Mathai Mammen, head of R&D for J&J’s Janssen unit (Rob Tannenbaum)
Last week, J&J took a step familiar to other pharma conglomerates in spinning out its consumer business to focus on R&D, but offered few details on what that might look like. But on Thursday, the company followed up with the scoop, and it’s making some bold predictions.
Over the course of a two-plus hour presentation on its pharmaceutical business, execs outlined their strategy for the new, slimmer J&J, promising investors it will file about 14 drugs for approval through 2025. Across all these drugs, J&J said it expects $4 billion average peak annual sales, and five could top the $5 billion mark.
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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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Jay Luly, Enanta CEO (via YouTube)
A Massachusetts biotech will discontinue the development of its oral drug intended to treat patients suffering from chronic hepatitis B infections, the company said Thursday.
Enanta Pharmaceuticals will no longer develop EDP-721. The news comes after safety signals were seen in healthy participants in a Phase I trial after they were administered the drug, and despite a clean safety profile demonstrated in preclinical trials.
The Congressional Budget Office on Thursday evening made abundantly clear that President Biden’s push to allow Medicare to negotiate prescription drug prices for a limited number of single source drugs will only make a minor dent in the pocketbook of the biopharma industry, and likely cost industry just 10 new drugs over the next 30 years.
The provisions are part of a huge, $1.8 trillion spending package that the Democrats and Biden have been pushing for all summer. The bill is expected to pass this morning in the House.
In a surprise setback, Merck has slammed the brakes on the development of an experimental HIV drug — including a Phase II trial — after investigators flagged a drop in immune cell counts that an external committee determined was related to treatment.
The Phase II study that first sounded the alarm, dubbed IMAGINE-DR, was testing the once-weekly combination of MK-8507 (a non-nucleoside reverse transcriptase inhibitor) and islatravir, or ISL, a nucleoside reverse transcriptase translocation inhibitor.
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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Kathryn Corzo — an oncology veteran and the program head behind Sanofi’s multiple myeloma monoclonal antibody isatuximab — is now in the C-suite.
The newest member at cell therapy player bit.bio as their COO, the longtime drug developer left Takeda (where she served, in turn, as the head of oncology cell therapy and then a partner in its venture arm) to join the small biotech. For Corzo, bit.bio presented a unique opportunity to try and solve issues that had been plaguing cell therapy — and one of the three reasons why she left Takeda.
The US Securities and Exchange Commission has launched a probe into claims that Cassava Sciences, an Austin-based drug developer, manipulated data key to its case for its experimental Alzheimer’s drug simufilam, the Wall Street Journal reported Wednesday.
The report comes just two days after Cassava in an SEC filing revealed that ‘certain government agencies’ had asked the biotech for documentation. It wasn’t clear which agencies were inquiring or what information they sought, and Cassava went out of its way to say the requests weren’t accusations of wrongdoing.
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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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