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Test shows results of Repatha in cognitive function trials

American Pharmacy News Reports | Mar 23, 2017
The study showed that on other cognitive domain tests – working memory, memory function and psychomotor speed – Repatha was not statistically different than placebo.

Amgen recently announced the results of the Repatha (evolocumab) cognitive function trial that examined cognitive function for 1,974 patients enrolled in the Repatha cardiovascular outcomes study. Read More »

Settlement paves way for Mylan's global commercialization of Heceptin

American Pharmacy News Reports | Mar 23, 2017
Mylan has one of the industry's broadest portfolios with 16 biosimilar products in development.

Mylan N.V. recently announced that it settled a case relating to patents for Herceptin, from Genentech Inc. and F. Hoffman-La Roche Ltd., giving Mylan global licenses for its trastuzumab product. Read More »

Experts skeptical of 'drug price transparency' bills

John Breslin | Mar 20, 2017
Sen. Ron Wyden's bill would require PBMs to disclose the rebates provided by drug manufacturers.

Sen. Ron Wyden (D-OR) last week introduced legislation that he says would increase pricing "transparency" among pharmacy benefit managers.  Read More »

Allergan to license Editas Medicine genome-editing ocular programs

American Pharmacy News Reports | Mar 20, 2017
CRISPR treats LCA10, a retinal degenerative disease that can cause blindness in children.

Allergan and Editas Medicine have entered a strategic research and development alliance that gives Allergan exclusive access and the option to license up to five of Editas Medicine’s genome-editing ocular programs. Read More »

Amgen unveils positive data from Phase 3 '482 study

American Pharmacy News Reports | Mar 20, 2017
Multiple myeloma develops within plasma cells in bone marrow.

Amgen recently announced positive data from the Phase 3 '482 study, which is the largest international multiple myeloma trial ever conducted. Read More »

Amgen to present results from Phase 3 ENDEAVOR trial

American Pharmacy News Reports | Mar 20, 2017
ENDEAVOR met its key secondary endpoint, showing that patients treated with KYPROLIS and dexamethasone lived 7.6 months longer than patients who were treated with velcade and dexamethasone.

Amgen's positive results from a planned overall survival interim analysis of the Phase 3 head-to-head ENDEAVOR trial. Read More »

Diplomat Pharmacy to dispense KISQALI as breast cancer tretament

Mark Iandolo | Mar 20, 2017
More than 315,000 women are expected to be diagnosed with breast cancer in 2017.

Diplomat Pharmacy Inc. recently announced that it will dispense KISQALI as a first-line treatment for postmenopausal women with serious forms of breast cancer. Read More »

MainPointe signs with Acura for NEXAFED marketing rights

American Pharmacy News Reports | Mar 19, 2017
MainPointe will receive all manufacturing and commercialization activities for NEXAFED products.

Acura Pharmaceuticals Inc. and MainPointe Pharmaceuticals LLC recently entered a licensing agreement that will give MainPointe exclusive marketing rights for NEXAFED and NEXAFED Sinus in the United States and Canada. Read More »

Abbot receives FDA approval for its FlexAbility ablation catheter

American Pharmacy News Reports | Mar 17, 2017
The FDA’s approval is a further step in the company’s electrophysiology portfolio expansion.

Abbot recently announced that the U.S. Food and Drug Administration (FDA) approved its FlexAbility Ablation Catheter. Read More »

Acorda creates Amazon Alexa skill for MS Awareness Month

American Pharmacy News Reports | Mar 17, 2017
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 »

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

American Pharmacy News Reports | Mar 17, 2017
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 »

Regeneron and Sanofi to present Praluent data at ACC 17

American Pharmacy News Reports | Mar 17, 2017
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 »

FDA accepts application for Keryx Pharmaceutical's Auryxia

American Pharmacy News Reports | Mar 16, 2017
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 »

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 »

Pfizer China’s XELJANZ approved for rheumatoid arthritis treatment

American Pharmacy News Reports | Mar 16, 2017
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 »

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

American Pharmacy News Reports | Mar 16, 2017
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 »

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

American Pharmacy News Reports | Mar 16, 2017
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 »

FDA committees find OPANA ER's risks outweigh benefits

American Pharmacy News Reports | Mar 16, 2017
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 »

FDA gives Servier's UCART19 therapy IND clearance

American Pharmacy News Reports | Mar 15, 2017
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 »

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

American Pharmacy News Reports | Mar 15, 2017
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 »

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