Go or no go? Novartis, Sanofi and Regeneron await US verdicts
May looks to be a fairly quiet month for US drug approvals, though Novartis's gene therapy should make headlines.
Wave crashes again – this time on toxicity concerns
A run of bad news leaves investors questioning Wave Life Sciences’ ability to deliver on its promises.
Galapagos flies with more Finch data
Filgotinib could be the safest Jak inhibitor yet, but Galapagos will need to make the most of this as it squares up to Abbvie.
After Alzheimer’s collapse, Biogen must win Tecfidera patent challenge
A successful Mylan challenge would see generic entry within two years – though Biogen has fought off copycats before.
Upcoming events – Fibrogen and Alnylam look to broaden their horizons
Duchenne muscular dystrophy attracts a new entrant in pamrevlumab, while Alnylam awaits more pivotal data with givosiran.
Myonexus becomes the third string to Sarepta’s muscular dystrophy bow
Keenly awaited results from the first trial of MYO-101 broadly beat expectations, leading Sarepta to buy the gene therapy’s originator.
Upcoming events – Pivotal data for Galapagos and Cara
Galapagos will discover if filgotinib can hang on to its reputation as one of the safest Jak inhibitors in the industry, while Cara is itching for pivotal trial success…
Upcoming events – Ascendis and Lilly hope for growth with pivotal data
Ascendis aims to hit the Heights, while Lilly hopes for success with Olumiant in eczema, a new indication for the troubled Jak inhibitor.
Moment of truth for Sarepta and Myonexus
A limb-girdle muscular dystrophy gene therapy Sarepta licensed last year faces its first clinical test.
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