Hints and tips:
...The FDA is expected to soon grant an emergency use authorisation for the Russian-made jabs....
...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....
...The African Union will pay three times more for Russia’s Sputnik V jab than it is paying for the Oxford/AstraZeneca and Novavax vaccines, undermining Moscow’s claim that it is supplying poor countries with...
...Earlier data increases our economists conviction in a V-shaped recovery: Economic data in aggregate have continued to surprise to the upside, building our confidence in a V-shaped recovery....
...Mr Kulkarni said the sector would become more like “Apple v Samsung”, where biotechs competed on adding generation after generation of features....
...WPP will also reduce is planned capex from £400m to v£300m....
...The FDA cleared the IND to begin a Phase II study that will assess 2 vaccinations of 50μg or 100μg mRNA-1273 dosed 28 days apart....
...We think that we could see a potential approval in very short order meaning weeks, and timing nowhere near a typical FDA review cycle. ......
...The company will submit an IND with the FDA later this year and now aims to generate interim clinical data in mid-2021....
...Gottlieb lead the FDA through tough issues such as the opioid crisis and teenage vaping. President Donald Trump credited him with helping to lower drug prices. More here....
...Before the FDA ruling, it faced a lawsuit from Unilever (since dropped), which took exception to the term mayonnaise for an eggless product....
...The company points out that OxyContin was — and still is — approved by the US Food and Drug Administration and the risks are described on its FDA-approved label....
...The drugmaker called the price “appropriate” shortly after its FDA approval to treat leukaemia....
...(The Guardian) Nationalism v internationalism “The climate deal and the defeat of the National Front signified a good weekend for the globalists,” writes Gideon Rachman....
..., are much more stringent than those set by the FDA, the EPA, and the WHO....
...The case was brought about a patent that was awarded on Oracea only after Mylan received its FDA approval. To carry the day, Paul Hastings had to build a new legal argument with no direct precedent....
...beyondbrics India v China: a new race in biopharmaceuticals, beyondbrics...
...The FDA committee’s “risk versus reward” decision framework reviews many different factors....
...The most notorious of these is the Supreme Court’s 2006 decision in eBay v MercExchange, which reduced the likelihood that patentees could enjoin deliberate patent infringement....
...that bans drug lawsuits can make an exception for claims that manufacturers obtained FDA approval through fraud....
...Voting 8-1 in Riegel v Medtronic, the justices barred a suit from the widow of a man injured by a heart catheter that had been approved for sale by the Food and Drug Administration....
...Wyeth said in court papers that the Vermont ruling “would empower courts to review and override FDA’s careful and comprehensive balancing of safety and effectiveness concerns in prescription drug labelling...
...The case before the court, Riegel v Medtronic, could have big implications for makers of medical devices and possibly other products....
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