27 Sep 21 | Hikma Pharmaceuticals announced that it will acquire Custopharm for an initial cash consideration of USD $375 million with a further USD $50 million in contingent consideration payable upon the achievement of certain commercial milestones.
27 Sep 21 | CN | JW Therapeutics announced that China’s NMPA has approved the IND for a clinical trial of BCMA-targeted Chimeric Antigen Receptor (CAR) T cell JWCAR129 in treating relapsed or refractory multiple myeloma.
27 Sep 21 | JP | AbbVie, Eisai Co and EA Pharma announced Humira® (adalimumab) has received additional approvals in Japan for its high-dose regimen in adults with ulcerative colitis and in a new regimen in paediatric patients.
27 Sep 21 | A new study published in Annals of Internal Medicine reported that a live virus Varicella-Zoster vaccine in immunosuppressed patients receiving biologic therapies may be a reasonable option if no alternative vaccine is available.
28 Sep 21 | US | Eli Lilly announced that the FDA has approved Erbitux® (cetuximab) in combination with Braftovi® (encorafenib) for the treatment of metastatic colorectal cancer with a BRAF V600E mutation.
29 Sep 21 | US | The US House Judiciary Committee voted in favour of the Preserve Access to Affordable Generics and Biosimilars Act. If passed, this act would allow the FTC to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connected with the sale of a drug or biological product.
30 Sep 21 | EU | Xbrane Pharma and STADA announced that the MAA for Xlucane™ (proposed biosimilar ranibizumab) has been submitted to the EMA.
01 Oct 21 | US, KR | Korea Biomedical Review reported that Celltrion has submitted an application for CT-P16 (proposed biosimilar bevacizumab) in the US and Korea.
01 Oct 21 | US | Coherus Biosciences announced that the FDA has accepted for review the BLA for CHS-201 (proposed biosimilar ranibizumab).