Pipeline

November 5, 2018

Company	Drug/Device	Medical Condition	Status
Aquestive Therapeutics, Inc.	SYMPAZAN™ (clobazam)	Seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older	Granted approval by the FDA
Sandoz	Hyrimoz (Adalimumab), biosimilar to AbbVie’s Humira	Metastatic squamous non-small cell lung cancer (NSCLC)	Granted approval by the FDA
Merck	Keytruda	Metastatic squamous non-small cell lung cancer (NSCLC)	FDA has approved, in combination with chemotherapy, as a first-line treatment
Cerus Corporation	Pathogen-reduced cryoprecipitate	Massive hemorrhage	Granted Breakthrough Device designation by the FDA
Alkermes	ALKS 5461	Depression	FDA advisory committee rejected New Drug Application
Genentech	Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab)	Previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions	Randomized Phase III CLL14 trial met its primary endpoint; showed a statistically significant reduction in risk of disease worsening or death compared to standard-of-care Gazyva plus chlorambucil
Genmab and Johnson & Johnson’s Janssen	Darzalex (daratumumab)	Multiple myeloma	In Phase III MAIA trial, met its primary endpoint of improved progression-free survival (PFS) at a pre-planned interim analysis
Bio-Thera Solutions, Ltd.	HER2 Antibody-Drug Conjugate (ADC), BAT8001	HER-2 positive metastatic breast cancer	Initiated Phase III clinical trial evaluating the efficacy and safety
Gilead Sciences, Inc.	Biktarvy® (bicte-gravir 50 mg/emtricitabine 200 mg/tenofovir alafen-amide 25 mg tab-lets, BIC/FTC/TAF)	HIV-1 infection	Results from Phase III randomized, double-blinded trial; found to be statistically non-inferior to a regimen of dolutegravir and emtricitabine/tenofovir alafenamide (50 mg) (DTG+FTC/TAF) through 96 weeks of therapy