Content about Specialty Pharmacy

October 12, 2010

Smith Medical Partners, a business focused on specialty pharmaceutical distribution and solutions, announced the launch...

October 7, 2010

Swiss drug maker Roche has bought the rights to an investigative treatment for hepatitis C,...

BASEL, Switzerland Swiss drug maker Roche has bought the rights to an investigative treatment for hepatitis C, Roche said.

 

The company announced Thursday that it had purchased global development and commercialization rights to the drug RG7227/ITMN-191 (danoprevir) from InterMune for $175 million.

 

 

Roche said the drug had shown promise in preclinical and early clinical development. The two companies have been developing the drug since 2006.

 

October 6, 2010

The global pharmaceutical market will reach a value of $880 billion next year, according to...

NORWALK, Conn. The global pharmaceutical market will reach a value of $880 billion next year, according to a report by market research firm IMS Health.

 

IMS Health forecasted 5% to 7% growth in 2011 in its annual IMS Market Prognosis, compared with 4% to 5% growth this year.

 

 

October 5, 2010

An investigative biotech drug administered together with chemotherapy helped extend the lives of cancer patients...

THOUSAND OAKS, Calif. An investigative biotech drug administered together with chemotherapy helped extend the lives of cancer patients without their disease getting worse, also known as progression-free survival, according to results of two clinical trials announced this week by Amgen.

 

October 4, 2010

Specialty pharmacy provider Axium Healthcare Pharmacy will serve as a limited distribution provider for a...

October 4, 2010

The city of Flint soon will give rise to a new job-generating industry in the...

October 4, 2010

Human Genome Sciences and Novartis have decided not to further develop an investigative biologic treatment...

ROCKVILLE, Md. Human Genome Sciences and Novartis have decided not to further develop an investigative biologic treatment for hepatitis C following the Food and Drug Administration’s decision to decline its approval, HGS said Tuesday.

 

HGS said it received a complete response letter from the FDA concerning the drug Zalbin (albinterferon alfa-2b). The FDA delivers a complete response letter to indicate that it has finished reviewing an application, but questions remain that preclude final approval.

 

 

October 3, 2010

The Food and Drug Administration has awarded almost $3 million for tuberculosis research, the agency...

September 30, 2010

Data published in the latest issue of medical journal The Lancet showed that a recently...

BRIDGEWATER, N.J. Data published in the latest issue of medical journal The Lancet showed that a recently approved drug reduced the risk of death in men with a certain form of prostate cancer by more than a quarter.

 

September 29, 2010

The biotech division of Johnson & Johnson is hoping to expand the use of a...

HORSHAM, Pa. The biotech division of Johnson & Johnson is hoping to expand the use of a treatment for autoimmune disorders.

 

Centocor Ortho Biotech said it had filed an application with the Food and Drug Administration to get approval for Simponi (golimumab) to stop the progression of structural damage, induce major clinical response, maintain reductions in signs and symptoms, and improve physical function in the treatment of rheumatoid arthritis.

 

 

September 28, 2010

The drug market for Crohn's disease treatments will see moderate growth over the next decade,...

BURLINGTON, Mass. The drug market for Crohn's disease treatments will see moderate growth over the next decade, Decision Resources reported Wednesday.

The research firm projected that the market will increase a little more than 31%, from $3.2 billion in 2009 to $4.2 billion in 2019, in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Decision Resources said the the modest growth rate masks such market changes as new and emerging biologics, as well as generic competition.

September 28, 2010

Keryx has begun its phase-3 clinicial trial of a drug designed to treat elevated serum...

NEW YORK Keryx has begun its phase-3 clinicial trial of a drug designed to treat elevated serum phosphorous levels in patients with end-stage renal disease on dialysis.

September 28, 2010

While biosimilars promise to provide therapies for a wide range of diseases, their biggest fans...

September 28, 2010

The subject of specialty pharmacy reached a whole new level of nuance as a wide...

September 27, 2010

The market for hypertension drugs will drop by $3 billion by the end of the...

BURLINGTON, Mass. The market for hypertension drugs will drop by $3 billion by the end of the decade due to generic competition, according to a new report by healthcare market research firm Decision Resources.

The report, announced Tuesday, found that the market for drugs to treat high blood pressure would decline from 2009’s $26 billion to $23 billion by 2019 in the United States, United Kingdom, France, Italy, Spain and Japan.

 

September 27, 2010

Pfizer has halted a late-stage trial of a drug therapy in men with prostate cancer,...

NEW YORK Pfizer has halted a late-stage trial of a drug therapy in men with prostate cancer, the drug maker said.

Pfizer announced the discontinuation of “SUN 1120,” a phase-3 trial of Sutent (sunitinib malate) combined with the generic drug prednisone in men with advanced castration-resistant prostate cancer that had progressed despite chemotherapy. An analysis of data from the trial found that the men were not more likely to improve overall survival when taking the two drugs together than when they took prednisone alone.

 

September 27, 2010

The Hart-Scott-Rodino waiting period for Bristol-Myers Squibb’s acquisition of Seattle-based biotech company ZymoGenetics has expired,...

NEW YORK The Hart-Scott-Rodino waiting period for Bristol-Myers Squibb’s acquisition of Seattle-based biotech company ZymoGenetics has expired, enabling Bristol’s acquisition to go through, the drug maker said Tuesday.

 

The drug maker announced the deal to acquire ZymoGenetics for $885 million, or $9.75 per share, earlier this month.

 

 

September 26, 2010

An investigational drug made by Johnson & Johnson for treating pain showed significant reduction in...

RARITAN, N.J. An investigational drug made by Johnson & Johnson for treating pain showed significant reduction in pain intensity compared with placebo in patients with moderate to severe lower back pain, according to results of a late-stage clinical trial announced Monday.

September 22, 2010

The Food and Drug Administration has accepted AstraZeneca’s regulatory application for an investigational cancer drug,...

LONDON The Food and Drug Administration has accepted AstraZeneca’s regulatory application for an investigational cancer drug, the Anglo-Swedish drug maker said Thursday.

 

AstraZeneca announced the FDA’s acceptance of its application for vandetanib, a drug for treating patients with advanced medullary thyroid cancer. The agency gave the drug priority review status and expected to take action on it in January.

 

 

September 21, 2010

Swiss drug maker Novartis said its investigational drug is the first to show promise in...

EAST HANOVER, N.J. Swiss drug maker Novartis said its investigational drug is the first to show promise in a late-stage clinical trial for Cushing’s disease, a potentially fatal hormonal disorder.

 

September 20, 2010

A Food and Drug Administration advisory committee has recommended approval of a drug for patients...

RIDGEFIELD, Conn. A Food and Drug Administration advisory committee has recommended approval of a drug for patients with atrial fibrillation.

 

The FDA cardiovascular and renal drugs advisory committee voted unanimously to recommend approval for Boehringer Ingelheim's Pradaxa (dabigatran etexilate), for preventing strokes in atrial fibrillation patients. For the last 50 years, warfarin has been the only oral anticoagulant drug available for this purpose.

 

 

September 19, 2010

Biotech company Genentech has amended its application to the Food and Drug Administration seeking an...

SOUTH SAN FRANCISCO, Calif. Biotech company Genentech has amended its application to the Food and Drug Administration seeking an additional approval for one of its drugs, which the FDA has deemed a “major amendment,” Genentech said Monday.

 

September 16, 2010

Boehringer Ingelheim has started a late-stage clinical trial of a drug for treating breast cancer,...

INGELHEIM, Germany Boehringer Ingelheim has started a late-stage clinical trial of a drug for treating breast cancer, the German drug maker said Friday.

 

The phase 3 trial, dubbed the “LUX-Breast 1” trial, will evaluate the drug afatinib in patients with advanced breast cancer. The drug is a tablet that BI said was the first to inhibit two chemicals involved in tumor growth -- the epidermal growth factor receptor, or EGFR, and the human epidermal receptor, also known as HER2.

 

 

September 16, 2010

Emergent BioSolutions has landed a $51 million contract from the Department of Health and Human...

WASHINGTON Emergent BioSolutions has landed a $51 million contract from the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority to develop a new anthrax vaccine.

In the first two years of the contract, Emergent will develop the final vaccine formulation and test its stability. HHS said it can extend the contract annually for up to three years to support scale-up and optimization for large-scale manufacturing, as well as additional animal studies needed to apply for Food and Drug Administration approval of the vaccine.

September 16, 2010

The Food and Drug Administration has accepted for review a regulatory approval application for a...

WOODCLIFF LAKE, N.J. The Food and Drug Administration has accepted for review a regulatory approval application for a patch made by Eisai to treat Alzheimer’s disease, the drug maker said Friday.

 

The agency will review a patch formulation of Aricept (donepezil hydrochloride), a weekly patch for treating mild, moderate and severe stages of the disease. The drug already is available in tablet form.