Content about Pharmacology

May 13, 2013

The Generic Pharmaceutical Association has promoted Jason Money to associate VP federal government affairs, the trade group said Monday.

WASHINGTON — The Generic Pharmaceutical Association has promoted Jason Money to associate VP federal government affairs, the trade group said Monday.

Money, who has worked for the GPhA for six years, was previously the organization's senior director for federal affairs. In the new position, he will continue lobbying on behalf of the generic drug industry in Congress.

May 13, 2013

New Jersey Gov. Chris Christie signed legislation into law that will allow patients using prescription eye drops to get early refills in order to prevent interruptions in therapy.

TRENTON, N.J. — New Jersey Gov. Chris Christie signed legislation into law Monday that will allow patients using prescription eye drops to get early refills in order to prevent interruptions in therapy.

May 13, 2013

The Food and Drug Administration's temporary stay pending its appeal of a district court decision ordering all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions was extended through May 28 by the U.S. Court of Appeals for the Second Circuit.

NEW YORK — The Food and Drug Administration's temporary stay pending its appeal of a district court decision ordering all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions was extended through May 28 by the U.S. Court of Appeals for the Second Circuit on Monday. 

The Second Circuit will entertain the appeal on that day. 

May 10, 2013

The Food and Drug Administration has approved a biotech drug made by Novartis for treating a form of arthritis that affects children, the Swiss drug maker said Friday.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a biotech drug made by Novartis for treating a form of arthritis that affects children, the Swiss drug maker said Friday.

May 10, 2013

Senior U.S. District Judge Edward Korman on Friday denied a Food and Drug Administration motion for a stay pending an appeal of Korman's earlier decision that all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions.

NEW YORK — Senior U.S. District Judge Edward Korman on Friday denied a Food and Drug Administration motion for a stay pending an appeal of Korman's earlier decision that all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions. 

However, Korman did grant a stay "pending the hearing or submission of the defendants’ motion for a stay in the Court of Appeals on the condition that the motion for a stay be filed by noon on May 13, 2013."

May 10, 2013

The Specialty Pharmacy Certification Board will begin certifying specialty pharmacists who pass a comprehensive exam in October. The exam is designed to cover the entire specialty pharmacy process, including intake, clinical management, fulfillment and outcomes.

The National Association of Specialty Pharmacy, which oversees the SPCB, is bringing to bear some real advocacy and structure to the highly fragmented specialty pharmacy marketplace. The DSN Group, including its specialty pharmacy publication of the same name Specialty Pharmacy, applauds these efforts.

The Specialty Pharmacy Certification Board will begin certifying specialty pharmacists who pass a comprehensive exam in October. The exam is designed to cover the entire specialty pharmacy process, including intake, clinical management, fulfillment and outcomes. 

May 9, 2013

The Drug Enforcement Administration collected more than 371 tons of unused medications last month as part of its sixth annual drug take-back program, the agency said.

WASHINGTON — The Drug Enforcement Administration collected more than 371 tons of unused medications last month as part of its sixth annual drug take-back program, the agency said.

May 9, 2013

Declining use overall of healthcare services drove down spending on medicines in the United States by 3.5% per capita last year, according to a new study.

PARSIPPANY, N.J. — Declining use overall of healthcare services drove down spending on medicines in the United States by 3.5% per capita last year, according to a new study.

May 9, 2013

Bipartisan legislation that would let pharmacists devote more time to Medicare beneficiaries and less to adjudicating claims with pharmacy benefit management firms was introduced in the U.S. Senate and won the backing of the National Community Pharmacists Association earlier this week.

ALEXANDRIA, Va. — Bipartisan legislation that would let pharmacists devote more time to Medicare beneficiaries and less to adjudicating claims with pharmacy benefit management firms was introduced in the U.S. Senate and won the backing of the National Community Pharmacists Association earlier this week.

May 9, 2013

The November 2011 expiration of Pfizer's patent on the cholesterol drug Lipitor and Ranbaxy Labs' release of the generic version received significant play in the media, particularly due to the theretofore status of Lipitor (atorvastatin calcium) as the drug with the highest sales in the country, $7.7 billion in the United States, according to healthcare analytics firm IMS Health.

The November 2011 expiration of Pfizer's patent on the cholesterol drug Lipitor and Ranbaxy Labs' release of the generic version received significant play in the media, particularly due to the theretofore status of Lipitor (atorvastatin calcium) as the drug with the highest sales in the country, $7.7 billion in the United States, according to healthcare analytics firm IMS Health.

May 9, 2013

Wrigley announced the company is temporarily stopping the sale and marketing of its new Alert Energy caffeinated gum "out of respect" for the Food and Drug Administration as they agency investigates the safety of added caffeine in foods.

WASHINGTON — Wrigley announced late Wednesday the company is temporarily stopping the sale and marketing of its new Alert Energy caffeinated gum "out of respect" for the Food and Drug Administration as the agency investigates the safety of added caffeine in foods.

May 9, 2013

One of the difficulties that federal regulators ran into during the nationwide scandal surrounding the New England Compounding Center — the Massachusetts-based pharmacy blamed for a nationwide fungal meningitis epidemic that has sickened hundreds and killed dozens — was the issue of when such pharmacies cross the line from compounding to manufacturing.

WASHINGTON — One of the difficulties that federal regulators ran into during the nationwide scandal surrounding the New England Compounding Center — the Massachusetts-based pharmacy blamed for a nationwide fungal meningitis epidemic that has sickened hundreds and killed dozens — was the issue of when such pharmacies cross the line from compounding to manufacturing.

May 8, 2013

Drug maker Bristol-Myers Squibb foresees significant effects on its business from the Patient Protection and Affordable Care Act, company executives told attendees of its recent shareholder meeting.

WASHINGTON — Drug maker Bristol-Myers Squibb foresees significant effects on its business from the Patient Protection and Affordable Care Act, company executives told attendees of the its recent shareholder meeting.

May 8, 2013

Drug maker Merck is seeking regulatory approval for an experimental tablet placed under the tongue that could be used to treat ragweed allergies.

WHITEHOUSE STATION, N.J. — Drug maker Merck is seeking regulatory approval for an experimental tablet placed under the tongue that could be used to treat ragweed allergies.

Merck said the Food and Drug Administration accepted a regulatory application for its ragweed pollen sublingual allergy immunotherapy tablet. Ragweed, also known as Ambrosia artemisiifolia, is a major cause of seasonal allergies in the United States. Merck also submitted an application for a similar drug, for Timothy grass pollen allergies, in March.

May 8, 2013

There is as much as $10 billion in branded pharmaceutical sales that could make the switch from prescription-only to over-the counter in the next five years, suggested Joseph Papa, Perrigo chairman, CEO and president, to analysts on Tuesday.

ALLEGAN, Mich. — There is as much as $10 billion in branded pharmaceutical sales that could make the switch from prescription-only to over-the counter in the next five years, suggested Joseph Papa, Perrigo chairman, CEO and president, to analysts on Tuesday. And as much as $5 billion in the next three years. 

May 7, 2013

A Walgreens survey found that 37% of Medicare Part D beneficiaries have daily concerns about their prescription drug costs, and 1-in-5 say they’ve had to make sacrifices, such as delaying filling a prescription or skipping doses, to help manage medication costs.

DEERFIELD, Ill. — A Walgreens survey released Tuesday found that 37% of Medicare Part D beneficiaries have daily concerns about their prescription drug costs, and 1-in-5 say they’ve had to make sacrifices, such as delaying filling a prescription or skipping doses, to help manage medication costs.

That's almost 11.7 million seniors. 

May 7, 2013

The global market for biosimilars will be worth nearly $2.5 billion this year, according to a new study.

LONDON — The global market for biosimilars will be worth nearly $2.5 billion this year, according to a new study.

The study, by British market research firm Visiongain, forecast that the $2.445 billion market size marked more than 20% of growth from 2012 and would account for about 2% of the overall market for biologics. The market is expected to grow rapidly through 2023 as biosimilars hit the market in the United States and European Union.

May 6, 2013

Pfizer is attempting to stem the rise of counterfeit medicines by selling one of its most popular drugs — and one of the most popular targets for counterfeiters — online.

NEW YORK — Pfizer is attempting to stem the rise of counterfeit medicines by selling one of its most popular drugs — and one of the most popular targets for counterfeiters — online.

The drug maker announced that it had launched Viagra (sildenafil citrate) home delivery, a prescription-fulfillment website for the drug, which is powered by CVS/pharmacy and accessible through Viagra.com.

May 6, 2013

The Food and Drug Administration has approved a drug for HIV in infants and toddlers.

PRINCETON, N.J. — The Food and Drug Administration has approved a drug for HIV in infants and toddlers.

May 6, 2013

The Food and Drug Administration has approved a new drug made by Merck for treating high cholesterol, the drug maker said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a new drug made by Merck for treating high cholesterol, the drug maker said.

Merck announced the approval of Liptruzet (ezetimibe and atorvastatin). The drug combines two preexisting cholesterol drugs: ezetimibe, which Merck markets under the brand name Zetia, and atorvastatin, which Pfizer markets under the name Lipitor. Both drugs are available as generics, but because Liptruzet is a novel combination of them, it required FDA approval as a new drug.

May 6, 2013

An experimental drug regimen under development by AbbVie could change the way hepatitis C is treated, according to a special designation it received from the Food and Drug Administration.

NORTH CHICAGO, Ill. — An experimental drug regimen under development by AbbVie could change the way hepatitis C is treated, according to a special designation it received from the Food and Drug Administration.

May 6, 2013

The Food and Drug Administration may soon find itself in another Plan-B-generated quandary — the complications around granting a three-year marketing exclusivity for a medicine that is both prescription-only and over-the-counter, according to an FDA Law Blog posted Sunday by Hyman, Phelps & McNamara.

WASHINGTON — The Food and Drug Administration may soon find itself in another Plan-B-generated quandary — the complications around granting a three-year marketing exclusivity for a medicine that is both prescription-only and over-the-counter, according to an FDA Law Blog posted Sunday by Hyman, Phelps & McNamara

May 6, 2013

Florida's state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.

NEW YORK — Florida's state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.

The bill, which was approved last Tuesday and is scheduled to take effect on July 1, institutes requirements for pharmacists to substitute biosimilars when they are determined to be biosimilar to and interchangeable with the brand name product, while also requiring the state board of pharmacy to maintain a current list of interchangeable products.

May 6, 2013

The five associations representing the dietary supplement industry on Monday requested that the Food and Drug Administration issue revised guidance on new dietary ingredient notifications, with a specific focus on the information to be included to identify the new dietary ingredient.

SILVER SPRING, Md. — The five associations representing the dietary supplement industry on Monday requested that the Food and Drug Administration issue revised guidance on new dietary ingredient notifications, with a specific focus on the information to be included to identify the new dietary ingredient. 

May 6, 2013

Retail pharmacies, drug makers and law enforcement have a variety of methods used to fight organized crime, and the New Jersey Office of the Attorney General has drawn up a list of best practices that pharmacies can use to keep stores, drugs, staff and customers safe.

NEW YORK — Retail pharmacies, drug makers and law enforcement have a variety of methods used to fight organized crime, and the New Jersey Office of the Attorney General has drawn up a list of best practices that pharmacies can use to keep stores, drugs, staff and customers safe.