Content about Specialty Pharmacy

November 24, 2010

Eli Lilly and Australian drug maker Acrux have received approval from the Food and Drug Administration for a testosterone replacement therapy for men, the two companies announced Tuesday.

INDIANAPOLIS — Eli Lilly and Australian drug maker Acrux have received approval from the Food and Drug Administration for a testosterone replacement therapy for men, the two companies announced Tuesday.

The FDA approved Axiron (testosterone) topical solution as a treatment for men with various conditions that lead to deficiency of the hormone. The drug, a controlled substance, is designed for application under the arm.

November 22, 2010

NEW YORK A daily dose of an anti-retroviral pill appears to prevent HIV infection, according to results of a study conducted by University of California at San Francisco researchers, published in The New England Journal of Medicine on Tuesday.

November 22, 2010

Specialty pharmacy provider Axium Healthcare Pharmacy has received recognition from the National Hemophilia Foundation for its treatment programs ...

LAKE MARY, Fla. Specialty pharmacy provider Axium Healthcare Pharmacy has received recognition from the National Hemophilia Foundation for its treatment programs, Axium said.

The NHF said Axium “meets or exceeds” the standards of the organization’s Medical and Scientific Advisory Council, meaning that it has staff knowledgeable about and provides a full range of treatments, has 24-hour access to pharmacy staff and has good record-keeping, billing and product recall processes.

November 21, 2010

Pfizer has extended the deadline of its $3.6 billion offer to buy King Pharmaceuticals, Pfizer...

NEW YORK Pfizer has extended the deadline of its $3.6 billion offer to buy King Pharmaceuticals, Pfizer said Monday.

 

Pfizer said it had extended its tender offer to Dec. 17 because certain conditions had not been met, but the two companies plan to have it finished by the end of this year or the beginning of next year.

 

 

King, based in Bristol, Tenn., specializes in branded opioid prescription painkillers.

 

November 21, 2010

Diplomat Specialty Pharmacy has promoted Steven Miesowicz to VP human resources, planning and government relations,...

FLINT, Mich. Diplomat Specialty Pharmacy has promoted Steven Miesowicz to VP human resources, planning and government relations, the company said Monday.

 

Miesowicz previously served as the company’s senior director for human resources and as a business management consultant. He had a large role in securing the Michigan Economic Growth Authority tax credit that the company received in connection with the relocation to its new Flint, Mich., headquarters.

 

 

November 21, 2010

An intensive cancer patient management program by Walgreens’ specialty pharmacy professionals could save health plan...

DEERFIELD, Ill. An intensive cancer patient management program by Walgreens’ specialty pharmacy professionals could save health plan payers $2,000 to $4,000 per patient each month, the company announced.

November 18, 2010

The Food and Drug Administration has approved a treatment for preventing skeletal injuries in patients...

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for preventing skeletal injuries in patients whose cancer has spread to the bone.

 

The FDA announced Friday the approval of Thousand Oaks, Calif.-based biotech company Amgen’s Xgeva (denosumab) for bone metastases.

 

 

November 18, 2010

Pfizer got promising results from a late-stage clinical trial of a cancer treatment, the drug...

NEW YORK — Pfizer got promising results from a late-stage clinical trial of a cancer treatment, the drug maker said Friday.

 

Pfizer announced results of the phase-3 “AXIS 1032” trial of the kidney cancer drug axitinib, saying that it “significantly” extended the lives of patients with advanced renal cell carcinoma compared with Nexavar (sorafenib), made by Bayer HealthCare and Onyx Pharmaceuticals.

 

 

November 18, 2010

Johnson & Johnson and the U.S. government are suing two generic drug makers to stop...

NEW YORK — Johnson & Johnson and the U.S. government are suing two generic drug makers to stop them from launching a generic drug for HIV, according to published reports.

 

Bloomberg reported Thursday that Tibotec, a subsidiary of J&J, and the government were separately suing Mylan and Lupin over a generic version of the drug Prezista (darunavir ethanolate), alleging patent infringement.

 

 

November 17, 2010

Pharmacy benefit manager Express Scripts has created what it calls the industry’s most comprehensive specialty...

ST. LOUIS — Pharmacy benefit manager Express Scripts has created what it calls the industry’s most comprehensive specialty benefits organization, the company announced Thursday.

 

November 16, 2010

Patients living with chronic obstructive pulmonary disease said the illness prevented them from living life...

RESEARCH TRIANGLE PARK, N.C. Patients living with chronic obstructive pulmonary disease said the illness prevented them from living life to its fullest, according to research conducted by drug maker GlaxoSmithKline.

 

November 16, 2010

A Food and Drug Administration advisory committee has recommended expanded approval of a vaccine for...

WHITEHOUSE STATION, N.J. — A Food and Drug Administration advisory committee has recommended expanded approval of a vaccine for genital warts.

Merck announced Wednesday that the FDA Vaccines and Related Biological Products Advisory Committee recommended approval of Gardasil (human papillomavirus quadrivalent [types 6, 11, 16 and 18] vaccine, recombinant) for males and females ages 9 to 26 years to prevent anal cancer and anal intraepithelial neoplasia, both diseases that result from infection by the human papillomavirus.

November 16, 2010

A decision by a Food and Drug Administration advisory committee could pave the way for...

ROCKVILLE, Md. A decision by a Food and Drug Administration advisory committee could pave the way for the first new drug to treat lupus in decades.

 

The FDA’s Arthritis Advisory Committee voted 13-2 Tuesday to recommend approval for Benlysta (belimumab), a drug for systemic lupus erythematosus made by British drug maker GlaxoSmithKline and U.S.-based Human Genome Sciences, the two companies announced. Lupus is an inflammatory disorder that affects internal organs, joints and skin and, in its severest forms, can be fatal.

 

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 10, 2010

A specialty pharmacy provider and a manufacturer will collaborate to provide treatments for erectile dysfunction....

LAKE MARY, Fla. A specialty pharmacy provider and a manufacturer will collaborate to provide treatments for erectile dysfunction.

 

Axium Healthcare Pharmacy and Firma Medical announced the partnership Wednesday where by Axium’s erectile dysfunction line of injectable compounded pharmaceuticals will be marketed to Firma’s physician and patient customers around the country. The companies said the deal would give Axium broader distribution while increasing the number of treatment options for Firma’s customers.

 

November 9, 2010

Watson Pharmaceuticals biotech subsidiary Eden Biodesign has signed a manufacturing agreement with Dutch biotech company...

RESEARCH TRIANGLE PARK, N.C. Watson Pharmaceuticals biotech subsidiary Eden Biodesign has signed a manufacturing agreement with Dutch biotech company Crucell that will give Watson access to Crucell’s cell line technology, the two companies announced Wednesday.

 

Under the agreement, Eden will provide process development and current good manufacturing practice services using Crucell’s PER.C6 technology to licensees using the technology to develop vaccines and gene therapies.

 

 

November 9, 2010

A company that provides pharmaceutical care for the elderly is splitting its pharmacy services business...

COVINGTON, Ky. A company that provides pharmaceutical care for the elderly is splitting its pharmacy services business into two divisions, hoping to make its services more effective and focused on customers.

 

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 8, 2010

A vaccine for a bacterial infection that affects the gastrointestinal tract has been granted expedited...

SWIFTWATER, Pa. A vaccine for a bacterial infection that affects the gastrointestinal tract has been granted expedited approval by the Food and Drug Administration.

 

French drug maker Sanofi-Aventis announced Tuesday that it had received fast-track designation from the FDA for its investigational Clostridium difficile vaccine. The FDA grants the designation to ease the development of new drugs and vaccines for serious or life-threatening conditions or unmet medical needs.

 

 

November 7, 2010

Armada Health Care’s seventh annual Specialty Pharmacy Summit next May is expected to have a...

November 7, 2010

Eli Lilly's acquisition of a leader in molecular imaging development could boost its Alzheimer's disease...

INDIANAPOLIS and PHILADELPHIA Eli Lilly's acquisition of a leader in molecular imaging development could boost its Alzheimer's disease drug pipeline.

November 3, 2010

Swiss drug maker Biogen Idec and U.S. drug maker Cardiokine have terminated an agreement to...

WESTON, Mass. Swiss drug maker Biogen Idec and U.S. drug maker Cardiokine have terminated an agreement to develop a treatment for abnormally low sodium levels in the blood, the two companies said Wednesday.

 

The agreement will give Cardiokine all rights to lixivaptan, a treatment for the condition, known as hyponatremia. The collaboration began in 2007, and the drug is in late-stage clinical studies.

 

 

November 3, 2010

Nearly 100 drugs are in development for treating Alzheimer’s disease, according to a new report...

WASHINGTON Nearly 100 drugs are in development for treating Alzheimer’s disease, according to a new report by the main lobby for the pharmaceutical industry.

 

The Pharmaceutical Research and Manufacturers of America said 98 medicines for dementia, mostly Alzheimer’s, were in clinical trials or under review by the Food and Drug Administration.

 

 

November 3, 2010

A vaccine for the mosquito-borne illness dengue fever is in the final stages of development,...

LYON, France A vaccine for the mosquito-borne illness dengue fever is in the final stages of development, Sanofi-Aventis said Thursday.

 

Sanofi said the first phase-3 trial of the vaccine was under way in Australia.

 

 

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.