PharmaShots Weekly Snapshots (October 23–27, 2023)

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PharmaShots Weekly Snapshots (October 23–27, 2023)

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

The US FDA approved Celltrion's Zymfentra (Infliximab-Dyyb) for the treatment of inflammatory bowel disease

Read more: Celltrion

The US FDA granted BMS's BMS-986278 a break through designation for the treatment of pulmonary and progressive pulmonary fibrosis (IPF & PPF)

Read more: BMS

The US FDA granted approval to Servier’s Tibsovo for the treatment of Myelodysplastic Syndromes (MDS)

Read more: Servier

ViiV Healthcare's Vocabria in combination with Rekambys receives the NMPA’s approval as an HIV-1 injectable treatment

Read more: ViiV Healthcare

The US FDA has approved Eli Lilly’ Omvoh (mirikizumab-mrkz) for adults with moderately to severely active ulcerative colitis. based on the (LUCENT) program incl. 2 P-III trials i.e., one 12wk. induction study (UC-1) and one 40wk. maintenance study (UC-2) for 52wks.

Read more: Eli Lilly

The US FDA has approved Genentech’s Vabysmo (faricimab-svoa) for retinal vein occlusion, based on the P-III (BALATON) for branch retinal vein occlusion and (COMINO) studies for central retinal or hemiretinal vein occlusion

Read more: Genentech

The US FDA has accepted the IND application to initiate a P-I trial of Mustang Bio’ MB-109, a novel combination of MB-101 and MB-108 in adult patients with recurrent GBM and high-grade astrocytomas

Read more: Mustang Bio

Amgen presents the data for Lumakras and Vectibix in P-III clinical trial for the treatment of metastatic colorectal cancer at ESMO 2023

Read more: Amgen

The results from the P-III clinical trials evaluating TrenibotulinumtoxinE (BoNT/E) for treatment of glabellar lines were reported by Allergan and AbbVie

Read more: Allergan and AbbVie

Revolo Biotherapeutics reports the P-IIa trial results for IRL201104 in seasonal allergic rhinitis

Read more: Revolo Biotherapeutics

Imugene reports the initiation of the P-I (OASIS) study for onCARlytics in solid tumor patients

Read more: Imugene

The results from the P-III trial evaluating Leqembi as subcutaneous dosage form for Alzheimer’s Disease were presented by Eisai and BioArctic at CTAD 2023

Read more: Eisai and BioArctic

MaaT Pharma received positive opinion from DSMB for MaaT013 in P-III trial to treat graft versus host disease (GvHD)

Read more: MaaT Pharma

Pfizer and BioNTech highlighted P-I/II study result of mRNA-based combination vaccine program against influenza and COVID-19 which showed robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains

Read more: Pfizer and BioNTech

BioCryst initiated the patient enrolment in proof-of-concept trial of BCX10013 for the treatment of complement-mediated diseases

Read more: BioCryst

The US FDA approved Medinol’s EluNIR-PERL drug-eluting coronary stent system to treat coronary artery disease

Read more: Medinol

Fresenius Medical Care recalls few models of haemodialysis machines for potential exposure to toxic substances "IN" the US

Read more: Fresenius Medical Care

PENTAX Medical INSPIRA (EPK-i8020c) and i20c Endoscope Series by PENTAX Medical debuted in USA at ACG 2023

Read more: PENTAX Medical

Alaya.bio acquired Ixaka France to strengthen its novel in vivo CAR-T immunotherapy platform

Read more: Alaya.bio and Ixaka France

Roche acquires Telavant along with its asset RVT-3101 from Roivant to treat inflammatory bowel disease

Read more: Roche and Telavant

Together with AstraZeneca and Everton, LumiraDx intends to launch a heart and lung screening center for its NT-proBNP test in England

Read more: AstraZeneca and Everton

GSK entered into a license agreement with Hansoh for HS-20089 to treat gynecologic cancer 

Read more: GSK and Hansoh

Eli Lilly signed a collaboration and licence agreement with Elektrofi to develop patient-centered subcutaneous therapies

Read more: Eli Lilly and Elektrofi

Mithra & Searchlight signed a license and supply agreement for Donesta in Canada

Read more: Mithra & Searchlight

Related Post: PharmaShots Weekly Snapshots (October 16–20, 2023)

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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