Content about Pharmacology

February 1, 2011

The Food and Drug Administration has turned down an application for an anti-obesity drug.

SAN DIEGO — The Food and Drug Administration has turned down an application for an anti-obesity drug.

Orexigen Therapeutics and Takeda Pharmaceutical said Tuesday that the FDA had issued a complete response letter for their application for Contrave (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets.

February 1, 2011

Just when you thought the low end of the generic drug price spectrum couldn’t get any more commoditized, the $2 price point debuted with a big splash in September 2010.


February 1, 2011

NEW YORK — The U.S. healthcare system could get at least $70 billion in savings over the next four years thanks to loss of patent protection for branded drugs, according to published reports.


IMS Health SVP Murray Aitken said at the Reuters Health Summit that generics also would increase their dominance in terms of prescriptions dispensed, increasing from 77% during the first half of this year to perhaps 85% by 2014, Reuters reported.


February 1, 2011

ISSAQUAH, Wash. — Vic Curtis has come a long way since he began working for Costco Wholesale in 1991 as a pharmacy manager. 


Recently, he was promoted to SVP pharmacy and has seen action in prescription and OTC merchandising, pharmacy operations, mail-order and Internet-based pharmacy, and pharmacy benefit management services, as part of Costco’s team led by Charlie Burnett, the “dean” of Costco’s pharmacy/health and beauty business.

February 1, 2011

Fears about the likelihood of medication errors have officials in Pennsylvania mulling the possibility of restrictions on patients transferring prescriptions from one pharmacy to another, according to published reports.

NEW YORK — Fears about the likelihood of medication errors have officials in Pennsylvania mulling the possibility of restrictions on patients transferring prescriptions from one pharmacy to another, according to published reports.

CNBC reported Sunday that a rule recently put in place by the Ohio Board of Pharmacy that allows only one transfer per year had inspired Pennsylvania officials to consider a similar rule for their own state.

February 1, 2011

Years 2009 and 2010 were up and down for the generic drug industry and its main trade group, the Generic Pharmaceutical Association. On one hand, there were the departures of president and CEO Kathleen Jaeger and member company Teva Pharmaceutical Industries.

January 31, 2011

Nearly half a million people participated in AstraZeneca's prescription savings programs.

WILMINGTON, Del. — Nearly half a million people participated in AstraZeneca's prescription savings programs.

The drug maker reported that it provided $947 million in savings last year to the more than 545,000 patients in the United States who participated. Participation in the AZ&Me prescription savings programs has increased steadily over the past three years, up 7% over 2009 and 19% over 2008, AstraZeneca said.

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 25, 2011

Generic drug maker Mylan has entered settlements with Pfizer concerning two drugs for treating cholesterol.

PITTSBURGH — Generic drug maker Mylan has entered settlements with Pfizer concerning two drugs for treating cholesterol.

Mylan announced Tuesday that it had settled patent litigation suits with Pfizer concerning Lipitor (atorvastatin calcium) and Caduet (atorvastatin calcium and amlodipine besylate).

Under the Caduet agreement, the lawsuit will be dismissed, and Mylan can launch its generic version on Nov. 30. Terms of the Lipitor agreement remain confidential.

January 25, 2011

Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

JERUSALEM — Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

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 24, 2011

As many as 71% of cough-cold sufferers in search of decongestant relief oppose a prescription requirement for pseudoephedrine, according to a survey commissioned by the Asthma and Allergy Foundation of America released Monday.

WASHINGTON — As many as 71% of cough-cold sufferers in search of decongestant relief oppose a prescription requirement for pseudoephedrine, according to a survey commissioned by the Asthma and Allergy Foundation of America released Monday.

January 21, 2011

A drug for major depressive disorder worked better than placebo, according to results of a late-stage clinical trial announced Thursday.

NEW YORK — A drug for major depressive disorder worked better than placebo, according to results of a late-stage clinical trial announced Thursday.

U.S. drug maker Forest Labs and French drug maker Pierre Fabre Medicament said that while the overall difference between patients treated with levomilnacipran and those treated with the placebo was not statistically significant, the drug consistently demonstrated improvement relative to the placebo over the course of the phase-3 trial.

January 21, 2011

Pfizer again has extended the expiration date on its tender offer to buy Bristol, Tenn.-based King Pharmaceuticals to Jan. 28, the drug maker said Friday.

NEW YORK — Pfizer again has extended the expiration date on its tender offer to buy Bristol, Tenn.-based King Pharmaceuticals to Jan. 28, the drug maker said Friday.

Pfizer announced in October that it would buy King for $3.6 billion, or $14.25 per share. King manufactures branded prescription drugs, including several painkillers.

January 21, 2011

Generic drug maker Watson Pharmaceuticals expects sales of $4.2 billion for 2011, the company said Friday.

NEW YORK — Generic drug maker Watson Pharmaceuticals expects sales of $4.2 billion for 2011, the company said Friday.

The company expected the forecasted sales for the year to include between $2.8 billion and $3 billion in global generics sales, compared with around $2.35 billion in 2010. Total sales for 2010 were around $3.5 billion, according to preliminary financial results released last week.

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 18, 2011

Healthcare market research firm IMS Health will buy privately held market research firm SDI Health, IMS said.

NEW YORK — Healthcare market research firm IMS Health will buy privately held market research firm SDI Health, IMS said.

Terms of the transaction were not disclosed, but the deal would bring together two of the leading healthcare analytics companies. In terms of drug industry analytics, IMS focuses on drug sales and dispensed prescriptions, while SDI provides data on prescriptions written by physicians and other prescribers.

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 18, 2011

Transcept Pharmaceuticals has resubmitted its regulatory application for a drug to treat insomnia to the Food and Drug Administration, following a previous denial of approval by the agency, the drug maker said Tuesday.

POINT RICHMOND, Calif. — Transcept Pharmaceuticals has resubmitted its regulatory application for a drug to treat insomnia to the Food and Drug Administration, following a previous denial of approval by the agency, the drug maker said Tuesday.

Transcept sent in its application for Intermezzo (zolpidem tartrate), a pill placed under the tongue for treating patients who awake in the middle of the night and have difficulty falling asleep again.

January 17, 2011

A new drug application for Anglo-Swedish drug maker AstraZeneca's vandetanib has been extended.

LONDON — A new drug application for Anglo-Swedish drug maker AstraZeneca's vandetanib has been extended.

The drug maker recently announced that the Food and Drug Administration asked AstraZeneca to submit a Risk Evaluation and Mitigation Strategy, which accordingly extended the Prescription Drug User Fee Act from Jan. 7 to April 7.

AstraZeneca will continue to work closely with the FDA to support the review of vandetanib, a drug for treating patients with advanced medullary thyroid cancer.

January 14, 2011

The battle for the prescription status of methamphetamine precursor/popular cough-cold ingredient pseudoephedrine now is heating up in Kentucky, just a few days following a Nevada news report that suggested the state will be considering PSE prescription-only requirements just as soon as a bill is introduced by Nevada Sen. Sheila Leslie, D-Reno.

FRANKFORT, Ky. — The battle for the prescription status of methamphetamine precursor/popular cough-cold ingredient pseudoephedrine now is heating up in Kentucky, just a few days following a Nevada news report that suggested the state will be considering PSE prescription-only requirements just as soon as a bill is introduced by Nevada Sen. Sheila Leslie, D-Reno.

January 14, 2011

Pernix Therapeutics Holdings on Wednesday announced an exclusive co-promotion agreement with ParaPro for a medication to treat head lice.

MAGNOLIA, Texas — Pernix Therapeutics Holdings on Wednesday announced an exclusive co-promotion agreement with ParaPro for a medication to treat head lice.

A new drug application for the prescription product currently is under review by the Food and Drug Administration. The proposed medication contains the active ingredient spinosad, which is derived from a naturally occurring soil bacterium.

January 13, 2011

Nevada Sen. Sheila Leslie, D-Reno, is working with Carson City district attorney Neil Rombardo on introducing a bill to require a prescription for pseudoephedrine as a tool to cut down on illicit methamphetamine production, the Las Vegas Review-Journal reported Wednesday evening.

LAS VEGAS — Nevada Sen. Sheila Leslie, D-Reno, is working with Carson City district attorney Neil Rombardo on introducing a bill to require a prescription for pseudoephedrine as a tool to cut down on illicit methamphetamine production, the Las Vegas Review-Journal reported Wednesday evening.

January 12, 2011

Drug maker Merck and drug industry services organization Parexel International will work together to develop biosimilars, the two said Wednesday.

WHITEHOUSE STATION, N.J. — Drug maker Merck and drug industry services organization Parexel International will work together to develop biosimilars, the two said Wednesday.

Under the agreement, Parexel will give Merck BioVentures access to clinical and regulatory services for the development of biosimilars. Financial terms of the agreement were not disclosed.

January 12, 2011

The independent pharmacy lobby has issued a letter to the House Committee on Oversight and Government Reform chairman, Rep. Darrell Issa, R-Calif., with insight on how certain current or proposed federal regulations can burden pharmacies and their patients.

ALEXANDRIA, Va. — The independent pharmacy lobby has issued a letter to the House Committee on Oversight and Government Reform chairman, Rep. Darrell Issa, R-Calif., with insight on how certain current or proposed federal regulations can burden pharmacies and their patients.