John Oyler, BeiGene CEO (Endpoints News, PharmCube)
Count Novartis in for the burgeoning TIGIT race.
After starting the year by plunking down $650 million upfront to license BeiGene’s PD-1 inhibitor — with positive Phase III data stacking up ever since — Novartis is returning to its biotech partner to pick up a Phase III TIGIT drug while entrusting it with marketing five of its approved cancer treatments in China.
The structure of the deal is reminiscent of the 2017 Celgene pact that put BeiGene on the map, which also saw the partners swap an experimental compound for commercial operations.
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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 (Credit: World Economic Forum/Valeriano Di Domenico)
In a surprise move, Biogen announced Monday that it will cut in half the price of its controversial Alzheimer’s drug Aduhelm, 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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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.
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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Tim Van Hauwermeiren, argenx CEO
If you look on argenx’s website today, you’ll see a burst of confetti. That’s because — in addition to getting a new type of therapy past the FDA for patients with a chronic neuromuscular disease called myasthenia gravis — the company is celebrating its first drug approval.
Regulators on Friday gave the thumbs up to argenx’s efgartigimod, now marketed as Vyvgart, for patients with generalized myasthenia gravis (gMG) who test positive for the anti-acetylcholine receptor (AChR) antibody. CEO Tim Van Hauwermeiren said in a statement that the approval triggers the ‘start of a new era for argenx.’
Richard Pazdur (via AACR)
There’s no denying that Merck’s Keytruda set a high bar for checkpoint inhibitors in development everywhere. But when it comes to the often redundant development of PD(L)-1 antibodies worldwide, FDA’s top cancer doctors Rick Pazdur and Julia Beaver are calling for more industry coordination.
‘Efforts to corral this enthusiasm should focus on increased international partnerships between sponsors of approved checkpoint inhibitors and those developing novel agents to be used with anti–PD-1 and anti–PD-L1 antibodies rather than developing ‘me too’ drugs,’ Beaver and Pazdur wrote Wednesday in the New England Journal of Medicine.
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As JP Morgan moves #JPM22 fully virtual, so will Endpoints News. We’re taking our multi-day hybrid event schedule online, with no live cocktail hour or networking events but plenty of timely news, insightful panels and fireside chats previewing the new year. We’ll be sad to not see our friends and colleagues on site, but we encourage everyone to still register for the event and join the conversation.
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The FDA on Wednesday not only approved the first generic versions of the decades-old diabetes insipidus treatment vasopressin, but also simultaneously offered a particularly damning rebuke of a citizen petition attempting to block the generic, while promising to pass along the matter to the Federal Trade Commission.
The response could prove troublesome for the sponsor of the brand name version of the drug, Endo’s Par Sterile Products, which brought in more than $780 million in 2020 for its brand name version of the drug Vasostrict.
Robert Califf (Graeme Sloan/Sipa via AP Images)
As Rob Califf likely makes his return as FDA commissioner next month, his confirmation hearing yesterday offered a peek into some of the larger obstacles he’s going to face in the coming months and years.
The pandemic isn’t going away anytime soon with Omicron, and some vaccines and therapeutics may need to be tweaked or pulled from the market entirely as they prove to be ineffective against the new variant. The FDA, meanwhile, needs to get back on even footing with some longer-term direction.
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https://endpts.com/novartis-turns-to-beigene-again-for-the-next-big-checkpoint-target-paying-300m-to-jump-into-tigit-race/
