Content about Specialty pharmacy

January 6, 2011

The Food and Drug Administration has expanded the approved usage of a drug made by Genentech, part of Swiss drug maker Roche.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has expanded the approved usage of a drug made by Genentech, part of Swiss drug maker Roche.

The FDA approved Actemra (tocilizumab) for the inhibition and slowing of structural joint damage, improvement of physical function and achievement of clinical response in patients with moderate to severe rheumatoid arthritis. The drug originally was approved as a treatment for RA last year.

January 6, 2011

The Food and Drug Administration granted priority review to an approval application for a hepatitis C drug made by Merck, the drug maker said Thursday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration granted priority review to an approval application for a hepatitis C drug made by Merck, the drug maker said Thursday.

Merck said the FDA would seek to complete its review of the application for the drug boceprevir within six months. Authorities in the European Union have granted expedited review as well.

January 6, 2011

A U.S. biotech company plans to develop a biosimilar of a monoclonal antibody used to treat cancers and autoimmune disorders.

IRVINE, Calif. — A U.S. biotech company plans to develop a biosimilar of a monoclonal antibody used to treat cancers and autoimmune disorders.

Spectrum Pharmaceuticals announced Wednesday a deal with Viropro to develop a biosimilar rituximab, marketed under the brand name Rituxan by Roche’s Genentech division. Global sales of rituximab in 2009 were $5.6 billion, according to Spectrum.

January 5, 2011

The Food and Drug Administration has extended by six months the market exclusivity of a lung disease drug for use in children.

CLINTON, N.J. — The Food and Drug Administration has extended by six months the market exclusivity of a lung disease drug for use in children.

Drug maker Ikaria said Wednesday that the FDA had extended pediatric exclusivity period for the drug Inomax (nitric oxide) from January 2013 to July 2013.

Ikaria said the extension was based on results of a clinical study of the drug in preterm infants with bronchopulmonary dysplasia, a serious condition that results from lung injury.

January 5, 2011

Responding to what she termed an “unprecedented” shortage of prescription medicines for such serious conditions as cancer, Sen. Amy Klobuchar, D-Minn., is promising new legislation to deal with the problem.

EDINA, Minn. — Responding to what she termed an “unprecedented” shortage of prescription medicines for such serious conditions as cancer, Sen. Amy Klobuchar, D-Minn., is promising new legislation to deal with the problem. The senator said she also is pressing the Food and Drug Administration and the pharmaceutical industry to address a growing shortage of prescription medications, especially drugs for treating cancer.

January 4, 2011

The Food and Drug Administration has approved a topical testosterone replacement therapy made by Endo Pharmaceuticals, Endo said last week.

CHADDS FORD, Pa. — The Food and Drug Administration has approved a topical testosterone replacement therapy made by Endo Pharmaceuticals, Endo said last week.

The drug maker announced on Dec. 29 the approval of Fortesta (testosterone) gel, a treatment for men with low testosterone, which affects nearly 14 million men in the United States.

Endo said it planned to introduce Fortesta in the United States early this year.

January 4, 2011

The National Association of Chain Drug Stores Foundation is inviting health and pharmacy experts and other researchers to join the Herculean effort to improve patient adherence rates.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores Foundation is inviting health and pharmacy experts and other researchers to join the Herculean effort to improve patient adherence rates.

The invitation comes in the form of a new Request for Proposal, issued Tuesday by the NACDS Foundation. The foundation is seeking bids from research organizations to study primary medication nonadherence, which occurs when a patient fails to fill or pick up his or her newly prescribed medication.

January 4, 2011

Pfizer will pay Danish biotech company Santaris Pharma $14 million for access to its development platform for RNA-based therapies, Pfizer said Tuesday.

SAN DIEGO — Pfizer will pay Danish biotech company Santaris Pharma $14 million for access to its development platform for RNA-based therapies, Pfizer said Tuesday.

The drug maker said the deal would expand on an existing one between Hoersholm, Denmark-based Santaris and Wyeth, which Pfizer acquired in 2009. Santaris could take in up to $600 million in milestone payments, as well as royalties on products developed under the collaboration.

January 3, 2011

This past year saw a lower-than-usual number of new drugs approved by the Food and Drug Administration, due in part to delays at the agency, according to published reports.

NEW YORK — This past year saw a lower-than-usual number of new drugs approved by the Food and Drug Administration, due in part to delays at the agency, according to published reports.

The Wall Street Journal reported that 21 new drugs were approved through the year, compared with 25 in 2009 and 24 in 2008. The lag came in part due to stricter safety regulations, the newspaper reported.

January 3, 2011

Former president George W. Bush will deliver the keynote speech at Armada Health Care’s seventh annual Armada Specialty Pharmacy Summit, the specialty pharmacy contracting organization said.

FLORHAM PARK, N.J. — Former president George W. Bush will deliver the keynote speech at Armada Health Care’s seventh annual Armada Specialty Pharmacy Summit, the specialty pharmacy contracting organization said.

The conference, which will take place May 10 to 13 at the Wynn Hotel in Las Vegas, is considered one of the top conferences in the U.S. drug industry.

January 3, 2011

The Food and Drug Administration has approved an update to the label of a Johnson & Johnson drug for HIV, the company said Monday.

TITUSVILLE, N.J. — The Food and Drug Administration has approved an update to the label of a Johnson & Johnson drug for HIV, the company said Monday.

Tibotec Therapeutics, a subsidiary of J&J, said the FDA approved a 200-mg formulation of Intelence (etravirine) for treating HIV in patients who have taken previous treatments and whose virus has become resistant to antiretroviral drugs.

December 29, 2010

Recent news that the FDA has rejected Teva's application for a new lower-dose version of multiple sclerosis drug Copaxone likely will hold off the emergence of a generic version of the drug.

NEW YORK — One door closes; another door, well, closes. And that appears to be good news for Teva. Recent news that the Food and Drug Administration has rejected the drug maker's application for a new indication for multiple sclerosis drug Copaxone likely will mean the agency will not be so quick to approve a generic version of the drug without requiring a generic company to perform full clinical trials.

December 29, 2010

SXC Health Solutions has completed its acquisition of independent specialty pharmacy provider MedfusionRx.

LISLE, Ill. — SXC Health Solutions announced Wednesday that it had completed its acquisition of independent specialty pharmacy provider MedfusionRx in a deal worth $100 million in cash, with an additional $5.5 million subject to the achievement of certain performance targets in fiscal year 2012.

The waiting period under the Hart-Scott-Rodino Act expired Dec. 24.

December 28, 2010

Health professionals worry that little is known about the long-term effects of many drugs — which have been tested extensively on adult-patient populations — on children.

NEW YORK — More than 25% of children and teens take at least one medication on a daily basis, and nearly 7% are on two or more drugs, the Wall Street Journal reported Tuesday, citing 2009 data from Medco Health Solutions. Drawing additional data from IMS Health, the article noted that prescriptions for hypertension in people under the age of 20 years could reach 5.5 million for 2010 by the time year-end results are tabulated, which would mark a rise of 17% since 2007. 

December 23, 2010

Cephalon on Thursday appointed Kevin Buchi as CEO and a member of the company's board.

FRAZER, Pa. — Cephalon on Thursday appointed Kevin Buchi as CEO and a member of the company's board.

December 23, 2010

Merck on Wednesday announced that the Food and Drug Administration has approved Gardasil [human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant] for the prevention of anal cancer in males and females 9 to 26 years of age.

WHITEHOUSE STATION, N.J. — Merck on Wednesday announced that the Food and Drug Administration has approved Gardasil [human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant] for the prevention of anal cancer in males and females 9 to 26 years of age.

According to the company, Gardasil is the first HPV vaccine on the market available for use in both men and women, and the only one indicated  to help prevent cervical, vaginal, vulvar and anal cancers and pre-cancers, as well as genital warts, caused by certain types of HPV.

December 22, 2010

Same-store sales for specialty pharmacy group Assured Pharmacy rose 31.2% in November, compared with the year-ago period.

FRISCO, Texas — Same-store sales for specialty pharmacy group Assured Pharmacy rose 31.2% in November, compared with the year-ago period.

The company said the rise also represented a 6% increase over total sales in October.

December 21, 2010

Abbott has made a pact with a biopharmaceutical company to develop new cancer treatments by making small-molecule inhibitors.

ABBOTT PARK, Ill. — Abbott has made a pact with a biopharmaceutical company to develop new cancer treatments by making small-molecule inhibitors.

Under the terms of the agreement, Abbott will provide EpiTherapeutics with an up-front payment and will receive funding of research activities conducted at EpiTherapeutics. The biopharmaceutical company also is eligible, under certain conditions, to receive milestone payments as well as potential royalties on future revenues.

December 21, 2010

An Anglo-Swedish drug maker said it is discontinuing further development of a drug that is designed to prevent a respiratory virus that infects the lungs and breathing passages.

LONDON — An Anglo-Swedish drug maker said it is discontinuing further development of a drug that is designed to prevent a respiratory virus that infects the lungs and breathing passages.

AstraZeneca has requested the withdrawal of its pending biological license application for motavizumab from the Food and Drug Administration. Motavizumab is an investigational monoclonal antibody that could prevent serious respiratory syncytial virus disease.

AstraZeneca said it will incur a financial impairment charge of $445 million in fourth quarter 2010.

December 21, 2010

In a deal that will bolster its drug development capabilities, Biogen Idec has acquired a subsidiary of Swiss-based Neurimmune Holding AG.

WESTON, Mass. and ZURICH — In a deal that will bolster its drug development capabilities, Biogen Idec has acquired a subsidiary of Swiss-based Neurimmune Holding AG.

Among other assets, the agreement gives Biogen the worldwide rights to three preclinical immunotherapy programs. The three programs are focused on the discovery and development of novel human antibodies that address three central nervous system targets: alpha-synuclein, tau and TDP-43.

December 21, 2010

A Mylan subsidiary has settled a lawsuit brought on by the Department of Justice four years ago.

BASKING RIDGE, N.J. — A Mylan subsidiary has settled a lawsuit brought on by the Department of Justice four years ago.

December 21, 2010

Bristol-Myers Squibb has signed a definitive licensing pact with Oncolys BioPharma, a privately held Japanese biotech company, that will give it control of a promising new HIV treatment.

NEW YORK and TOKYO — Bristol-Myers Squibb has signed a definitive licensing pact with Oncolys BioPharma, a privately held Japanese biotech company, that will give it control of a promising new HIV treatment.

December 21, 2010

One month after announcing it would acquire a leader in molecular imaging development, Eli Lilly announced it has completed its acquisition of Avid Radiopharmaceuticals.

INDIANAPOLIS — One month after announcing it would acquire a leader in molecular imaging development, Eli Lilly announced it has completed its acquisition of Avid Radiopharmaceuticals.

December 21, 2010

A biopharmaceutical company exclusively will develop and commercialize oral formulations of a drug maker's insulins.

PRINCETON, N.J. — A biopharmaceutical company exclusively will develop and commercialize oral formulations of a drug maker's insulins.

Emisphere will be paid $57.5 million in potential product development and sales milestone payments by Novo Nordisk — of which $5 million dollars will be payable upon signing — as well as royalties on sales. Further financial details of the agreement were not disclosed.

December 21, 2010

A healthcare accrediting organization is revising three products in its Pharmacy Quality Management suite of programs.

WASHINGTON — A healthcare accrediting organization is revising three products in its Pharmacy Quality Management suite of programs.

URAC said its pharmacy committee approved revisions to its mail service, specialty pharmacy, and workers' compensation and property and casualty for pharmacy benefit management accreditation programs. The products revised include:

  • Mail-service pharmacy, version 2.0;

  • Specialty pharmacy, version 2.0; and