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Luye Pharma announced that it has enrolled its first subject in an international multi-center Phase 3 clinical study for its internally developed denosumab products (BA6101 and BA1102) to be carried out in Europe, the United States, and Japan. BA6101 and BA1102 are biosimil...

Bristol Myers Squibb announced that the FDA has accepted its sBLA, and the EMA has validated its Type II Variation Application, for Reblozyl® (luspatercept-aamt) to include treatment of anaemia (without previous use of erythropoiesis-stimulating agents in adults with very l...

A study published in Health Affairs has suggested the US 340B Drug Pricing Program has reduced biosimilar uptake in hospitals that participate in the Program.  The 340B Program offers eligible safety-net hospitals (almost one third of US hospitals) to purchase originator me...

On 1 May 2023, Amgen instigated proceedings in the US District Court of New Jersey against Sandoz, Novartis and Lek, alleging infringement of 21 patents relating to Amgen’s Prolia® and Xgeva® (denosumab) products.  Sandoz submitted its aBLA to the FDA in December 2022 (whic...

MSD announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted to support FDA approval of Lynparza® (olaparib) plus abiraterone and prednisone or prednisolone for the first-line treatment of BRCA-mutated metastatic castration-resistant prostate cancer (mCR...

Samsung Bioepis filed an IPR petition against Regeneron’s US patent no. 11,253,572directed to methods of treating an angiogenic eye disorder by intravitreal injection of aflibercept via a specified dosage regime, with a specified result.

Apotex (unsuccessfully) filed...

Novartis announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the grant of marketing authorization for Cosentyx® (secukinumab) in adults with active moderate to severe hidradenitis suppurativa, an inflammatory ...

Roche announced that the EU’s European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Columvi® (glofitamab) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) as a thi...

The European Commission (EC) has adopted a proposal for a new Directive and a new Regulation which will revise and replace the existing pharmaceutical legislation, and amount to the largest regulatory reform in the EU in over 20 years.  The Directive and Regulation have bee...