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. Read More
Apple Tree Partners cultivated its latest startup, Elstar Therapeutics Inc. – named for a European variety of the fruit – packed the C-suite with big pharma veterans and pollinated the newco with a $39 million series A. The round was sized to begin building a pipeline of candidates from Elstar's universal targeted immunotherapy, or Uniti, platform to address both hematologic and solid tumor indications. Read More
In the five years since it started collecting generic drug user fees, the FDA has hired 1,000 new employees, amped up its staff training and completely reorganized the way it reviews abbreviated new drug applications (ANDAs). Read More
Opthea Ltd., of Melbourne, Australia, said it started a phase Ib/IIa trial testing OPT-302 in patients with center-involved diabetic macular edema (DME). Read More
Venatorx Pharmaceuticals Inc., of Malvern, Pa., said the FDA granted the company's lead antibiotic program, VNRX-5133, an injectable broad-spectrum beta-lactamase inhibitor combined with a marketed beta-lactam antibiotic, qualified infectious disease product and fast track designations for both complicated urinary tract infections and complicated intra-abdominal infections. Read More
Australia's Therapeutic Goods Administration (TGA) began implementing its new manufacturing principles for drugs and active pharmaceutical ingredients this week. Although the principles went into effect Monday, the TGA is taking what it called a phased approach in assessing compliance with the principles during its on-site inspections. Read More
Arvinas LLC's PROTAC (PROteolysis TArgeting Chimeras) platform is "therapeutic area-agnostic, so the world is our oyster," head of biology Ian Taylor told BioWorld. Read More
LONDON – Oculis SA has cleared a path for its lead program OC-118 to become the first non-invasive treatment for diabetic macular edema (DME), raising CHF20 million (US$20.3 million) in a series B round that will enable the company to complete an ongoing phase IIb trial and file the IND for a U.S. phase III. Read More
