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Bloomberg reported that the Complete Response Letter (CRL) issued by the FDA in relation to Regeneron’s BLA for aflibercept 8mg identified deficiencies at Catalent Inc.’s facility in Bloomington, Indiana.  On 27 June 2023, Regeneron announced that that the FDA had issued a ...

Regeneron announced that the FDA has issued a Complete Response Letter (CRL) in relation to the Regeneron BLA for aflibercept 8 mg.  Aflibercept 8mg is being jointly developed by Regeneron and Bayer AG as a higher dose formulation of aflibercept (compared to the currently a...

UCB announced that its Biologics License Application (BLA) for bimekizumab to treat moderate to severe plaque psoriasis remains under review with the FDA.  The FDA acceptance was expected in Q2, 2023, however it is not anticipated that the FDA will do so in Q3 2023.  Bimeki...

Aurobindo Pharma subsidiary CuraTeQ Biologics informed stock exchanges that it has withdrawn marketing authorisation applications to the EMA for biosimilars ZEFYLTI®, biosimilar to Amgen’s Neupogen® (filgrastim) and DYRUPEG®, biosimilar to Amgen’s Neulasta® (pegfilgrastim)....

AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the MA for Astra Zeneca’s Soliris® (eculizumab) be expanded to include the treatment of refractory generalised myasthenia gravis (gMG) in ...

Ocuphire announced its phase II clinical trial poster was presented at the 83rd Scientific Sessions of the American Diabetes Association, titled “Oral APX3330 Reduces the DRSS Worsening after 24-weeks of Daily Treatment—Efficacy and Safety Results of the ZETA-1 Phase 2 Tria...

Boehringer Ingelheim announced that Optum Rx, pharmacy benefit manager, will place Cyltezo® (adalimumab-adbm), the FDA-approved Interchangeable biosimilar to AbbVie’s Humira® on its commercial formulary as a preferred brand.  Optum Rx covers more than 66 million members in ...