Dark-horse ALS player touts open-label survival data after mid-stage flop, with platform study due soon – Endpoints News

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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Zachary Brennan:
Hello. Good morning. I’m Zachary Brennan, senior editor at Endpoints News. And thank you for joining us virtually at BIO for our panel on decentralized trials. Joining me today, we have Ronan Brown, Senior Vice President of IQVIA, Craig Lipset, founder of Clinical Innovation Partners, and Bari Kowal, senior vice president of Regeneron. I’m excited for today’s discussion and I’m sure you are too, but before we get into it, we have a brief word from Vice President Matt Blume with today’s sponsor, Catalent.
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Zachary Brennan:
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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A not-so-funny thing happened to Novartis’ high-profile bid to take a PD-1 checkpoint out of China and get it approved in the US this year.
After paying BeiGene $650 million for US-plus ex-China commercialization rights for the drug — the latest in a long string of contenders to follow Keytruda and Opdivo — the FDA is deferring action on their application.
And there’s no new timeline on when the agency will make a decision.
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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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Only months after Texas-based TFF Pharmaceuticals netted a partnership with Catalent, the company is expanding its R&D and manufacturing operations in the capital of the Lone Star State, through the lease of a new 3,500-square-foot facility.
The new space will be centered on increasing TFF’s total lab space. The expansion adds a dedicated lab for the downstream processing of products created via its thin film freezing as the company is looking to increase its in-house research. The additional lab space will allow the company to house larger equipment to scale up its manufacturing abilities and produce supplies for preclinical studies. TFF plans to take its new space online by August.
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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The life science industry is no doubt still growing in the US, but research talent is getting more and more difficult to come by, according to the latest report from CBRE on 2021.
The report, titled “Life Science’s Research Talent 2022” noted that the life sciences sector has grown by 79% between 2001-2021, compared with 8% growth for all other occupations in the US.
Graduates in biological and biomedical sciences have totaled more than 163,000 in 2020, double the number just 15 years ago.
Supply chain snafus and high-profile drug and vaccine shortages and quality issues (e.g. Emergent’s Baltimore site) have played a major role during the pandemic so far. But in a new report to Congress, the FDA said that it’s continuing to see drug shortages decline ⁠— from a high of 250 drug shortages in 2011 to just 41 in 2021.
“The number of new drug shortages has not increased significantly during the COVID-19 pandemic,” FDA said. However, the agency also made clear that in 2021, “there were shortages of drug products from manufacturers in the U.S. and abroad, and there continues to be concern surrounding the supply chain and reliance on overseas manufacturing.”
President Joe Biden’s revival of the Cancer Moonshot initiative now includes a new Cancer Cabinet, with some big ideas to make the goals of the Moonshot feasible.
The White House’s so-called Cancer Cabinet — a new entity created when President Biden re-ignited the Cancer Moonshot in February 2022 — announced specific “priority initiatives” earlier this week as part of the initiative’s stated goal of trying to cut cancer fatality by half in 25 years. The Cabinet, according to the White House, includes multiple federal agencies, including the NCI, FDA, CDC, and NIH — and the recently-added Departments of Labor and Commerce, NASA and the White House Gender Policy Council.
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