Novo Nordisk nabs priority review voucher for $110M from Marinus as the biotech preps first drug launch – Endpoints News

Novo Nordisk nabs priority review voucher for $110M from Marinus as the biotech preps first drug launch – Endpoints News

When Marinus Pharmaceuticals completed its turnaround and finally pushed its sole drug across the FDA finish line, the company noted it would sell the priority review voucher it received for its efforts. On Thursday, Marinus revealed the buyer — and it’s a big name.

Danish pharma Novo Nordisk bought the voucher for $110 million, Marinus said in an SEC filing early Thursday, giving one of its programs a free pass to an accelerated review process. It’s the third voucher Novo has bought since 2014, according to the Endpoints News tally, tied for fourth-most among biopharma companies in that span.

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Hello, and welcome to today’s Fireside Chat. I’m Zachary Brennan, senior editor at Endpoints News and with me today is Ian Thompson, senior vice president of Amgen.

Today we’ll be discussing the evolution of the US biosimilar space, which has seen not only a slow start when we compare to our European counterparts, but also long delays between when certain biosimilars win approval and when they actually launch in the US market. So, first off I wanted to start by welcoming Ian and I also wanted to hear his take on how he’s seen the momentum building around the biosimilar industry in recent years, and maybe why he thinks that is the case that has been building more in recent years.

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As the megablockbuster Keytruda is set to lose exclusivity in 2028, Merck has been furiously trying to shore up its pipeline prospects. A new deal announced Wednesday marks a big step toward that goal.

In one of the biggest licensing deals of the year, the Big Pharma company is dropping $290 million upfront to team up with Orion on an experimental prostate cancer drug. The program, known as ODM-208, is an oral inhibitor of the CYP11A1 enzyme, which Orion says is designed to tamp down the steroid hormones implicated in the disease.

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One year after BARDA backed ContraFect’s MRSA treatment, the Yonkers, NY-based biotech said today it will stop its Phase III trial of the asset early due to futility.

Fighting to push its $8 billion acquisition of Grail past European regulators, Illumina suffered a key setback Wednesday when an EU court ruled an antitrust probe into the buyout can proceed.

Illumina was challenging the inquiry after the EU objected to the acquisition over concerns it would concentrate most available genetic sequencing tests under one roof. The company has said it would appeal the ruling to Europe’s highest court, Reuters reported, but the bloc’s antitrust group may not wait for that process — which could take years — to wrap up before deciding whether to block the deal.

Eight months after missing the primary and secondary endpoints on a mid-stage test of its ALS drug, Clene Nanomedicine is back with new data showing that its gold nanocrystal-based candidate decreased risk of death in an open-label extension study.

Clene is attempting to catch up with Amylyx, a biotech with a filing under FDA review and already authorized in Canada, running various studies on its own drug for Lou Gehrig’s disease. But mid-stage results last November put a damper on those ambitions.

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Two years after kicking things off with $5.4 million, a George Church spinout is refilling its coffers to fuel its efforts tackling protein therapeutics R&D.

Boston biotech Manifold Bio announced the new Series A Thursday, led by new VC Triatomic Capital, raising $40 million to advance its internal pipeline and expand its platform capabilities. CEO and co-founder Gleb Kuznetsov tells Endpoints News that the financing should last the biotech close to 2.5 years, depending on how fast the company spends it.

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