Hints and tips:
...The FDA approved Truvada for therapeutic and preventive use in 2004 and 2012, respectively....
...In August, Russia became the first country to approve a Covid-19 vaccine — named Sputnik V — for civilian use, but western experts cast doubt on its efficacy and safety....
...Bayer, the German pharmaceutical group, also said it would donate 3m of its malaria tablets, but as they are not approved in the US, they need an emergency authorisation from the FDA....
...Idexx said in October that the animal health market had experienced a “V-shaped recovery”....
...Large generics manufacturers including Mylan and Teva Pharmaceutical would not comment on potential supply chain problems....
...Beyond these three biotechs, Crispr could end up transforming the entire pharmaceutical industry....
...In 2015, he advised Mylan on a successful defence against a hostile bid by Teva Pharmaceuticals....
...In August, the FDA granted approval to Teva Pharmaceuticals for the first generic versions of the EpiPen and EpiPen Jr, introducing off-brand competitors to a key Mylan product line....
...The US Food and Drug Administration approved two generic versions — from Mylan and Dr. Reddy’s Laboratories — in June 2018....
...Mylan recently pressed its manufacturing partner Pfizer to do more to tackle shortages of the life-saving medicine, which was added to the FDA’s official shortages list earlier this year....
...Mylan does not make the EpiPens itself. It gave the job to Pfizer, the US pharmaceutical company, which it seems messed it up....
...The FDA’s decision comes after an initial rejection in 2017. Biosimilars mimic biologic drugs, which are made from living cells....
...Boehringer Ingelheim is the only company with an FDA-approved biosimilar that has not settled with AbbVie in the US and aims to launch its Humira substitute there “as early as legally possible . . . and...
...A rival allergy injector known as Adrenaclick, which is marketed by Amneal Pharmaceuticals, is also in short supply because of issues at a Pfizer plant in McPherson, Kansas, which makes the crucial ingredient...
...could subject Mylan to “significant damages among other remedies.”...
...Instead, their chief contribution to the world of pharmaceuticals was their ability to tinker with the formula of medicines to make them more convenient....
...Drugmakers such as Mylan have thwarted would-be copycat rivals by patenting the injector itself, rather than the active drug, but from now on the FDA will consider generic alternatives with subtle design...
...Dr Reddy’s is not the only company hoping to usurp Indivior’s market dominance: Mylan also has an FDA-approved competitor, while Alvogen’s medicine doesn’t infringe most of Suboxone’s patents....
...The price of Teva’s American shares fell by 14 per cent in early trading in New York, while Mylan jumped by 19 per cent....
...The launch of rival products has forced Mylan to offer large discounts on the EpiPen to the pharmacy benefit managers that negotiate drug prices in the US, the pharmaceuticals group said....
...Rajiv Malik, Mylan’s president, said that in the second quarter, the company “saw increased competition resulting from FDA’s focus on accelerating the approvals of the third, fourth, or fifth generic [version...
...“Mylan is in the process of reviewing this response and will provide an update on its application as soon as practicable once it has completed its review and discussed the FDA’s feedback with the agency,...
...And FDA action could actually harm companies like Mylan if certain medicines are opened up to greater competition. There is some good news for Mylan across the Atlantic....
...In March, Mylan’s Advair substitute was blocked by the FDA....
...It is the same categorisation received by Mylan in March when its own application to the FDA for a generic version of Advair was rejected....
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