Content about Regulatory and Washington

January 14, 2014

An educational program partially conceived by a group focused on lupus research is expected to receive $2 million through a congressional appropriations bill.

NEW YORK — An educational program partially conceived by a group focused on lupus research is expected to receive $2 million through a congressional appropriations bill.

January 14, 2014

Just slightly more than one-third of adults aged 18 to 64 got a flu shot last season, compared with two-thirds of seniors and more than half of children, according to an analysis released Tuesday by the Trust for America's Health.

WASHINGTON — Just slightly more than one-third of adults aged 18 to 64 got a flu shot last season, compared with two-thirds of seniors and more than half of children, according to an analysis released Tuesday by the Trust for America's Health.

January 14, 2014

The recent breach of customer data at Target has attracted the attention of two U.S. senators.

WASHINGTON — The recent breach of customer data at Target has attracted the attention of two U.S. senators.

January 13, 2014

According to this week's FluView report, overall flu activity continued to be high across the nation, with activity continuing to spread from state to state, the Centers for Disease Control and Prevention reported Friday.

ATLANTA — According to this week's FluView report, overall flu activity continued to be high across the nation, with activity continuing to spread from state to state, the Centers for Disease Control and Prevention reported Friday. Thirty-five states are now experiencing widespread activity, and 20 states are reporting high levels of influenza-like illness. 

January 13, 2014

The Consumer Healthcare Products Association on Friday pledged its support behind the introduction of legislation by Rep. Paul Harris, R-Wash., that would prohibit pharmacies or retail distributors from selling over-the-counter cough medicines containing dextromethorphan to those younger than 18 years without a prescription.

WASHINGTON — The Consumer Healthcare Products Association on Friday pledged its support behind the introduction of legislation by Rep. Paul Harris, R-Wash., that would prohibit pharmacies or retail distributors from selling over-the-counter cough medicines containing dextromethorphan to those younger than 18 years without a prescription. CHPA says the bill, H.B. 2163, is a step toward preventing teen abuse of the medicines containing DXM. 

January 13, 2014

The Food and Drug Administration has found possible violations of agency regulations at a manufacturing plant in India owned by drug maker Ranbaxy Labs, the company said Monday.

GURGAON, India — The Food and Drug Administration has found possible violations of agency regulations at a manufacturing plant in India owned by drug maker Ranbaxy Labs, the company said Monday.

Ranbaxy said it received a Form 483 from the FDA, a statement issued to a company's management after it has inspected a plant and found conditions that may violate the agency's regulations, and that products produced therein could be hazardous to people who use them. The plant in question is in Toansa, in India's Punjab region.

January 13, 2014

A drug maker has started a program to find the genetic determinants of human disease and speed the discovery and development of new drugs. The program includes a five-year project that it said would be one of the largest of its kind in terms of the number of patients involved.

TARRYTOWN, N.Y. — A drug maker has started a program to find the genetic determinants of human disease and speed the discovery and development of new drugs. The program includes a five-year project that it said would be one of the largest of its kind in terms of the number of patients involved.

January 13, 2014

Gov. Rick Snyder of Michigan has signed into law a bill that will allow medical marijuana to be sold in pharmacies if the federal government legalizes it for that purpose, according to published reports.

NEW YORK — Gov. Rick Snyder of Michigan has signed into law a bill that will allow medical marijuana to be sold in pharmacies if the federal government legalizes it for that purpose, according to published reports.

January 13, 2014

New York state has begun to legalize medical use of marijuana, albeit in limited form, according to published reports.

NEW YORK — New York state has begun to legalize medical use of marijuana, albeit in limited form, according to published reports.

Currently, 20 states and the District of Columbia allow the dispensing of marijuana for medical use, two of which — Colorado and Washington — have legalized recreational use, while Maryland allows medical use as a legal defense in criminal cases.

January 10, 2014

The Nonprescription Drugs Advisory Committee announced it would meet February 25 to discuss data submitted by Armstrong Pharmaceuticals in support of a new drug application for the over-the-counter marketing of Primatene HFA.

SILVER SPRING, Md. — The Nonprescription Drugs Advisory Committee on Thursday announced it would meet February 25 to discuss data submitted by Armstrong Pharmaceuticals in support of a new drug application for the over-the-counter marketing of Primatene HFA, an epinephrine inhalation aerosol 125 microgram (mcg)/actuation, as a temporary reliever of mild symptoms of intermittent asthma for consumers 12 years of age and older. 

January 10, 2014

The Food and Drug Administration has approved two drugs made by GlaxoSmithKline for use together in patients with advanced melanoma that can't be removed by surgery or has spread to other parts of the body, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved two drugs made by GlaxoSmithKline for use together in patients with advanced melanoma that can't be removed by surgery or has spread to other parts of the body, the agency said Friday.

The FDA announced the new approval for Mekinist (trametinib) and Tafinlar (dabrafenib). The agency originally approved the two drugs for use as single agents for the same indication in May 2013.

January 10, 2014

The Food and Drug Administration has approved a generic drug for high blood pressure made by Actavis, the company said Friday.

DUBLIN — The Food and Drug Administration has approved a generic drug for high blood pressure made by Actavis, the company said Friday.

Actavis announced the approval of telmisartan immediate-release tablets in the 20-mg, 40-mg and 80-mg strengths, which it intends to release immediately.

January 10, 2014

The Food and Drug Administraiton has approved a liquid formulation of an HIV drug made by Merck, the company said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administraiton has approved a liquid formulation of an HIV drug made by Merck, the company said.

Merck announced the approval of Isentress (raltegravir) for oral suspension, aimed at small children with HIV. The drug may be used by patients as young as four weeks, and the full line of formulations of Isentress now includes the orlal suspension, as well as chewable tablets and film--coated tablets. The company plans to launch the oral suspension in the third quarter of this year.

January 10, 2014

A company that ranks the nutritional value of foods sold in supermarkets is working with a public health organization in Texas to promote health and wellness.

QUINCY, Mass. — A company that ranks the nutritional value of foods sold in supermarkets is working with a public health organization in Texas to promote health and wellness.

January 9, 2014

A pharmacy professor and compounding pharmacy owner are candidates for president-elect of the American Pharmacists Association for 2015-2016, the group said.

WASHINGTON — A pharmacy professor and compounding pharmacy owner are candidates for president-elect of the American Pharmacists Association for 2015-2016, the group said.

The APhA said the candidates for the position are Virginia Commonwealth University School of Pharmacy professor and community pharmacy residency program director Jean-Venable Goode and Newport Beach, Calif.-based Westcliff Compounding Pharmacy owner Michael Pavlovich. Members will have the opportunity to meet the candidates at the APhA Annual Meeting and Exposition in Orlando, Fla., in March.

January 9, 2014

Rather than take vacation for Christmas and New Year’s, the editors of DSN worked to compile a list of the top 10 trends that will shake up the business in 2014.

Rather than take vacation for Christmas and New Year’s, the editors of DSN worked to compile a list of the top 10 trends that will shake up the business in 2014.

Clinics explode onto scene

Keep a close eye on retail-based health clinics come 2014.

The convenient care industry has come far since hitting the scene in 2000 and today — with nearly 1,500 clinics nationwide — they are proving their importance within the changing healthcare landscape.

January 9, 2014

Vulnerable patients, including seniors and cancer patients, suffer from lack of access to needed painkillers as efforts to combat diversion and misuse of controlled substances often result in drugs not getting into the hands of those who need them, according to a new pharmacist survey by the National Community Pharmacists Association.

ALEXANDRIA, Va. —Vulnerable patients, including seniors and cancer patients, suffer from lack of access to needed painkillers as efforts to combat diversion and misuse of controlled substances often result in drugs not getting into the hands of those who need them, according to a new pharmacist survey by the National Community Pharmacists Association. 

January 8, 2014

Japanese drug maker Daiichi Sankyo is seeking Food and Drug Administration approval for a once-daily tablet to reduce the risk of stroke in patients with atrial fibrillation and treatment of other conditions.

PARSIPPANY, N.J. — Japanese drug maker Daiichi Sankyo is seeking Food and Drug Administration approval for a once-daily tablet to reduce the risk of stroke in patients with atrial fibrillation and treatment of other conditions.

Daiichi Sankyo announced the submission of a new drug application for Savaysa (edoxaban). The company also is hoping to get the FDA's approval for the pill as a treatment for deep vein thrombosis and pulmonary embolism, as well as preventing the recurrence of symptomatic venous thromboembolism.

January 8, 2014

The Food and Drug Administration has approved a new drug made by Bristol-Myers Squibb and AstraZeneca for treating Type 2 diabetes, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Bristol-Myers Squibb and AstraZeneca for treating Type 2 diabetes, the agency said Wednesday.

The FDA announced the approval of Farxiga (dapagliflozin) tablets, designed for use with exercise and dietary adjustments to control blood sugar. Type 2 diabetes affects about 24 million people in the United States, accounting for more than 90% of diabetes cases.

January 8, 2014

Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.

OSAKA, Japan — Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.

Takeda announced the start of two phase-3 trials of MLN0002 (vedolizumab) in patients with severe ulcerative colitis and Crohn's disease. The trials are designed to find out the efficacy, safety and effects on the body of the drug, particularly to see if patients show a response after 10 weeks of treatment and disease remission after 60 weeks.

January 7, 2014

The Consumer Healthcare Products Association reported the makers of over-the-counter pediatric liquid medications have made significant progress in carrying out voluntary efforts to promote safe use through standardized dosing directions and dosing devices, as underscored by the results of a Centers for Disease Control and Prevention study released Monday in Pediatrics.

WASHINGTON — The Consumer Healthcare Products Association reported the makers of over-the-counter pediatric liquid medications have made significant progress in carrying out voluntary efforts to promote safe use through standardized dosing directions and dosing devices, as underscored by the results of a Centers for Disease Control and Prevention study released Monday in Pediatrics.

January 7, 2014

Growth in health spending has slowed in recent years, including spending by private and public payers, according to data released by the Centers for Medicare and Medicaid Services that also found a small contribution to the lower growth from the healthcare reform law.

WASHINGTON — Growth in health spending has slowed in recent years, including spending by private and public payers, according to data released Monday by the Centers for Medicare and Medicaid Services that also found a small contribution to the lower growth from the healthcare reform law.

January 7, 2014

The Federal Trade Commission announced a law enforcement initiative stopping national marketers that used deceptive advertising claims to peddle fad weight-loss products, from food additives and skin cream to dietary supplements.

WASHINGTON — The Federal Trade Commission on Tuesday announced a law enforcement initiative stopping national marketers that used deceptive advertising claims to peddle fad weight-loss products, from food additives and skin cream to dietary supplements.

January 7, 2014

The National Community Pharmacists Association on Tuesday expressed support of several policy changes proposed by the Centers for Medicare and Medicaid Services.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Tuesday expressed support of several policy changes proposed by the Centers for Medicare and Medicaid Services, according to a document filed in the Federal Register. 

January 7, 2014

Giving young children the influenza and pneumococcal vaccines together appears to increase their risk of fever, according to a study led by researchers from Columbia University Medical Center and the Centers for Disease Control and Prevention.

NEW YORK — Giving young children the influenza and pneumococcal vaccines together appears to increase their risk of fever, according to a study led by researchers from Columbia University Medical Center and the Centers for Disease Control and Prevention released Monday afternoon. However, the fever was brief, and medical care was sought for few children, supporting the routine immunization schedule for these vaccines, including the recommendation to administer them simultaneously.