TEVA PHARMACEUTICALS USA, INC: Teva to Present New Fremanezumab Data, Including Long-Term Data, at the American Headache Society’s 60th Annual Scientific Meeting

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced 23 abstracts, one late-breaking poster and three oral presentations of fremanezumab for the preventive treatment of migraine which will be presented at the American Headache Society’s (AHS) 60th Annual Scientific Meeting in San Francisco from June 28-July 1, 2018. Read More »

MCKESSON CORPORATION: Combination Therapy BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) for the Treatment of BRAF-mutant Melanoma, Available for Order at Biologics, Inc.

Biologics, Inc., a McKesson Specialty Health oncology, neurology and complex care pharmacy services company, has been selected by Array BioPharma, Inc. to be in the limited distribution network for the combination therapy BRAFTOVITM (encorafenib) and MEKTOVI®(binimetinib) for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by a U.S. Food and Drug Administration (FDA) approved test. Read More »

PFIZER: Pfizer Announces Overall Survival Results from Phase 3 PALOMA-3 Trial of IBRANCE® (Palbociclib) in HR+, HER2- Metastatic Breast Cancer

Pfizer today announced overall survival (OS) results from the Phase 3 PALOMA-3 trial, which evaluated IBRANCE® (palbociclib) in combination with fulvestrant compared to placebo plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer whose disease has progressed after prior endocrine therapy. Read More »

ELI LILLY AND COMPANY: First-ever Study of Lilly's Humulin® R U-500 Administered in an Insulin Pump Shows Improved A1C in People with Type 2 Diabetes

Eli Lilly and Company's (NYSE: LLY) Humulin® R U-500 administered via an investigational insulin pump (Omnipod® U-500™ Insulin Management System) provided greater A1C reduction with less daily insulin needed compared to multiple daily injections (MDI) in adults with type 2 diabetes on high dose insulin (201-600 units/day). Read More »

CVS HEALTH: CVS Health Statement Regarding Ohio Department of Medicaid's Report on PBM Performance for Managed Care Plans

CVS Health (NYSE: CVS) is pleased that a report issued today that was commissioned by the Ohio Department of Medicaid (ODM) on pharmacy benefit manager (PBM) performance for the state's Medicaid managed care plans confirms that our PBM, CVS Caremark, does not provide preferential pricing to CVS Pharmacy that would create an anti-competitive advantage over independent pharmacies. Read More »

ABBVIE: IMBRUVICA® (ibrutinib) Supplemental New Drug Application Accepted for Review by U.S. FDA with Potential to Broaden Treatment Use as a Combination Treatment Option with Rituximab in Waldenström's Macroglobulinemia (WM), A Rare Form of Blood Cancer

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) in combination with rituximab (RITUXAN®) as a new treatment option for Waldenström's macroglobulinemia (WM), a rare and incurable form of blood cancer. Read More »

INCYTE CORPORATION: Incyte Announces REACH1 Pivotal Trial Meets Primary Endpoint of Overall Response Rate for Ruxolitinib (Jakafi®) in Steroid-Refractory Acute Graft-Versus-Host Disease

Incyte Corporation (Nasdaq:INCY)today announced positive topline results from its ongoing pivotal Phase 2 REACH1 trial evaluating ruxolitinib (Jakafi®) in combination with corticosteroids for the treatment of patients with steroid-refractory acute graft-versus-host disease (GVHD). Read More »

BRISTOL-MYERS SQUIBB: U.S. Food and Drug Administration (FDA) Accepts Application for Opdivo Plus Low-Dose Yervoy for Treatment of First-Line Non-Small Cell Lung Cancer in Patients with Tumor Mutational Burden ≥10 mut/Mb

Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) in patients with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb). Read More »

AMGEN INC.: New Data Show Amgen's Repatha® (evolocumab) Significantly Reduced LDL-C And Non-HDL-C In High-risk Patients With Type 2 Diabetes

Amgen (NASDAQ:AMGN) today announced new data that show Repatha® (evolocumab) significantly reduced low-density lipoprotein cholesterol (LDL-C) and non-high density lipoprotein cholesterol (non-HDL-C) in patients with Type 2 diabetes and hypercholesterolemia or mixed dyslipidemia, taking the maximum tolerated dose of moderate/high-intensity statin therapy. Read More »

NOVARTIS CORPORATION: Novartis receives FDA approval for inclusion of new evidence that Cosentyx® inhibits progression of joint structural damage in psoriatic arthritis

Novartis announced today that the US Food and Drug Administration (FDA) approved the inclusion of new evidence that Cosentyx® (secukinumab) significantly slows the progression of joint structural damage at Week 24 versus placebo in those with active psoriatic arthritis (PsA).1 Read More »

U.S FOOD AND ADMINISTRATION: FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients

The U.S. Food and Drug Administration today expanded the approval of the MiniMed 670G hybrid closed looped system, a diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the user, to include individuals aged 7 to 13 with type 1 diabetes. Read More »

VALEANT PHARMACEUTICALS : FDA Issues Complete Response Letter For DUOBRII™ (Halobetasol Propionate and Tazarotene) Lotion

Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX), today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company's New Drug Application (NDA) for DUOBRII™1 (halobetasol propionate and tazarotene) (IDP-118) lotion in the treatment of plaque psoriasis. Read More »