Content about Pharmacology

February 25, 2011
Protalix receives CRL for Gaucher disease treatment

The Food and Drug Administration has declined to approve a biologic treatment for a rare genetic disorder by Israeli drug maker Protalix Biotherapeutics, Protalix said Friday.

KARMIEL, Israel — The Food and Drug Administration has declined to approve a biologic treatment for a rare genetic disorder by Israeli drug maker Protalix Biotherapeutics, Protalix said Friday.

The company said the FDA issued a complete response letter for its application for taliglucerase alfa, a treatment for Gaucher disease. The FDA issues a CRL when it has finished reviewing a regulatory application, but questions remain that preclude final approval.

February 25, 2011
Savient's Krystexxa launches in the United States

Savient said its newest drug is the first and only therapy available to treat chronic gout in adult patients refractory to conventional therapy.

EAST BRUNSWICK, N.J. — Savient said its newest drug is the first and only therapy available to treat chronic gout in adult patients refractory to conventional therapy.

The drug maker announced the U.S. commercial launch of Krystexxa (pegloticase).

February 25, 2011
Watson seeks regulatory approval for generic Adderall XR

Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

PHILADELPHIA — Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

British drug maker Shire announced Thursday that it had received notification that Watson filed for regulatory approval of a version of Adderall XR (dextroamphetamine and amphetamine) capsules with the Food and Drug Administration. Watson’s application contained a Paragraph IV certification, a legal assertion that the patent covering Adderall XR is invalid, unenforceable or won’t be infringed by Watson’s product.

February 23, 2011
Study: Amphetamine use could pose Parkinson's disease risk

Use of amphetamines could increase the risk of Parkinson’s disease, according to a new study.

ST. PAUL, Minn. — Use of amphetamines could increase the risk of Parkinson’s disease, according to a new study.

February 22, 2011
Report: Arkansas considers switching PSE to Rx only

Arkansas on Friday became the fourth state this year to entertain making the popular decongestant pseudoephedrine available only by prescription.

LITTLE ROCK, Ark. — Arkansas on Friday became the fourth state this year to entertain making the popular decongestant pseudoephedrine available only by prescription.

February 22, 2011
Rite Aid expands free Rx delivery

Rite Aid has expanded its free prescription delivery service to more than 400 stores in the New York metropolitan area, the retail pharmacy chain announced Monday.

CAMP HILL, Pa. — Rite Aid has expanded its free prescription delivery service to more than 400 stores in the New York metropolitan area, the retail pharmacy chain announced Monday.

The service allows patients to receive their medications between 10 a.m. and 7 p.m., though they must wait until the next day if they send their prescriptions after 11 a.m., and some limitations apply, such as for medications that require refrigeration.

February 18, 2011
Annual NACDS event will bring healthcare issues to light

As one retail pharmacy executive put it, "many members of Congress only experience the pharmacy industry through their eyes as a patient." Thanks to NACDS RxImpact Day on Capitol Hill, however, that no longer has to be the case.

WHAT IT MEANS AND WHY IT'S IMPORTANT — As one retail pharmacy executive put it, "many members of Congress only experience the pharmacy industry through their eyes as a patient." Thanks to NACDS RxImpact Day on Capitol Hill, however, that no longer has to be the case.

(THE NEWS: NACDS RxImpact Day 2011 takes aim at new lawmakers. For the full story, click here)

February 18, 2011
Anticipating regulations, biosimilars move through pipeline

Though efforts to repeal the Patient Protection and Affordable Care Act via the court system remain under way — with recent victories for opponents in Virginia and Florida — the attempt to repeal the healthcare-reform bill in Congress failed, thus leaving the bill and, most importantly, the regulatory approval pathway for follow-on biologics intact.


February 18, 2011
As innovaters prep for patent cliff, generics prosper from patent losses

A whole slew of drugs will lose patent protection this year, opening up opportunities for generic drug makers to market their own versions. Most notable among these is Pfizer’s cholesterol-
lowering drug Lipitor (atorvastatin), the world’s top-selling drug, with U.S. sales of $7 billion during the 12 months ended September 2010, according to IMS Health.


February 18, 2011
CVS flexes healthcare muscles

The news that CVS Caremark's Pharmacy Advisor program has been recognized by the Pharmacy Benefit Management Institute is yet one more illustration of how the company has positioned itself along the front lines to leverage its various points of care to improve outcomes and lower healthcare costs.

WHAT IT MEANS AND WHY IT'S IMPORTANT — The news that CVS Caremark's Pharmacy Advisor program has been recognized by the Pharmacy Benefit Management Institute is yet one more illustration of how the company has positioned itself along the front lines to leverage its various points of care to improve outcomes and lower healthcare costs.

(THE NEWS: CVS Caremark saluted for Pharmacy Advisor program. For the full story, click here)

February 18, 2011
Impax granted FDA approval for generic Adoxa

A generic drug maker received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.

HAYWARD, Calif. — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.

The drug maker on Friday said it received final approval of its abbreviated new drug application for doxycyline monohydrate capsules in the 150-mg strength. The drug, which is a tetracycline antibiotic used to treat bacterial infections, is a generic version of Adoxa. Adoxa is manufactured by PharmDerm, a Nycomed subsidiary.

Impax said its generic division, Global Pharmaceuticals, will launch the product.

February 18, 2011
Industry advocates tout
 increase in generics use

Generic drug usage already has been on the rise year after year, with no sign of slowing down. As Jody Fisher, VP marketing for healthcare analytics at market research firm SDI, has told Drug Store News, generics accounted for more than 70% of products dispensed at retail pharmacies and are set to increase further this year.


February 18, 2011
NACDS, NCPA call pharmacy 'backbone of Medicaid's drug benefit'

The National Association of Chain Drug Stores and the National Community Pharmacists Association on Friday sent a joint letter to every governor and state Medicaid director on the importance of pharmacies in Medicaid and the industry’s interest in working with state governments to cut costs.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores and the National Community Pharmacists Association on Friday sent a joint letter to every governor and state Medicaid director on the importance of pharmacies in Medicaid and the industry’s interest in working with state governments to cut costs.

February 18, 2011
Phone apps, telepharmacy 
streamline Rx experience

When ScriptPro started 
in­troducing pharmacy robots, it entered an industry where the pharmacist was mostly dolling out medications. Today, pharmacy automation and technology continue to evolve, freeing pharmacists’ time and taking on everything from workflow automation to smart-phone applications.

February 18, 2011
ReportersNotebook — Chain Pharmacy, 2/28/11

SUPPLIER NEWS — Drug maker Valeant Pharmaceuticals International has acquired U.S. and Canadian rights to certain formulations of a GlaxoSmithKline drug used to treat cold sores. Valeant acquired the rights to nonophthalmic topical formulations of Zovirax (acyclovir) from GSK for $300 million through its Canadian subsidiary, Biovail Labs.



February 18, 2011
Tech, interconnectivity 
focus of NCPDP summit

Technology is not only bringing more benefits to patients in the pharmacy, but it’s also offering them a host of products so they can be more involved in their health care. This was a theme at the National Council for Prescription Drug Programs’ educational summit, “Leveraging New Technologies: Impact on the Patient and the Healthcare Industry,” on Feb. 8 in Las Vegas.


February 18, 2011
Tennessee latest 
to fight PSE status

NASHVILLE, Tenn. — Tennessee makes the third state this year, joining Kentucky and Nevada, that is considering state legislation to mandate the sale of pseudoephedrine as prescription-only. That could prove a big concern for the legitimate market for PSE products on account of the potential snowball effect such legislation could have on neighboring states. According to a government review staff in Kentucky, at least 97.8% of all PSE sales are bought for legitimate use.

February 18, 2011
THE PHARMACY: Enter the ‘community health provider’



As the costs of primary care march steadily higher and patients endure ever-longer wait times to see a family physician, the need for accessible, cost-effective patient care alternatives has become both obvious and urgent. 


Enter Walgreens. Armed with new, time-saving 
pharmacy automation tools, a growing offsite-dispensing capability and an array of new adherence and disease-management services, the company heavily is promoting its pharmacists and in-store clinicians as the most cost-effective front-line resource for community-based patient care.


February 17, 2011
FDA OKs Abilify as maintenance treatment for bipolar disorder

The Food and Drug Administration has approved a psychiatric drug for treating bipolar disorder when used in combination with one of two other drugs.

PRINCETON, N.J. — The Food and Drug Administration has approved a psychiatric drug for treating bipolar disorder when used in combination with one of two other drugs.

The FDA approved Abilify (aripiprazole), made by Bristol-Myers Squibb and Otsuka Pharmaceutical, as an adjunct to lithium or valproate for maintenance treatment of bipolar I disorder.

February 17, 2011
Report: Exclusivity period for biotech drugs may be reduced to seven years

The Obama administration’s proposed budget for 2012 contains an item that could change the game for biosimilars, according to published reports.

WASHINGTON — The Obama administration’s proposed budget for 2012 contains an item that could change the game for biosimilars, according to published reports.

According to the reports, the administration would lower the 12-year data exclusivity period for biotech drugs mandated in the healthcare-reform law to seven years.

February 15, 2011
HealthWarehouse.com to acquire online assets of Hocks Pharmacy

HealthWarehouse.com on Tuesday announced that it has consummated two separate transactions to acquire all the online assets of Hocks Pharmacy, an online reseller of over-the-counter medications, diabetic supplies and medical equipment. HealthWarehouse.com also will merge with a newly formed subsidiary of Hocks Pharmacy.

CINCINNATI — HealthWarehouse.com on Tuesday announced that it has consummated two separate transactions to acquire all the online assets of Hocks Pharmacy, an online reseller of over-the-counter medications, diabetic supplies and medical equipment. HealthWarehouse.com also will merge with a newly formed subsidiary of Hocks Pharmacy.

February 15, 2011
PCMA leader: Generics, mail-order pharmacy help save money

Mark Merritt, the president and CEO of the Pharmaceutical Care Management Association, responded to a provision on the Pentagon's new budget proposal, which encourages Tricare members to use generic medications and mail-service pharmacies to save money.

WASHINGTON — Mark Merritt, the president and CEO of the Pharmaceutical Care Management Association, responded to a provision on the Pentagon's new budget proposal, which encourages Tricare members to use generic medications and mail-service pharmacies to save money.

February 15, 2011
Watson's global generics business sees boost

Watson's global generics business drove the drug maker's net revenue in the fourth quarter, according to a financial earnings release.

MORRISTOWN, N.J. — Watson's global generics business drove the drug maker's net revenue in the fourth quarter, according to a financial earnings release.

February 14, 2011
Report: Generic drug makers may look to diversify portfolios

An increase in consolidation among generic drug companies could be in the works, according to a new report from Thomson Reuters.

PHILADELPHIA — An increase in consolidation among generic drug companies could be in the works, according to a new report from Thomson Reuters.

According to the report, “Gaining Market Share in the Generic Drug Industry Through Acquisitions and Partnerships,” generic drug makers face competition, as well as government-mandated price cuts in Europe and such policies as lowest-price tendering. As a result, many could seek deals that would cause them to diversify their portfolios.

February 11, 2011
Congress nixing FSA rule changes is no surprise

It never made much sense to make health care less affordable under the Affordable Care Act — neither did the requirement of a prescription for a nonprescription remedy jive with proponents of flexible spending accounts. So it’s little wonder that the FSA rule changes were the first piece of ObamaCare to face a congressional axe, as was widely speculated just last week.

WHAT IT MEANS AND WHY IT’S IMPORTANT — It never made much sense to make health care less affordable under the Affordable Care Act — neither did the requirement of a prescription for a nonprescription remedy jive with proponents of flexible spending accounts. So it’s little wonder that the FSA rule changes were the first piece of ObamaCare to face a congressional axe, as was widely speculated just last week.