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...US Pharmacopeia (USP), a non-profit organisation that sets standards for medicines made in the US, has not published rFC standards, Lonza said....
...One example comes from a comparison of the disclosures by WuXi Biologics, a pharmaceutical company that listed in 2017, and WuXi XDC, a unit it spun off and listed last year....
...Vaccination remains critical to public health and continued protection against serious consequences of Covid-19, including hospitalisation and death,” said Peter Marks, director of the FDA’s Center for Biologics...
...Swiss pharmaceuticals group is following many rivals to focus its operations on higher-value innovative treatments rather than the cheaper off-patent drugs made by Sandoz, including generic versions of biologic...
...“Humira is the most valuable biologic drug ever and AbbVie is known as one of the most aggressive pharma companies ever....
...Biologics such as Humira, genetically engineered with living cells, can change patients’ lives but their price is now a painfully high barrier....
...Samsung Biologics has also been on the acquisition hunt....
...But it was expanded to include certain off-patent medicines, including biosimilars, or copies of biologic medicines....
...The drugs are “biologic” medicines that are administered by injection or infusion....
...But Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told the advisory panel there had been a “quite troubling surge” in hospitalisations during the recent wave of infections...
...Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told the panel that Novavax’s jab would provide an alternative for people who did not feel comfortable with mRNA vaccines....
...Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said recent data supplied by Pfizer prompted the agency to determine it needed to see data on a third dose before rescheduling...
...Last month a US Food and Drug Administration committee voted against recommending approval of a lung cancer treatment developed by Innovent Biologics and Eli Lilly because the trial was conducted in China...
...A standout example of the carve-out trend was Switzerland-based Lonza Group’s $4.6bn sale of its speciality ingredients business, LSI, to private equity firms Bain Capital and Cinven, allowing the remaining...
...A version of this article was first published by Nikkei Asia on December 23, 2021. ©2021 Nikkei Inc....
...Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said on Wednesday, however, that officials were still actively pursuing the idea of making boosters more widely available...
...Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said: “There seems to be some waning in protection against overall Covid-19 [infections]....
...Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, defended the organisation against accusations it had been slow to issue full legal approval....
...Mike Riley, president of Catalent Biologics, North America, said it was on track to meet its vaccine production commitments to all customers, including Moderna and J&J....
...Peter Marks, the head of the FDA’s Center for Biologics Evaluation and Research, said the vaccine would be ready to be shipped in coming days....
...News round-up KPMG UK chairman told staff to ‘stop moaning’ about work conditions (FT) German finance ministry lambasts regulator over Wirecard (FT) Reddit boosts valuation with $250m fundraising (FT) Lonza...
...(Vanity Fair) News round-up Tesla sends bitcoin to record high with $1.5bn investment (FT) Renesas to buy Apple supplier Dialog for $6bn (FT + Alphaville + Lex) Bain, Cinven agree $4.4bn deal for Lonza...
...placing public health at risk, undermining the historic vaccination efforts to protect the population from Covid-19,” said Stephen Hahn, FDA commissioner, and Peter Marks, director of the FDA’s Center for Biologics...
...Those folks who missed out on the 365 per cent surge following Samsung Biologics’ $1.9bn listing in 2016 will no doubt be keen on this latest offering....
...He cites platforms such as Cocoon from Lonza, and another from Ori Biotech, which are automating and standardising cell and gene therapy manufacturing....
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