The FDA approved AstraZeneca drug Voydeya as an add-on to standard therapies for paroxysmal nocturnal hemoglobinuria, a rare blood disorder. Alexion, now AstraZeneca’s rare disease subsidiary, added the small molecule to its pipeline via a 2019 acquisition.
Cell therapies were first validated in cancer, but Kyverna Therapeutics aims to show they’re safe enough for autoimmune diseases. The biotech plans to deploy its IPO cash across clinical trials in lupus nephritis, multiple sclerosis, systemic sclerosis, and myasthenia gravis.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Sanofi and Synthekine will work together to develop cytokine therapies for inflammatory diseases. This new alliance comes as Sanofi is salvaging a different cytokine therapy that showed disappointing efficacy in Phase 2 after the pharma giant acquired it in a $2.5 billion deal.
Spending on prescription drugs for autoimmune diseases has increased by 459% over the past decade, even surpassing cancer drugs. Yet despite driving around 30% of employers’ entire prescription spend, autoimmune diseases have remained completely overlooked in employer health spend.
FDA approval of UCB’s Bimzelx gives the Belgian drugmaker a contender in the crowded plaque psoriasis therapies market. In the rare disease generalized myasthenia gravis, the agency approved Zilbrysq, a UCB drug with advantages over two blockbuster AstraZeneca drugs addressing the same target.
“Botched math” in calculating clinical data for an autoimmune disease drug is one of the allegations Nektar Therapeutics makes in a legal complaint against Eli Lilly. The biotech claims its former partner tried to disadvantage the asset in order to advance development of another drug it acquired in a billion dollar deal.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Regeneron is paying Sonoma Biotherapeutics $75 million to begin a partnership focused on developing cell therapies based on regulatory T cells, or Tregs. Each company brings technological capabilities to the alliance, which is initially focused on ulcerative colitis and Crohn’s disease.
Takeda Pharmaceutical drug TAK-279 achieved the main goal of a mid-stage clinical trial in plaque psoriasis, setting the stage for Phase 3. The Japanese pharmaceutical giant sees the small molecule as complementary to its top-selling product, the blockbuster inflammatory bowel disorder drug Entyvio, and competitive against Bristol Myers Squibb's Sotyktu.
Fewer new drugs won FDA approvals in 2022 compared to previous years, but some of the products that passed regulatory muster are indicative of trends expected to continue into 2023. For example, more gene and cell therapies are on track to face regulatory decisions in the coming year.
Gilead Sciences is building up its autoimmune disease drug pipeline by turning to EVOQ Therapeutics, a startup with technology that takes a novel approach to restoring immune tolerance. For EVOQ, the Gilead deal is its second with a big pharma company.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
The second patient who died in the Phase 1 test of Alpine Immune Sciences cancer drug, davoceticept, reportedly suffered the same cardiovascular complication as the first patient. The biotech company is stopping enrollment in two clinical tests of the drug and assessing all participants in the studies.
Sudo Bioscience emerged with $37 million in funding and four programs that address TYK2, a promising target for autoimmune diseases. Bristol Myers Squibb drug Sotyktu recently won the first FDA approval for a TYK2 inhibitor but Sudo claims its molecules have the potential to be best in this new drug class.
Plaque psoriasis drug Vtama is now approved by the FDA, making it the first novel topical treatment for the chronic autoimmune disorder in a generation. Roivant Sciences subsidiary Dermavant Sciences acquired the drug from GlaxoSmithKline in 2018.
Sonata Therapeutics is developing drugs that reprogram cellular microenvironments to send signals intended to have curative effects. Cancer is the initial focus of the biotech, which Flagship Pioneering formed by combining two of its preclinical portfolio companies.
Nuvig Therapeutics is developing drugs that tap into one of the body’s natural mechanisms for controlling inflammation. Co-founder and CEO Pamela Conley, a veteran of Portola Pharmaceuticals, says Nuvig’s approach could offer efficacy similar to currently available autoimmune drugs but with a better safety profile.