Approvals

Aurobindo is set to join Lupin by competing against Johnson/Bayer’s blockbuster blood thinner Xarelto (rivaroxaban) 2.5mg tablets.

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Cipla will look to give its US operations a boost later this year by launching only the second Abraxane ANDA product.

After having its facility cleared by the FDA earlier in the year, Biocon Biologics finally saw its bevacizumab biosimilar receiving approval in the US.

Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Meitheal Pharmaceuticals said that its generic version of the GLP-1 agonist Victoza would be one of 22 planned launches during 2025, as the firm continues to build out its portfolio with the aid of its parent, Hong Kong King-Friend Industrial.

The US FDA approved anti-CD19 antibody Uplizna, from Amgen’s $27.8bn purchase of Horizon in 2023, for IgG4-related disease – a larger market than its original NMOSD indication.

The approval of another Novartis drug with a different mechanism means the company is further cornering multiple parts of IgAN pathogenesis.