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Health Affairs Blog comments on the Cures Act, FDA Draft Guidance

Mark Iandolo | Jun 15, 2017
The new administration has stated generally that they will work to eliminate

The Health Affairs Blog, a vehicle for commentary on health policy and issues, recently wrote about how the Cures Act and FDA Draft Guidance suggest flexibility on communication of real-world drug impacts. Read More »

Amgen's Fourier trial for Repatha meets primary and secondary endpoints

American Pharmacy News Reports | Jun 15, 2017
The key secondary composite endpoint involved whether the drug could reduce cardiovascular death.

Amgen's Fourier trial for Repatha met its primary composite endpoint and the key secondary composite endpoint. Read More »

CVS Health helps patients prevent, manage chronic disease

American Pharmacy News Reports | Jun 13, 2017
CVS believes pharmacists must play an important role in helping these patients manage their health.

CVS Health has released an article about making it easier for patients to prevent and manage chronic disease. Read More »

Spinraza gains European go-ahead to treat spinal muscular atrophy

American Pharmacy News Reports | Jun 13, 2017
Positive results from two major clinical studies contributed to endorsement of the product.

Spinraza (nusinersen) recently won European Commission authorization to treat 5q SMA — the most common form of spinal muscular atrophy — becoming the first such drug to achieve European approval, manufacturer Biogen announced from Cambridge, Massachusetts. Read More »

Express Scripts releases 2016 Drug Trend Report

American Pharmacy News Reports | Jun 13, 2017
Drug Channels also wrote about the year-over-year changes in drug spending.

Express Scripts has released its 2016 Drug Trend Report for the commercial market. Read More »

Pfizer meningitis drug gains European approval for young patients

American Pharmacy News Reports | Jun 13, 2017
Young people can be misled by meningococcal disease symptoms, which can resemble the flu.

Trumenba, Pfizer’s branded vaccine against certain forms of meningococcal disease, officially won approval from the European Commission for patients aged 10 years and up, representing progress for protection in the young adult demographic. Read More »

Legal expert issues warning over federal disclosure bills aimed at pharmacy benefit managers

John Breslin | Jun 12, 2017
Joanna Shepherd, professor, Emory School of Law

Government-mandated disclosure bills could have a negative impact on competition if pharmacy benefit managers are forced to publicly disclose too much information on their negotiations with drug companies, according to Emory School of Law professor Joanna Shepherd. Read More »

SCOTUS ruling in Sandoz v. Amgen will speed biosimilars to market, could save U.S. consumers billions

LocalLabs News Service | Jun 12, 2017

The U.S. Supreme Court issued a 9-0 ruling today that will have the effect of speeding the process for biosimilars going to market. Read More »

Drug companies set prices unrelated to rebates, according to PBM industry group study

Carol Ostrow | Jun 12, 2017
PCMA published its research in its “Increasing Prices Set by Drugmakers Not Correlated With Rebates” report.

As a Senate committee prepares to evaluate U.S. drug distribution at a hearing tomorrow, the Pharmaceutical Care Management Association readily demonstrates that manufacturers’ pricing does not correlate with agreed-upon rebates and discounts with pharmacy benefit managers. Read More »

Texas Pharmacy Association receives grant to create community health care platform

American Pharmacy News Reports | Jun 10, 2017
The project involves a workflow system designed to link patients, physicians, pharmacists, hospitals, clinics and other health care providers.

The Texas Pharmacy Association (TPA) has received a grant from the Community Pharmacy Foundation and Texas Department of State Health Services that will allow the association to create community-based health care provider digital linkages with pharmacists. Read More »

CMS approves McKesson Specialty Health's iKnowMed

American Pharmacy News Reports | Jun 10, 2017
The iKnowMed platform allows users to input information without going through a third party.

The Centers for Medicare and Medicaid Services recently authorized Texas-based McKesson Specialty Health as a Qualified Clinical Data Registry, rendering it eligible to participate in the Merit-Based Incentive Payment System for 2017. Read More »

Egalet patents tamper-resistant Guardian tablet

American Pharmacy News Reports | Jun 10, 2017
Egalet deterred potential product hijacking by using a unique adaptation of the commonly used injection molding process.

Fortified with time-release traits, Egalet Corp.’s Guardian tablet has received a U.S. patent, enabling the Pennsylvania-based firm to adapt the medication for potential future products. Read More »

Pfizer furthers partnership for affordable contraception in developing countries

Carol Ostrow | Jun 10, 2017
The all-in-one injection was distributed to 20 developing nations by the end of 2016.

Mutual recommitment to a partnership between Pfizer and two U.S. foundations has successfully ensured continued access to Pfizer’s Sayana Press contraceptive for women in the world’s poorest nations. Read More »

Otsuka, Proteus re-apply to FDA for digital drug approval

American Pharmacy News Reports | Jun 10, 2017
Otsuka and Proteus Digital Health requested FDA approval with an application for the invention.

A pioneering prototype blending a mood stabilizer with technology is on the radar for two companies determined to develop a combination drug/device that, if approved by the FDA, could potentially address serious mental health challenges. Read More »

Sanofi obtains FDA go-ahead for kidney transplant drug

Carol Ostrow | Jun 9, 2017
Thymoglobulin is intended for use in conjunction with standard immunosuppressive therapy following kidney transplants.

With kidney disease ranking in the nation’s top 10 causes of death, Sanofi recently announced a breakthrough with FDA approval of its branded Thymoglobulin for boosting immunosuppression for patients to prevent rejection following kidney transplants. Read More »

Pfizer, Celltrion present data on Inflectra at 12th ECCO Congress

American Pharmacy News Reports | Jun 9, 2017
Pfizer is in the midst of an ongoing 54-week study of Inflectra.

Pfizer Inc. and Celltrion Healthcare presented data at the 12th Congress of the European Chron’s and Colitis Organisation showing Inflectra (infliximab CT-P13) delivers similar efficacy and safety as Remicade (infliximab) for treating Chron’s Disease. Read More »

AstraZeneca sells U.S. and Canada commercialization rights for Zoladex

American Pharmacy News Reports | Jun 9, 2017
Zoladex, an injectable luteinizing hormone-releasing hormone agonist, was first approved in the United States and Canada in 1989.

AstraZeneca and TerSera Therapeutics LLC (TerSera) have entered a agreement that gives TerSera the commercial rights to Zoladex in the United States and Canada. Read More »

Pfizer plans Phase 3 study of Clostridium difficile vaccine

American Pharmacy News Reports | Jun 9, 2017
Clostridium difficile, a spore-forming pathogen, often targets people with altered gut microbial flora.

Pfizer Inc. recently shared positive data from its Phase 2 study examining Clostridium difficile (C. difficile) vaccine candidate, PF-06425090, a product created to help prevent C. difficile infection (CDI), which can include life-threatening diarrhea and pseudomembranous colitis. Read More »

Pfizer's Xeljanz receives positive opinion from European committee

American Pharmacy News Reports | Jun 9, 2017
More than 2.9 million people are currently living with moderate to severe rheumatoid arthritis in Europe.

Pfizer Inc. recently announced that its Xeljanz drug for treating moderate to severe active rheumatoid arthritis (RA) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Read More »

Government waste watchdog group urges Nevada governor to veto Rx 'transparency' bill

LocalLabs News Service | Jun 8, 2017

A Nevada bill headed to the desk of Governor Brian Sandoval (R) would do nothing to decrease prescription drug costs, according to the Council of Citizens Against Government Waste (CCAGW). Read More »

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