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Alvotech & Advanz Pharma
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

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Meitheal Pharmaceuticals
NEWS

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

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NEWS

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

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Iterum Therapeutics
NEWS

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

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The US FDA New Drug Approvals in September 2024
INSIGHTS+

The US FDA New Drug Approvals in September 2024

Shots:      PharmaShots has compiled a list of US FDA-approved drugs in the month of September 2024      The US FDA has approved a total of 7 new drugs including 4 new molecular entities and 3 biologics leading to the treatment of patients and advances in the healthcare industry        The major highlighted drugs were Roche’s Tecentriq Hybreza & Ocrevus Zunovo for…
October 22, 2024

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Teva and Alvotech
NEWS

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

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NEWS

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

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NEWS

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

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AstraZeneca & Ionis
NEWS

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

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