Content about Pharmaceuticals policy

November 15, 2010

The Centers for Medicare and Medicaid Services has proposed a rule shortening the traditional 30-day...

ALEXANDRIA, Va. — The Centers for Medicare and Medicaid Services has proposed a rule shortening the traditional 30-day drug cycle for long-term care centers to seven days when brand-name drugs are dispensed, prompting a supportive response from an organization representing independent pharmacies.

 

November 15, 2010

The Food and Drug Administration has granted orphan drug designation to a drug for treating...

SAN DIEGO — The Food and Drug Administration has granted orphan drug designation to a drug for treating sickle cell disease.

 

November 14, 2010

William Gibson, the science-fiction author who helped create the cyberpunk genre in the 1980s and...

WALTHAM, Mass. — William Gibson, the science-fiction author who helped create the cyberpunk genre in the 1980s and paved the way for “The Matrix” movie franchise, once said, “The future is already here—it’s just not evenly distributed.”

He was correct. Emerging technologies, ranging from computers to mobile phones, historically have migrated from the theoretical to the inaccessible to the aristocratic to the indispensable and finally to the mundane.

November 14, 2010

The world of generic drugs has a big year ahead of it. Actually, it has...

The world of generic drugs has a big year ahead of it. Actually, it has a few big years ahead of it. But 2011 in particular carries a certain symbolic value as the year in which Pfizer, the world’s biggest drug maker, loses control of its patent for the cholesterol-lowering drug Lipitor (atorvastatin calcium), the world’s top-selling drug.

November 14, 2010

A backlog of more than 2,000 drug entities and devices is awaiting approval. That’s the...

ROCKVILLE, Md. — A backlog of more than 2,000 drug entities and devices is awaiting approval. That’s the situation facing the Food and Drug Administration and the generic pharmaceutical industry—and it’s the chief impetus behind the FDA’s push to impose user fees on generic drug makers seeking the agency’s review and approval for their brand-equivalent medicines.

November 14, 2010

A ghost from 2008 soon could come back to haunt 2010....

NEW YORK — A ghost from 2008 soon could come back to haunt 2010.

According to published reports, the Food and Drug Administration may be considering adopting tougher standards for certain classes of generic drugs if it determines that some are not equivalent to their branded counterparts.

November 14, 2010

Humana and Wal-Mart Stores on Monday announced that Mary Lee Reinscheld became the first Medicare...

LOUISVILLE, Ky. — Humana and Wal-Mart Stores on Monday announced that Mary Lee Reinscheld became the first Medicare beneficiary to sign up for the new Humana Walmart-Preferred Rx Plan at one of the Humana informational kiosks available in approximately 3,000 Walmart stores nationwide.

 

Reinscheld signed her Humana application at Walmart store No. 1170 here as the annual enrollment period for Medicare beneficiaries, including seniors and people with disabilities, got under way.

 

November 14, 2010

In a ruling hailed by retail pharmacy leaders, the Department of Defense now is insisting...

ALEXANDRIA, Va. — In a ruling hailed by retail pharmacy leaders, the Department of Defense now is insisting that drug manufacturers extend the same discounts for prescription drugs sold at community pharmacies that the military gets for medicines dispensed through base dispensaries or mail order.

November 14, 2010

The often wide gap between what consumers will pay out of pocket for a branded...

NEW YORK —The often wide gap between what consumers will pay out of pocket for a branded versus a generic drug is one big factor driving the continually rising demand curve for me-too medicines.

November 14, 2010

Look for a big surge in brand-to-generic drug switches at the pharmacy counter over the...

NEW YORK — Look for a big surge in brand-to-generic drug switches at the pharmacy counter over the next year.

November 14, 2010

K-V Pharmaceutical has created a new marketing subsidiary for generic drugs, the company said. K-V...

November 14, 2010

In an effort to help seniors navigate changes in Medicare Part D plans, Walgreens is...

DEERFIELD, Ill. — In an effort to help seniors navigate changes in Medicare Part D plans, Walgreens is offering a free plan comparison report to make it easier for Medicare beneficiaries and caregivers to determine how much money can be saved under different plans.

Open enrollment for Medicare Part D drug plans began Monday, and enrollees have until Dec. 31 to review their coverage options for 2011.

November 9, 2010

Walgreens on Wednesday released a survey that found 2-in-5 American households have at least one...

November 9, 2010

Budget cuts in Washington state to its Medicaid programs have created a “perilous situation” for...

ALEXANDRIA, Va. Budget cuts in Washington state to its Medicaid programs have created a “perilous situation” for retail pharmacies and their patients, the National Association of Chain Drug Stores warned on Wednesday, and could “pose danger as a precedent for other states across the nation as well,” according to the group.

 

November 9, 2010

To express it in modern parlance, follow-on biologics will be a hot mess....

NEW YORK To express it in modern parlance, follow-on biologics will be a hot mess.

 

While speaking at the Reuters Health Summit, according to Reuters, Food and Drug Administration commissioner Margaret Hamburg didn’t put it quite that colorfully, but she had said the science will evolve, meaning a regulatory approval pathway never will be a truly done deal.

 

 

November 9, 2010

Rite Aid on Wednesday announced its pharmacists have been prepared to assist seniors during the...

CAMP HILL, Pa. Rite Aid on Wednesday announced its pharmacists have been prepared to assist seniors during the 2011 Medicare Part D open enrollment period. With the first of the baby boomers officially turning 65 years old in 2011, more seniors are expected to hit drug stores looking for information about Part D options and open enrollment.

 

Open enrollment begins on Nov. 15.

 

 

November 8, 2010

Government officials said problems have arisen with the Food and Drug Administration’s approval of a...

NEW YORK Government officials said problems have arisen with the Food and Drug Administration’s approval of a generic blood-thinning drug due to its previous relationship with the generic drug’s manufacturer, according to published reports.

 

November 4, 2010

Under the Affordable Care Act, the average savings for those enrolled in traditional Medicare is...

WASHINGTON Under the Affordable Care Act, the average savings for those enrolled in traditional Medicare is expected to amount to more than $3,500 over the next 10 years — and will be even higher for seniors and people with diabetes who have high drug costs — according to the U.S. Department of Health and Human Services.

 

November 3, 2010

Sales for generic drug maker Watson Pharmaceuticals grew 33%, to $882.4 million, in third quarter...

MORRISTOWN, N.J. Sales for generic drug maker Watson Pharmaceuticals grew 33%, to $882.4 million, in third quarter 2010, according to an earnings report released Thursday.

 

The sales figure for the current quarter compared with $662.1 million in third quarter 2009. Profits were $105.9 million, compared with $90 million in third quarter 2009.

 

 

“Watson delivered another quarter of strong financial results and continued progress against our strategic objectives,” Watson president and CEO Paul Bisaro said.

November 2, 2010

The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of...

SILVER SPRING, Md. The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of generic drugs, testified Wednesday at a hearing sponsored by the Food and Drug Administration to collect public and industry input on the implementation of the regulatory approval pathway for follow-on biologics included in the healthcare-reform bill.

 

November 2, 2010

The Food and Drug Administration has approved a generic treatment made by Lupin Pharmaceuticals for...

SILVER SPRING, Md. The Food and Drug Administration has approved a generic treatment made by Lupin Pharmaceuticals for allergies, according to FDA records.

 

The drug is a generic version of Schering-Plough’s Clarinex.

 

 

Clarinex has annual sales of around $229 million, according to IMS Health data reported by several media in India, where Lupin is based.

 

November 1, 2010

Strong generic sales helped Endo edge analyst expectations for the third quarter, the company noted....

CHADDS FORD, Pa. Strong generic sales helped Endo edge analyst expectations for the third quarter, the company noted.

Net income reached $54.2 million, compared with $49.4 million during the period ended Sept. 30. Net sales jumped 23% to $444.1 million, versus $361 million during the same period a year ago. Analysts had estimated sales of $443.36 million for the quarter.

November 1, 2010

The National Association of Chain Drug Stores is urging federal health officials to adopt a...

ALEXANDRIA, Va. The National Association of Chain Drug Stores is urging federal health officials to adopt a simpler means of communicating drug safety and efficacy information to patients, and to clear the way for an approval pathway for generic versions of biologically engineered drugs.

 

NACDS made its priorities known in a letter Monday to Margaret Hamburg, commissioner of the Food and Drug Administration. The letter came from Kevin Nicholson, the group’s VP government affairs and public policy.

 

November 1, 2010

The Food and Drug Administration should ensure patient access, safety and efficacy; create a transparent...

WASHINGTON The Food and Drug Administration should ensure patient access, safety and efficacy; create a transparent and scientific regulatory structure; and enable innovation and competition when creating regulations governing follow-on biologics, according to testimony released in advance of an FDA hearing by a drug lobbying group.

November 1, 2010

Generic drug maker Watson Pharmaceuticals will distribute an authorized generic version of a drug used...

MORRISTOWN, N.J. Generic drug maker Watson Pharmaceuticals will distribute an authorized generic version of a drug used to treat attention deficit hyperactivity disorder, Watson said Tuesday.

Watson entered an agreement with Johnson & Johnson subsidiary Ortho-McNeil-Janssen Pharmaceuticals to distribute an authorized generic of Concerta (methylphenidate hydrochloride) extended-release tablets. An authorized generic is a branded drug sold under its generic name, usually by a third-party company.