The US FDA has approved Novartis’ Cosentyx (secukinumab) as the first intravenous formulation for Rheumatic Diseases
Read more: Novartis
TFDA has approved CANbridge’ CAN108 (Livmarli) for the treatment of cholestatic pruritus in patients with Alagille syndrome in Taiwan
Read more: CANbridge
The US FDA has approved Foundation Medicine’ FoundationOne CDx for Eli Lilly’s Retevmo to treat solid tumors
Read more: Foundation Medicine
The US FDA has granted ODD to SELLAS’ SLS009 for the treatment of Acute Myeloid Leukemia, based on the P-I study
Read more: SELLAS
The US FDA has granted FTD to ImmPACT Bio’ IMPT-514 for Refractory Lupus Nephritis and Systemic Lupus Erythematosus
Read more: ImmPACT Bio
The US FDA has approved Pfizer’s Braftovi (encorafenib) + Mektovi (binimetinib) or BRAF V600E-mutant metastatic non-small cell lung cancer, based on the P-II trial (PHAROS)
Read more: Pfizer
The EMA’s CHMP has adopted a positive opinion recommending approval of Santhera’ Agamree for DMD patients aged ≥4yrs
Read more: Santhera
Kyverna Therapeutics Receives the US FDA’s IND Clearance to Initiate the P-I/II Study of KYV-101 for the Treatment of Scleroderma
Read more: Kyverna Therapeutics
Janssen highlighted P-IIIb study (ESCAPE-TRD) results of Spravato (esketamine nasal spray) for treatment-resistant major depressive disorder showed that patients achieved PHQ-9-defined remission
Read more: Janssen
Innovent dosed the first patient of Efdamrofusp Alfa (IBI302) in the P-III clinical study (STAR) for neovascular age-related macular degeneration
Read more: Innovent
Ventyx Biosciences highlighted P-II trial results of VTX002 for moderate-to-severely active ulcerative colitis showed that 28% of patients on 60mg dose & 24% on 30mg dose achieved the 1EPs of clinical remission at 13wk.
Read more: Ventyx Biosciences
AnaptysBio highlighted P-III trial (GEMINI-1) results of Imsidolimab (Il-36r) for Generalized Pustular Psoriasis which met its 1EPs & achieved rapid clearance of pustulation, erythema & scaling through 4wk.
Read more: AnaptysBio
Roche highlighted P-III studies (BALATON) & (COMINO) results of Vabysmo (faricimab) for the treatment of retinal vein occlusion which showed early & sustained vision improvement
Read more: Roche
Merck highlighted P-III trial (KEYNOTE-671) results of Keytruda for Resectable Stage II, IIIA or IIIB non-small cell lung cancer met its dual 1EPs of OS
Read more: Merck
Genentech highlighted P-III study (OCARINA II) results of Ocrevus for the treatment of Multiple Sclerosis showing that Ocrevus (SC) was non-inferior to IV infusion
Read more: Genentech
Merck reported 5year results from the P-II OLE trial of Evobrutinib for Relapsing Multiple Sclerosis which showed sustained clinical efficacy & safety with no evidence of clinical worsening
Read more: Merck
Incyte highlighted positive 52-week P-IIb trial results of Povorcitinib (INCB54707) for extensive nonsegmental vitiligo showed mean percentage total body & facial depigmentation improvement from baseline
Read more: Incyte
AbbVie highlighted P-III (Measure Up 1), (Measure Up 2), and (AD Up) studies results of Rinvoq for Atopic Dermatitis at 32nd EADV Congress 2023 achieved the co-1EPs of improvement in skin clearance measured by an EASI 75 & vIGA-AD 0/1 at 16wk.
Read more: AbbVie
BMS highlighted 3yr. results from the P-III (POETYK PSO) LTE trial of Sotyktu (deucravacitinib) for moderate-to-severe plaque psoriasis showed a consistent safety profile with no increases in the rates of AEs or serious AEs over time
Read more: BMS
Eli Lilly highlighted P-III study (VIVID-1) results of Mirikizumab for the treatment of Crohn’s Disease met the co-primary i.e., patients achieved clinical response at 12wk. & clinical remission at 52wk.
Read more: Eli Lilly
AbbVie reported P-IIb study results of Rinvoq (upadacitinib) for Non-Segmental Vitiligo met the 1EPs of percent change from baseline in F-VASI at 24wk. with the 11 & 22mg doses
Read more: AbbVie
BMS to acquire Mirati Therapeutics for ~$5.8B. The latest acquisition strengthens and diversifies BMS’ oncology portfolio
Read more: BMS and Mirati Therapeutics
The US FDA has approved Bio-Thera Solutions’ Tofidence (IV), the first biosimilar to reference Actemra for moderately to severely active RA, polyarticular JIA & systemic JIA
Read more: Bio-Thera Solutions
Biocon & Juno Pharmaceuticals collaborated to commercialize Liraglutide to Treat Type 2 diabetes and Obesity in Canada
Read more: Biocon & Juno Pharmaceuticals
TaiGen & YSP collaborated to develop new drugs in Malaysia and Singapore. YSP will be responsible for the NDA and market sales within the authorized region
Read more: TaiGen & YSP
Astria Therapeutics & Ichnos Sciences collaborated for the OX40 portfolio in Atopic Dermatitis and other allergic and immunological diseases
Read more: Astria Therapeutics & Ichnos Sciences
Indivior & Alar collaborated to develop and commercialize ALA-1000 and future buprenorphine-based LAI product candidates
Read more: Indivior & Alar
BioMap & Sanofi collaborated to co-develop AI modules & advance drug discovery for biotherapeutics using BioMap’s AI platform
Read more: BioMap & Sanofi
EpimAb Biotherapeutics & Almirall collaborated to develop bispecific antibodies for up to three undisclosed target pairs
Read more: EpimAb Biotherapeutics & Almirall
MediLink Therapeutics & BioNTech collaborated to develop next-generation anti-cancer antibody-drug conjugate
Read more: MediLink Therapeutics & BioNTech
Related Post: PharmaShots Weekly Snapshots (October 03–06, 2023)
