The U.S. Food and Drug Administration has accepted a supplemental New Drug Application for Auryxia tablets from Keryx Biopharmaceuticals Inc., a company specializing in innovative medicines to fight renal disease. Read More »

Amgen’s recent Phase 3 study of the effects of Repatha on patients who receive apheresis for low-density lipoprotein cholesterol showed a promising reduction in the need for the recurring procedure. Read More »

Chinese authorities recently approved Pfizer China’s oral Janus kinase inhibitor XELJANZ, with active ingredient tofacitinib citrate, indicated for treating adults with moderate to severely active rheumatoid arthritis. Read More »

Regeneron Pharmaceutical Inc. and Sanofi recently presented the results of their one-year Phase 3 CHRONOS study, showing that investigational drug DUPIXENT combined with topical corticosteroids achieved better results in treating uncontrolled moderate-to-severe atopic dermatitis than TCS alone. Read More »

The U.S. Food and Drug Administration recently issued its final approval for Mylan’s Abbreviated New Drug Application for its Exemestane Tablets in a 25mg dosage, which are a generic version of Pfizer’s Aromasin tablets. Read More »

Two U.S. Food and Drug Administration committees recently voted 18 to 8, with one abstention, that Endo International’s OPANA ER (oxymorphone hydrochloride extended release) no longer has a positive risk-to- benefits ratio. Read More »

The U.S. Food and Drug Administration recently issued Investigational New Drug clearance for Servier’s UCART19, allowing the company to proceed with clinical development of the allogeneic, gene-edited cellular therapy. Read More »

Mylan N.V. recently launched its Desvenlafaxine extended-release tablets, a generic version of Pfizer’s Pristiq tablets, to treat major depressive disorder in the U.S. market in 50 and 100 mg doses. Read More »

The results from Amgen’s four-year follow up OSLER-1 study on Repatha, which is so far the longest PCSK9 inhibitor clinical trial, were recently published in JAMA Cardiology. Read More »

The U.S. Patent and Trademark Office Patent Trials and Appeal Board recently upheld four patents held by Acorda Therapeutics Inc. related to its AMPYRA (dalfampridine) Extended Release Tablets in 10 mg dosages. Read More »

The American Society of Health-System Pharmacists recently released “The Effective Pharmacy Preceptor,” a reference to assist pharmacists in training students and residents through experiential education techniques. Read More »

The U.S. Food and Drug Administration has accepted Allergan PLC's filing of a supplemental New Drug Application based on new clinical data that would allow the company to list maintenance on its product label for VRAYLAR (cariprazine), a drug used to treat adults with schizophrenia. Read More »

Pharmacists in Maine are seeking an end to direct and indirect remuneration fees. Read More »

The American Society of Health-System Pharmacists (ASHP) recently announced that the current Alabama legislature session is seeking to attempt to have the state codify collaborative drug therapy management (CDMT) as part of pharmacy practice. Read More »

Pfizer Inc. is renewing its partnership with the Union for International Cancer Control through a grant of $530,000 for the Seeding Progress and Resources for the Cancer Community: Metastatic Breast Cancer Challenge. Read More »

Pernix Therapeutics Holdings Inc. recently announced that it has been given positive feedback on its litigation in regards to the proposed generic version of Zohydro ER with Actavis Laboratories FL Inc. Read More »

The Biosimilars Council is hoping the Supreme Court will acknowledge the savings that biosimilar medications can offer to both patients and health systems.  Read More »

The Office of Tissue Advancement Therapies, a branch of the Center for Biologics Evaluation and Research of the FDA, has progressed toward the acceptance of Ampio Pharmaceuticals' Ampion for a viable treatment option for severe osteoarthritis of the knee. Read More »

Bristol-Myers Squibb Co. and Pfizer Inc. will present eight of their abstracts at the American College of Cardiology's 66th Annual Scientific Session in Washington, D.C. March 17-19. Read More »

Merck, which is known as MSD outside the United States and Canada, and Pfizer Inc. recently announced the acceptance for review of three New Drug Applications by the U.S. Food and Drug Administration. Read More »