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On 16 October 2024, the Economic Times reported that the Delhi High Court has reinstated an injunction preventing Zydus from manufacturing, selling or marketing Sigrima™, biosimilar to Roche’s Perjeta® (pertuzumab).

The 16 October 2024 decision of the Delhi High Cour...

On 16 October 2024, Chinese insulin maker Gan & Lee Pharmaceuticals reported its development of an injectable GLP-1 agonist, GZR18, which it claims has outperformed Novo Nordisk’s Ozempic® (semaglutide) in reducing glycated haemoglobin (HbA1c) and body weight in a...

On 15 October 2024, Johnson & Johnson (J&J) reported its results for Q3 2024, which saw sales growth of 5.2% to $22.5B. J&J’s significant regulatory announcements this quarter include applications for expanded US and EU indications of Darzalex® (daratumumab) and...

On 14 October 2024, UCB announced that the US FDA has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of Bimzelx® (bimekizumab-bkzx), adding to the already approved 1 ml (160 mg) device presentation.

On 23 September 2024, UCB re...

On 14 October 2024, AstraZeneca, in partnership with Daiichi Sankyo, announced that Enhertu® (trastuzumab deruxtecan) has received conditional approval in China for use as monotherapy in patients with unresectable, locally advanced or metastatic non-small cell lung cancer w...

On 11 October 2024, Pfizer announced that the US FDA has approved its Hympavzi™ (marstacimab-hncq) for the treatment of adults and adolescents with haemophilia A or B without inhibitors.  The approval is based on results from the Phase 3 BASIS trial (NCT03938792) demonstrat...

On 9 July 2024, Roche received a temporary injunction order against Zydus from a previous bench of the Delhi High Court, restraining Zydus from marketing or selling their product Sigrima™, biosimilar to Roche’s Perjeta® (pertuzumab), till the next date of hearing.

Th...

On 11 October 2024, Meiji Seika Pharma Co., Ltd. announced that the US Food and Drug Administration (FDA) has approved its Imuldosa™ (DMB-3115, ustekinumab-srlf), biosimilar to Janssen’s Stelara® (ustekinumab).

The FDA approval follows Accord BioPharma’s announcement...