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...Leqembi, priced at $26,500 a year, was the first drug with a black-box warning — the most severe designation about possible side effects — to be granted full approval by the US Food and Drug Administration...
...A Humira biosimilar from Teva Pharmaceuticals working with Alvotech earlier this year became the first drug that the US Food and Drug Administration granted interchangeable status, which lets pharmacists...
...A decision from the US Food and Drug Administration on Eli Lilly’s donanemab drug was originally due by the end of the first quarter but the breakthrough medicine will now be subject to a further review...
...Emblaveo, marketed in Europe by US pharmaceutical company Pfizer, combines two existing medicines to tackle so-called Gram-negative bacteria that are among the leading drug-resistance threats....
...These will be the first results from a study designed around landmark US Food and Drug Administration guidelines for researching psychedelics that were outlined last year, a decision that encouraged investors...
...Since the third quarter of 2023 when it had 82 new drugs in development, the company has jettisoned 16 drugs and added 12 others, including the weight-loss drug it gained through its $3.1bn acquisition of...
...The US Food and Drug Administration recently approved the first-ever drug designed specifically for the most common liver disease, metabolic dysfunction-associated steatohepatitis or mash, developed by Madrigal...
...Eli Lilly said that it plans to submit the results to the US Food and Drug Administration and other medicine regulators worldwide to seek approval for tirzepatide as a sleep apnoea treatment beginning this...
...The push into prescriptions and drug delivery is unusual for a pharmaceutical manufacturer, pitting Eli Lilly against pharmacies such as CVS and Walgreens....
...Scientists have invented a potential drug candidate that successfully combats antibiotic-resistant “superbugs” in non-human tests, according to research....
...The UK-based pharmaceutical group reported revenue of $12.7bn, well ahead of consensus estimates of $11.9bn....
...The US Food and Drug Administration will allow Florida to import medicines from Canada, making it the first state to capitalise on rules designed to lower the cost of prescription drugs....
...The results will renew attention on the possible effectiveness of lixisenatide, which is made by French pharmaceutical group Sanofi, and other so-called GLP-1 drugs against neurodegenerative conditions....
...The ruling came after Escobar Inc, the company set up by his brother, filed an application in 2021 with the European Union Intellectual Property Office (EUIPO) for registration of the word sign Pablo Escobar...
...The National Institute for Health and Care Excellence announced on Tuesday that it would not approve the medication Enhertu, developed by pharmaceutical companies Daiichi Sankyo and AstraZeneca, to treat...
...The rush to secure manufacturing capacity comes as Wegovy and Mounjaro, which is also commonly prescribed off-label for weight loss, are in short supply, according to the US Food and Drug Administration....
...The company has been working with the pharmaceutical giant GSK, focusing on immuno-oncology drugs....
...Orchard, a UK-based biotech that was recently bought by Japanese pharmaceutical group Kyowa Kirin, argued that the lack of other treatments for MLD justified the price....
...Eli Lilly’s weight-loss drug tirzepatide significantly reduced sleep apnoea problems in a late-stage clinical trial, the pharmaceutical group said on Wednesday, adding to evidence that could encourage more...
...Of drugs authorised in the year to December 2023, 56 were approved sooner in Europe than in the UK, while eight have not yet been approved. Just four drugs were approved faster by the MHRA....
...Lab monkey prices in China have plummeted as a post-pandemic slowdown in drug development ripples through the pharmaceutical sector in the world’s second-largest economy....
...The US Food and Drug Administration says there is a shortage of Novo Nordisk’s and Eli Lilly’s diabetes drugs, while Belgium has banned the off-label use of Novo Nordisk’s diabetes drug for obesity treatments...
...The US Food and Drug Administration has approved the first Alzheimer’s drug that can slow the progression of the neurodegenerative disease, paving the way for millions of American patients to access the...
...A top EU court has ruled that the name of the dead Colombian drug kingpin Pablo Escobar cannot be registered as a trademark in the EU....
...A decision on Eli Lilly’s donanemab drug from the US Food and Drug Administration was originally due by the end of the first quarter, but the medicine will now be subject to a further review by an advisory...
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