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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

October 4, 2021
Company Drug/Device Medical Condition Status
Trials Authorized
Bexion Pharmaceuticals BXQ-350 Newly diagnosed stage 4 metastatic colorectal cancer IND approved by the FDA
Pharmazz centhaquine Hypovolemic shock IND approved by the FDA
Everest Medicines SPR206 (EVER206) Multi-drug resistant gram-negative bacterial infections IND approved by China’s regulatory authority
I-Mab enoblituzumab in combination with pembrolizumab (Keytruda) Selected solid tumors IND approved by China’s regulatory authority for a phase 2 trial
Transcenta Holding TST002 Postmenopausal osteoporosis IND approved by China’s regulatory authority
AB Science masitinib Treatment of patients with symptomatic mild-to-moderate COVID-19 Approval for a phase 2 trial granted by Russia and South Africa’s regulatory authorities
Krystal Biotech KB407 Cystic fibrosis Approval for a phase 1 trial granted by Australia’s regulatory authority
MRM Health MH002 Ulcerative colitis Approval for a Phase 1b/2a trial granted by Belgium’s regulatory authority
Revelation Biosciences REVTx-99 Prevention of influenza Approval for a Phase 2b trial granted by Belgium’s regulatory authority
Kintor Pharma Proxalutamide Hospitalized COVID-19 patients Approval for a phase 3 trial granted by Brazil’s regulatory authority
Lipidor AKP02 Psoriasis Approval for a phase 3 trial granted by India’s regulatory authority
Trials Initiated
ADC Therapeutics ADCT-901 Selected advanced solid tumors Initiation of phase 1 trial
CyanVac

Blue Lake Biotechnology
CVXGA1 intranasal COVID-19 vaccine COVID-19 vaccine Initiation of phase 1 trial
Dicerna DCR-AUD Alcohol use disorder Initiation of phase 1 trial
Glyscend Polymer duodenal exclusion therapy Obesity Initiation of phase 1 trial
VBI Vaccines VBI-2905 SARS-CoV-2 vaccine Initiation of phase 1b trial
Artios Pharma ART4215 Advanced or metastatic solid tumors Initiation of phase 1/2 trial
GenFleet Therapeutics

Innovent
GFH925 KRAS G12C mutated late-stage nonsmall-cell lung cancer and gastrointestinal cancer Initiation of phase 1/2 trial
Addex Therapeutics dipraglurant Blepharospasm Initiation of phase 2a trial
Allena Pharmaceuticals ALLN-346 Gout in patients with chronic kidney disease Initiation of phase 2a trial
Immunic IMU-838 Progressive multiple sclerosis Initiation of phase 2 trial
InMed Pharmaceuticals INM-755 (cannabinol) cream Epidermolysis Bullosa Initiation of phase 2 trial
Arrowhead Pharmaceuticals ARO-APOC3 Mixed dyslipidemia. Initiation of phase 2b trial
Pfizer PF-07321332, co-administered low dose ritonavir Prevention of COVID-19 infection Initiation of phase 2/3 trial
SAB Biotherapeutics SAB-185 Nonhospitalized patients with mild-to-moderate COVID-19 Initiation of phase 3 portion of phase 2/3 trial
Janssen Respiratory syncytial virus (RSV) vaccine Lower respiratory tract disease caused by RSV Initiation of phase 3 trial
Syros Pharmaceuticals SY-2101 Newly diagnosed acute promyelocytic leukemia patients Initiation of phase 3 trial
Approvals
AbbVie Qulipta (atogepant) Preventive treatment of episodic migraine in adults Approved by the FDA
Amgen Repatha (evolocumab) Adjunct for the treatment of patients older than 10 years old with heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C Approved by the FDA for expanded indication
Eli Lilly Erbitux (cetuximab injection) in combination with Braftovi (encorafenib) Adults with previously treated metastatic colorectal cancer with a BRAF V600E mutation Approved by the FDA for new indication
Mirum Pharmaceuticals Livmarli (maralixibat) oral solution Cholestatic pruritus in patients with Alagille syndrome older than one year of age Approved by the FDA
Biotronik Orsiro Mission bioabsorbable polymer drug-eluting stent system Percutaneous coronary intervention device Approved by the FDA
ANP Technologies NIDS COVID-19 Antigen Rapid Test Kit Detection of SARS-CoV-2 Emergency Use Authorization granted by the FDA
Astellas

SeaGen
Padcev (enfortumab vedotin) Radically unresectable urothelial carcinoma that has progressed after anti-cancer chemotherapy Approved in Japan
ChemoCentryx

Kissei Pharmaceuticals
Tavneos (avacopan) Microscopic polyangiitis and granulomatosis with polyangiitis Approved in Japan
Pfizer Cibnqo (abrocitinib) moderate-to-severe atopic dermatitis in patients older than 12 years of age Approved in Japan

 

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