Pharminent

FDA grants accelerated approval to Inovio’s Voceryq for RRP

The FDA granted accelerated approval to Inovio’s DNA-based immunotherapy Voceryq for recurrent respiratory papillomatosis (RRP). The product carries a $460,000 list price.

FDA approves generic lenacapavir HIV prevention shot

The FDA approved a generic version of the HIV prevention injection lenacapavir, a step toward widening access across dozens of lower-income countries.

uniQure’s Huntington’s gene therapy faces May FDA decision

The FDA has begun its review of uniQure’s gene therapy for Huntington’s disease, with a decision due in May, and will convene an advisory committee meeting.

Lonza to buy five US CDMO sites from Merck KGaA

Lonza has agreed to acquire five US contract development and manufacturing sites from Merck KGaA, adding 1,100 employees to Lonza’s workforce as Merck KGaA exits the CDMO business.

Bavarian Nordic wins four-year UK mpox vaccine supply contract

Bavarian Nordic secured a four-year contract from the UK Government to supply its MVA-BN vaccine for the prevention of mpox and smallpox.

EVERSANA acquires UK HEOR firm Estima

EVERSANA has acquired Estima, a UK-based AI-powered health economics and outcomes research firm, to help customers “modernise commercialisation.”

Karyopharm files for bankruptcy, to sell itself at auction

Karyopharm will sell itself through a court-supervised auction, with the parent of cell therapy maker Gamida Cell serving as lead bidder. The company recently struck a forbearance deal to defer debt payments.

Pfizer raises full-year outlook and names Cecile Guegan CFO

Pfizer raised its full-year guidance alongside third-quarter results and said Cecile Guegan, who has held leadership roles at the company over the past 20 years, became CFO this month.

Genmab shares double after string of cancer trial wins

Genmab’s shares have doubled over three months following a series of positive cancer drug trial results, as the company moves to own more of the medicines it develops.

AstraZeneca sets restructuring as Alnylam and Regeneron report

AstraZeneca said it will “redeploy resources” through a new restructuring program, while Alnylam shares sold off on concerns about a top drug and Regeneron reported a record quarter.