Category - Developments

Developments

FDA rejects Savara’s Molgradex for autoimmune pulmonary alveolar proteinosis

Following a Type C FDA meeting, Savara (NASDAQ:SVRA) reported that the agency did not recommend it submit a biologics license application (BLA) for Molgradex for the treatment of autoimmune pulmonary alveolar...

October 2, 2019

Developments

LumiThera enrolls first patient in U.S. multi-center trial in dry AMD

Closely-held LumiThera enrolled the first patient in its multi-center U.S. clinical trial in patients with dry age-related macular degeneration (AMD). The study, called LIGHTSITE III, will evaluate LumiThera’s Valeda...

October 1, 2019

Developments

FDA clears Ziopharm Oncology IND for CAR-T therapy

The FDA has cleared Ziopharm Oncology’s (NASDAQ:ZIOP) IND for CD19-specific CAR-T for the treatment of relapsed CD19+ leukemias and lymphomas. The drug candidate is based on Ziopharm’s non-viral T cell modification...

October 1, 2019

Developments

Catabasis Pharma exceeds target enrollment for global Phase 3 DMD trial

Catabasis Pharmaceuticals (NASDAQ:CATB) completed enrollment for its Phase 3 trial of edasalonexent for the treatment Duchenne muscular dystrophy (DMD). Taking place at 40 clinical sites in eight countries, the trial...

October 1, 2019

Developments

Heron resubmits NDA for postoperative pain drug

Heron Therapeutics (NASDAQ:HRTX) resubmitted its NDA for HTX-011 – a dual-acting combination of the local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug, meloxicam – to the FDA. The resubmission was...

October 1, 2019

Developments

BeyondSpring presents novel NSCLC study design for plinabulin

At the recent European Society for Medical Oncology Congress, BeyondSpring Pharmaceuticals (NASDAQ:BYSI) presented its novel study design for DUBLIN-3, a global Phase 3 trial assessing plinabulin in non-small cell lung...

October 1, 2019

Developments

Titan Pharma’s Probuphine now available at Crossroads of Southern Nevada rehabilitation facilities

Titan Pharmaceuticals (NASDAQ:TTNP) reported that Crossroads of Southern Nevada rehabilitation facility has trained health care providers in the insertion and removal of Probuphine implants, which will now be offered to...

October 1, 2019

Developments

Geron imetelstat gets FDA fast track designation for myelofibrosis

Geron’s (NASDAQ:GERN) imetelstat, a telomerase inhibitor, received FDA fast track designation for the treatment of relapsed/refractory myelofibrosis (MF). MF is a chronic blood cancer that impairs normal blood...

September 30, 2019

Developments

AVEO Oncology begins enrollment for Phase 1b/2 study of FOTIVDA for HCC

AVEO Oncology (NASDAQ:AVEO) began enrolling patients for its Phase 1b/2 clinical trial evaluating FOTIVDA, in combination with AstraZeneca’s IMFINZI, in patients with hepatocellular carcinoma (HCC) who have not received...

September 30, 2019

Developments

FDA clears Turning Point Therapeutics’ IND for TPX-0046

The FDA cleared Turning Point Therapeutics’ (NASDAQ:TPTX) IND for TPX-0046, a dual RET and SRC tyrosine kinase inhibitor (TKI) being developed for the treatment of solid tumors. The company plans to initiate a first-in...

September 30, 2019

Category - Developments

FDA rejects Savara’s Molgradex for autoimmune pulmonary alveolar proteinosis

LumiThera enrolls first patient in U.S. multi-center trial in dry AMD

FDA clears Ziopharm Oncology IND for CAR-T therapy

Catabasis Pharma exceeds target enrollment for global Phase 3 DMD trial

Heron resubmits NDA for postoperative pain drug

BeyondSpring presents novel NSCLC study design for plinabulin

Titan Pharma’s Probuphine now available at Crossroads of Southern Nevada rehabilitation facilities

Geron imetelstat gets FDA fast track designation for myelofibrosis

AVEO Oncology begins enrollment for Phase 1b/2 study of FOTIVDA for HCC

FDA clears Turning Point Therapeutics’ IND for TPX-0046

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