March, 2017 Stories | American Pharmacy News

Maine’s House and Senate are assessing companion bills to prohibit payers from assessing retroactive DIR fees on pharmacies.

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

FDA accepts Allergan filing for schizophrenia maintenance treatment drug

The multinational study was randomized, double blind and placebo-controlled and featured parallel groups.

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 »

ASHP releases reference manual for pharmacy preceptors

The publication was created by Mate Soric, Stacey Schneider and Scott Wisneski.

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 »

Acorda’s AMPYRA patents upheld by federal officials

Acorda is awaiting the results of a challenge to these patents.

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 »

JAMA Cardiology publishes findings from Amgen's 4-year study of Repatha

The OSLER-1 open-label extension study involved 1,324 patients.

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 »

Mylan gains FDA approval for generic Pristiq in extended-release form

Sales of the tablets in both dosages in the U.S. drew approximately $853 million for the 12-month period ending on Jan. 31.

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 »

FDA gives Servier's UCART19 therapy IND clearance

Servier is sponsoring a UCART19 study titled CALM Phase 1 that began in the U.K. in August 2016.

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 »

FDA committees find OPANA ER's risks outweigh benefits

The FDA will take the committee’s votes into consideration as it determines whether or not to take regulatory action on the drug.

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 »

Mylan launches Exemestane tablets in U.S. market following FDA approval

Exemestane tablets garnered approximately $100 million in sales between February 2016 and the end of January 2017.

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 »

Data shared from Phase 3 study on DUPIXENT treatment of atopic dermatitis

Patients who received DUPIXENT in combination with TCS had significantly higher baseline improvements.

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 »

Pfizer China’s XELJANZ approved for rheumatoid arthritis treatment

JAK disrupt a signalling pathway that is believed to play a role in RA-associated inflammation.

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 »

Amgen Phase 3 Repatha data shows reduced need for apheresis

Caitlin Nordahl | Mar 16, 2017

Amgen’s study shows that treating those patients with Repatha can significantly reduce their need for LDL-C apheresis.

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 »

FDA accepts application for Keryx Pharmaceutical's Auryxia

Keryx Biopharmaceuticals specializes in innovative medicines to fight renal disease.

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 »

Regeneron and Sanofi to present Praluent data at ACC 17

Presentations will include the results of testing in several patient subsets, including those with diabetes.

Regeneron and Sanofi are set to present new data from the Phase 3 Praluent (alirocumab) injection clinical trial program at this weekend’s American College of Cardiology Scientific Sessions (ACC 17) in Washington, D.C. Read More »

Pfizer's combination antibiotic approved in U.K., Germany

Zaficefta is a useful tool in treating infections that are increasingly resistant to available antibiotics.

Pfizer Inc.'s combination antibiotic Zavicefta is now available in the United Kingdom and Germany for the treatment of Gram-negative bacterial infections requiring hospitalization. Read More »

Acorda creates Amazon Alexa skill for MS Awareness Month

The skill uses content adapted from Acorda’s award-sinning MS self app, which users can access with the voice command “Alexa, start MS Awarness.”

In honor of Multiple Sclerosis Awareness Month, Acorda Therapeutics recently launched a new Alexa skill called MS Awareness Facts that will help Amazon Alexa users learn more about the chronic disease and its symptoms. Read More »

Abbot receives FDA approval for its FlexAbility ablation catheter