is now facing additional scrutiny as part of a pair...
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Jan 05, 2022
Assessment of Key Products that Got FDA Approval in Second Half (H2) of 2021
Although COVID-19 continued to dominate headlines in 2021, pharmaceutical companies did not cease developing new treatments this year. The US Food and Drug Administration maintained a rapid rate of new drug approvals this year, all while managing the urgent examination of COVID-19 tests, treatments, and vaccines un...
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