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  • 2017

Majority of PCSK9 inhibitor prescription claims initially rejected

American Pharmacy News Reports | Mar 24, 2017
Amgen's result suggests a utilization management process not driven by any observable clinical criteria.

Amgen's data from two studies shows that for appropriate patients in the United States, the majority of prescription claims for PCSK9 inhibitors, such as Repatha (evolocumab), were initially rejected. Read More »

Alkermes to launch Phase 3 study for ALKS 8700

American Pharmacy News Reports | Mar 24, 2017
Alkemes believes ALKS 8700 can be valuable for those suffering with MS.

Alkermes PLC has launched a Phase 3 study for its product ALKS 8700 – a novel, oral monomethyl fumarate drug in development that will be used for patients with relapsing forms of multiple sclerosis. Read More »

DEA rule would classify Syndros drug as controlled substance

American Pharmacy News Reports | Mar 24, 2017
The product is a cannabinoid that can be used to help treat anorexia in patients with AIDS.

An interim final rule introduced by the Drug Enforcement Agency would result in Insys Therapeutics Inc.'s Syndros product being placed in Schedule II of the Controlled Substances Act. Read More »

Rxight genetic testing panel can help ADHD patients assess prescription drugs

American Pharmacy News Reports | Mar 24, 2017
In 2006, the FDA warned that ADHD medicines could lead to psychotic events.

MD Labs, the makers of the Rxight genetic testing panel, recently announced that the U.S. Food and Drug Administration warns that ADHD medications can cause adverse psychiatric effects and that the Rxight genetic testing can help patients better assess prescription drugs. Read More »

Teva launches authorized generic of Minastrin 24 Fe as oral contraceptive

Mark Iandolo | Mar 24, 2017
One of every two oral contraceptive prescriptions in the U.S. involves a Teva-marketed product.

Teva Pharmaceuticals Industries Ltd. has launched its authorized generic of Minastrin 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) 1 mg/20 mcg in the U.S. Read More »

Amgen receives European approval to market Amgevita

American Pharmacy News Reports | Mar 24, 2017
Amgevita treats select inflammatory diseases in adults, such as moderate-to-severe rheumatoid arthritis.

Amgen recently announced that the European Commission (EC) granted the company authorization to bring to market Amgevita in all available indications. Read More »

CVS Health launches Reduced RX discount program with Novo Nordisk

Mark Iandolo | Mar 25, 2017
 CVS Health and Novo Nordisk will help patients with high out-of-pocket costs afford essential medications.

CVS Health has launched a prescription savings program called Reduced RX that will provide various discounts for certain medications through CVS Caremark directly to patients. Read More »

FDA tentatively OKs Mylan's HIV/AIDS drug for developing nations

American Pharmacy News Reports | Mar 25, 2017
Developing countries will now be able to use the drug as a first-line regimen for treating HIV/AIDS patients.

Mylan N.V., a global pharmaceutical company, recently announced the U.S. Food and Drug Administration (FDA) tentatively approved the company's New Drug Application for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg ("TLE400"). Read More »

Allergan's Juvéderm Vollure XC approved for sale in the U.S.

American Pharmacy News Reports | Mar 25, 2017
Juvéderm Vollure XC will be available in the U.S. starting in April.

The U.S. Food and Drug Administration has approved Allergan PLC’s Juvéderm Vollure XC for use correcting moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over 21. Read More »

Data analysis shows Eliquis leads to fewer strokes than warfarin

American Pharmacy News Reports | Mar 25, 2017
The analysis showed Eliquis led to a lower risk of stroke or embolism.

Bristol-Myers Squibb Company and Pfizer Inc. recently announced findings from a real-world data analysis of the U.S. Medicare database that compares risk of stroke or systemic embolism and rate of major bleeding among patients with non-valvular atrial fibrillation who were treated with direct oral anticoagulants versus warfarin. Read More »

Allergan to sell FDA-approved Restasis in first multi-dose bottle

American Pharmacy News Reports | Mar 27, 2017
Restasis Multidose, which is designed with new and patented air filter technology, will be available for the same price of single-use vials.

Restasis MultiDose will now be available and approved by the U.S. Food and Drug Administration for help treating patients with a type of Chronic Dry Eye by helping them make more of their own tears. Read More »

Study shows Repatha can reduce chances of heart attacks and strokes

American Pharmacy News Reports | Mar 27, 2017
This benefit of Repatha starts in patients who take the drug for at least six months.

Based on 27,564 patient cardiovascular outcomes study, Amgen has established that maximally reducing low-density lipoprotein cholesterol levels with Repatha leads to a further reduction in major cardiovascular events, including heart attacks, strokes and coronary revascularizations. 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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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