18 Sep 21 | Merck announced that the first results from Ph III trials of Keytruda® (pembrolizumab) showed a statistically significant and clinically meaningful improvement in recurrence-free survival compared to placebo in patients with resected high-risk stage II melanoma.
18 Sep 21 | KR | Celltrion announced that South Korea’s MFDS has approved regdanvimab for the extended use in elderly patients aged 50 years and over, or with at least one underlying medical condition with mild symptoms of COVID-19, and in adults patients with moderate symptoms of COVID-19.
20 Sep 21 | US | Samsung Bioepis and Biogen announced that the FDA has approved Byooviz® (biosimilar ranibizumab) for the treatment of neovascular (wet) age-related macular degeneration, macular edema and myopic choroidal neovascularisation.
20 Sep 21 | US | AbbVie announced it has submitted the regulatory application for Skyrizi® (risankizumab) for the treatment of patients 16 years and older with moderate to severe Crohn’s Disease.
20 Sep 21 | 180 Life Sciences and Celltrion announced that they have entered into a Memorandum of Understanding for the supply of an anti-TNF biosimilar drug to be used for new indications with significant unmet medical needs.
23 Sep 21 | Business Standard reported that Aurobindo Pharma (through the subsidiary CuraTeQ Biologics) has submitted a Marketing Authorisation Application to the EMA for BP14 (proposed biosimilar pegfilgrastim).
23 Sep 21 | PharmGene Science and Access Bio announced that they have signed a Memorandum of Understanding for the joint development and commercialisation of a biosimilar mRNA COVID-19 vaccine.
23 Sep 21 | Merck announced that it has entered into a global settlement and license agreement with Pfizer resolving the ongoing dispute relating to Merck’s pneumoccocal conjugate vaccine products.