Even if Congress and U.S. President Donald Trump can't agree on opening all the federal government, they must at least get the FDA fully funded. To do otherwise puts the health and safety of Americans at risk and jeopardizes future scientific discovery and innovation. Read More
Bridgebio Pharma LLC, an active creator of lean new ventures built around a common core, has closed a new $299.2 million financing round to support its efforts to target genetic disease through existing R&D programs. Its work spans subsidiaries focused on dermatology, oncology, cardiology, neurology, endocrinology, renal disease and ophthalmology. The round was co-led by existing investors KKR and Viking Global Investors. Other existing investors included Perceptive Advisors, AIG, Aisling Capital, Cormorant Capital and Hercules Capital. New investors Sequoia Capital and an unidentified blue-chip long-term investor also participated. Read More
Elsalys Biotech SAS, a 2013 spinout from Transgene SA, achieved a significant milestone with the finding that lead candidate inolimomab (Leukotac) showed clinical benefit during long-term follow-up of up to 8.5 years in individuals treated in the phase III study in acute steroid-resistant graft-vs.-host disease (SR-aGVHD). The positive overall survival (OS) outcome in the long-term analysis positions the Lyon, France-based company for a regulatory filing in the EU next year and puts discussions with commercial partners on the front burner – admirable achievements for a company of just 16 employees that's raised less than €20 million (US$22.8 million). Read More
CEO Andrew McDonald told BioWorld that Attune Pharmaceuticals Inc. made 1,200 compounds – "a tour de force, from a medicinal chemistry perspective" – in order to find two that worked the way the company wanted as oral plasma kallikrein inhibitors in the prophylactic treatment of hereditary angioedema (HAE). Read More
DUBLIN – Biontech AG is bolstering its antibody discovery capabilities by acquiring the antibody generation unit of its erstwhile partner, Mab Discovery GmbH, for an undisclosed sum. Mainz, Germany-based Biontech gains an 18-person unit, based in Munich, as well as the assets and know-how required to generate antibodies from Mab Discovery's rabbit-based antibody discovery platform. Read More
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is launching a pilot good clinical practices (GCP) program in the hopes of launching a routine GCP inspections program. Read More
Mouse models are notoriously difficult to translate into a better understanding of disease mechanisms in humans. They haven't proved particularly useful in understanding diabetes and the vascular problems tied to it that result in serious complications in the limb and eye vasculature that can lead to pain, non-healing wounds, blindness and even amputation. Read More
Apollomics Inc., of Foster City, Calif., appointed Wilson W. Cheung executive vice president and chief financial officer and Debra L. Thoma Vallner senior vice president, development operations. Read More
Mirati Therapeutics Inc., of San Diego, said it closed its underwritten public offering of 1.85 million shares, including the exercise in full by the underwriters of their option to purchase up to 241,935 additional shares, at $62 each. The gross proceeds were approximately $115 million. Read More
The U.S. Court of Appeals for the Federal Circuit Wednesday gave a lower court and the U.S. Patent and Trademark Office (USPTO) a lesson in the plain meaning of the law when it comes to patent term adjustments (PTAs). In a precedent-setting decision, the Federal Circuit reversed the district court's grant of summary judgment to the USPTO and sent Supernus Pharmaceuticals Inc. v. Iancu back to the court for a do-over. Read More
Primevax Immuno-Oncology Inc., of New York, signed an exclusive, worldwide license with the U.S. Army Medical Materials Development Activity authorizing Primevax to use the dengue virus-1 #45AZ5 strain for treatment of cancer. Primevax's therapeutic approach combines the dengue fever virus with dendritic cell therapy. The FDA recently allowed Primevax to begin a trial with their dendritic cells first. In the trial, Primevax will continue treating metastatic melanoma patients after standard-of-care therapies have failed. Read More
