Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)
With a jam-packed pipeline to parse, Novartis chief Vas Narasimhan has helped investors out in the past by highlighting a few key programs his team thinks could be easy winners. One of those drugs has now hit the skids in two late-stage tests, losing some of its luster as a potential centerpiece medicine moving ahead.
Novartis’ ligelizumab, a ‘high-affinity’ anti-immunoglobulin E antibody failed to beat out standard-of-care Xolair — its own partnered drug with Genentech — in two Phase III studies in patients with the skin disease chronic spontaneous urticaria, the company said Monday.
In the Phase III PEARL-1 and PEARL-2 studies, ligelizumab bested a placebo control after 12 weeks of dosing but couldn’t match up to Xolair in reducing patients’ symptoms. The drugmaker will dive into these data as it reconsiders its path forward for the drug in this disease, Novartis said. Novartis R&D chief John Tsai added: ‘We are disappointed that we have been unable to demonstrate superior efficacy for ligelizumab versus standard of care in the treatment of CSU. We will continue to evaluate the potential for ligelizumab to bring benefit to patients in the areas of chronic inducible urticaria (CIndU) and food allergy, where there is significant unmet need.’
The setback comes just weeks after Narasimhan touted the candidate as a likely winner. Novartis is still planning to pursue ligelizumab’s case in inducible urticaria and food allergy, where it still believes the candidate has a chance of success. This setback against Xolair is particularly vexing given that ligelizumab showed head-to-head benefit over Xolair in reducing hives in a Phase IIb dose-finding study.
As ligelizumab’s chances in this disease falter, Novartis has also trialed remibrutinib, its next-gen BTK inhibitor, in multiple Phase III trials in CSU, hoping for a better result.
CALQUENCE is a registered trademark of the AstraZeneca group of companies.
At the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, blood cancer researchers from around the world gathered virtually to discuss the progress that has been made in the field of hematology. Over the past decade, that progress has been tremendous. We’ve seen not only breakthrough approaches to care, but also significant improvement upon existing novel treatments and exploring combinations within those medicines.1 These advances have transformed expectations of what a blood cancer diagnosis now means for patients. While we’ve come a long way, I believe the most exciting scientific discovery is yet to come, and that future advances will truly transform patient care.
Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)
In a surprise move, Biogen announced Monday that it will cut the price of its controversial Alzheimer’s drug Aduhelm in half, slashing the cost from $56,000 to $28,000.
The sudden discount marks a sudden turnaround for the big biotech as it struggles to turn around a drug whose stuck-in-the-mud sales and political ramifications have sent the company into turmoil and triggered the ousting of its longtime chief scientist. Biogen’s leadership had resisted calls since June to reduce the price of the drug.
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One of Pfizer’s new vaccine TV commercials never mentions its vaccine brand Comirnaty. In fact, it doesn’t mention vaccines or Covid-19 at all and doesn’t show people wearing masks or social distancing. Yet it’s clear the ad is talking about the pharma’s Covid-19 vaccines.
The ad’s voiceover talks about the unremarkable moments and routines that matter, like getting a coffee refill at a diner or Sunday grocery shopping. The images shift from those everyday moments to a scientists and purple lidded glass vials spinning off a production line and being packed into freezers.
Right as the new Omicron variant is poised to increase rapidly across the US, the federal government has effectively run out of the only monoclonal antibody treatment that works against it, and at least one major hospital system is now halting all mAb infusions.
Late last month, the federal government paused shipments of GlaxoSmithKline and Vir’s mAb treatment sotrovimab in order to conserve supplies of the only treatment that might work against the Omicron variant. Last week, however, HHS told Endpoints News that the move to hold back sotrovimab was unrelated to Omicron, and due to a surplus of Eli Lilly mAbs, which aren’t effective against Omicron.
Sen. Joe Manchin (D-WV) at the Capitol on Friday, Dec. 17 (J. Scott Applewhite/AP Images)
Sen. Joe Manchin on Sunday derailed President Biden’s trillion-dollar spending package, effectively halting the Democrats’ best chance yet to allow Medicare to negotiate drug prices, among a bevy of other health-related provisions tacked onto the Build Back Better Act.
White House press secretary Jen Psaki, stunned by Manchin’s announcement on Fox News, said in a statement: ‘Senator Manchin claims that this change of position is related to inflation, but the think tank he often cites on Build Back Better — the Penn Wharton Budget Institute — issued a report less than 48 hours ago that noted the Build Back Better Act will have virtually no impact on inflation in the short term, and, in the long run, the policies it includes will ease inflationary pressures.’
Brian Culley, Lineage Cell Therapeutics CEO
In a lucrative market for ocular degeneration, Roche has long sat on a gold mine with its drug Lucentis — but the times are changing. Now, Roche will bet on a regenerative approach to eye disease with a small biotech with some very early but promising data.
Genentech will pay $50 million upfront and a potential $620 million in downstream milestones for licensing rights to Lineage Cell Therapeutics’ OpRegen program, a cell therapy that aims to regenerate healthy versions of retinal pigment epithelial cells in patients’ eyes, the companies said Monday.
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Stéphane Bancel, Moderna CEO (Andrew Harnik/AP Images)
Moderna has backed down on its patent fight with the NIH, calling a truce by dropping its patent application for now.
Following a heated feud regarding who invented its lifesaving Covid-19 vaccine that was increasingly spilling into public view, the biotech said it ‘has decided at this time not to pursue’ a patent issuance for the mRNA sequence of its jab. But Moderna also filed a continuation application so that some of the claims may still be issued later.
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As the new year rapidly approaches, and gyms and health food stores across America prepare for a wave of people seeking weight loss, Novo Nordisk has announced that it does not expect to meet demand for Wegovy, its prescription injectable weight-loss medication for obesity, until the second half of 2022 in the US.
The shortage comes due to manufacturing issues at a contract manufacturer that was tasked with filling syringes for the pens. The news comes just days after Novo announced that it would invest roughly $2.58 billion to expand its manufacturing hub in Kalundborg, Denmark with three new facilities and the expansion of a fourth to keep up with the success of its diabetes and obesity med semaglutide, Wegovy and Rybelsus.
Mene Pangalos (AstraZeneca via YouTube)
After last year’s Phase III results, there was little question that the FDA would approve Amgen and AstraZeneca’s long-incubating antibody for asthma, barring any manufacturing delays or shocking statistical snafus. The key question was how many asthma patients would be approved by regulators.
The answer was a lot, it turned out. Despite mixed data in some settings, the FDA on Friday OK’d tezepelumab for virtually any patient 12 years or older with severe asthma.
https://endpts.com/weeks-after-earning-ceos-stamp-of-approval-a-novartis-skin-drug-loses-head-to-head-battle-with-standard-of-care/
