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February 22, 2013

The Food and Drug Administration has approved a new treatment for late-stage breast cancer, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for late-stage breast cancer, the agency said Friday.

The FDA announced the approval of Genentech's Kadcyla (ado-trastuzumab emtansine) for HER2-positive breast cancer that has spread to other parts of the body. HER2 is a protein involved in the growth of normal cells but found in increased amounts in some kinds of cancer cells, which contributes to cancer cell growth and survival. Genentech is the U.S. subsidiary of Swiss drug maker Roche.

February 21, 2013

The Food and Drug Administration has approved a new vial size for a drug made by CSL Behring to treat a bleeding disorder and an immune disorder, the company said.

KING OF PRUSSIA, Pa. — The Food and Drug Administration has approved a new vial size for a drug made by CSL Behring to treat a bleeding disorder and an immune disorder, the company said Thursday.

February 21, 2013

Valeant Pharmaceuticals has bought rights to a drug used to treat skin cancer from Eisai, the companies said Thursday.

WOODCLIFF LAKE, N.J. — Valeant Pharmaceuticals has bought rights to a drug used to treat skin cancer from Eisai, the companies said Thursday.

Valeant has bought the rights to Targretin (bexarotene) capsules and gel from Eisai for $65 million upfront, plus additional payments based on certain milestones. Under the deal, Eisai has transferred its regulatory approval application to Valeant, which will assume responsibilities for all regulatory obligations associated with the product in the United States. Eisai will retain rights to the drug outside the United States.

February 20, 2013

A division of drug maker Mylan has distributed auto-injectors of an emergency drug used for severe allergic reactions to schools nationwide.

BASKING RIDGE, N.J. — A division of drug maker Mylan has distributed autoinjectors of an emergency drug used for severe allergic reactions to schools nationwide.

Mylan Specialty said Wednesday that since its August 2012 launch of the EpiPen4Schools program, thousands of schools around the country had elected to participate and receive free EpiPen and EpiPen Jr (epinephrine) auto-injectors. The program was launched to help schools have improved access to epinephrine in the event that a person experiences a life-threatening allergic reaction, also known as anaphylaxis.

February 20, 2013

Lobbying groups for the retail pharmacy industry have a few suggestions for the Drug Enforcement Administration for drug take-back programs.

ARLINGTON, Va. — Lobbying groups for the retail pharmacy industry have a few suggestions for the Drug Enforcement Administration for drug take-back programs.

The National Association of Chain Drug Stores expressed support for a rule the DEA proposed in December to govern the secure disposal of controlled substances by DEA registrants - including pharmacies - and patients, as well as people acting on their behalf.

February 19, 2013

For the week ended Feb. 9, influenza activity decreased to 3.2% — still above the baseline of 2.2%, but an indicator this year's flu season is on its way out.

ATLANTA — For the week ended Feb. 9, influenza activity decreased to 3.2% — still above the baseline of 2.2%, but an indicator this year's flu season is on its way out. 

Eleven states and New York City were still experiencing high influenza-like illness activity, while 10 states reported moderate activity.

February 19, 2013

The Food and Drug Administration has granted priority review to an experimental drug made by ViiV Healthcare for HIV, the company, a joint venture between British drug maker GlaxoSmithKline and American drug maker Pfizer, announced.

LONDON — The Food and Drug Administration has granted priority review to an experimental drug made by ViiV Healthcare for HIV, the company, a joint venture between British drug maker GlaxoSmithKline and American drug maker Pfizer, announced.

The FDA gave the designation to dolutegravir, designed for use in combination with other antiretrovirual drugs in adults and adolescents. The agency gives priority review to drugs that offer significant improvement compared with products already on the market.

February 19, 2013

The Food and Drug Administration and the Federal Trade Commission issued a number of warning letters to distributors of "unapproved medicines," noting that because each of the products identified claimed to prevent or treat the cold or flu, they need to be registered and approved by the FDA.

SILVER SPRING, Md. — The Food and Drug Administration and the Federal Trade Commission last week issued a number of warning letters to distributors of "unapproved medicines," noting that because each of the products identified claimed to prevent or treat the cold or flu, they need to be registered and approved by the FDA. And because none of the ingredients listed are in fact monographed OTC cough, cold or flu symptom relievers, those products would additionally need to be filed as "new drugs."

February 19, 2013

Drug maker Gilead Sciences has recalled a single lot of an injected drug used to treat an opportunistic infection in AIDS patients due to the presence of foreign matter, the company said.

FOSTER CITY, Calif. — Drug maker Gilead Sciences has recalled a single lot of an injected drug used to treat an opportunistic infection in AIDS patients due to the presence of foreign matter in some vials, the company said.

Gilead announced the voluntary recall of lot B120217A of Vistide (cidofovir), an injected drug used to treat cytomegalovirus retinitis in patients with AIDS, due to particulate matter.

February 15, 2013

According to research published in the New England Journal of Medicine, not all respiratory ailments that generate influenza-like symptoms can be attributed to the flu.

BOSTON — According to research published Thursday in the New England Journal of Medicine, not all respiratory ailments that generate influenza-like symptoms can be attributed to the flu. The human metapneumovirus — which is not a strain of influenza, is impervious to antiviral medicines like Tamiflu and does not have an available vaccine according to reports — causes just as many hospitalizations and outpatient visits among children as does the flu. 

February 15, 2013

Two Democrats from West Virginia are sponsoring legislation in the House and Senate to combat prescription drug abuse.

WASHINGTON — Two Democrats from West Virginia are sponsoring legislation in the House and Senate to combat prescription drug abuse.

February 14, 2013

The Food and Drug Administration has granted special designation to a drug made by Eisai for treating thyroid cancer.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has granted special designation to a drug made by Eisai for treating thyroid cancer.

The drug maker said Thursday that its experimental drug E7080 (lenvatinib) had received orphan drug designation from the FDA for follicular, medullary, anapestic and metastatic or locally advanced papillary thyroid cancer.

February 14, 2013

The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said.

SILVER SPRING, Md. — The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said Thursday.

The FDA originally declined to approve the drug, treprostinil diolamine extended-release tablets, in a letter submitted to the company in October 2012.

The agency plans to decide whether or not to approve the drug in March of this year, United Therapeutics said.

February 13, 2013

Bi-Lo on Wednesday launched in all of its pharmacies a prescription program that significantly enhances the offerings of its existing program.

GREENVILLE, S.C. — Bi-Lo on Wednesday launched in all of its pharmacies a prescription program that significantly enhances the offerings of its existing program. The expanded program runs through the Bi-Lo BonusCard and offers deep discounts on more than 450 generic medications and varied discounts on name-brand and other generic medication.

February 13, 2013

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

More than seven dozen members of the House of Representatives are urging the U.S. Postal Service to continue delivering medications to all Americans six days a week.

WASHINGTON — More than seven dozen members of the House of Representatives are urging the U.S. Postal Service to continue delivering medications to all Americans six days a week.

February 13, 2013

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

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

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

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

Teva Pharmaceutical Industries has added a University of California at Los Angeles medical professor to its board of directors, the Israeli drug maker said.

JERUSALEM — Teva Pharmaceutical Industries has added a University of California at Los Angeles medical professor to its board of directors, the Israeli drug maker said.

Teva announced the appointment of Arie Belldegrun, who is a director at the UCLA Institute of Urology Oncology and professor and chair of urologic oncology at the David Geffen School of Medicine. The company appointed Belldegrun at its Feb. 5 meeting to fill a vacancy, and Belldegrun's term will extend the drug maker's 2013 annual shareholder meeting.

February 12, 2013

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

The Food and Drug Administration declined to approve two insulin products made by Danish drug maker Novo Nordisk, the company said Sunday.

BAGSVÆRD, Denmark — The Food and Drug Administration declined to approve two insulin products made by Danish drug maker Novo Nordisk, the company said Sunday.

Novo Nordisk said it received complete response letters from the FDA for Tresiba (insulin degludec) and Ryzodeg (insulin degludec and insulin aspart). The FDA issues a complete response letter when it has finished reviewing an application for a drug, but determines that the application can't be approved in its current form.

February 11, 2013

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

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.