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Home » Drug & Device Pipeline News
Drug & Device Pipeline News
August 22, 2022
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
Daewoong Pharmaceutical | DWP213388 | Autoimmune diseases | IND approved by the FDA |
Enlivex Therapeutics | Allocetra | Advanced solid tumors | Approval for a phase 1/2 trial granted by Israel’s regulatory authority |
Trials Initiated | |||
BridgeBio Pharma | BBP-671 | Propionic acidemia and methylmalonic acidemia | Initiation of phase 1 trial |
CureVac | CV0501 COVID-19 booster | COVID-19 | Initiation of phase 1 trial |
Innovent Biologics | IBI311 | Active thyroid associated ophthalmopathy | Initiation of phase 1 trial |
Mersana Therapeutics | XMT-1660 | Breast, endometrial and ovarian cancer | Initiation of phase 1 trial |
Tessa Therapeutics | TT11 plus Opdivo (nivolumab) | Relapsed or refractory CD30-positive classical Hodgkin lymphoma | Initiation of phase 1b trial |
Passage Bio | PBFT02 | Frontotemporal dementia with granulin mutations | Initiation of phase 1/2 trial |
ALX Oncology | Evorpacept in combination with Erbitux (cetuximab) and Keytruda (pembrolizumab) | Refractory microsatellite stable metastatic colorectal cancer in patients who have progressed on at least two lines of systemic therapy | Initiation of phase 2 trial |
Genexine | GX-188E, GX-I7 and nivolumab | Head and neck squamous cell carcinoma | Initiation of phase 2 trial |
Greenwich LifeSciences | GLSI-100 | HER2/neu-positive breast cancer in patients with residual disease or high-risk pathologic complete response at surgery who completed neoadjuvant and postoperative adjuvant trastuzumab treatment | Initiation of phase 3 trial |
Palisade Bio | LB1148 | Return of bowel function in adults undergoing gastrointestinal surgery | Initiation of phase 3 trial |
Approvals | |||
Bluebird bio | Zynteglo (betibeglogene autotemcel) | Beta thalassemia in adult and pediatric patients who require regular red blood cell transfusions | Approved by the FDA |
Daiichi Sankyo AstraZeneca |
Enhertu (fam-trastuzumab deruxtecan-nxki) | Previously treated HER2-mutant metastatic non-small cell lung cancer | Approved by the FDA for new indication |
Roche | Xofluza (baloxavir marboxil) | Treatment of acute uncomplicated influenza in otherwise healthy children age five to less than 12 years who have been symptomatic for no more than 48 hours | Approved by the FDA for expanded indication |
Roche | Xofluza | Postexposure prophylaxis of influenza in children age five to less than 12 years after contact with someone with influenza | Approved by the FDA for expanded indication |
Moderna | mRNA-1273.214 (Spikevax Bivalent Original/Omicron) | Omicron-specific COVID-19 booster in patients age 18 years and older | Conditional authorization in the UK |
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