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Oct 16, 2024
On 16 October 2024, Australia's Therapeutic Goods Administration (TGA) reported its decision not to register Leqembi® (lecanemab) for the treatment of patients with mild Alzheimer's dementia (early Alzheimer’s disease) and mild cognitive impairment (MCI) due to...
Oct 16, 2024
On 16 October 2024, Formycon announced that results of a comparative analytical evaluation of its FYB206, published in Drugs in R&D, showed FYB206 to be structurally and functionally “highly similar” to MSD’s Keytruda® (pembrolizumab). FYB206 is currently being...
Oct 16, 2024
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 Court...
Oct 16, 2024
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...
Oct 15, 2024
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®...
Oct 14, 2024
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...
Oct 14, 2024
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...
Oct 11, 2024
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)...
Oct 11, 2024
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. The...
Oct 11, 2024
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...
Oct 10, 2024
On 10 October 2024, Samsung Bioepis released its quarterly US Biosimilar Market Report. The report has been published every quarter since April 2023 and details average sales price information for US launched biosimilars and market share and price trends. The Q4 2024...
Oct 10, 2024
New Zealand’s drug-funding body, Pharmac, has announced that Eli Lilly/Merck KgGa's Erbitux® (cetuximab) will now be funded for left-sided, RAS and BRAF wild-type, metastatic colorectal cancer. Minor amendments have also been made to eligibility criteria for...
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