NEWS

Alvotech and Advanz Pharma Reports the EMA’s MAA Acceptance of AVT05 (Biosimilar, Simponi)

Shots: The EMA has accepted the MAA of AVT05, biosimilar version of J&J's Simponi & Simponi Aria (golimumab), for the treatment of several chronic inflammatory diseases, with the decision expected in Q4’25 Alvotech, in Apr 2024, reported top-line data from a confirmatory trial of AVT05 vs Simponi in patients with moderate to severe rheumatoid arthritis,…

November 4, 2024

Meitheal Pharmaceuticals Receives Exclusive Commercial Rights of Three Biosimilars Across the US

Shots: Meitheal Pharmaceuticals & its parent, Hong Kong King-Friend Industry (HKF), have entered into an exclusive licensing agreement for commercializing biosimilars of pegfilgrastim & filgrastim in oncology and follitropin alpha for fertility treatment in the US Pegfilgrastim (SC, once per cycle) & filgrastim (SC, IV, daily for 14 days in CT treatment cycle) are bone…

October 31, 2024

Serum Institute of India Reports the CHMP’s Positive Opinion of Siiltibcy as a Diagnostic Aid for Mycobacterium Tuberculosis Infection

Shots: The CHMP has recommended Siiltibcy (0.5μg/mL rdESAT-6 & rCFP-10) to diagnose Mycobacterium tuberculosis infection in individuals (age: ≥28 days), valid in the EU plus Norway, Iceland & Liechtenstein. Separate MAA will be submitted to the UK MHRA Siiltibcy’s sensitivity & specificity was assessed in comparison with QuantiFERON TB Gold In-Tube test (QFT, in-vitro test)…

October 30, 2024

Iterum Therapeutics’ Orlynvah (Oral Sulopenem) Receives the US FDA’s Approval to Treat uUTIs

Shots: The US FDA has approved Orlynvah (sulopenem etzadroxil & probenecid) to treat uUTIs in adult women, specifically addressing infections caused by E.coli, Klebsiella pneumoniae, or Proteus mirabilis, particularly when there are few or no other oral therapy available Approval was based on two pivotal P-III studies (SURE 1 & REASSURE) that assessed the safety…

October 25, 2024

Alvotech and Teva Reports the US FDA’s Approval for the Additional Presentation of Selarsdi (Biosimilar, Stelara)

Shots: Alvotech and Teva have received the US FDA’s approval of Selarsdi’s new dosing presentation of 130mg/26mL (5mg/mL) solution in a single-dose vial for IV infusion for the same indications as Stelara (ustekinumab). It will be launched in the US during Q1’25 The US FDA, in Apr 2024, approved Selarsdi’s dosing of 45mg/0.5mL & 90mg/mL…

October 22, 2024

AstraZeneca and Ionis’ Wainzua (Eplontersen) Receives the CHMP’s Positive Opinion to Treat Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy

Shots: The opinion of Wainzua for ATTRv-PN (stage 1/2 polyneuropathy) was supported by its P-III (NEURO-TTRansform) study vs external PBO for over wk.66, with a follow-up until wk.85 & an end-of-trial evaluation. Eligible patients could then enter an ongoing OLE study Study depicted sustained benefits in co-1EPs of serum transthyretin (TTR) levels & neuropathy…

October 21, 2024

Lindis Biotech’ Korjuny (Catumaxomab) Receives the CHMP’s Positive Opinion to Treat Malignant Ascites (MA)

Shots: The CHMP has granted a positive opinion to Korjuny (trifunctional anti-CD3 x anti-EpCAM Ab) for treating malignant ascites in adults with EpCAM+ carcinomas, not eligible for systemic anti-cancer treatment. EC’s decision is anticipated by YE’24, & will be valid in the EU plus Norway, Iceland & Liechtenstein The opinion was based on P-II/III…

October 21, 2024

Dong-A ST Receives the CHMP’s Positive Opinion for Imuldosa (Biosimilar, Stelara)

Shots: Following the MAA submission by Accord Healthcare (Intas’ subsidiary) in 2023, the EMA’s CHMP has granted positive opinion to Imuldosa, a biosimilar version of Stelara (ustekinumab) Intas Pharmaceuticals with its subsidiaries (Accord BioPharma & Accord Healthcare) will commercialize the biosimilar across the US, EU, UK & Canada while Meiji & Dong-A ST will provide…

October 21, 2024

Novo Nordisk’s Alhemo Gains the CHMP’s Positive Opinion as a Prophylatic Treatment of Hemophilia A or B

Shots: The CHMP has recommended Alhemo (QD, SC) as a prophylactic treatment of hemophilia A/B with inhibitors in patients (≥12yrs.), with the EC’s decision anticipated within ~2mos. The opinion was based on the P-III (explorer7) study assessing the efficacy & safety of Alhemo to treat haemophilia A or B with inhibitors. Alhemo will be available…

October 18, 2024

Astellas Reports the US FDA’s Approval of Vyloy (Zolbetuximab-clzb) to Treat Advanced G/GEJ Cancer

Shots: The US FDA has granted approval to Vyloy plus fluoropyrimidine & Pt-based CT as a 1L treatment of locally advanced unresectable or metastatic CLDN 18.2+, HER2-ve G/GEJ adenocarcinoma Approval was based on the P-III (SPOTLIGHT & GLOW) studies assessing Vyloy + mFOLFOX6 and Vyloy + CAPOX, respectively, vs PBO as a 1L treatment of…

October 18, 2024

NEWS

Alvotech and Advanz Pharma Reports the EMA’s MAA Acceptance of AVT05 (Biosimilar, Simponi)

Meitheal Pharmaceuticals Receives Exclusive Commercial Rights of Three Biosimilars Across the US

Serum Institute of India Reports the CHMP’s Positive Opinion of Siiltibcy as a Diagnostic Aid for Mycobacterium Tuberculosis Infection

Iterum Therapeutics’ Orlynvah (Oral Sulopenem) Receives the US FDA’s Approval to Treat uUTIs

Alvotech and Teva Reports the US FDA’s Approval for the Additional Presentation of Selarsdi (Biosimilar, Stelara)

AstraZeneca and Ionis’ Wainzua (Eplontersen) Receives the CHMP’s Positive Opinion to Treat Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy

Lindis Biotech’ Korjuny (Catumaxomab) Receives the CHMP’s Positive Opinion to Treat Malignant Ascites (MA)

Dong-A ST Receives the CHMP’s Positive Opinion for Imuldosa (Biosimilar, Stelara)

Novo Nordisk’s Alhemo Gains the CHMP’s Positive Opinion as a Prophylatic Treatment of Hemophilia A or B

Astellas Reports the US FDA’s Approval of Vyloy (Zolbetuximab-clzb) to Treat Advanced G/GEJ Cancer

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