Pipeline

August 23, 2021

Company	Drug/Device	Medical Condition	Status
Novatek Pharmaceuticals	TQ Formula	oral treatment for COVID-19 patients in an outpatient setting	IND approved by the FDA
Occlutech	Flex II PFO occluder	patients with cryptogenic stroke	Investigational Device Exemption approved by the FDA
Angel Pharmaceuticals	CPI-818	relapsed/refractory T-cell lymphomas	IND approved by the China National Medical Products Administration
Enlivex Therapeutics	Allocetra	treatment of patients with severe and critical COVID-19 experiencing acute respiratory distressed syndrome	authorization granted by the Israeli Ministry of Health for a phase 2b trial
Istari Oncology	PVSRIPO	head and neck squamous-cell carcinoma	initiation of phase 1/2 substudy
Turning Point Therapeutics	repotrectinib in combination with trametinib	RAS G12D-mutated advanced solid tumors	initiation of phase 1b/2 trial
Trigone Pharma	TRG-100	interstitial cystitis/ bladder pain syndrome	initiation of phase 2 trial
Cali Biosciences	CPL-01 (extended-release injectable ropivacaine hydrochloride)	long-acting postoperative analgesic	initiation of phase 2b trial
Pfizer-BioNTech	COVID-19 Vaccine	COVID-19	Emergency Use Authorization (EUA) amended to include an additional shot in certain immunocompromised people
Moderna	COVID-19 Vaccine	COVID-19	EUA amended to include an additional shot in certain immunocompromised people
Spectrum Solutions	SDNA-1000 saliva collection device	at-home COVID-19 testing	EUA amended to include the unsupervised self-collection of saliva
Eli Lilly	Lyumjev (insulin lispro-aabc injection) subcutaneous pump	glycemic control in adults with type 1 and type 2 diabetes	approved by the FDA for expanded administration
GlaxoSmithKline	Jemperli (dostarlimab)	adults with dMMR recurrent or advanced solid tumors	approved by the FDA for expanded indication
Jazz Pharmaceuticals	Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution	idiopathic hypersomnia	approved by the FDA for new indication
Merck	Welireg (belzutifan)	treatment of adult patients with certain types of Von Hippel-Lindau disease-associated tumors	approved by the FDA
Pfizer	Ticovac tick-borne encephalitis (TBE) vaccine	active immunization to prevent TBE in individuals age one year and older	approved by the FDA
GC Pharma	GreenGene F (beroctocog alfa) recombinant human coagulation factor VIII for injection	control and prophylaxis of bleeding episodes in patients with hemophilia A	approved in China
Nasus Pharma	Taffix intranasal powder	viral infections	approved in Spain
Photocure	Hexvix (hexaminolevulinate HCl)	management of bladder cancer	approved in Chile