Content about Specialty Pharmacy

February 1, 2011

A federal judge in Florida has overturned a key portion of the healthcare-reform law and ruled that the entire law must be scrapped.

PENSACOLA, Fla. — A federal judge in Florida has overturned a key portion of the healthcare-reform law and ruled that the entire law must be scrapped.

January 31, 2011

A pharmaceutical wholesaler has promoted one of its executives.

SPRINGFIELD, Ill. — A pharmaceutical wholesaler has promoted one of its executives.

H. D. Smith said Harvey Tanenbaum — an industry veteran with more than 30 years of experience — now will serve as the company's EVP, responsible for all efforts connected to metro New York area expansion.

January 31, 2011

Pfizer has completed its tender offer for Bristol, Tenn.-based King Pharmaceuticals, Pfizer said Monday.

NEW YORK — Pfizer has completed its tender offer for Bristol, Tenn.-based King Pharmaceuticals, Pfizer said Monday.

Pfizer said 230.7 million shares valued at $14.25 each were tendered, representing about 92.5% of King.

Pfizer made its $3.6 billion offer for King in October 2010. The offer cleared the waiting period mandated by the Hart-Scott-Rodino Antitrust Improvements Act of 1976 on Friday.

January 31, 2011

Transcept announced Monday that the Food and Drug Administration has classified the drug maker's insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

POINT RICHMOND, Calif. — Transcept announced Monday that the Food and Drug Administration has classified the drug maker's insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

Transcept resubmitted its new drug application for Intermezzo (zolpidem tartrate) on Jan. 18 after receiving a complete response letter from the FDA in October 2009. The drug maker said for the completion of the NDA review, the FDA set the PDUFA action date for July 14.

January 28, 2011

A former Albertsons executive has been named the newest VP pharmacy at ECRM.

NEW YORK — A former Albertsons executive has been named the newest VP pharmacy at ECRM.

Italo Pennella, a licensed pharmacist, will utilize his insight on the pharmaceutical supply chain as ECRM's newest executive. At Albertsons, Pennella's career spanned more than 10 years, which included oversight of all brand manufacturer relationships. Prior to joining ECRM, Pennella most recently served as associated director of trade for Otsuka and Schering-Plough/Organon.

January 27, 2011

The Food and Drug Administration declined to approve a regulatory approval application from British drug maker GlaxoSmithKline concerning a cancer drug, GSK said Wednesday.

LONDON — The Food and Drug Administration declined to approve a regulatory approval application from British drug maker GlaxoSmithKline concerning a cancer drug, GSK said Wednesday.

GSK said the FDA issued a complete response letter for its application seeking approval for Avodart (dutasteride) to reduce the risk of prostate cancer in men at increased risk of developing the disease. The drug already is approved to treat enlarged prostate.

January 27, 2011

A Mylan subsidiary has inked a nonexclusive license agreement with Tibotec Pharmaceuticals to manufacture, market and distribute a generic version of an HIV treatment.

PITTSBURGH — A Mylan subsidiary has inked a nonexclusive license agreement with Tibotec Pharmaceuticals to manufacture, market and distribute a generic version of an HIV treatment.

Pending the regulatory approval of TMC278 (rilpivirine hydrochloride), Matrix Labs will have the right to manufacture once-daily 25-mg TMC278 as a single-agent medicine and a fixed-dose combination product, Mylan said. Matrix also will be able to market the drug in sub-Saharan Africa, certain developing countries and India.

January 26, 2011

Generic drug makers Teva Pharmaceutical Industries and APP Pharmaceuticals have launched their version of a chemotherapy drug, the two companies said Wednesday.

JERUSALEM — Generic drug makers Teva Pharmaceutical Industries and APP Pharmaceuticals have launched their version of a chemotherapy drug, the two companies said Wednesday.

Teva and APP launched gemcitabine hydrochloride injfection in 200-mg and 1-g single-dose vials. The drug is a version of Eli Lilly’s Gemzar, which had sales of about $785 million in the United States in 2010, according to IMS Health. The drug is used to treat cancers of the lungs, pancreas, breasts and ovaries.

January 24, 2011

An investigational schizophrenia drug appears effective in reducing agitation in patients with the disease, according to results of a late-stage clinical trial published in the British Journal of Psychiatry.

MOUNTAIN VIEW, Calif. — An investigational schizophrenia drug appears effective in reducing agitation in patients with the disease, according to results of a late-stage clinical trial published in the British Journal of Psychiatry.

Alexza Pharmaceuticals announced results of a phase-3 trial of the inhaled drug AZ-004 (loxapine), which showed statistically significant improvement in symptoms of agitation in patients compared with the placebo.

January 20, 2011

A nonprofit clinic that caters to New York’s gay, lesbian, bisexual and transgender communities and people living with HIV and AIDS has opened a new pharmacy.

NEW YORK — A nonprofit clinic that caters to New York’s gay, lesbian, bisexual and transgender communities and people living with HIV and AIDS has opened a new pharmacy.

January 20, 2011

British drug maker ProStrakan Group will partner with two U.S. companies to administer its risk evaluation and mitigation strategy for a cancer pain drug.

ATLANTA — British drug maker ProStrakan Group will partner with two U.S. companies to administer its risk evaluation and mitigation strategy for a cancer pain drug.

ProStrakan said it would use RelayHealth Pharmacy Solutions’ and McKesson Specialty Care Solutions’ services to administer the REMS for Abstral (fentanyl citrate), a drug that patients can place under the tongue to treat breakthrough pain associated with cancer when they already have received and become tolerant of opioid painkillers.

January 19, 2011

Drug maker Genentech is hoping to keep a breast cancer treatment on the market as the Food and Drug Administration considers whether to revoke its approval for the disease, according to published reports.

NEW YORK — Drug maker Genentech is hoping to keep a breast cancer treatment on the market as the Food and Drug Administration considers whether to revoke its approval for the disease, according to published reports.

The San Francisco Business Times reported Tuesday that Genentech, part of Swiss drug maker Roche, is appealing the FDA’s plan to revoke approval for the drug Avastin (bevacizumab) as a first-line treatment for advanced HER2-negative breast cancer in combination with paclitaxel chemotherapy.

January 19, 2011

Patients taking an investigational drug made by Genentech for advanced skin cancer fared better than those receiving standard treatments, according to results of a late-stage clinical trial announced Wednesday.

SOUTH SAN FRANCISCO, Calif. — Patients taking an investigational drug made by Genentech for advanced skin cancer fared better than those receiving standard treatments, according to results of a late-stage clinical trial announced Wednesday.

The company, part of Swiss drug maker Roche, said patients with advanced melanoma containing a mutated version of a protein called BRAF lived longer when receiving the orally administered personalized investigational medicine RG7204 than those receiving the injected chemotherapy drug dacarbazine.

January 18, 2011

Pfizer president and general manager for specialty care and oncology, Geno Germano, will deliver the “State of the Pharma/Biotech Industry Address” at the 2011 Armada Specialty Pharmacy Summit, Armada Health Care said Tuesday.

FLORHAM PARK, N.J. — Pfizer president and general manager for specialty care and oncology, Geno Germano, will deliver the “State of the Pharma/Biotech Industry Address” at the 2011 Armada Specialty Pharmacy Summit, Armada Health Care said Tuesday.

The summit, which will take place in Las Vegas in May, is in its seventh year and is expected to bring 1,500 participants representing 400 specialty healthcare organizations, including specialty pharmacy providers, pharmaceutical and biotech companies, wholesale distributors and others.

January 18, 2011

Generic drug maker Sandoz has started a mid-stage clinical trial of a monoclonal antibody used to treat cancer and autoimmune disease, the company said.

HOLZKIRCHEN, Switzerland — Generic drug maker Sandoz has started a mid-stage clinical trial of a monoclonal antibody used to treat cancer and autoimmune disease, the company said.

Sandoz (pronounced “SAN-doh”), the generics arm of Swiss drug maker Novartis, announced the start of a phase-2 trial of rituximab, a biosimilar of Genentech’s Rituxan, used to treat such conditions as non-Hodgkin’s lymphoma and rheumatoid arthritis.

January 17, 2011

Japanese drug maker Takeda Pharmaceutical has signed an agreement with Durham, N.C.-based Zinfandel Pharmaceuticals to develop a test for assessing Alzheimer’s disease risk in adults, the two companies said.

OSAKA, Japan — Japanese drug maker Takeda Pharmaceutical  has signed an agreement with Durham, N.C.-based Zinfandel Pharmaceuticals to develop a test for assessing Alzheimer’s disease risk in adults, the two companies said.

January 14, 2011

Specialty pharmacy and home infusion provider CarePoint Partners has acquired a Houston-based infusion company that it said would make it a leader in the Texas market.

CINCINNATI — Specialty pharmacy and home infusion provider CarePoint Partners has acquired a Houston-based infusion company that it said would make it a leader in the Texas market.

CarePoint announced the acquisition of ivA Lifetec, a home-infusion pharmacy that specializes in infusions for children, as well as nursing. Financial details were not disclosed. CarePoint said Lifetec was its 10th acquisition since December 2007, and that it now provides home infusion and specialty services in seven states.

January 14, 2011

The Food and Drug Administration has approved a new formulation of a drug for treating acetaminophen poisoning.

NASHVILLE, Tenn. — The Food and Drug Administration has approved a new formulation of a drug for treating acetaminophen poisoning.

Cumberland Pharmaceuticals announced Thursday that the agency had approved a version of Acetadote (acetylcysteine) injection that does not contain preservatives or stabilization and chelating agents, and will replace the currently marketed version. The drug originally was approved in 2004.

January 13, 2011

Specialty pharmacy provider Axium Healthcare Pharmacy has launched an online portal to complement its services, the company said Wednesday.

LAKE MARY, Fla. — Specialty pharmacy provider Axium Healthcare Pharmacy has launched an online portal to complement its services, the company said Wednesday.

AxiumPortal.com allows patients to manage their accounts, request refills, make co-payments, set reminders and perform other functions.

January 13, 2011

K-V Pharmaceutical announced Wednesday that the Food and Drug Administration extended its Prescription Drug User Fee Act action date to April 13 for a drug under development for preventing preterm birth.

ST. LOUIS — K-V Pharmaceutical announced Wednesday that the Food and Drug Administration extended its Prescription Drug User Fee Act action date to April 13 for a drug under development for preventing preterm birth.

K-V, which acquired the injected drug Gestiva (hydroxyprogesterone caproate) from Hologic in 2008, said Hologic originally had been told the FDA would take action Thursday.

K-V said it was confident the drug would receive approval and that the FDA would take action on or before the new PDUFA date.

January 13, 2011

Various companies in the healthcare industry are uncertain about the benefits of the Food and Drug Administration’s risk evaluation and mitigation strategy program, and most think it needs a major overhaul, according to a study by the Tufts University Center for the Study of Drug Development.

BOSTON — Various companies in the healthcare industry are uncertain about the benefits of the Food and Drug Administration’s risk evaluation and mitigation strategy program, and most think it needs a major overhaul, according to a study by the Tufts University Center for the Study of Drug Development.

The CSDD called the study the first systematic look at REMS since the FDA introduced the program in 2008. The FDA requires drug companies to create a REMS when the agency decides it is necessary to ensure that a drug’s benefits outweigh its risks.

January 10, 2011

PakSense has launched a small device for monitoring the temperatures of medicines, the company said Monday.

BOISE, Idaho — PakSense has launched a small device for monitoring the temperatures of medicines, the company said Monday.

PakSense said its BIOmed Label is about the size of a sugar packet and can be used to digitally monitor the temperatures of pharmaceuticals, biologics and vaccines during storage and distribution.

January 10, 2011

It appears that French drug maker Sanofi-Aventis’ efforts to acquire U.S. biotech company Genzyme are getting somewhere, according to company and media reports.

CAMBRIDGE, Mass. — It appears that French drug maker Sanofi-Aventis’ efforts to acquire U.S. biotech company Genzyme are getting somewhere, according to company and media reports.

January 7, 2011

Pfizer has paid Seattle Genetics $8 million to license its antibody technology, Seattle Genetics said Thursday.

BOTHELL, Wash. — Pfizer has paid Seattle Genetics $8 million to license its antibody technology, Seattle Genetics said Thursday.

Seattle Genetics, based in Bothell, Wash., said Pfizer would pursue antibodies for treating an unspecified form of cancer using its antibody-drug conjugate technology. ADCs are monoclonal antibodies that selectively deliver anti-cancer agents to tumor cells. Seattle Genetics has developed anti-tumor drugs called auristatins, which are attached to antibodies and then used to kill the cancer cells while sparing noncancer cells.

January 6, 2011

The Food and Drug Administration has accepted the approval application for a chemotherapy drug to treat lung cancer from AdventRx Pharmaceuticals, the drug maker said Thursday.

SAN DIEGO — The Food and Drug Administration has accepted the approval application for a chemotherapy drug to treat lung cancer from AdventRx Pharmaceuticals, the drug maker said Thursday.

The FDA accepted AdventRx’s application for Exelbine (vinorelbine). The drug is a branded generic, being formulated with the same active ingredient as Navelbine, originally marketed by French drug maker Pierre Fabre and now available as a generic from seven companies.