AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced notification by the U.S. Food and Drug Administration (FDA) that it requires extended time to review additional information regarding the results of liver function tests provided by AbbVie in connection with its New Drug Application (NDA) for elagolix in endometriosis-associated pain. The Prescription Drug User Fee Act (PDUFA) date has been extended three months to Q3 2018. Read More »

Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that its REDUCE-IT cardiovascular outcomes study of Vascepa® (icosapent ethyl) is estimated to have reached the onset of the targeted 1,612 primary major adverse cardiovascular events (MACE) specified in the study design. Read More »

Amgen (NASDAQ:AMGN) today announced that new pre-clinical data for several of its novel investigational oncology candidates will be presented at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, April 14-18, 2018. Read More »

Aetna’s continuing work on helping combat the opioid epidemic includes a study suggesting the strength of the drug might not be the best predictor of misuse. Read More »

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-COMPARE clinical trial showing that after 12 weeks, upadacitinib (15 mg, once-daily) met the primary endpoints of ACR20a and clinical remissionb versus placebo.1 All ranked secondary endpoints were also achieved versus either placebo or adalimumab (40 mg every other week). Read More »

ASHP’s virtual House of Delegates recently approved professional policies on gene therapy, unit dose packaging availability, and drug dosing in conditions that modify pharmacokinetics or pharmacodynamics, among other topics. Following discussion in the House of Delegates community on ASHP Connect, delegates voted online during the week of March 16–23. Read More »

Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, today announced an update to its revenue guidance for the first quarter of 2018, reiteration of full year revenue guidance, further progress towards completing its potential landmark cardiovascular outcomes study, REDUCE-IT, and initiation of previously announced Vascepa® promotion initiatives. Read More »

The Aetna Foundation announced the next step in its funding initiative to fight the ongoing opioid epidemic with a $1 million grant to the Pennsylvania Department of Health. Read More »

AbbVie (NYSE: ABBV) will announce its first-quarter 2018 financial results on Thursday, Apr. 26, 2018, before the market opens. AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern). Read More »

Acorda Therapeutics, Inc. (Nasdaq:ACOR) will host a conference call and webcast to report its first quarter 2018 financial results on Wednesday, May 2 at 8:30 a.m. ET. Read More »

The Physician-Patient Alliance for Health & Safety (PPAHS) announced that it intends to host a Guide to Patient Monitoring, Improved Patient Safety and Outcomes. Read More »

Enteris BioPharma, Inc., a biotechnology company developing innovative drug products built around its proprietary delivery technologies, announced that it has entered into a feasibility development agreement with Ferring Pharmaceuticals to utilize Enteris' proprietary oral delivery platform, Peptelligence®, to develop an oral formulation of a peptide-based injectable therapeutic from Ferring. Read More »

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) will present corporate updates at two upcoming investor conferences in March Read More »

Grady Memorial Hospital is the only civilian hospital in the country that has formed a partnership with the U.S. Army Special Forces to provide additional, formal instruction and preparation for its Green Beret Special Operations Combat Medics (SOCM 18 Delta). Read More »

Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), announced that they have entered into a license agreement with Pint Pharma GmbH to commercialize rigosertib, a novel and targeted anti-cancer compound currently in a Phase 3 study for the treatment of MDS, a group of rare hematologic malignancies. Pint Pharma is a European-based pharmaceutical company focused on the development, registration and commercialization of specialty-based treatments for the Latin American market. Read More »

Biologics, Inc., a McKesson Specialty Health oncology and complex care pharmacy services company, has been selected by the Janssen Pharmaceutical Companies of Johnson & Johnson1 to be in the limited distribution network for ERLEADA™ (apalutamide), the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer (NM-CRPC). The addition of this critical patient therapy brings the total number of oncology and supportive therapies accessible through Biologics to 115. Read More »

Pfizer Inc. (NYSE:PFE) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended against expanding use of SUTENT® (sunitinib) to include the adjuvant treatment of adult patients at a high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancerous kidney). Read More »

Allergan plc, (NYSE: AGN) a leading global pharmaceutical company, and Medicines360, a global nonprofit women's health pharmaceutical company with a mission of expanding access to quality medicines, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Medicines360's supplemental New Drug Application (sNDA). Read More »

Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) seeking approval of its recently acquired developmental product stannsoporfin. Read More »

One of the U.S. Food and Drug Administration’s highest priorities is our role in ensuring the safety of the foods that Americans consume. Read More »