Here is a selection of this week's news from around the world
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Priority Review awarded to Xtandi for prostate cancer The US Food and Drug Administration (FDA) has accepted for review the filing of a supplemental New Drug Application (sNDA) for Astellas and Pfizer’s Xtandi (enzalutamide), the companies have announced. To read more follow this PharmaTimes link |
Celgene wins approval for drug key to Bristol buyout Celgene on Friday won U.S. approval for Inrebic, a treatment for myelofibrosis that is one of five drugs Bristol-Myers Squibb regarded as particularly valuable in its $74 billion deal to buy Celgene. To read more follow this BioPharmaDive link |
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FDA boxed warning for AbbVie's JAK inhibitor clouds Gilead's The Food and Drug Administration's decision to approve a new rheumatoid arthritis treatment with a boxed safety warning could limit the potential for the entire drug class, one Wall Street analyst cautioned in a Sunday note to investors. To read more follow this BioPharmaDive link |
‘Unhappy’ pupils more likely to be smokers and drinkers Specifically, 51% of young people aged 11 to 15 who had recently drunk alcohol, smoked cigarettes and taken drugs reported experiencing low levels of happiness compared to 36% who had recently done just one of these things, and 22% who hadn’t recently smoked, drank or taken drugs. To read more follow this PharmaTimes link |
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Sarepta’s DMD drug hit with FDA Complete Response Letter Sarepta Theraputics has announced the reception of a Complete Response Letter (CRL) from the US Food and Drug Administration, (FDA) regarding accelerated approval of golodirsen injection. To read more follow this PharmaTimes link |
Nabriva wins FDA's favor on pneumonia antibiotic Nabriva Therapeutics on Monday gained U.S. approval for its pneumonia treatment lefamulin, bringing a new antibiotic option to a commercially difficult market. To read more follow this BioPharmaDive link |