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Oct 3, 2024
On 3 October 2024, BMS announced that the FDA has approved Opdivo® (nivolumab) for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK)...
Oct 3, 2024
On 3 October 2024, the US Patent Trial and Appeal Board (PTAB) instituted inter partes review (IPR) of Johns Hopkins University’s US patent no. 11,643,462 in IPR2024-00648. MSD filed a petition on 13 March 2024, challenging the validity of the patent, which is...
Oct 3, 2024
On 3 October 2024, Teva Pharmaceuticals and mAbxience (majority owned by Fresenius Kabi) each announced that they have entered into a new global licensing agreement for the development of an unnamed anti PD-1 oncology biosimilar candidate. Under the agreement,...
Oct 3, 2024
The UK National Health Service (NHS) launched a consultation on a phased rollout of Eli Lilly’s obesity drug Mounjaro® (tirzepatide), prioritising patients who are most likely to benefit from weight loss. In a proposal made to National Institute for Health and Care...
Oct 2, 2024
On 2 October 2024, Eisai reported that it has submitted an application for approval of Leqembi® (lecanemab) in Saudi Arabia for Alzheimer’s disease . The news follows approval of Leqembi® in the UK for the treatment of mild cognitive impairment (MCI) and mild dementia...
Oct 2, 2024
On 2 October 2024, South Korea-headquartered ABL Bio announced it has entered a clinical collaboration and supply agreement with MSD to evaluate the bispecific antibody ABL 103 in combination with MSD’s Keytruda® (pembrolizumab) in patients with advanced or metastatic...
Oct 1, 2024
On 1 October 2024, AstraZeneca and Daiichi Sankyo’s supplemental Biologics Licence Application for Enhertu® (fam-trastuzumab deruxtecan-nxki) was granted priority review by the US FDA. The treatment is proposed to be used in HER2-low or HER2 ultra-low unresectable or...
Oct 1, 2024
On 1 October 2024, Johnson & Johnson (J&J) announced a $2b investment in a new, advanced technology biologics manufacturing facility in North Carolina. J&J states that the new facility will expand production of the company’s biologics portfolio and...
Oct 1, 2024
On 1 October 2024, the prestigious journal Nature published an article describing a retrospective cohort study comparing the efficacy of Evenity® (romosozumab) and Prolia® (denosumab) in treating male osteoporosis over 12 months, focusing on bone mineral density (BMD)...
Sep 30, 2024
On 30 September 2024, the Australian Therapeutic Goods Administration (TGA), in collaboration with the Australian Border Force (ABF), issued a notice advising of the detection of counterfeit Ozempic®-labelled pens being imported into Australia. The TGA warns that the...
Sep 27, 2024
On 27 September 2024, Sanofi and Regeneron announced that Dupixent® (dupilumab) has been approved in the US as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. On the...
Sep 27, 2024
On 27 September 2024, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Ixifi™, biosimilar to Janssen’s Remicade® (infliximab), in 100mg powder for injection vial for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic...
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