PIPELINE WATCH: Five Approvals, Four Filings And Two Launches

This week's Pipeline Watch, a snapshot of all the late-stage R&D and regulatory events in the pharma and biotech industries, is now available to view.

The table records clinical and regulatory developments using data from Biomedtracker. It lists all drugs for which an event was recorded from June 10 to June 16, 2016, divided by event type.

Events can include latest launches, approvals, withdrawals, suspensions, regulatory filings, CHMP recommendations, Phase III clinical trial initiations, development discontinuations, and the granting of orphan drug and fast-track status.

Pipeline Watch – June 10 to June 16, 2016

Source: BioMedTracker.

Lead Company	Partner Company	Drug	Indication	Market	Comments
REGULATORY APPROVAL
PaxVax Inc.	-	Vaxchora vaccine	cholera prevention	US	The only single-dose cholera vaccine approved worldwide.
TaiGen Biotechnology Co. Ltd.	-	Taigexyn (nemonoxacin)	community-acquired pneumonia	China	An oral quinolone.
SUPPLEMENTAL REGULATORY APPROVAL
Roche	-	Gazyvaro (obinutuzumab)	follicular lymphoma	EU	In combination with bendamustine.
Shire PLC	Kamada Ltd.	Glassia (alpha-1 proteinase inhibitor)	emphysema	US	Expanded approval for self-infusion at home.
Swedish Orphan Biovitrum AB	-	Orfadin (nitisinone)	hereditary tyrosinemia type-1	US	A higher-strength 20mg capsule.
REGULATORY FILING ACCEPTED
Charleston Laboratories Inc.	Daiichi Sankyo Co. Ltd.	CL-108 (promethazine, hydrocodone and acetaminophen)	moderate to severe pain	US	A bilayered tablet to minimize opioid-induced nausea and vomiting.
ORPHAN DRUG DESIGNATION
Emergent BioSolutions Inc.	-	BioThrax (anthrax vaccine adsorbed)	anthrax	US	For post-exposure prophylaxis.
FAST-TRACK STATUS
GlycoMimetics Inc.	-	GMI-1271	acute myeloid leukemia	US	An E-selectin antagonist.
ProMetic Life Sciences Inc.	-	Prometic (plasminogen)	congenital plasminogen deficiency	US	Currently in a Phase II/III study.
COMPLETE RESPONSE LETTER
KemPharm Inc.	-	Apadaz (benzhydrocodone and acetaminophen)	acute pain	US	A week earlier, FDA requested an NDA amendment.
REGULATORY FILING
Marathon Pharmaceuticals LLC	-	deflazacort	Duchenne muscular dystrophy	US	Other versions of deflazacort are available for non-DMD indications outside the US.
Perrigo Co. PLC	-	ingenol mebutate gel	psoriasis	US	ANDAs for a generic version of Leo Pharma AS’s Picato.
SUPPLEMENTAL REGULATORY FILING
Janssen-Cilag International	-	Eprex (epoetin alfa)	anemia in low or intermediate-1 risk myelodysplastic syndromes	EU	Submitted in France in the mutual recognition procedure.
PHASE III TRIAL INITIATION
Bellerophon Therapeutics Inc.	-	INOpulse (pulsatile inhaled nitric oxide)	pulmonary arterial hypertension	-	The INOvation-1 study of a delivery system in a chronic setting.
Boehringer Ingelheim GMBH	-	Ofev (nintedanib)	idiopathic pulmonary fibrosis	-	Combined with sildenafil.
SymBio Pharmaceuticals Ltd.	The Medicines Co.	Ionsys (SyB P-1501)	acute post-op pain	Japan	Product already available in the US and EU.
Vertex Pharmaceuticals Inc.	-	Orkambi (lumacaftor plus ivacaftor)	cystic fibrosis	-	In subjects aged two to five years.
PRODUCT LAUNCH
Eisai Inc.	-	Fycompa (perampanel) oral suspension	epilepsy	US	Interchangeable with tablets for patients who have difficulty swallowing.
Actelion Pharmaceuticals Ltd.	Nippon Shinyaku Co. Ltd.	Uptravi (selexipag)	pulmonary arterial hypertension	Germany	An oral selective prostacyclin receptor agonist.