This week PharmaShots’ news was all about the updates on clinical trials, regulatory, biotech, pharma, M&A, and biosimilar. Check out our full report below:

• 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)