Content about Pharmacology

February 13, 2013
FDA gives breakthrough therapy designations to experimental cancer drug

The Food and Drug Administration has given a special, new designation to a cancer drug under development by Johnson & Johnson and Pharmacyclics, the companies said.

RARITAN, N.J. — The Food and Drug Administration has given a special designation to a cancer drug under development by Johnson & Johnson and Pharmacyclics, the companies said.

J&J subsidiary Janssen Research & Development and Pharmacyclics announced that the FDA had given breakthrough therapy designations to the experimental drug ibrutinib as a standalone therapy for relapsed or refractory mantle cell lymphoma in patients who have received prior therapy and for Waldenstrom's macroglobulinemia.

February 13, 2013
NCPA outlines legislative priorities

The National Community Pharmacists Association on Wednesday announced its federal and state legislative priorities with the release of the Independent Community Pharmacy Checklist.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Wednesday announced its federal and state legislative priorities with the release of the Independent Community Pharmacy Checklist. The one-page document details the main legislative actions NCPA and its members will advocate for this year at the federal and state levels. 

February 13, 2013
State of the Union address draws mixed responses from drug industry

Some people liked President Barack Obama's State of the Union address Tuesday night, and some people didn't, and the response from the drug industry was no less mixed.

WASHINGTON — Some people liked President Barack Obama's State of the Union address Tuesday night, and some people didn't, and the response from the drug industry was no less mixed.

The Generic Pharmaceutical Association called for measures to lower healthcare costs, including ensuring that generic pharmaceuticals and biosimilars reach patients' hands quickly and also avoiding measures intended to provide savings that the GPhA said would raise prescription drug costs, though the grow didn't specify what those measures were.

February 12, 2013
Galderma drug for common skin condition becomes available

A topical medication made by Galderma Labs for treating melasma of the face is now available in pharmacies, Galderma said.

FORT WORTH, Texas — A topical medication made by Galderma Labs for treating melasma of the face is now available in pharmacies, Galderma said.

Tri-Luma (fluocinolone acetonide 0.01%, hydroquinone 4%), tretinoin 0.05%) is described as the only Food and Drug Administration-approved triple combination topical product for the short-term treatment of moderate to severe melasma. The chronic skin condition affects more than 7 million people in the United States.

February 12, 2013
Post-approval drug problems could be due to poor adherence in trials, study finds

Unexpected toxicities from prescription drugs that emerge years after regulatory approval may be due to poor medication adherence in clinical trials, according to a new study.

MCLEAN, Va. — Unexpected toxicities from prescription drugs that emerge years after regulatory approval may be due to poor medication adherence in clinical trials, according to a new study.

While much attention on medication adherence has focused on patients not taking the already approved drugs prescribed to them or not taking them properly, the new study, released Tuesday by Consumer Health Information, found problems with adherence in clinical trials as well.

February 12, 2013
Putney aims to compete in generic pet drug market with new launch

Putney has launched a generic version of a veterinary skin infection drug, the company said.

PORTLAND, Maine — Putney has launched a generic version of a veterinary skin infection drug, the company said.

Putney announced the launch of cefpodoxime proxetil, a generic version of Pfizer's Simplicef, used to treat certain skin infections in dogs. Putney said its product was the only generic version of Simplicef approved by the Food and Drug Administration.

February 12, 2013
Reports: GSK among companies looking to acquire Brazil's fourth-largest drug firm

GlaxoSmithKline may be looking to buy a Brazilian drug maker for up to $4 billion, according to published reports.

NEW YORK — GlaxoSmithKline may be looking to buy a Brazilian drug maker for up to $4 billion, according to published reports.

Reuters, citing unnamed sources, said GSK was one of several drug companies looking to buy Ache Laboratorios Farmaceuticos for $3 billion to $4 billion. Other companies looking to buy the drug maker included Novartis, Pfizer and Abbott Labs.

Reuters noted that the company was attractive to drug makers looking to expand their footprints in Latin America and that it was a major producer of prescription and OTC medications.

February 12, 2013
Tough new regulations for compounding pharmacies could be on the way, attorney says

Massachusetts and New Jersey lately have been cracking down on sterile compounding pharmacies alleged to violate safety regulations, but the crackdown may soon go nationwide, predicted a legal firm focused on the matter.

WASHINGTON — Massachusetts and New Jersey lately have been cracking down on sterile compounding pharmacies alleged to violate safety regulations, but the crackdown may soon go nationwide, predicted a legal firm focused on the matter.

LeClairRyan attorney Michael Ruggio said officials in several states were increasing scrutiny of compounding pharmacies in the wake of an outbreak of fungal meningitis linked to the New England Compounding Center, which so far sickened 696 people and killed 45, according to the Centers for Disease Control and Prevention.

February 11, 2013
Shire to pay Impax $48 million in authorized generic Adderall XR case

Generic drug maker Impax Labs has settled with Shire Labs over an authorized generic version of a Shire drug for treating attention deficit hyperactivity disorder, Impax said.

HAYWARD, Calif. — Generic drug maker Impax Labs has settled with Shire Labs over an authorized generic version of a Shire drug for treating attention deficit hyperactivity disorder, Impax said.

February 11, 2013
Titan Medical Enterprises shut down after violating drug, supplement good manufacturing practices

A federal judge has ordered a California company and its owner to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration reported.

SILVER SPRING, Md. — A federal judge has ordered a California company and its owner to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration reported Friday. 

February 8, 2013
FDA approves generic diabetes drug

The Food and Drug Administration has approved a generic diabetes drug made by Macleods Pharma, according to agency records.

SILVER SPRING, Md. - The Food and Drug Administration has approved a generic diabetes drug made by Macleods Pharma, according to agency records.

The FDA approved Macleods' pioglitazone hydrochloride tablets in the 15 mg, 30 mg and 45 mg strengths.

The drug is a generic version of Takeda's Actos, branded and generic versions of which had sales of about $2.7 billion during the 12-month period that ended in August 2012, according to IMS Health.

February 8, 2013
FDA approves multiple myeloma drug

The Food and Drug Administration has approved a new drug made by Celgene for treating the cancer multiple myeloma, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Celgene for treating the cancer multiple myeloma, the agency said Friday.

The FDA announced the approval of Pomalyst (pomalidomide) for patients whose disease has progressed after treatment with other cancer drugs.

February 8, 2013
FDA gives tentative approval to Dr. Reddy's hypertension drug

The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

 SILVER SPRING, Md. - The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

The FDA granted tentative approval to Dr. Reddy's Labs' valsartan tablets in the 40 mg, 80 mg, 160 mg and 320 mg strengths.

The drug is a generic version of Novartis' Diovan. Various versions of the drug had sales of $1.6 billion during the 12-month period that ended in June, according to IMS Health.

February 8, 2013
Report: New FDA switch paradigm could bring $36 billion in prescription revenue to the front end

A new switch paradigm could open the door to $35.7 billion in OTC opportunity, according to a new report recently released by Francesco International.

MONMOUTH BEACH, N.J. — A new switch paradigm could open the door to $35.7 billion in OTC opportunity, according to a new report recently released by Francesco International. 

February 8, 2013
Reports: Amgen plans six biosimilars

Biotech drug maker Amgen plans to launch six biosimilar drugs starting in 2017, according to published reports.

NEW YORK — Biotech drug maker Amgen plans to launch six biosimilar drugs starting in 2017, according to published reports.

February 8, 2013
Reports: Mass. health authorities shut down 10 compounding pharmacies over violations

Surprise inspections at 40 compounding pharmacies in Massachusetts last fall have led to 10 being ordered to stop sterile compounding, according to published reports.

NEW YORK - Surprise inspections at 40 compounding pharmacies in Massachusetts last fall have led to 10 being ordered to stop sterile compounding, according to published reports.

State health authorities sent cease-and-desist letters to 11 pharmacies, telling 10 to stop compounding altogether and one to stop compounding the drug sildenafil citrate. Twenty-one other pharmacies were allowed to continue compounding, but were cited for minor violations.

February 8, 2013
Rx-to-OTC switches could be boon as FDA looks at switch paradigm

A new report by Francesco International identified $35.7 billion worth of potential Rx-to-OTC switches in a wide range of indications, from hypertension and chronic obstructive pulmonary disorder to high cholesterol and erectile dysfunction, and the Food and Drug Administration has been looking at ways technology and pharmacists could be employed to ensure that patients taking drugs new to the consumer health space take them appropriately.

With growth in traditional pharmaceuticals expected to slow down significantly, a growing number of drug makers — branded and generic alike — see specialty drugs as their main sources of revenue for the foreseeable future. At the same time, those drug makers not invested in specialty may be looking for growth opportunities in consumer health.

A new report by Francesco International identified $35.7 billion worth of potential Rx-to-OTC switches in a wide range of indications, from hypertension and chronic obstructive pulmonary disorder to high cholesterol and erectile dysfunction, and the Food and Drug Administration has been looking at ways technology and pharmacists could be employed to ensure that patients taking drugs new to the consumer health space take them appropriately

February 7, 2013
CVS Caremark announces expansion of Pharmacy Advisor program

CVS Caremark has announced the extension of its Pharmacy Advisor program to cover an additional five chronic conditions, including asthma, breast cancer, chronic obstructive pulmonary disease, depression and osteoporosis.

WOONSOCKET, R.I. — CVS Caremark has announced the extension of its Pharmacy Advisor program to cover an additional five chronic conditions, including asthma, breast cancer, chronic obstructive pulmonary disease, depression and osteoporosis.

February 7, 2013
Patient follow-up could reduce complications with medication side effects, study finds

Researchers in Canada found that pharmacists who call their patients after a prescription has been filled can help reduce and manage adverse drug reactions for those patients.

QUEBEC — Researchers in Canada found that pharmacists who call their patients after a prescription has been filled can help reduce and manage adverse drug reactions for those patients.

The researchers used automated calls to follow-up with 629 patients at family practices in Quebec three days and then again 17 days after a presciption was filled with four simple "yes-or-no" questions.

February 7, 2013
Purdue Pharma drug 'significantly' reduces time to fall back asleep in insomnia patients, study finds

An insomnia drug made by Purdue Pharma "significantly" reduced the time it took patients to return to sleep after they'd woke up in the middle of the night, according to a new study.

STAMFORD, Conn. — An insomnia drug made by Purdue Pharma "significantly" reduced the time it took patients to return to sleep after they'd woke up in the middle of the night, according to a new study.

The placebo-controlled study, published in the journal Sleep, tested the drug Intermezzo (zolpidem tartrate) sublingual tablets on 295 adults with primary insomnia and difficulty returning to sleep after waking up in the middle of the night. Purdue said Intermezzo was the only drug approved by the Food and Drug Administration for treating such patients.

February 6, 2013
FDA approves Elite Pharmaceuticals' opioid painkiller

The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

NORTHVALE, N.J. — The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

Elite announced the FDA approval of its supplemental application for the manufacture and packaging of naltrexone hydrochloride tablets in the 50-mg strength. The company said the approval would allow it to start manufacturing and packaging the drug for its sales and marketing partner, Mikah Pharma, from which it bought rights to the drug in September 2010.

February 6, 2013
FDA approves Sandoz antibiotic

The Food and Drug Administration has approved a generic antibiotic made by Sandoz, the drug maker said Wednesday.

PRINCETON, N.J. — The Food and Drug Administration has approved a generic antibiotic made by Sandoz, the drug maker said Wednesday.

Sandoz, the generics arm of Swiss drug maker Novartis, announced the approval and launch of clindamycin in 5% dextrose in minibag form, the first generic version of Pfizer's Cleocin Phosphate in Dextrose 5%.

Sales of the branded version were $52.2 million in 2012, according to IMS Health.

February 6, 2013
Reports: Senators introduce bill to ban 'pay-for-delay' settlements

Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.

NEW YORK — Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.

February 5, 2013
CueScript launches patient engagement, medication adherence tool for pharmacy

CueScript on Tuesday launched an innovative platform that delivers on-demand prescription-specific videos and other value-added services designed to engage patients, improve health literacy and improve medication adherence.

LAKE MARY, Fla. — CueScript on Tuesday launched an innovative platform that delivers on-demand prescription-specific videos and other value-added services designed to engage patients, improve health literacy and improve medication adherence. 

February 5, 2013
CVS promotes heart health

CVS Caremark is marking American Heart Month by encouraging heart-healthy behavior in February, the company said Tuesday.

WOONSOCKET, R.I. — CVS Caremark is marking American Heart Month by encouraging heart-healthy behavior in February, the company said Tuesday.