Reforms to a US national security regulation are putting off foreign investors and driving down VC investment in the biotech space by as much as 20 percent, says BIO’s David Thomas. In August 2018, Congress passed the Foreign Investment Risk Review Modernization Act (FIRRMA) as part of the Fiscal 2019 National Defense Authorization Act. The […]

AstraZeneca has turned to Novoheart’s “human heart-in-a-jar” technology to create a preclinical model that mimics a form of heart failure for which there is no effective therapy available. Based on Novoheart’s human ventricular cardiac organoid chamber (hvCOC) technology, the companies are aiming to develop a new in vitro model that can reproduce the characteristics of […]

La Jolla Pharmaceutical is turning its focus to its lone FDA-approved product and another one in the pipeline after an experimental drug for a rare blood disease failed a late-stage study. On Monday, La Jolla Pharma (NASDAQ: LJPC) said it was halting a clinical trial testing LJPC-401, its drug candidate for iron overload in patients […]

The FDA on Monday approved a Global Blood Therapeutics treatment for sickle cell disease, three months before the agency’s decision was expected. Regulators evaluated the drug, voxelotor (Oxbryta), under a pathway that allows for a speedier review using less evidence than is typically required. This pathway is reserved for drugs that address an unmet medical […]

Kymera Therapeutics’ new leader comes from within. Nello Mainolfi, the company’s co-founder, president, and chief scientific officer, has been promoted to president and CEO. Mainolfi’s experience includes positions at the Novartis Institutes for Biomedical Research, Atlas Venture, and Raze Therapeutics. He is succeeding former Kymera CEO Laurent Audoly, who announced in July that he would […]

A cancer tumor is a veritable patchwork of cells with a variety of genetic fingerprints. Immunitas Therapeutics is using single-cell genomics—an approach that studies the genetic activity of individual cells—to peer deeply into patient tumors and more precisely determine what is fueling the growth. With that knowledge, the company plans to develop new targets for […]

William Chou has been appointed CEO of Aruvant Sciences. Chou was most recently a vice president and global disease lead for the Novartis (NYSE: NVS) cell and gene therapy unit. Before Novartis, he worked at Boston Consulting Group. Aruvant, which splits its operations between New York and Basel, Switzerland, is developing therapies for severe blood […]

A drug candidate once shelved by Takeda Pharmaceutical (NYSE: TAK) has found new life within Roivant Sciences spinout Myovant as a potential once-daily oral hormone therapy for patients with advanced prostate cancer. The Brisbane, CA-based biotech company (MYSE: MYOV) reported Tuesday that the drug, relugolix, met the primary goal of a Phase 3 trial, lowering […]

Pedro Heurtas has joined Inozyme Pharma as chief medical officer, the same position he held most recently at Sentien Pharmaceuticals. His experience also includes positions at Eloxx Pharmaceuticals, Genzyme, Shire, and Amicus Therapeutics (NASDAQ: FOLD). In other moves, Boston-based Inozyme appointed Gus Khursigara its vice president of medical affairs and clinical operations, and Catherine Nestor […]

A resTORbio respiratory drug has failed a late-stage test, and the company is stopping further development of the compound for lung infections in elderly patients. In the first of two Phase 3 studies, ResTORbio on Friday released preliminary data showing that its drug, RTB101, did not beat a placebo. Though the Boston-based company won’t proceed […]

The list of activities our smartphones can control grows daily. Transfer money? It’s simple. Order groceries? That, too. Turn off the bedroom lights? Check. How about contraception? Advancing new forms of birth control is a central focus at Daré Bioscience (NASDAQ: DARE), a San Diego-based biopharma company that’s built a pipeline of experimental devices and […]

Another of the biopharma startups created as part of a collaboration between San Diego investment firm Avalon Ventures and GlaxoSmithKline has been acquired—but not by GSK. Instead, the company, Calporta Therapeutics, is being absorbed by Merck (NYSE: MRK), which is interested in its preclinical work on potential treatments for lysosomal storage and neurodegenerative diseases, including […]