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We reported on 26 August 2024 that JAMP had filed an application in the Canadian Competition Tribunal seeking leave to bring an action under the Competition Act regarding Stelara® (ustekinumab).  JAMP alleged that Janssen had abused its dominant market position, in contrave...

On 20 November 2024, Jazz Pharmaceuticals announced that the US FDA has granted accelerated approval of Ziihera® (zanidatamab-hrii) for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, as detected by an...

On 20 November 2024, Pfizer announced that the European Commission (EC) has approved its Hympavzi™ (marstacimab) for the routine prophylaxis of bleeding episodes in patients 12 years of age and older weighing at least 35 kg with severe haemophilia A without FVIII inhibitors...

On 20 November 2024, UCB announced that Bimzelx® (bimekizumab-bkzx) was approved by the FDA as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa.

This follows the recommendation of the EMA’s Committee for Medicinal Prod...

On 19 November 2024, Reuters reported that Novo Nordisk has launched Wegovy® (semaglutide) in China.  The report states that sales will initially be made without insurance subsidy, although Novo Nordisk is investigating mechanisms to reduce costs for Chinese consumers.

On 19 November 2024, the Economic Times reported that the Supreme Court of India has directed the Delhi High Court to move quickly on reconsidering an injunction, which was reinstated in October 2024, preventing Zydus from manufacturing, selling and marketing Sigrima™, bios...

On 19 November 2024, MSD (Merck in the US and Canada) announced positive topline results from its Phase 3 trial evaluating subcutaneous (SC) administration of pembrolizumab, together with Alteogen’s berahyaluronidase alfa, administered with chemotherapy.  The SC pembrolizum...

On 19 November 2024, Xbrane and Intas announced they have entered an exclusive, global licensing and co-development agreement in relation to Xbrane´s nivolumab biosimilar candidate (referencing BMS’ Opdivo®).  The biosimilar will be commercialised through Intas’ subsidiary ...