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 »

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 »

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 »

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 »

MERCK: European Medicines Agency Validates Type II Variation for Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed (ALIMTA®) and Platinum Chemotherapy as First-Line Therapy in Metastatic Nonsquamous NSCLC, Based on Phase 3 KEYNOTE-189 Trial

Merck known as MSD outside the United States and Canada, announced that following validation by the European Medicines Agency (EMA), the centralized review process has begun for the company’s Type II Variation, which seeks approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA®) and platinum chemotherapy (cisplatin or carboplatin) for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC). Read More »

ASTELLAS PHARMA US, INC.: Astellas Submits New Drug Applications for Approval of Gilteritinib for the Treatment of FLT3mut+ Relapsed or Refractory Acute Myeloid Leukemia

Astellas Pharma Inc. announced that it submitted on March 23, 2018, a new drug application (NDA) for marketing approval of gilteritinib (generic name) in Japan for the treatment of adult patients with FLT3 mutation-positive (FLT3mut+) relapsed or refractory acute myeloid leukemia (AML). Read More »

MERCK: Pivotal Phase 3 Study of Merck’s Investigational Beta-Lactamase Inhibitor Relebactam in Combination with Imipenem/Cilastatin Demonstrated Favorable Overall Response Against Certain Imipenem–Non-Susceptible Bacterial Infections

Merck known as MSD outside the United States and Canada, announced that a pivotal Phase 3 study of relebactam, the company’s investigational beta-lactamase inhibitor, in combination with imipenem/cilastatin, demonstrated a favorable overall response in the treatment of certain imipenem–non-susceptible bacterial infections, the primary endpoint, with lower treatment-emergent nephrotoxicity (kidney toxicity), a secondary endpoint, compared to a Colistin (colistimethate sodium) plus imipenem regimen. Read More »