Pfizer Inc. has initiated a Phase 1b clinical trial for its mini-dystrophin gene therapy candidate, PF-06939926, in boys with Duchenne muscular dystrophy (DMD). The first boy received an infusion of the mini-dystrophin gene on March 22nd, administered under the supervision of principal investigator, Edward Smith, MD, Associate Professor of Pediatrics and Neurology at Duke University Medical Center.
Orchard Therapeutics has snapped up GlaxoSmithKline’s portfolio of approved and investigational rare disease gene therapies. The deal sees GSK become an investor in Orchard, with a 19.9 percent equity stake along with a seat on the firm’s board. The UK drugs giant also stands to receive royalties and commercial milestone payments related to the acquired portfolio.
First Human Proof-of-Concept (PoC) Trial to Test the Superiority of RK-01 over Metformin in Type 2 Diabetes Patients with Inadequate Glycemic Control.
Eli Lilly and Company and Sigilon Therapeutics, a privately held biopharmaceutical company, announced a global collaboration to develop encapsulated cell therapies for potentially treating Type 1 diabetes. The deal is worth up to $473 million. Sigilon is focused on discovering and developing “living therapeutics” using its Afibromer technology product platform.
Boehringer Ingelheim, headquartered in Ingelheim, Germany, and OSE Immunotherapeutics, based in Nantes, Frances, signed a collaboration and license deal to jointly develop OSE-172 for myeloid cancers.
Based on the recommendation of the DMC, the trial will continue to evaluate progression-free survival (PFS), which is a secondary endpoint. Results from KEYNOTE-042 will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide.
The U.S. Food and Drug Administration (FDA) issued two Complete Response Letters (CRLs) to South Korean manufacturer Celltrion. One was for a proposed biosimilar for Genentech and Biogen’s Rituxan for lymphomas and leukemias, and a proposed biosimilar to AbbVie’s Humira for rheumatoid arthritis, plaque psoriasis, Crohn’s disease and other autoimmune disorders.
Pfizer and Allogene Therapeutics Enter into Asset Contribution Agreement for Pfizer’s Allogeneic CAR T Immuno-oncology Portfolio
Although inflammatory arthritis can be treated systemically, drugs are often injected directly into affected areas, particularly when the disease affects just one or a few joints. Problem is, injectable drugs are usually cleared quickly from the joint, limiting their effectiveness. A new delivery system could improve the efficacy and durability of arthritis treatments, as well as cut down on nasty side effects caused by systemic therapy.
Purchase includes Lynnwood, WA Biologics Manufacturing Facility
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