CRISPR Therapeutics (NASDAQ:CRSP) and Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today announced that the U.S.Food and Drug Administration (FDA) has placed a clinical hold on the Investigational New Drug Application (IND) for CTX001 for the treatment of sickle cell disease pending the resolution of certain questions that will be provided by the FDA as part of its review of the IND. Read More »

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that preliminary data from the dose escalation part of an ongoing phase 1/2 study with investigational U3-1402 in heavily pretreated patients with HER3-positive metastatic breast cancer will be presented during a Poster Discussion Session on Monday, June 4 at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL (Abstract 2512; 3:00 – 4:15 PM CDT). Read More »

Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S.Food and Drug Administration (FDA) has approved the 2-mg dose of OLUMIANT® (baricitinib), a once-daily oral medication for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies. Read More »

Global biotherapeutics leader CSL Behring today announced that the US Food and Drug Administration (FDA) has approved a 3500 IU (international unit) vial size for IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP)], its novel, long-acting recombinant albumin fusion protein for treating hemophilia B. Read More »

Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) lifted a partial clinical hold placed on CA209-602 (CheckMate -602), a randomized, open-label Phase 3 study evaluating the addition of Opdivo (nivolumab) to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. Read More »

AstraZeneca and MedImmune, its global biologics research and development arm, today presented results from the Phase III (‘1053’) clinical trial that evaluated moxetumomab pasudotox in 80 patients with relapsed or refractory hairy cell leukaemia (HCL) who had received at least two prior lines of therapy. Read More »

Amgen (NASDAQ:AMGN) today announced results from the Phase 3 A.R.R.O.W. trial of a once-weekly KYPROLIS® (carfilzomib) dosing regimen in patients with relapsed and refractory multiple myeloma. Read More »

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced findings from an interim analysis of the Phase 3 iNNOVATE (PCYC-1127) study evaluating IMBRUVICA® (ibrutinib) plus RITUXAN® (rituximab) in previously untreated and relapsed/refractory patients with Waldenström's macroglobulinemia (WM), a rare type of non-Hodgkin's lymphoma (NHL). Read More »

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has accepted, with Priority Review, the company's New Drug Application (NDA) for gilteritinib for the treatment of adult patients who have relapsed or refractory (resistant to treatment) Acute Myeloid Leukemia (AML) with a FLT3 mutation as detected by an FDA-approved tes Read More »

The Pharmaceutical Care Management Association (PCMA) released the following statement today on the Congressional Budget Office’s (CBO) $43 billion score of point-of-sale rebates in Medicare Part D. Read More »

AstraZeneca and MedImmune, its global biologics research and development arm, today announced top-line results from TERRANOVA, the second of two pivotal Phase III trials for Fasenra (benralizumab) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Read More »

ASHP (American Society of Health-System Pharmacists), the 45,000-member national association representing pharmacists who serve as patient care providers in acute and ambulatory care settings, is calling for swift action from policymakers to address the persistent shortages of critical medications in hospitals and health systems. Read More »

Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Read More »

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the European Medicines Agency (EMA) has completed formal validation of Acorda’s Marketing Authorization Application (MAA) for INBRIJA. Read More »

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today confirmed that the U.S. Food and Drug Administration (FDA) has extended the goal date of the Biologics License Application (BLA) for fremanezumab, an investigational therapy for the preventive treatment of migraine. Read More »

Eisai Inc. and Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has extended the action date for the supplemental New Drug Application (sNDA) for lenvatinib for the potential first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Read More »

Boehringer-Ingelheim issued the following announcement on May 21.Breckenridge Pharmaceutical, Inc. announced today the supplemental approval for the 40mg strength of Duloxetine Delayed-Release Capsules. Read More »

AstraZeneca and MedImmune, its global biologics research and development arm, today announced positive overall survival (OS) results for the Phase III PACIFIC trial, a randomised, double-blinded, placebo-controlled, multi-centre trial of Imfinzi (durvalumab) in patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease had not progressed following platinum-based chemotherapy concurrent with radiation therapy (CRT). Read More »

The U.S. Food and Drug Administration (FDA) has accepted Sanofi's regulatory filing for Zynquista (sotagliflozin). Read More »

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the use of Prolia® (denosumab) for the treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. Read More »