Lead Company	Partner Company	Drug	Indication	Market	Comments
REGULATORY APPROVAL
Gilead Sciences Inc.	-	Epclusa (sofosbuvir plus velpatasvir)	hepatitis C	US	The first and only all-oral pan-genotypic therapy.
AstraZeneca PLC	Allergan PLC	Zavicefta (ceftazidime plus avibactam)	intra-abdominal and urinary tract infections, and hospital-acquired pneumonia	EU	An iv antibiotic for severe Gram-negative infections.
Bial-Portela & CA SA	-	Ongentys (opicapone)	Parkinson’s disease	EU	As adjunctive therapy.
Swedish Orphan Biovitrum AB	Biogen	Eloctate (efmoroctacog alfa)	hemophilia A	Switzerland	Recombinant Factov-VIII fusion protein given every three to five days.
Cytori Therapeutics Inc.	-	Cytori Cell Therapy	knee osteoarthritis	Japan	Autologous cell therapy approved under a new law in Japan.
SUPPLEMENTAL REGULATORY APPROVAL
Merck & Co. Inc.	Janssen Biotech Inc.	Simponi (golimumab)	polyarticular juvenile idiopathic arthritis	EU	Combined with methotrexate.
REGULATORY FILING ACCEPTED
Advanced Accelerator Applications SA	-	Lutathera (Lu-177 labeled somatostatin analog)	neuroendocrine tumors	US	Also granted priority review status.
Genentech Inc. (Roche)	-	Ocrevus (ocrelizumab)	relapsing and primary progressive multiple sclerosis	US, EU, Australia, Switzerland	Also granted priority review.
Teva Pharmaceutical Industries Ltd.	-	fluticasone dry powder inhaler	adult and adolescent asthma	US	In Teva’s RespiClick device, an NDA filing.
Teva Pharmaceutical Industries Ltd.	-	fluticasone plus salmeterol	adult and adolescent asthma	US	In Teva’s RespiClick device, an NDA filing.
Cempra Inc.	-	solithromycin	community acquired bacterial pneumonia	EU	The first fluoroketolide, submission completed for iv and oral formulations.
Puma Biotechnology Inc.	-	neratinib	breast cancer	EU	As adjuvant in early-stage disease previously treated with trastuzumab.
ORPHAN DRUG DESIGNATION
Kiadis Pharma Netherlands BV	Pfizer Inc.	ATIR101	graft-verus-host disease	EU	Extended to include use in hematopoetic stem cell transplant, regardless of underlying disease.
Antisense Therapeutics Ltd.	-	ATL1103	acromegaly	EU	Already granted in US.
Mereo BioPharma Group Ltd.	-	BPS-804	osteogenesis imperfecta	EU	A registration trial will start in 2H 2016.
FAST-TRACK STATUS
Cascadian Therapeutics Inc.	-	ONT-380 (a small-molecule HER2 inhibitor)	breast cancer	US	In Phase II studies, in advanced HER2+ disease.
BREAKTHROUGH THERAPY DESIGNATION
AbbVie Inc.	Janssen Biotech Inc.	Imbruvica (ibrutinib)	graft-versus-host disease	US	Its fourth designation; also designated an orphan drug.
Ultragenyx Pharmaceutical Inc.	Kyowa Hakko Kirin Co. Ltd.	KRN23	X-linked hypophosphatemia	US	An anti-fibroblast growth factor-23 antibody.
Bristol-Myers Squibb Co.	-	Opdivo (nivolumab)	bladder cancer	US	The sixth designation.
CHMP POSITIVE OPINION ON FIRST APPROVAL
Teva Pharmaceutical Industries Ltd.	-	Cinqaero (reslizumab)	eosinophilic asthma	EU	An interleukin-5 antagonist.
MolMed SPA	-	Zalmoxis	stem cell transplant	EU	Allogeneic T-cells with nerve growth factor and Herpes simplex thymidine kinase genes.
CHMP POSITIVE OPINION ON SUPPLEMENTAL APPROVAL
Merck & Co	-	Keytruda (pembrolizumab)	non-small cell lung cancer	EU	As second-line therapy.
COMPLETE RESPONSE LETTER
Lipocine Inc.	-	LPCN 1021 (an oral testosterone product)	hypogonadism	US	Dosing algorithm different to that used in Phase III.
REGULATORY FILING
Array BioPharma Inc.	-	binimetinib	NRAS-mutant melanoma	US	A subset of advanced disease, and Array’s first filing.
SUPPLEMENTAL REGULATORY FILING
Horizon Pharma PLC	-	Ravicti (glycerol phenylbutyrate) oral liquid	urea cycle disorders	US	From two months of age rather than two years.
PHASE III TRIAL INITIATION
Actinium Pharmaceuticals Inc.	-	Iomab-B (BC8 antibody coupled to iodine-131)	acute myeloid leukemia	-	In SIERRA trial as conditioning agent for stem cell transplant.
Cara Therapeutics Inc.	-	CR845	pruritus	-	In patients with chronic kidney disease.
Xcovery LLC	-	X-396	non-small cell lung cancer	-	Versus crizotinib in Alk-positive patients.
Intra-Cellular Therapies Inc.	-	ITI-007-201	agitation in dementia	-	Including Alzheimer’s disease patients.
Anthera Pharmaceuticals Inc.	-	Sollpura (liprotamase)	exocrine pancreatic insufficiency	-	In cystic fibrosis patients.
Astellas Pharma Inc.	-	gilteritinib	acute myelogenous leukemia	-	With and without azacitidine.
Boehringer Ingelheim GMBH	-	bevacizumab	colorectal cancer	-	A biosimilar.of Roche’s Avastin.
PRODUCT LAUNCH
Basilea Pharmaceutica Ltd.	-	Cresemba (isavuconazole)	invasive aspergillosis and mucormycosis	Italy	Launched in Germany, Austria and the UK.

PIPELINE WATCH: Six Approvals, Eight Filings And One Launch

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