FDA approval of Takeda Pharmaceutical drug Eohilia introduces a new therapeutic option for patients with eosinophilic esophagitis, inflammation of the esophagus that causes swallowing difficulty. It will compete against Dupixent, a Sanofi and Regeneron Pharmaceuticals drug already approved for this disorder.
Autolus will apply the capital to its CAR T-cell therapy currently under FDA review in cancer and in early clinical development in lupus. Meanwhile, BioNTech will gain access to Autolus’s cell therapy manufacturing assets as well as technologies that could support the R&D of in vivo therapies and antibody drug conjugates.
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.
Pfizer’s Litfulo is the first treatment approved for treating adolescents with severe alopecia areata. The drug’s approval also covers adults, were it will compete against Eli Lilly’s Olumiant.
Frexalimab, a Sanofi drug candidate with roots at Dartmouth’s medical school, has met the main goal of its Phase 2 test. The encouraging data for this program come as different experimental Sanofi MS drug nears its one-year anniversary under FDA clinical hold.
Merck is acquiring Prometheus Biosciences and a lead drug candidate in development for inflammatory bowel disorders. The deal comes as Merck looks for drug prospects that could make up for revenue declines facing blockbuster seller Keytruda, which faces patent expirations in coming years.
Sanofi submitted the first unsolicited offer to acquire Horizon Therapeutics, but Amgen ultimately won what became a competitive bidding process. Amgen says Horizon's drug lineup complements its own portfolio of autoimmune and inflammatory disorder products.
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.
Zenas BioPharma’s Series B financing was the biggest one of the week. Other startups that emerged with new cash include Juvena Therapeutics, Sensorium Therapeutics, and NRG Therapeutics.
Human Immunology Biosciences aims to stand apart in autoimmune disease drug research with therapies that address cells at the root of a range of allergic and inflammatory disorders. The biotech has a lead program licensed from MorphoSys in clinical development for two rare kidney diseases and $120 million to support that antibody and other biologic drugs in its pipeline.
Motto is the latest startup built at Redesign Health. The startup is virtual care platform that is now available for Californians and Texans with autoimmune and chronic inflammatory conditions. It seeks to increase access to care by offering virtual appointments with rheumatologists, condition management services and lifestyle coaching on its telehealth platform.
GSK drug otilimab failed a Phase 3 test in rheumatoid arthritis. Though the antibody drug met the main goal in two other pivotal studies, GSK said the limited efficacy in the third study means the company will not seek regulatory approval.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
Dice Therapeutics reported the first human data for its oral psoriasis drug designed to hit the same pro-inflammatory protein blocked by blockbuster antibody drugs from Novartis and Eli Lilly. The potential for Dice’s pill to offer a competitive oral alternative pushed the biotech’s stock skyward by nearly 80%.
Rubius Therapeutics is laying off about 75% of its workforce in a restructuring that spells the end of its red blood cell therapies in early clinical development for cancer. The biotech is turning its focus to a new platform for making cell therapies that it says offers key advantages over its current technology.
Amgen’s drug portfolio boasts several biologic drugs that are blockbuster sellers. In acquiring ChemoCentryx for $3.7 billion, the pharmaceutical giant gains a company entirely focused on developing small molecule alternatives to biologic medicines.
The drugmaker emphasized the full global rights it would acquire to Momenta's lead asset, nipocalimab, which it is developing for several autoantibody-driven diseases and that in certain indications could have peak sales of more than $1 billion.
While there had been some risks to filgotinib's approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval by at least a year. Shares of both companies fell sharply on the news.