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FDA approves fingernail psoriasis data for Humira

American Pharmacy News Reports | Apr 3, 2017
Fingernail psoriasis affects half of all psoriasis patients.

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 warned to avoid tampering with Medicare drug pricing

John Breslin | Apr 3, 2017
Sen. Ron Wyden's proposal would require a minimum percentage of rebates and discount to be passed from a PBM to a health plan.

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 »

Smith Drug Co. supports end to retroactive Medicare D billing

American Pharmacy News Reports | Apr 1, 2017
The billing tactics impact Medicare patients’ costs and CMS disbursements.

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 »

FDA approves benefit-risk ratio for Genentech blood cancer drug

American Pharmacy News Reports | Apr 1, 2017
The FDA should make a decision on whether to approve Rituxan by June 26.

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 publishes Phase 2 study results for Blincyto

Mark Iandolo | Apr 1, 2017
Sixteen patients went into complete remission by the end of two cycles of treatment with Blincyto.

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 teams with Avillion for psoriasis treatment

American Pharmacy News Reports | Mar 31, 2017
Merck has completed Phase I for the Anti IL-17 A/F Nanobody product.

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 »

Pharmacy industry report says price discounts miss mark

Michael Carroll | Mar 30, 2017
Out-of-pocket costs for drugs is dropping overall,  according to the Centers for Medicare and Medicaid Services.

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 »

Tildrakizumab filing with European agency validated

American Pharmacy News Reports | Mar 29, 2017
The Phase III clinical trials included in the filing had more than 1,800 participants.

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 joins ORIEN Avatar Research Program

American Pharmacy News Reports | Mar 29, 2017
The ORIEN Avatar Program helps researchers and doctors match eligible patients to clinical trials that may best treat their cancers.

AbbVie has joined three other pharmaceutical companies in the Oncology Research Information Exchange Network Avatar Research Program. Read More »

Pfizer's TRUMENBA moves closer to European approval

American Pharmacy News Reports | Mar 29, 2017
Data showed TRUMENBA produced a protective serum antibody response to meningococcal group B strains.

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 designates 50 pharmacies as cancer care centers

American Pharmacy News Reports | Mar 29, 2017
Walgreens is positively impacting the health care of over 1.2 million people nationwide living with or in remission from a blood cancer.

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 »

European Commission approves XELJANZ for rheumatoid arthritis

American Pharmacy News Reports | Mar 29, 2017
The EC approval was based in part on the results of the Phase III Oral Rheumatoid Arthritis Trials.

XELJANZ (tofacitinib citrate) has been approved by the European Commission in mono or combination therapy for rheumatoid arthritis. Read More »

Cumberland's multicenter study supports Vaprisol Injection

Mark Iandolo | Mar 28, 2017
The open label multicenter study – published in March – joins a growing body of literature supporting Vaprisol.

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 »

Rituxan receives breakthrough status from FDA

American Pharmacy News Reports | Mar 28, 2017
Genentech's Phase 3 study is enrolling patients.

Genentech's drug Rituxan was recently granted Breakthrough Therapy Designation Status by the U.S. Food and Drug Administration. Read More »

FDA approves Symproic once-daily tablets to treat OIC

American Pharmacy News Reports | Mar 28, 2017
Shionogi also submitted a petition to remove Symproic from controlled substance classification.

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 »

Phase 3 trials for sarecycline meet primary endpoints

American Pharmacy News Reports | Mar 28, 2017
Sarecycline was created to treat patients with moderate to severe acne in the community setting.

Allergan PLC and Parateks Pharmaceuticals' Phase 3 trials of sarecycline met their 12-week primary efficacy endpoints. Read More »

Bavencio treatment for Merkel cell carcinoma patients gains FDA approval

American Pharmacy News Reports | Mar 28, 2017
The FDA’s approval comes after the conclusion of the Javelin Markel 200 trial.

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 »

Auryxia by Keryx has been picked up by nation's largest Medicare Part D sponsor

American Pharmacy News Reports | Mar 27, 2017
Auryxia is approved in the U.S. for controlling serum phosphorous levels in patients suffering from chronic kidney disease on dialysis.

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 to bring Pharmacists Teach program to Pittsburgh public schools

American Pharmacy News Reports | Mar 27, 2017
CVS Health recently entered a partnership with the University of Pittsburgh School of Pharmacy.

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 »

FDA fast-tracks Shire's SHP655 for patients with ADAMTS13

American Pharmacy News Reports | Mar 27, 2017
Shire noted that this does not guarantee FDA approval.

Shire PLC's recombinant ADAMTS13 drug, SHP655, has been given fast-track designation by the U.S. Food and Drug Administration. Read More »

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