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.
More Sanofi dengue setbacks could benefit Takeda
Sanofi might only get the US go-ahead for its dengue vaccine Dengvaxia in a narrow population, leaving the door open for its rival Takeda.
Go or no go? Johnson & Johnson awaits Spravato nod
Others hoping to get FDA approvals include Sage Therapeutics and Novartis, but hopes look dimmer for Lexicon and Sanofi.
Adcom gives Karyopharm a second chance with selinexor
Incredibly, a US FDA panel has left the door open for approval of Karyopharm’s selinexor in multiple myeloma, despite concerns about safety.
DBV perseveres with peanut project
DBV plans to refile Viaskin Peanut in the third quarter, but things look all but smooth.
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