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Following Alvotech’s listing on the NASDAQ and NASDAQ First North growth market last month, the board of directors has approved an increase in its share capital by an amount of $270,721.67 through the issuance of 27,072,167 ordinary shares.  The share capital increase was e...

Viatris announced that it was voluntarily recalling one batch of insulin glargine 100 units/mL, 3mL prefilled pens (batch BF21002895) due to the potential for the label to be missing on some pens.  This recall pertains only to the unbranded interchangeable biosimilar Insuli...

Xbrane Biopharma confirmed that it will resubmit a BLA for its biosimilar to Lucentis® (ranibizumab) this year.  Xbrane previously announced that it would withdraw the BLA after receiving feedback from the FDA in May that additional information was required for the FDA to a...

PDS Biotechnology announced that the FDA has granted fast-track designation to PDS0101 (novel T-cell HPV-specific immunotherapy) in combination with Keytruda® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.

The results of a phase III study of Iranian biopharmaceutical company AryoGen Pharmed’s denosumab biosimilar Arylia in osteoporosis patients showed that its efficacy and safety were not inferior to Amgen’s Prolia®.

Shanghai Henlius Biotech announced that the IND for HLX53 (anti-TIGIT Fc fusion protein) has been accepted by China’s NMPA.  HLX23 is being developed for the treatment of patients with advanced/metastatic solid tumours or lymphomas.

Regeneron announced that the FDA has accepted for review the sBLA for Eylea® (aflibercept) for a 16-week 2mg dosing regimen (after initial monthly doses) in patients with diabetic retinopathy.  The FDA has set a target action date of 28 February 2023.