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Approvals

Crohn’s Gets More Competitive As Lilly Lands Second Omvoh Okay

The FDA has approved the IL-23 inhibitor for Crohn's disease to add to its ulcerative colitis approval and put the drug in a position to compete with the likes of AbbVie's Skyrizi and Johnson & Johnson's Stelara.

Ustekinumab Approvals Arrive In UK And Canada For Formycon And Fresenius

Partners Fresenius and Formycon have racked up another pair of approvals for their Otulfi ustekinumab biosimilar rival to Stelara, this time in the UK and Canada.

Pipeline Watch: Six Approvals And Eight Phase III Readouts

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.

ANI Continues To Spearhead FDA’s CGT Path With Prucalopride Launch

ANI Pharmaceuticals will compete with a product bringing in annual sales of more than $150m after launching the first generic with 180-day exclusivity via the FDA’s competitive generic therapy pathway.

Biocon Dreams To Be Among The Top Three Biosimilar Firms As Stelara Rival Gets Japan Approval

Celebrating its first birthday as a transformed and integrated company, Biocon casts a wider net for its ustekinumab biosimilar.

Chinese Firms Expand Solo Global Phase III Activity Including US Sites

Throughout 2024, Chinese firms as sole sponsors initiated a total of seven global Phase III trials that including US sites. BeiGene, Genfleet and InnoCare are expected to add four similar studies this year.

EU Biosimilar Filings, Opinions And Approvals

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Aurobindo Ramps Up In Biosimilars With UK Bevacizumab Nod

Aurobindo’s biosimilars business is continuing to gain momentum, with a UK approval for bevacizumab in hand and further European nods expected.

China Greenlights First Stem Cell Therapy On Mixed Clinical Findings

China has granted its first approval for a stem cell therapy, to domestic firm Platinum Life Biotech’s umbilical cord-derived mesenchymal stem cell product for corticosteroid-failed acute graft-versus-host disease with gut involvement.

Pipeline Watch: Thirteen Approvals And A Phase III Readout

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.