PRIME THERAPEUTICS LLC: Analyzing integrated medical, pharmacy drug claims essential in forecasting eculizumab’s (Soliris®) cost

A study by pharmacy benefit manager Prime Therapeutics LLC (Prime) designed to forecast the potential use and cost of eculizumab (Soliris®), a drug billed through the medical benefit, to treat Myasthenia Gravis (MG) found the expanded use could lead to nearly a twofold increase in Soliris forecasted cost trend in 2018 and beyond. Read More »

TAKEDA PHARMACEUTICAL COMPANY: TRINTELLIX® (vortioxetine) Prescribing Information Now Includes New Data Showing Improvement in Processing Speed, an Important Aspect of Cognitive Function in Acute Major Depressive Disorder (MDD)

Takeda Pharmaceutical Company Limited (Takeda; TSE: 4502) and H. Lundbeck A/S (Lundbeck; LUN.CO, LUN DC, HLUYY) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application for TRINTELLIX® (vortioxetine). Read More »

PORTOLA PHARMACEUTICALS: U.S. FDA Approves Portola Pharmaceuticals’ Andexxa®, First and Only Antidote for the Reversal of Factor Xa Inhibitors

Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that the U.S. Food and Drug Administration (FDA) has approved Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Read More »

VALEANT PHARMACEUTICALS: Bausch + Lomb Launches LUMIFY, The First And Only OTC Redness Relieving Eye Drop With Low-Dose Brimonidine

Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Valeant Pharmaceuticals International (NYSE/TSX: VRX), today announced the launch of LUMIFY™ (brimonidine tartrate ophthalmic solution 0.025%), the first and only over-the-counter (OTC) eye drop developed with low-dose brimonidine tartrate for the treatment of eye redness. Read More »

GENENTECH, INC:Genentech Provides Update on Phase III Study Of TECENTRIQ (Atezolizumab) and COTELLIC (Cobimetinib) in People With Heavily Pre-Treated Locally Advanced or Metastatic Colorectal Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMblaze370 study evaluating the combination of TECENTRIQ® (atezolizumab) and COTELLIC ® (cobimetinib) did not meet its primary endpoint of overall survival (OS) compared to regorafenib. Read More »

MYLAN INC: Mylan Statement on Supply of EpiPen® (epinephrine injection, USP) Auto-Injectors from Meridian Medical Technologies, a Pfizer company

The U.S. Food and Drug Administration (FDA) posted a supply notification about EpiPen® (epinephrine injection, USP) 0.3 mg and EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths, on its website to provide greater transparency and confirm that the product remains available. Read More »