Mylan comments on Advair Diskus ANDA status
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 »
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 »
Genentech's drug Rituxan was recently granted Breakthrough Therapy Designation Status by the U.S. Food and Drug Administration. Read More »
Shionogi Inc. and Purdue Pharma L.P.'s Symproic 0.2 mg tablets C-II have been approved by the U.S. Food and Drug Administration for use as a once-daily oral peripherally-acting mu-opioid receptor antagonist medication in treating opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. Read More »
Allergan PLC and Parateks Pharmaceuticals' Phase 3 trials of sarecycline met their 12-week primary efficacy endpoints. Read More »
EMD Serano, the biopharmaceutical business of Merck KGaA, and Pfizer Inc. recently received approval from the U.S. Food and Drug Administration to market Bavencio Injection 20 mg/mL for intravenous use. Read More »
Keryx Pharmaceuticals Inc.'s largest Medicare Part D plan sponsor in the United States has added the company’s Auryxia drug to its Medicare Part D plan formularies. Read More »
CVS Health recently announced a partnership with the University of Pittsburgh School of Pharmacy and the Pittsburgh Public Schools that will showcase the company’s Pharmacists Teach prescription drug prevention program to public school students with the help of student pharmacists from the university. Read More »