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