Amgen recently announced that the company submitted to the U.S. Food and Drug Administration (FDA) a supplemental Biologics License Application (sBLA) for Xgeva (denosumab). The company also seeks approval from the European Medicines Agency (EMA). Read More »
The European Medicines Agency has accepted a Marketing Authorization Application for brexpiprazole, and its review is anticipated in the second quarter of 2018. Read More »
Acorda Therapeutics Inc. recently announced that the United States District Court for the District of Delaware invalidated four of its patents related to Ampyra extended release tablets. Read More »
Incyte Corp. and Merck have initiated a clinical development program that will examine the possibility of combining epacadostat, Incyte’s investigational oral selective IDO1 enzyme inhibitor, with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with metastatic melanoma, non-small cell lung cancer (NSCLC), bladder cancer, renal cell carcinoma (RCC), and squamous cell carcinoma of the head and neck (SCCHN). Read More »
Mylan N.V. has acquired the global rights to Cold-EEZE, a cold remedy line of products, from ProPhase Labs Inc. Read More »
Allergy & Asthma Network and Avella Specialty Pharmacy have released a white paper underscoring latex allergy risks and how that relates to the health care industry. Read More »
Mylan N.V. recently released a brief statement regarding the status of its Abbreviated New Drug Application for its generic iteration of GlaxoSmithKline's Advair Diskus bronchodilator product. Read More »
AbbVie has received approval from the U.S. Food and Drug Administration to include moderate to severe fingernail psoriasis data in the Humira (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis. Read More »
Senators pushing for changes to Medicare Part D drug pricing reporting requirements should be wary of messing with the program, according to a former administrator of the Centers for Medicare and Medicaid Services. Read More »
In an effort to obtain legitimate protections for seniors, taxpayers and pharmacies, pharmaceutical wholesaler Smith Drug Company recently expressed support for Congressional legislation to prevent benefit managers from billing customers retroactively for Medicare Part D prescriptions. Read More »
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee voted 11-0 on a favorable benefit-risk ratio for Genentech's rituximab/hyaluronidase subcutaneous injections in treating certain blood cancers. Read More »
Amgen's esults from its Phase 2, open-label ALCANTARA study evaluating the efficacy and safety of BLINCYTO has been published in the Journal of Clinical Oncology. Read More »
Merck KGaA has signed an agreement with U.K.-based research and development firm Avillion for an investigative, branded pharmaceutical product designed to address plaque psoriasis, with Avillion’s financial support. Read More »
A group representing pharmacy benefit managers is criticizing a report by a drug industry lobbying group that concludes the managers are not passing along drug rebates and discounts to patients. Read More »
The regulatory filing of investigational IL-23p19 inhibitor tildrakizumab with the European Medicines Agency was validated last week, according to Almirall and Sun Pharmaceutical Industries. Read More »
AbbVie has joined three other pharmaceutical companies in the Oncology Research Information Exchange Network Avatar Research Program. Read More »
Pfizer Inc.'s meningococcal group B vaccine TRUMENBA has received a positive opinion from the European Medicines Agency Committee for Medicinal Products for Human Use. Read More »
Walgreens recently designated over 50 of its nationwide pharmacy locations as cancer specialty centers outfitted with highly trained staff in breast, prostate, colorectal, lung and blood cancer directives with specialized curricula. Read More »
XELJANZ (tofacitinib citrate) has been approved by the European Commission in mono or combination therapy for rheumatoid arthritis. Read More »
Cumberland Pharmaceuticals Inc.'s open label multicenter study, published in Drug Design, Development and Therapy, supports the efficacy and use of Vaprisol Injection for treating hyponatremic patients with severe hepatic impairment. Read More »
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