Hints and tips:
...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....
...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 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....
...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....
...CanSino Biologics, the Chinese biotech, has tested its potential vaccine in a single dose — but is now starting a two-dose trial....
...As competition from biosimilars — generic alternatives to biologic drugs — began, sales of Humira dropped more than 30 per cent in international markets in 2019....
...The pandemic is bringing a bonanza to Samsung Biologics....
...As well as women’s health, it will sell branded drugs in dermatology, pain and respiratory diseases, as well as biosimilars, which are generic versions of biologic medicines....
...Sales of drugs including Neulasta and Neupogen, which stimulate the production of white blood cells in cancer patients, dropped by over 30 per cent each, because of competition from generic versions of biologics...
...The three companies receiving the approvals are CanSino Biologics, Sinovac Biotech and the Wuhan Institute of Biological Products, the state news agency has said....
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