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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

September 6, 2021
Company Drug/Device Medical Condition Status
Approvals
Ascendis Pharma Skytrofa (lonapegsomatropin-tcgd) Growth failure in children age one year and older from inadequate secretion of endogenous growth hormone Approved by the FDA
BeiGene Brukinsa (zanubrutinib) Waldenström’s macroglobulinemia Approved by the FDA for new indication
Janssen Invega Hafyera (6-month paliperidone palmitate) Long-acting treatment of schizophrenia Approved by the FDA
Merck Keytruda Locally advanced or metastatic urothelial carcinoma in patients who are not eligible for any platinum-containing chemotherapy Approved by the FDA for expanded indication
UCB Briviact (brivaracetam) CV tablets, oral solution and injection Partial-onset seizures in children age one month and older Approved by the FDA for expanded indication
Intelivation Technologies Golden Isles pedicle-screw system Degenerative and traumatic procedures Approved by the FDA
MicroTransponder MicroTransponder Vivistim paired vagus nerve-stimulation system Moderate-to-severe upper extremity motor deficits associated with chronic ischemic stroke Approved by the FDA
Morphosys

Incyte
Minjuvi (tafasitamab) in combination with lenalidomide Relapsed or refractory diffuse large B-cell lymphoma Approved in the European Union
Trials Authorized
Anixa Biosciences CAR T-cell therapy Ovarian cancer IND approved by the FDA
Diffusion Therapeutics trans sodium crocetinate (TSC) Interstitial lung disease IND approved by the FDA
Immunolight X-PACT X-ray psoralen-activated cancer treatment system Solid tumors Phase 1 trial authorized by the FDA
KAHR DSP107 Acute myeloid leukemia and myelodysplastic syndrome IND approved by the FDA
Poseida Therapeutics P-BCMA-ALLO1 Relapsed/refractory multiple myeloma IND approved by the FDA
Harbor Biomedical batoclimab Chronic inflammatory demyelinating polyneuropathy IND approved by the FDA and by China’s regulatory authority
Laekna Therapeutics afuresertib (LAE002) Locally advanced or metastatic HR+, HER2- breast cancer IND approved by the FDA and by China’s regulatory authority
AlzeCure Pharma ACD856 Alzheimer's disease Phase 1 trial authorized by Sweden’s regulatory authority
Medivir MIV-818 Patients with hepatocellular carcinoma who have progressed on, or are intolerant of, first-line standard therapy Phase 1/2a trial authorized by the British regulatory authority
Relief Therapeutics/AdVita Lifescience Inhaled aviptadil Sarcoidosis Phase 2 trial authorized by the German regulatory authority
Trials Initiated
Lumen Bioscience LMN-Cdiff01 Treatment and prevention of recurrent C. difficile infection Initiation of phase 1 trial
Pardes Biosciences PBI-0451 Antiviral to treat and prevent infections with SARS-CoV-2 Initiation of phase 1 trial
Bayer elinzanetant Vasomotor symptoms during menopause Initiation of phase 3 trial
GlaxoSmithKline

SK Bioscience
GBP510 COVID-19 vaccine Initiation of phase 3 trial
Merck

Ridgeback Biotherapeutics
molnupiravir Postexposure prophylaxis of COVID-19 infection Initiation of phase 3 trial
Pfizer Respiratory syncytial virus (RSV) vaccine Prevention of RSV in adults age 60 years and older Initiation of phase 3 trial
Roche giredestrant Estrogen receptor-positive, HER2 negative early breast cancer Initiation of phase 3 trial

 

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