NEWS Archives - PharmaShots

NEWS

Roche Reports P-III (INShore) Trial Findings on Gazyva (Obinutuzumab) for Idiopathic Nephrotic Syndrome

Shots:Roche has reported the P-III (INShore) trial findings assessing Gazyva (Obinutuzumab; Wk. 0, 2, 24 & 26) vs mycophenolate mofetil (MMF; QD) in 85 pts (>2-25yrs.) with frequently relapsing or steroid-dependent nephrotic syndromeTrial met its 1EP, with more pts achieving sustained complete remission at 1yr., & certain 2EPs. Gazyva showed significant benefits in…

3 hours ago

GSK Collaborates with Empirico to Advance EMP-012 Across Inflammatory Respiratory Diseases

Shots:GSK has entered into a worldwide exclusive license agreement with Empirico to develop & commercialize EMP-012As per the deal,Empirico will lead P-I development of EMP-012, following which GSK will take over global development, regulatory filings, & commercialization, with Empirico receiving $85M upfront, ~$660M in development, regulatory & commercial milestones, & tiered royalties on…

4 hours ago

AstraZeneca Reports the US FDA’s Approval of Koselugo (Selumetinib) for Treating Neurofibromatosis Type 1

Shots:The EC has approved Koselugo for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adults with neurofibromatosis type 1 (NF1)Approval was based on the P-III (KOMET) study assessing Koselugo (PO) vs PBO in 145 adults with NF1 & symptomatic, inoperable PNs across 13 countries incl. North America, South America, Europe, Asia &…

5 hours ago

Syndax Pharmaceuticals’ Revuforj (Revumenib) Receives the US FDA’s Approval for NPM1-Mutated R/R Acute Myeloid Leukemia

Shots:The US FDA has approved label expansion of Revuforj to treat pts (≥1yrs.) with nucleophosmin 1 (NPM1)-mutated r/r acute myeloid leukemia (AML) who have no satisfactory alternative treatment optionsApproval was supported by P-II results from the P-I/II (AUGMENT-101) trial, which showed a 23% CR + CRh rate (15/65), median response time of 2.8mos.,…

7 hours ago

Incyte Partners with Enable Injections for enFuse On-Body Delivery System

Shots:Incyte has partnered with Enable Injections to develop and commercialize specific assets in Incyte’s portfolio, incl. INCA033989, a mutCALR selective mAb, with Enable’s enFuse On-Body Delivery SystemAs per the deal, Incyte will obtain exclusive global rights to use enFuse tech with INCA033989 for essential thrombocythemia & myelofibrosis, with potential expansion to other assets &…

8 hours ago

Eli Lilly’s Omvoh (mirikizumab-mrkz) Receives the US FDA’s Approval for Ulcerative Colitis

Shots:The US FDA has approved Omvoh (200mg/2mL, SC, QM) as a maintenance treatment of adults with mod. to sev. active ulcerative colitis; PFS & prefilled pen to be available in early 2026Approval was based on P-I trial assessing Omvoh (200mg/2mL, SC) single injection vs 2 100mg/1mL injections in participants, which showed bioequivalence between the…

9 hours ago

Merck Reports the US FDA’s Approval of Winrevair (Sotatercept-csrk) to Treat Adults with Pulmonary Arterial Hypertension (PAH)

Shots:The US FDA has approved Winrevair to treat adults with PAH (WHO Group 1) functional class (FC) II or IIIApproval was based on the global P-III (ZENITH) trial (N=172) evaluating Winrevair (n=86; 0.7 mg/kg; SC; Q3W) + background therapy vs PBO (n=86) in adults with PAH (WHO FC III/IV) at high mortality risk. WINREVAIR…

1 day ago

Eisai and Biogen Report the Health Canada’s Approval of Leqembi (Lecanemab) to Treat Alzheimer’s Disease

Shots:Health Canada has approved Leqembi with conditions for adults with mild cognitive impairment or mild dementia due to early Alzheimer’s disease who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathologyApproval was based on the P-III (Clarity AD) trial assessing Leqembi vs PBO in pts with MCI or mild dementia due to…

1 day ago

GSK Secures Exclusive License to Syndivia’s ADC Candidate for Prostate Cancer

Shots:Syndivia has granted GSK exclusive global rights to develop and commercialize a preclinical ADC for the treatment of metastatic castration-resistant prostate cancer (mCRPC)As per the deal, GSK will handle global development, manufacturing, & commercialization of the ADC in exchange for an upfront payment, along with development & commercial milestone payments up to a total of…

1 day ago

Eli Lilly Strengthens its Gene Therapy Capabilities with Adverum Acquisition

Shots:Eli Lilly has entered into a definitive agreement to acquire Adverum Biotechnologies, incl. its asset Ixo-vecAs per the deal, Lilly will acquire Adverum for $3.56/share plus a CVR of ~$8.91 per share, tied to milestones: for ~$1.78 per CVR on Ixo-vec’s FDA approval within 7yrs. of closing & ~$7.13 per CVR upon achieving $1B…

1 day ago

NEWS

Roche Reports P-III (INShore) Trial Findings on Gazyva (Obinutuzumab) for Idiopathic Nephrotic Syndrome

GSK Collaborates with Empirico to Advance EMP-012 Across Inflammatory Respiratory Diseases

AstraZeneca Reports the US FDA’s Approval of Koselugo (Selumetinib) for Treating Neurofibromatosis Type 1

Syndax Pharmaceuticals’ Revuforj (Revumenib) Receives the US FDA’s Approval for NPM1-Mutated R/R Acute Myeloid Leukemia

Incyte Partners with Enable Injections for enFuse On-Body Delivery System

Eli Lilly’s Omvoh (mirikizumab-mrkz) Receives the US FDA’s Approval for Ulcerative Colitis

Merck Reports the US FDA’s Approval of Winrevair (Sotatercept-csrk) to Treat Adults with Pulmonary Arterial Hypertension (PAH)

Eisai and Biogen Report the Health Canada’s Approval of Leqembi (Lecanemab) to Treat Alzheimer’s Disease

GSK Secures Exclusive License to Syndivia’s ADC Candidate for Prostate Cancer

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