The EMA’s CHMP has issued a positive opinion for the Kinpeygo budesonide 4mg modified-release hard capsules hybrid medicine developed by Calliditas that will be marketed in Europe by Stada. Meanwhile, four generics from Accord, Fresenius Kabi, Gedeon Richter and Sun have also been endorsed by the committee.

ANI Pharmaceuticals appeared confident about its Cortrophin gel launch and integration of Novitium Pharma as it rounded up its Q1 results, but net losses have dampened the company’s share value.

Accord Healthcare has struck a European licensing deal with Myovant Sciences for its Orgovyx (relugolix) treatment for advanced hormone-sensitive prostate cancer. The move comes shortly after sister company Accord Biopharma launched the Camcevi (leuprolide) prostate cancer treatment in the US.

The Global Generics & Biosimilars Awards returns to Frankfurt this November, celebrating the greatest achievements across the generics, biosimilars and value added medicines industries. Entries are now open and you can book tickets to attend, both of which are free of charge.

Oral delivery of biosimilars could bring significant benefits for patients as well as offering a key differentiating factor for competing developers, especially in the US adalimumab arena, Rani Therapeutics CEO Talat Imran tells Generics Bulletin.

This month, Eli Lilly’s Alimta blockbuster will lose patent protection in the US, while Teva – which will also publish its Q1 financial results – will see Bristol Myers Squibb begin its appeal process against a key UK ruling involving the originator’s Eliquis (apixaban) anticoagulant.

Development partners Teva and MedinCell are not licking their wounds after being denied USFDA approval for their proposed 505(b)(2) hybrid risperidone long-acting injectable product.

Value-added medicines firm Hyloris has raised €15m from new and existing investors through a private equity offering of nearly one million new shares.

Shanghai Henlius Biotech has revealed the latest update on its proposed ophthalmic version of biosimilar bevacizumab, with a global Phase III trial beginning as the firm also pursues international filings with partner Essex Bio-Technology.