EHA 2019 – Global Blood faces sickle cell questions
More data with voxelotor shouldn’t hurt the project’s bid for accelerated approval, but there are still doubts about its effect on a harder patient outcome.
Go or no go? Merck, Regeneron and Alexion await US expansion
Approvals for new uses of old drugs should far outweigh nods for novel projects in June.
No news equals bad news for Nabriva and Heron
Manufacturing issues prompt the US regulator to knock back projects from Nabriva and Heron Therapeutics, both of which insist that the problems are easily solvable.
Novartis and Biogen face spinal muscular atrophy reckoning
The upcoming American Academy of Neurology meeting could provide clues on how the market will shake out.
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.
Peanut therapy makers face pricing pushback
An Icer report questioning the cost effectiveness of Aimmune and DBV's peanut allergy projects is yet another reason to be cautious about the companies'…
Zogenix’s pain is GW Pharma’s gain
A regulatory misstep puts Zogenix even further behind its epilepsy rival GW Pharma, which in turn is waiting for data that could give it another boost.
Go or no go? Abbvie, Glaxo and Heron await FDA verdicts
Notable US regulatory decisions due in April feature a major pipeline hope from Abbvie, a non-opioid pain medication from Heron and Glaxo’s two-pill HIV regimen.
ACC 2019 round-up – Esperion and Amarin prepare to go it alone
As approval decisions near, further data fail to answer lingering questions about Esperion's bempedoic acid and Amarin's Vascepa.
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