FDA advisors considering Linhaliq, an experimental Aradigm Corp. drug for a rare but severe respiratory disease in patients with chronic lung infections, declined to support a new drug application for it, citing inconsistent efficacy data and concern over the endpoint of pivotal trials.
SAN FRANCISCO – Little more than five minutes' drive from Botox-maker Allergan plc's chief research center in Irvine, Calif., Evolus Inc. is prepping for a $75 million IPO that, if successful, could create new competition for the botulinum toxin king.
SAN FRANCISCO – Exuberance over China's ascendant biopharma sector formed a near-deafening roar at the 6th Annual Wuxi Global Forum Tuesday, where Ruyi He, chief scientist of the CFDA's Center for Drug Evaluation (CDE), spoke to the accelerating pace of the Republic's regulatory reform.
SAN FRANCISCO – The 36th Annual J.P. Morgan Healthcare Conference started off with a bang Monday, as Celgene Corp. talked up a proposed $7 billion acquisition of San Diego-based Impact Biomedicines Inc. built around Impact’s lead candidate, the phase III JAK2 inhibitor fedratinib, a potential treatment for myelofibrosis, a rare disease of the bone marrow.
Gossamer Bio Inc., a new company looking to leverage what it called "an asset-rich in-licensing environment," has raised $100 million from Arch Venture Partners and Omega Funds to rev up operations, advance trials for its early and late-stage candidates, and further augment its pipeline.
Stoke Therapeutics Inc., a new company developing antisense oligonucleotide therapies for severe genetic diseases, raised a $40 million series A financing from Apple Tree Partners, its sole investor.
Expansion Therapeutics Inc. has raised a $55.3 million series A round to advance its portfolio of RNA-targeted small-molecule medicines to treat rare diseases.
Just days before one of biotech's busiest weeks, a quartet of IPO filings by Menlo Therapeutics Inc., Restorbio Inc., Armo Biosciences Inc. and Solid Biosciences LLC are outlining the case for investing millions of dollars in the development of new therapies.
An off-the-shelf T-cell therapy for people with rituximab-refractory Epstein-Barr virus (EBV) flagged by the FDA for both orphan and breakthrough status is headed into dual phase III trials after the agency green-lighted its developer, Atara Biotherapeutics Inc., to make the move. Earlier data on the candidate, tabelecleucel, formerly known as ATA-129, suggests it might significantly improve the odds of survival for people who develop lymphomas and other lymphoproliferative disorders caused by EBV after solid organ or blood cell transplants.
Two months ahead of its PDUFA date, La Jolla Pharmaceutical Co. has won FDA approval for a new vasopressor capable of increasing blood pressure in adults with septic or other distributive shock.
