Biogen Inc. and Samsung Bioepis Co. Ltd. gained FDA clearance for Byooviz (ranibizumab-nuna), a biosimilar that references the VEGF therapy Lucentis (ranibizumab) from Roche Holding AG, as a treatment for wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization. Read More
Despite Beyondspring Pharmaceuticals Inc.’s phase III study meeting its primary and key secondary endpoints of a plinabulin/docetaxel combination in treating non-small-cell lung cancer (NSCLC), the company stock (NADAQ:BYSI) took a pounding. Shares sunk 32.9% on Sept. 20 to close at $15.36 each. Read More
Takeda Pharmaceutical Co. Ltd. has grabbed a slice of the non-small-cell lung cancer (NSCLC) market, becoming the first company to gain FDA approval for an oral drug targeted against a rare form of the disease. Read More
Everest Medicines Ltd. has in-licensed a Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of renal diseases from Suzhou Sinovent Pharmaceuticals Co. Ltd. and Sinomab Bioscience Ltd. in a deal worth up to $561 million. Everest gained global rights to develop, produce and commercialize the candidate, XNW-1011. Read More
Celltrion Inc. is riding high after receiving full approval for Regkirona (regdanvimab), as a treatment for COVID-19 in South Korea, seven months after the Ministry of Food and Drug Safety (MFDS) granted it conditional marketing approval in February 2021. Read More
A new law in China will grant physicians the right to use off-label drugs, giving clearer definition to a gray area and lending hope that it could benefit pharma companies. Read More
While 2020 is certainly a hard year to beat, 2021 has so far recorded a respectable amount of biopharma deals and is on track to exceed every other year. The number this year, including licensings, collaborations and joint ventures, is trailing 2020 by only 3%. BioWorld has recorded 1,447 deals valued at $131.75 billion in 2021 vs. 1,488 worth $141.56 billion last year. That puts 2021 about 7% behind 2020 on deal values. Read More
Data to be presented at ESMO Congress 2021, including: Acepodia, Bridge, Coherus, Cstone, Daiichi Sankyo, Eqrx, Junshi, Laekna Therapeutics Shanghai, Sarah Cannon Research Institute. Read More
