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President Biden has made an Executive Order to advance “biotechnology and biomanufacturing innovation for a sustainable, safe, and secure American bioeconomy”, including in relation to “health, climate change, energy, food security, agriculture, supply chain resilience, and...

MSD reported that it presented data at the European Society for Medical Oncology (ESCO) Congress in Paris on 11 September, including:

in patients with metastatic nonsquamous NSCLC, data from KEYNOTE-189 demonstrating KEYTRUDA plus pemetrexed (ALIMTA®) and platinum ...

Spectrum Pharmaceuticals announced that the FDA has approved its novel long-acting GCSF (LA-GCSF) ROLVEDON™ (eflapegrastim-xnst) to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosupp...

AstraZeneca published the results of a 5-year follow up study of Lynparza® (Olaparib) with or without bevacizumab in newly diagnosed patients with advanced ovarian cancer. AstraZeneca reported that Olaparib with bevacizumab reduced the risk of death by 38% in HRD-positive p...

Biogen filed a sealed complaint against Sandoz and Polpharma for infringement of 28 Biogen patents in the District of Delaware relating to Sandoz’s biosimilar natalizumab (Tysabri®).  Whilst the complaint was accepted under seal, Biogen was ordered to file a redacted compla...

Regeneron announced that the primary endpoints were met in two pivotal trials evaluating aflibercept 8mg with 12 and 16 week dosing regimes in diabetic macular edema and wet age-related macular degeneration.

Organon announced the release of the ‘Biosimilars: A global roadmap for policy sustainability’ setting out a number of priorities to achieve long-term sustainability of biosimilars in Australia, including:

Ensuring alignment of financial incentives that benefit all...

Lupin and DKSH announced that they have signed an exclusive licensing and supply agreement to market five of Alvotech’s biosimilar products in the Philippines.  The biosimilars include AVT03 (biosimilar denosumab – Prolia® and Xgeva®), AVT05 (biosimilar golimumab/Simp...

Genentech and Samsung Bioepis filed a joint stipulation of dismissal in the District Court of Delaware in the bevacizumab BPCIA dispute, settling all claims and counter-claims.  Genentech filed the suit against Samsung Bioepis in June 2020, alleging infringement of 14 paten...

Yonhap News Agency reported that Celltrion’s ustekinumab biosimilar CT-P43 Ph III trials demonstrated comparable efficacy and safety to Janssen’s Stelara®.  Data from the global 28-week study in 509 plaque psoriasis patients was presented at the European Academy of Dermatol...