Content about Collaborative Care

March 26, 2013

The Food and Drug Administration has declined to approve a bird flu vaccine made by GlaxoSmithKline due to an administrative issue, the drug maker said.

LONDON — The Food and Drug Administration has declined to approve a bird flu vaccine made by GlaxoSmithKline due to an administrative issue, the drug maker said.

GSK said it received a complete response letter from the FDA for its vaccine for pandemic influenza A virus monovalent adjuvanted candidate vaccine, also known as Q-Pan H5N1. The FDA issues a complete response letter when it needs additional time to review a drug application for approval.

March 25, 2013

Generic drug maker Actavis has reached a deal with AstraZeneca that will allow it to launch a version of a drug used to treat cholesterol in three years, Actavis said Monday.

PARSIPPANY, N.J. — Generic drug maker Actavis has reached a deal with AstraZeneca that will allow it to launch a version of a drug used to treat cholesterol in three years, Actavis said Monday.

Under a deal to settle a patent-infringement lawsuit, Actavis will be allowed to launch its generic version of Crestor (rosuvastatin calcium) tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths 67 days before July 8, 2016, when the drug's market exclusivity for use in children expires, at a fee of 39% of net sales to AstraZeneca.

March 25, 2013

The percentage of people who are at risk of developing Type 2 diabetes and aware of it has risen slightly over the past few years, but remains low, according to a report by the Centers for Disease Control and Prevention.

ATLANTA — The percentage of people who are at risk of developing Type 2 diabetes and aware of it has risen slightly over the past few years, but remains low, according to a report by the Centers for Disease Control and Prevention.

March 25, 2013

More than 400 drugs are under development for the 10 most common chronic health conditions affecting elderly people, according to a new report by a drug industry trade group.

WASHINGTON — More than 400 drugs are under development for the 10 most common chronic health conditions affecting elderly people, according to a new report by a drug industry trade group.

March 25, 2013

The Food and Drug Administration has approved a treatment for managing a type of bacterial infection in patients with cystic fibrosis.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a treatment for managing a type of bacterial infection in patients with cystic fibrosis.

Swiss drug maker Novartis announced the approval of Tobi Podhaler (tobramycin inhalation powder) for managing cystic fibrosis patients with Pseudomonas aeruginosa, or Pa bacteria, in the lungs.

March 25, 2013

Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said.

RIDGEFIELD, Conn. — Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said Monday.

BI and Lilly announced the submission of a regulatory application to the Food and Drug Administration for empagliflozin. The drug belongs to a new drug class known as SGLT2 inhibitors, which work by removing excess glucose through the urine by blocking its reabsorption in the kidneys. The companies are testing the drug in a late-stage clinical trial for which they plan to enroll 14,500 patients.

March 25, 2013

The Supreme Court heard arguments Monday in a case that could determine the future of generic drugs in America.

NEW YORK — The Supreme Court heard arguments Monday in a case that could determine the future of generic drugs in America.

The case, Federal Trade Commission v. Actavis, marks the latest attempt by federal authorities to put an end to what they say are deals between branded and generic drug companies that delay release of generic drugs to consumers.

March 22, 2013

AstraZeneca will pay $420 million to Moderna Therapeutics in a deal to develop drugs for a variety of diseases using a technology developed by Moderna, AstraZeneca said.

NEW YORK — AstraZeneca will pay $420 million to Moderna Therapeutics in a deal to develop drugs for a variety of diseases using a technology developed by Moderna, AstraZeneca said.

March 22, 2013

The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

SILVER SPRING, Md. — The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

March 22, 2013

Disease relapse rates and worsening of disability were low among patients taking a drug made by Genzyme for multiple sclerosis, the company said.

CAMBRIDGE, Mass. — Disease relapse rates and worsening of disability were low among patients taking a drug made by Genzyme for multiple sclerosis, the company said.

Genzyme, a division of French drug maker Sanofi, announced results of an extension study of the drug Lemtrada (alemtuzumab). The study was a follow-up to two other late-stage clinical studies of the drug, finding that relapse rates and sustained accumulation of disability remained low among patients who had previously received the drug.

March 22, 2013

A drug made by Novo Nordisk for Type 2 diabetes produced a 6% loss of weight in a trial of the drug in obese patients, the company said.

BAGSVÆRD, Denmark — A drug made by Novo Nordisk for Type 2 diabetes produced a 6% loss of weight in a trial of the drug in obese patients, the company said.

The Danish drug maker announced results of a 56-week phase-3 trial to investigate the potential of Victoza (liraglutide) to produce and maintain weight loss in overweight and obese patients with Type 2 diabetes.

March 22, 2013

Culturally competent coaching may be effective in reducing the risk of coronary artery disease among South Asian patients, according to a new study presented as a poster at an American Heart Association conference taking place in New Orleans.

MOUNTAIN VIEW, Calif. — Culturally competent coaching may be effective in reducing the risk of coronary artery disease among South Asian patients, according to a new study presented as a poster at an American Heart Association conference taking place in New Orleans.

March 21, 2013

Alcon has launched a mobile website designed to facilitate dialogue between patients and pharmacists about eye and ear treatments, the company said.

NEW YORK — Alcon has launched a mobile website designed to facilitate dialogue between patients and pharmacists about eye and ear treatments, the company said Thursday.

Alcon announced the launch of Drops101 Web Tools, which offers access to information about two of its products: Ciprodex Otic (ciprofloxacin and dexamethasone), for acute otitis externa and acute otitis media in children with tymponostomy tubes; and Moxeza ophthalmic solution (moxifloxacin hydrochloride) for bacterial conjunctivitis.

March 21, 2013

A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said.

SILVER SPRING, Md. — A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said Thursday.

March 21, 2013

Gov. Bob McDonnell of Virginia has signed into law the first bill that could limit the reach of follow-on biologics, though the bill includes a two-year sunset clause, meaning it will expire in 2015.

WASHINGTON — Gov. Bob McDonnell of Virginia has signed into law the first bill that could limit the reach of follow-on biologics, though the bill includes a two-year sunset clause, meaning it will expire in 2015.

McDonnell signed House bill 1422 and the identical Senate bill 1285, which would prevent a pharmacist from dispensing a biosimilar to substitute for the original, branded biologic if the prescriber indicated that substitution was not allowed or if the patient insisted on receiving the branded product.

March 20, 2013

A group of doctors and public health professors are hoping the Food and Drug Administration will place stronger regulations on energy drinks to protect children and adolescents from what they call the harmful effects of high caffeine consumption.

NEW YORK — A group of doctors and public health professors are hoping the Food and Drug Administration will place stronger regulations on energy drinks to protect children and adolescents from what they call the harmful effects of high caffeine consumption.

March 20, 2013

Hamacher Resource Group is offering pharmacists a new service that it said would allow them to get the top prescriptions dispensed in their two-digit ZIP code to ensure they are accurately and competitively pricing drugs.

WAUKESHA, Wis. — Hamacher Resource Group is offering pharmacists a new service that it said would allow them to get the top prescriptions dispensed in their two-digit ZIP code to ensure they are accurately and competitively pricing drugs.

HRG said the service, Rx Top Sellers, would provide data on the top 200, 500, 750 or 1,000 prescriptions and include cash median prices that are charged by food-drug retailers and independent pharmacies, as well as mass merchandise retailers.

March 20, 2013

The Hy-Vee Drugstore in Cherokee, Iowa, will merge with the company's supermarket in the town next month, the supermarket pharmacy chain said Wednesday.

CHEROKEE, Iowa — The Hy-Vee Drugstore in Cherokee, Iowa, will merge with the company's supermarket in the town next month, the supermarket pharmacy chain said Wednesday.

"Having all our pharmacists together at the same location creates a more efficient operation and enables us to add Sunday hours, a service customers have requested," Hy-Vee assistant VP operations for the company's northwest district Tim Stupka said.

March 20, 2013

Generic drug maker Sagent Pharmaceuticals has appointed James Hussey as its president, the company said.

SCHAUMBURG, Ill. — Generic drug maker Sagent Pharmaceuticals has appointed James Hussey as its president, the company said.

Sagent said the board of directors' appointment of Hussey, 53, would be effective Monday. Hussey will be responsible for the company's commercial operations, including development, regulatory affairs, supply chain activities, sales, marketing and human resources.

March 20, 2013

The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

PRINCETON, N.J. — The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Estarylla (norgestimate and ethinyl estradiol tablets) and Tri-Estarylla (norgestimate and ethinyl estradiol tablets), generic versions of Johnson & Johnson's Ortho Cyclen and Ortho Tri-Cyclen, respectively. Sandoz said the launches brought the total number of oral contraceptives it has launched since the beginning of 2011 to six.

March 20, 2013

Rebates on healthy foods may lead patients to purchase them more frequently, according to a new study by researchers in South Africa.

NEW YORK — Rebates on healthy foods may lead patients to purchase them more frequently, according to a new study by researchers in South Africa.

The study, published in the American Journal of Preventive Medicine, examined a program offered by Discovery, South Africa's largest health plan. The HealthyFood program provides a cash-back rebate of up to 25% on healthy food purchases in more than 400 designated supermarkets around the country.

March 20, 2013

Teva Pharmaceutical Industries has appointed a former executive from Dyax to its executive team, the Israeli generic drug maker said.

JERUSALEM — Teva Pharmaceutical Industries has appointed a former executive from Dyax to its executive team, the Israeli generic drug maker said.

Teva announced the appointment of Ivana Magovčević-Liebisch as SVP and head of corporate business development, effective April 1. Magovčević-Liebisch served as EVP and COO for Dyax, a Burlington, Mass.-based drug company.

March 19, 2013

The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said Tuesday.

In a memo sent out to staff of the Center for Drug Evaluation and Research, the section of the agency that oversees the OGD, CDER director Janet Woodcock wrote that Uhl most recently served as senior adviser to director Greg Geba, who announced his resignation Thursday.

March 19, 2013

A survey of 114 researchers, government officials, insurers, employers, business leaders and trade groups found nearly one-third say comparative effectiveness research will have a "moderate improvement" on healthcare decision making over the next 12 months.

WASHINGTON — A survey of 114 researchers, government officials, insurers, employers, business leaders and trade groups found nearly one-third say comparative effectiveness research will have a "moderate improvement" on healthcare decision making over the next 12 months.

March 19, 2013

The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.

WASHINGTON — The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.