No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
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...
Oct 10, 2024
On 10 October 2024, Johnson & Johnson (J&J) announced that it submitted a Type II variation application to the EMA seeking an indication extension for Darzalex® (daratumumab) subcutaneous formulation in combination with bortezomib, lenalidomide and...
Oct 10, 2024
On 10 October 2024, STADA announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab). Under an agreement with Alvotech entered in June 2024, STADA has...
Oct 9, 2024
On 9 October 2024, Ono Pharma Taiwan received additional approval of Opdivo® (nivolumab) intravenous infusion in combination with cisplatin and gemcitabine, from the Taiwan Food and Drug Administration, for the first-line treatment of adult patients with unresectable...
Oct 9, 2024
On 9 October 2024, Biogen announced that its felzartamab received FDA Breakthrough Therapy Designation (BTD) for the treatment of late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients. Felzartamab is an investigational...
Oct 9, 2024
On 9 October 2024, Nanjing Leads Biolabs announced that China’s Center for Drug Evaluation of National Medical Products Administration granted Breakthrough Therapy Designation to LBL-024, an anti-PD-L1/4-1BB bispecific antibody, for the treatment of patients with...
Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.