Content about Pharmacology

SILVER SPRING, Md. —The Food and Drug Administration announced Friday the approval of Waltham, Mass.-based Thermo Fisher’s QMS Everolimus Immunoassay, a test that monitors the blood for levels of Novartis’ drug Zortress (everolimus).

Zortress is a drug used to prevent rejection of transplanted kidneys.

“QMS Everolimus is the first FDA-cleared test physicians can use to maintain appropriate levels of the immunosuppressant everolimus,” FDA Center for Devices and Radiological Health director Jeffrey Shuren said.

NORTH WALES, Pa. — Teva earlier this week announced it had submitted a request to the Food and Drug Administration to allow for the sale of the emergency contraceptive Plan B One-Step to women under the age of 17 years without a prescription, according to published reports.

NEW YORK — This year’s upcoming $29 billion wave of margin-friendly generic pharmaceuticals will be as big a growth catalyst for supermarket pharmacies as it will be for their pureplay drug store cousins, Credit Suisse research analyst Ed Kelly stated in a note published Thursday.

Conservative projection models place the generic impact at 3% to 5% accretive to 2012 earnings, he reported, given that the channel fills between 10% and 15% of all retail prescriptions.

SAN DIEGO — Medication education can help patients with diabetes stay compliant with their medication regimens, according to a new study published in the February issue of the journal Annals of Pharmacotherapy.

NEW YORK — Sandoz is developing as many as 10 new follow-on biologics, according to published reports.

Reuters, citing an interview with Sandoz head Jeff George in the German newspaper Handelsblatt, said the generics arm of Swiss drug maker Novartis had eight to 10 new biosimilar molecules in development.

ATLANTA — A drug designed to treat an eye condition caused by diabetes may provide a long-term option for patients, according to Alimera Sciences.

Alimera said in two three-year, phase-3 pivotal clinical trials — collectively known as the FAME Study — of Iluvien, which is designed to treat diabetic macular edema, the drug improved visual acuity among patients.

AMITYVILLE, N.Y. — Hi-Tech Pharmacal subsidiary ECR Pharmaceuticals has launched a drug for treating insomnia.

ECR announced Friday the launch of Zolpimist (zolpidem tartrate) oral spray. The drug comes in units that provide 60 metered sprays, administering 5-mg or 10-mg doses of the active ingredient. As a hypnotic agent, the drug is classified as a CIV controlled substance by the federal government.

ALEXANDRIA, Va. — A free, publicly accessible and searchable healthcare resource developed last year by the charitable arm of the National Association of Chain Drug Stores dramatically has grown since its inception.

MUMBAI, India — The Food and Drug Administration has approved a generic Alzheimer’s disease treatment from Sun Pharmaceutical Industries.

Sun said Thursday that the FDA had approved its galantamine hydrobromide extended-release capsules in the 8-mg, 16-mg and 24-mg strengths.

The drug is a generic version of Johnson & Johnson’s Razadyne ER, which has annual sales of about $50 million, according to Sun.

WASHINGTON — The Department of Health and Human Services is encouraging state governments to save money with generic drugs.

In a document released Thursday, HHS secretary Kathleen Sebelius urged all 50 state governors to increase the use of generic drugs in their state Medicaid programs.

WASHINGTON — A new report developed by the Pharmaceutical Research and Manufacturers of America revealed that nearly 300 heart disease and stroke medicines are in development.

PhRMA said that while 299 medicines are in development by the nation's biopharmaceutical companies, there is a growing need for such drugs; African-Americans have a 1.5 times greater rate of heart disease death than other Americans and a 1.8 times greater rate of fatal stroke.

As soon as members of Congress took their seats last month, the new Republican majority announced it would make good on its pledge to repeal the Patient Protection and Affordable Care Act. The effort largely is symbolic and unlikely to succeed, so at least one portion of the healthcare-reform law will likely remain in effect, namely the abbreviated approval pathway for follow-on biologics, also known as the Biologics Price Competition and Innovation Act.