The FDA approved X4 Pharmaceuticals drug Xolremdi for treating WHIM syndrome. The molecule, which addresses the underlying cause of this rare immunodeficiency, was licensed from Sanofi’s Genzyme subsidiary.
Ono Pharmaceutical’s acquisition of Deciphera Pharmaceuticals adds to a cancer drug pipeline that already spans multiple modalities. Deciphera develops drugs that target the on-off switch of enzymes that drive cancer cell growth.
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.
The FDA has approved Beqvez, a Pfizer gene therapy developed for moderate-to-severe hemophilia B. The one-time treatment carries a $3.5 million price tag, the same as a CSL Behring gene therapy already available for treating the inherited bleeding disorder.
Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The regulatory decision for Ojemda covers a broader swath of patients than a drug combination from Novartis approved for treating this childhood cancer.
ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The novel immunotherapy works by sparking activity from three types of immune cells.
Real-world analysis can provide insights into how factors largely out of rural residents’ control impact health outcomes and access to medical care.
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.
The FDA expanded the approval of Roche’s Alecensa to include adjuvant treatment of non-small cell lung cancer. The targeted therapy addresses cancers driven by the ALK genetic mutation.
Cerevel Therapeutics drug tavapadon met the main and secondary goals of a pivotal Parkinson’s disease clinical trial. That drug and others will join the neuroscience portfolio of AbbVie, which is in the process of acquiring Cerevel.
Eli Lilly drug tirzepatide, marketed as Zepbound for weight management, has results from two Phase 3 studies showing reductions in the breathing problems caused by obstructive sleep apnea. Lilly is now preparing regulatory submissions to add this indication to the drug’s label.
Intra-Cellular Therapies reported its drug Caplyta met the main and secondary goals in the first of three pivotal studies in major depressive disorder. Success in two of them could support expanding the label of the drug, which is currently approved in schizophrenia and bipolar depression.
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The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia. But Neumora remains on track with its lead program, a different drug in late-stage clinical testing for major depressive disorder.
Pharmaceutical companies use Feel Therapeutics’ technology to monitor the mental state of participants in clinical trials of behavioral medications. But the startup envisions its technology eventually also finding a place as a part of clinical care.
Torl BioTherapeutics’ $158 million Series B-2 financing will finance clinical testing of its pipeline of antibody drug conjugates in development for various types of cancer. Neuroscience and immunology are among the therapeutic areas represented in our roundup of other recent biotech financings.
Novartis gains global rights to an Arvinas protein degrading drug that targets the androgen receptor to treat prostate cancer. The deal also includes a preclinical molecule addressing an androgen receptor variant.
Seaport Therapeutics’ drug candidates are delivered through the lymphatic system, an approach that could overcome some limitations of neuropsychiatric medicines, including products from Sage Therapeutics. The startup stems from the research of PureTech Health.