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Pipeline
June 7, 2021
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Breegi Scientific | Negative Pressure SteriDome | protection from airborne pathogens in hospitalized patients with suspected or confirmed diagnosis of COVID-19 | Emergency Use Authorization (EUA) granted by the FDA |
| GlaxoSmithKline Vir Biotechnology |
sotrovimab | mild-to-moderate COVID-19 in adults and pediatric patients who are at high risk for progression to severe COVID-19 | EUA granted by the FDA |
| Asklepios BioPharmaceutical | LION-101 | limb-girdle muscular dystrophy type 2I/R9 | IND approved by the FDA |
| Dicerna Pharmaceuticals Eli Lilly |
LY3819469 | cardiometabolic diseases | IND approved by the FDA |
| Merakris Therapeutics | dermacyte amniotic wound care liquid | nonhealing venous stasis ulcers | IND approved by the FDA |
| Scopus Biopharma | CpG-STAT3siRNA | B-cell nonHodgkins lymphoma | IND approved by the FDA |
| Tarus Therapeutics | TT-4 | advanced solid tumors | IND approved by the FDA |
| Transgene BioInvent |
BT-001 | solid tumors | IND approved by the FDA |
| AffaMed Therapeutics | AM006 | early Parkinson's disease | clinical trial application (CTA) approved by China's National Medical Products Administration for phase 2b trial |
| Ryvu Therapeutics | RVU120 (SEL120) | relapsed/refractory metastatic or advanced solid tumors | CTA approved in Poland |
| Acutis Medical | AcQBlate Force Sensing ablation catheter and system | paroxysmal and persistent atrial fibrillation | Investigational Device Exemption approved by the FDA |
| Alkermes | Lybalvi (olanzapine and samidorphan) | schizophrenia and bipolar 1 disorder | approved by the FDA |
| Amgen | Lumakras (sotorasib) | adult patients with KRAS G12C-mutated locally advanced or metastatic nonsmall-cell lung cancer | approved by the FDA |
| Biohaven Pharmaceutical | Nurtec ODT (rimegepant ) | preventive treatment of migraine | approved by the FDA for new formulation |
| BridgeBio Pharma QED Therapeutics Helsinn Group |
Truseltiq (infigratinib) | patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement | approved by the FDA |
| Bristol-Myers Squibb | Zeposia (ozanimod) | moderately- to severely-active ulcerative colitis | approved by the FDA |
| Forsee Pharmaceuticals | Camcevi (ready-to-use six-month subcutaneous depot formulation of leuprolide mesylate) | advanced prostate cancer | approved by the FDA |
| Janssen Pharmaceutical | Rybrevant (amivantamab-vmjw) | adult patients with locally advanced or metastatic nonsmall-cell lung cancer with EGFR exon 20 insertion mutations | approved by the FDA |
| Merck Sanofi Pasteur |
Vaxelis | vaccine against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to haemophilus influenzae type b for use in children six weeks through four years of age | approved by the FDA |
| Myovant Sciences Pfizer |
Myfembree(relugolix, estradiol and norethindrone acetate) | heavy menstrual bleeding associated with uterine fibroids in premenopausal women | approved by the FDA |
| Novartis | Cosentyx (secukinumab) | moderate-to-severe plaque psoriasis in pediatric patients six years and older | approved by the FDA for expanded indication |
| Paratek Pharmaceuticals | Nuzyra (omadacycline) | community-acquired bacterial pneumonia | approved by the FDA for new formulation |
| Scynexis | Brexafemme (ibrexafungerp tablets) | vulvovaginal candidiasis | approved by the FDA |
| ITO | D Function | electrical muscle stimulator for TMJ pain relief | approved by the FDA |
| JenaValve Technology | Trilogy heart valve system | aortic regurgitation and aortic stenosis | approved by the FDA |
| Lantheus Holdings | Pylarify | prostate-specific membrane antigen-targeted PET imaging agent | approved by the FDA |
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