Content about Specialty Pharmacy

December 20, 2010

Drug maker Amylin Pharmaceuticals has submitted the first of a series of sections of a regulatory approval application for a biotech drug to treat patients with a rare lipid disorder.

SAN DIEGO — Drug maker Amylin Pharmaceuticals has submitted the first of a series of sections of a regulatory approval application for a biotech drug to treat patients with a rare lipid disorder.

December 20, 2010

Drug makers King Pharmaceuticals and Acura Pharmaceuticals have submitted a regulatory approval application to the Food and Drug Administration for an opioid pain reliever.

BRISTOL, Tenn. — Drug makers King Pharmaceuticals and Acura Pharmaceuticals have submitted a regulatory approval application to the Food and Drug Administration for an opioid pain reliever.

The two drug makers announced Tuesday the submission for Acurox (oxycodone hydrochloride), an immediate-release tablet for relief of moderate to severe pain.

The tablets use Acura’s aversion technology, designed to deter abuse of the drug by dissolving or crushing the pills.

December 16, 2010

An investigational treatment for irritable bowel syndrome could become a blockbuster by the end of the decade, according to a report by Decision Resources.

BURLINGTON, Mass. — An investigational treatment for irritable bowel syndrome could become a blockbuster by the end of the decade, according to a report by Decision Resources.

The report, which the healthcare market research firm said it would publish later this month, found that linaclotide — made by Ironwood Pharmaceuticals, Forest Labs, Almirall and Astellas Pharma — would emerge as the market leader for IBS and achieve sales of $1.1 billion in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan by 2019.

December 16, 2010

Just a few months after a Food and Drug Administration advisory committee recommended limiting the use of a Genentech drug designed to treat breast cancer, the regulatory agency is looking to revoke the approval altogether.

SILVER SPRING, Md. — Just a few months after a Food and Drug Administration advisory committee recommended limiting the use of a Genentech drug designed to treat breast cancer, the regulatory agency is looking to revoke the approval altogether.

December 14, 2010

The Accreditation Commission for Health Care has accredited specialty pharmacy provider Axium Healthcare Pharmacy, Axium said Tuesday.

LAKE MARY, Fla. — The Accreditation Commission for Health Care has accredited specialty pharmacy provider Axium Healthcare Pharmacy, Axium said Tuesday.

December 14, 2010

The Food and Drug Administration has approved a revised dosage for a drug combination, which includes a Johnson & Johnson drug, in HIV patients who have received treatment but whose virus has not become immune to the J&J drug.

TITUSVILLE, N.J. — The Food and Drug Administration has approved a revised dosage for a drug combination, which includes a Johnson & Johnson drug, in HIV patients who have received treatment but whose virus has not become immune to the J&J drug.

December 14, 2010

The Food and Drug Administration has accepted a regulatory approval application for a pain drug made by Pacira Pharmaceuticals, Pacira said Tuesday.

PARSIPPANY, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a pain drug made by Pacira Pharmaceuticals, Pacira said Tuesday.

The drug maker submitted its application for the long-acting painkiller Exparel (bupivacaine) in September.

The drug is a topical medication for managing pain following surgery. The FDA expects to finish reviewing the application in July 2011.

December 13, 2010

Biotech company Genzyme still is saying “no thanks” to French drug maker Sanofi-Aventis’ tender offer of $18.5 billion, or $69 per share, to acquire it, saying the offer “substantially undervalues” the company.

CAMBRIDGE, Mass. — Biotech company Genzyme still is saying “no thanks” to French drug maker Sanofi-Aventis’ tender offer of $18.5 billion, or $69 per share, to acquire it, saying the offer “substantially undervalues” the company.

The offer has been extended until Jan. 11, Genzyme said.

Sanofi has sought to buy Genzyme since August. Genzyme, based in Cambridge, Mass., specializes in treatments for rare genetic disorders, such as Fabry disease and Gaucher disease.

December 10, 2010

Biotech drugs will help drive the markets for acute and chronic gout through 2019, according to a new report by market research firm Decision Resources.

BURLINGTON, Mass. — Biotech drugs will help drive the markets for acute and chronic gout through 2019, according to a new report by market research firm Decision Resources.

The report, titled “Acute and Chronic Gout — New Agents Target Refractory Patients and Tap Market Opportunity,” found that the acute gout drug market would triple in size to $117 million, while the chronic gout market would reach $1.83 billion.

December 9, 2010

A new three-drug combination may work as a front-line treatment for cancer of the plasma cells, according to an early-stage clinical study.

ANN ARBOR, Mich. — A new three-drug combination may work as a front-line treatment for cancer of the plasma cells, according to an early-stage clinical study.

December 9, 2010

An investigational treatment for lung cancer made by Boehringer Ingelheim Pharmaceuticals extended patients’ survival by more than four months, according to results of a late-stage clinical trial announced Thursday.

RIDGEFIELD, Conn. — An investigational treatment for lung cancer made by Boehringer Ingelheim Pharmaceuticals extended patients’ survival by more than four months, according to results of a late-stage clinical trial announced Thursday.

BI said the phase 2b/3 “LUX-Lung 1” trial of BIBW 2992 (afatinib) showed a fourfold increase in survival among advanced non-small cell lung cancer patients taking the drug versus those taking placebo, whose survival was extended by one month.

December 8, 2010

Chemotherapy drugs made by Johnson & Johnson and Merck will become the standard second-line treatment for ovarian cancer within the decade, replacing a treatment made by Bristol-Myers Squibb and generic versions, according to a new report by market research firm Decision Resources.

BURLINGTON, Mass. — Chemotherapy drugs made by Johnson & Johnson and Merck will become the standard second-line treatment for ovarian cancer within the decade, replacing a treatment made by Bristol-Myers Squibb and generic versions, according to a new report by market research firm Decision Resources.

December 8, 2010

A Food and Drug Administration advisory committee has recommended approval for an investigational diet pill.

SAN DIEGO — A Food and Drug Administration advisory committee has recommended approval for an investigational diet pill.

Orexigen Therapeutics and Takeda Pharmaceutical announced Tuesday that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13-7 that clinical trial data demonstrated that the benefits of the drug Contrave (naltrexone and bupropion) outweighed its risk and supported approval. The committee also voted 11-8 to recommend a study to examine Contrave’s effect on risk for cardiac disease.

December 7, 2010


NEW YORK — Walgreens. Costco. CVS Caremark. Rite Aid. H-E-B. Wegmans. Kerr Drug. The list goes on. In all, it was a veritable who’s who of retailing as Drug Store News’ annual Industry 
Issues Summit, which also included a Specialty Pharmacy Roundtable and Diabetes Roundtable, attracted more than 200 attendees — a new attendance record — and featured the most diverse retail panelists to date.


December 6, 2010

The specialty pharmacy market is set to reach $90 billion this year, so it’s clear that managed care organizations have a lot at stake.

PHILADELPHIA — The specialty pharmacy market is set to reach $90 billion this year, so it’s clear that managed care organizations have a lot at stake.

That was the overarching theme at a symposium organized by specialty pharmacy provider ACRO Pharmaceutical Services, in conjunction with Armada Health Care, last Thursday at the Hyatt Regency at Penn’s Landing in Philadelphia.

December 6, 2010

A drug made by Amgen maintained blood platelet counts in patients with an autoimmune bleeding disorder, according to results of a five-year study released Sunday.

ORLANDO, Fla. — A drug made by Amgen maintained blood platelet counts in patients with an autoimmune bleeding disorder, according to results of a five-year study released Sunday.

December 6, 2010

A biotech drug made by Roche subsidiary Genentech allowed patients with a blood cancer, who did not show symptoms, to delay starting on chemotherapy or radiotherapy, and decreased the risk of their disease worsening, according to results of a late-stage clinical trial.

SOUTH SAN FRANCISCO, Calif. — A biotech drug made by Roche subsidiary Genentech allowed patients with a blood cancer, who did not show symptoms, to delay starting on chemotherapy or radiotherapy, and decreased the risk of their disease worsening, according to results of a late-stage clinical trial.

December 3, 2010

The Specialty Pharmacy Nursing Network has entered a partnership with ViroPharma’s CinryzeSolutions support program, a training and monitoring program for patients using ViroPharma’s Cinryze (C1 esterase inhibitor [human]) who wish to administer the drug themselves.

SARASOTA, Fla. — The Specialty Pharmacy Nursing Network has entered a partnership with ViroPharma’s CinryzeSolutions support program, a training and monitoring program for patients using ViroPharma’s Cinryze (C1 esterase inhibitor [human]) who wish to administer the drug themselves.

Cinryze is a drug administered via infusion for the treatment of hereditary angioedema, and the partnership will allow patients to receive training and follow-up support from SPNN nurses, as well as direction from their physicians.

December 3, 2010

Pharmacy benefit manager SXC Health Solutions will acquire Birmingham, Ala.-based specialty pharmacy provider MedfusionRx for $100 million, SXC said Thursday.

LISLE, Ill. — Pharmacy benefit manager SXC Health Solutions will acquire Birmingham, Ala.-based specialty pharmacy provider MedfusionRx for $100 million, SXC said Thursday.

SXC also may pay an additional $5.5 million if unspecified performance targets are met through fiscal year 2012, the company said. MedfusionRx operates pharmacies in Alabama, Mississippi, Louisiana, Tennessee, West Virginia and Kansas, and serves more than 9,000 patients.

December 1, 2010

Nearly all surveyed patients using BioPlus Specialty Pharmacy’s services over the last six years adhered to their therapies, according to recent statistics.

ALTAMONTE SPRINGS, Fla. — Nearly all surveyed patients using BioPlus Specialty Pharmacy’s services over the last six years adhered to their therapies, according to recent statistics.

Quarterly data collected between 2004 and 2010 found that of 17,000 patients analyzed, compliance at the time of discharge was 92%.

December 1, 2010

Specialty pharmacy provider BioScrip has appointed David Froesel as EVP, CFO and treasurer, the company said Wednesday. Froesel will begin immediately, replacing Stan Rosembaum, who plans to leave the company before the year ends.

ELMSFORD, N.Y. — Specialty pharmacy provider BioScrip has appointed David Froesel as EVP, CFO and treasurer, the company said Wednesday. Froesel will begin immediately, replacing Stan Rosembaum, who plans to leave the company before the year ends.

Froesel previously worked at Omnicare, which provides pharmaceutical care services to the elderly, for close to 14 years, serving as SVP and CFO from March 1996 until December 2009. Before working for Omnicare, Froesel worked at Mallinckrodt Group for 18 years.

December 1, 2010

Regional specialty pharmacy chain ReCept has appointed several people to new executive positions, the company said Wednesday.

FORT WORTH, Texas — Regional specialty pharmacy chain ReCept has appointed several people to new executive positions, the company said Wednesday.

ReCept, which owns 15 stores in Texas and specializes in compounding pharmacy services for people with such conditions as HIV/AIDS and cancer, announced the appointments of Nicky Otts as chairman and CEO, Carmine DeNardo as president and COO, Rob Jarvis as EVP sales and chief marketing officer, Jeff Brumbaugh as chief information officer and Stephanie Romero as VP finance.

December 1, 2010

Drug maker Savient Pharmaceuticals has begun shipping its new gout treatment to specialty distributors, the company said Tuesday.

EAST BRUNSWICK — Drug maker Savient Pharmaceuticals has begun shipping its new gout treatment to specialty distributors, the company said Tuesday.

Savient announced the shipment of Krystexxa (pegloticase), saying it would become available by prescription starting Wednesday.

The drug, designed for administration by IV, received approval on Sept. 14 from the Food and Drug Administration for treating chronic gout.

November 30, 2010

Leaders in specialty pharmacy gathered in New York on Tuesday at the New York Athletic Club to attend the second annual Specialty Pharmacy Roundtable discussion presented by Drug Store News and Armada Health Care.

NEW YORK — Leaders in specialty pharmacy gathered in New York on Tuesday at the New York Athletic Club to attend the second annual Specialty Pharmacy Roundtable discussion presented by Drug Store News and Armada Health Care.

David Galardi, co-founder of Apogenics Inc., moderated the robust panel, which was comprised of Nick Calla of Walgreens Specialty Pharmacy, John Musil of The Apothecary Shops, Tim Kaplan of Amber Pharmacy, Jeanne Ann Stasny of Walmart Specialty Pharmacy and Albert Thigpen of CVS Caremark, among others.

November 29, 2010

The Food and Drug Administration has extended its review period for a multiple sclerosis drug made by EMD Serono, the drug maker said Friday.

ROCKLAND, Mass. — The Food and Drug Administration has extended its review period for a multiple sclerosis drug made by EMD Serono, the drug maker said Friday.

EMD Serono — the U.S. subsidiary of German drug maker Merck KGaA, which uses the name to avoid confusion with U.S.-based Merck — said the FDA had extended the review time for cladribine tablets to Feb. 28. The drug is a disease-modifying drug for relapsing MS.