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 18, 2024
On 18 October 2024, Astellas Pharma announced that the FDA has approved Vyloy™ (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or...
Oct 17, 2024
At its October 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for Novo Nordisk’s Alhemo® (concizumab) for routine prophylaxis of bleeding in patients of 12 years of age...
Oct 17, 2024
On 17 October 2024, Fresenius Kabi announced its Canadian launch of Tyenne®, biosimilar to Roche’s Actemra® (tocilizumab), in both IV and subcutaneous formulations. Tyenne® is indicated for the treatment of several inflammatory and immune diseases, including...
Oct 17, 2024
At its October meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Accord HealthCare’s, Imuldosa® (DMB-3115) and Absimky® (DMB-3115), biosimilars to Janssen’s Stelara® (ustekinumab). Both...
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)...
Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.