Michel Vounatsos (Biogen via YouTube)
RBC analyst Brian Abrahams is back with an update on the death of an Alzheimer’s patient on Biogen’s controversial aducanumab, and this time he says that there are solid reasons to believe that the event was likely drug related and may have been preventable.
Abrahams, a physician, notes that he obtained new information using FOIA, getting the ‘detailed case report’ about the aducanumab patient he was first to report on.
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For years, paper-based processes and individual point solutions dominated the clinical research landscape, and patient participation in clinical trials was largely an in-person engagement. But when the COVID-19 pandemic took a stronghold, traditional clinical trial methods emerged as inadequate, putting clinical trials and the life sciences industry at a crossroads. Practically overnight, the industry had to rapidly shift to decentralized clinical trial methods, while maintaining data quality and regulatory compliance.
Douglas Fambrough, Dicerna CEO (Dicerna via YouTube)
Early this year researchers at Novo Nordisk were beaming as they announced the first drug identified in their RNAi alliance with Dicerna was headed into the clinic. And now they’re coming back for the whole thing.
This morning the Copenhagen-based pharma giant put out word that it is buying Dicerna $DRNA — an RNAi pioneer that has had its up and downs over the years — for $3.3 billion. Novo is paying $38.25 a share — an 80% premium.
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Gilead is going all in — hook, line and sinker — on its oncology alliance with Arcus. And they are going for broke.
The big biotech unveiled a deal that now delivers $725 million in opt-in payments covering the clinical development programs for Arcus, ranging from their closely watched anti-TIGIT programs for domvanalimab and AB308 to etrumadenant (the A2a/A2b adenosine receptor antagonist) and quemliclustat, the small molecule CD73 inhibitor. Gilead will also cover half of the development costs, handing Terry Rosen’s biotech a deal that gives them a clear cash runway to achieving all its goals in oncology.
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Catherine Stehman-Breen and Vic Myer, Chroma CEO and CSO
A handful of the world’s most prominent gene editing-focused academics have been working for over a year on a new company built around a new approach for modifying DNA to treat disease. Known as Chroma Medicine, it launched on Wednesday with $125 million in early funding from Atlas, Newpath, Cormorant and several other VCs.
Chroma will focus on a markedly different way of modifying the genome than most of the gene editing biotechs that have arisen since CRISPR was pioneered nearly a decade ago. Instead of trying to erase or rewrite portions of a patient’s actual DNA — those As, Ts, Cs and Gs — Chroma will try to change the way that DNA is expressed in the cell.
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A 178-acre property on a stretch of the Pittsburgh riverfront used to be the home of an old steel mill that shut down in the 1990s. Now, it will get an upgrade from a $100 million grant out of the Richard King Mellon Foundation to turn it into a bio manufacturing facility run by the University of Pittsburgh.
The site, known as Hazelwood Green, is nearly half the size of Pittsburgh’s downtown and will be transformed into a home for cell and gene therapy. It will be dubbed Pitt BioForge, and offer research teams, commercial and research partners high-tech manufacturing capabilities, a wet lab and other spaces for innovation.
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Thermo Fisher CEO Mark Casper
Another week, another win for the North Carolina biotech community.
This time, it’s Thermo Fisher Scientific, the Massachusetts-based contract giant, that recently announced it had plans to build a manufacturing plant. The winner is? Mebane, NC, a 15,000-person town 25 miles northwest of Durham.
The 375,000-square-foot plant at the Buckhorn Industrial Park will manufacture pipette tips for laboratory research and bioscience use. It’s a result from a $192.5 million contract with the Department of Defense that was announced back in September, in which the company pledged to increase its ability to support Covid-19 testing.
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President Joe Biden listens as Pfizer CEO Albert Bourla speaks (Patrick Semansky/AP Images)
Pfizer’s pill to treat Covid-19 is outpacing its top rival from Merck not only in terms of efficacy data but now in the size of its US government contract, too.
The US on Thursday announced it will pay $5.29 billion for 10 million courses of Pfizer’s potential treatment, which is the largest single procurement of any therapeutic or vaccine since the pandemic began. And at $529 per course for the Pfizer pill, that’s significantly cheaper than the $2.2 billion the US paid for just 3 million courses of Merck’s treatment, which adds up to about $730 per course.
Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)
Two big things are going on right now at Novartis that have the investor crowd on high alert.
First, CEO Vas Narasimhan has signaled he’s now ready to sell or spin off the big generics arm, Sandoz. In Big Pharma land, anything that drags on performance — like consumer arms with aging therapeutics — is being hived off as organizations zero in on innovation as the future.
Second, they just sold that big block of Roche shares for $21 billion. And what do they plan to do with all that money?
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Merck is making room for yet another use on its Keytruda label — this time, as the first adjuvant immunotherapy for certain renal cell carcinoma patients after they’ve had kidney surgery.
The FDA has approved Keytruda in the adjuvant setting three weeks before its goal date, marking the latest in a streak of label expansions and giving the PD-1 superstar a leg up on its checkpoint inhibitor rivals.
https://endpts.com/rbc-analyst-reports-aducanumab-case-file-points-to-the-controversial-alzheimers-drug-as-a-likely-cause-of-patient-death/
