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 »

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 (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 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 (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 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 »

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 »

The U.S. Food and Drug Administration today approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence.. Read More »

The Department of Homeland Security released the following statement regarding the Supreme Court’s decision to uphold President Trump’s Proclamation 9645 Enhancing Vetting Capabilities and Processes for Detecting Attempted Entry Into the United States by Terrorists or Other Public-Safety Threats: Read More »

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 »

Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced the U.S. launch of Bivalirudin for Injection, 250 mg single-dose vial, a generic version of Angiomax® from The Medicines Company. Read More »

Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced the presentation of two long-term, Phase III studies: one each for biosimilar Zessly® (infliximab)[4],[5] and biosimilar Erelzi®(etanercept).[6],[7] Read More »

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S.Food and Drug Administration (FDA) has approved KEYTRUDA®, the company’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. Read More »

Bristol-Myers Squibb Company (NYSE:BMY) today announced that the ELOQUENT-3 trial, an international Phase 2 study evaluating the addition of Empliciti (elotuzumab) to pomalidomide and low-dose dexamethasone (EPd) in patients with relapsed/refractory multiple myeloma (RRMM), achieved its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients treated with EPd compared with pomalidomide and dexamethasone (Pd) alone. Read More »

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the presentation of investigational data from a new analysis of undetectable minimal residual disease (uMRD) rates from the pivotal Phase 3 MURANO trial of venetoclax, a first-in-class oral B-cell lymphoma-2 (BCL-2) inhibitor, in combination with rituximab (VenR) in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). Read More »

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced a change in the clinical development program of fremanezumab in chronic cluster headache. Read More »

Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease (PD).. Read More »

AstraZeneca and Eli Lilly and Company (Lilly) are discontinuing the global Phase III clinical trials of lanabecestat, an oral beta secretase cleaving enzyme (BACE) inhibitor, for the treatment of Alzheimer’s disease. Read More »

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add the positive overall survival (OS) data from the Phase 3 ASPIRE trial to the U.S. Prescribing Information for KYPROLIS® (carfilzomib). Read More »

Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, today announced the release of new topline clinical trial data on Bimatoprost SR, the first-in-class sustained-release, biodegradable implant for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Read More »