Content about Clinical research

September 10, 2013

One trend that generic companies and pharmacy retailers alike should keep an eye on is the patent cliff.

One trend that generic companies and pharmacy retailers alike should keep an eye on is the patent cliff. One of the reasons why generic prescriptions will likely peak at 86% to 87%, Long said, is that after the patent on Crestor expires In 2016, there simply won't be a lot of top-selling branded drugs.

September 5, 2013

Japanese drug maker Otsuka Pharmaceutical Co. is buying U.S.-based Astex Pharmaceuticals for $886 million, Otsuka said Thursday.

TOKYO — Japanese drug maker Otsuka Pharmaceutical Co. is buying U.S.-based Astex Pharmaceuticals for $886 million, Otsuka said Thursday.

Astex, based in Dublin, Calif., uses a drug-discovery system known as fragment-based drug discovery, which enables rapid discovery and development of compounds for target proteins implicated in diseases and works by evaluating binding of target proteins with small molecules through 3D structural analysis. Astex developed and launched the chemotherapy drug Dacogen (decitabine), currently sold by Eisai.

September 3, 2013

The Food and Drug Administration has approved a new vial size for a treatment for a rare immune system disorder.

KING OF PRUSSIA, Pa. — The Food and Drug Administration has approved a new vial size for a treatment for a rare immune system disorder.

CSL Behring announced the approval of a 10-g, or 50-mL, vial size for Hizentra (immune globulin subcutaneous [human]). The product is used to prevent infections in patients with primary immunodeficiency, and the new vial size will be available in October.

September 3, 2013

Sage North America last week announced that it partnered with McKesson Pharmacy Systems & Automation, a division of McKesson, to help develop the McKesson Mobile Delivery application for prescription delivery services.

IRVINE, Calif. — Sage North America last week announced that it partnered with McKesson Pharmacy Systems & Automation, a division of McKesson, to help develop the McKesson Mobile Delivery application for prescription delivery services. 

August 29, 2013

The Food and Drug Administration has approved the latest drug in BD's Simplist line, the company said Thursday.

FRANKLIN LAKES, N.J. — The Food and Drug Administration has approved the latest drug in BD's Simplist line, the company said Thursday.

BD announced the approval of ondansetron injection in the 4 mg/2 mL strength, an injectable drug used to prevent nausea and vomiting after surgery. The drug is currently on the FDA's drug shortage list due to recent increases in demand and supply issues faced by other manufactures, BD said.

August 29, 2013

The Food and Drug Administration is concerned about bills in several state legislatures that seek to restrict pharmacists' ability to dispense biosimilars, according to published reports.

NEW YORK — The Food and Drug Administration is concerned about bills in several state legislatures that seek to restrict pharmacists' ability to dispense biosimilars, according to published reports.

Biopharma-Reporter.com quoted an FDA spokeswoman as saying "efforts to undermine trust in these products" were cause for worry and did not serve the interests of patients.

August 28, 2013

The Food and Drug Administration has approved a drug made by Galderma Labs for treating a side effect of rosacea in adults, the company said.

FORT WORTH, Texas — The Food and Drug Administration has approved a drug made by Galderma Labs for treating a side effect of rosacea in adults, the company said.

Galderma announced the approval of Mirvaso (brimonidine) topical gel in the 0.33% strength for the topical treatment of facial erythema of rosacea. The drug is applied once per day to reduce redness and lasts up to 12 hours. The company expects the drug to become available in pharmacies next month.

August 26, 2013

The Food and Drug Administration approved a new drug made by Ceptaris Therapeutics for treating a type of lymphoma, the company said.

MALVERN, Pa. — The Food and Drug Administration approved a new drug made by Ceptaris Therapeutics for treating a type of lymphoma, the company said Monday.

August 22, 2013

The Food and Drug Administration has approved a supplemental regulatory application from Mylan for a generic antidepressant that was subject last year to scrutiny by the agency amid reports of efficacy problems, Mylan said Thursday.

PITTSBURGH — The Food and Drug Administration has approved a supplemental regulatory application from Mylan for a generic antidepressant that was subject last year to scrutiny by the agency amid reports of efficacy problems, Mylan said Thursday.

The drug maker announced the approval of its supplemental abbreviated new drug application, or sANDA, for bupropion hydrochloride extended-release tablets in the 300-mg strength. The drug is a generic version of GlaxoSmithKline's Wellbutrin XL.

August 19, 2013

The Food and Drug Administration is looking to regulate flavored cigars, according to published reports.

NEW YORK — The Food and Drug Administration is looking to regulate flavored cigars, according to published reports.

According to the New York Times, the FDA intends to regulate cigars and other tobacco products, much as it regulates cigarettes, but it hasn't given a timetable. Under the Family Smoking Prevention and Tobacco Control Act of 2009, the agency banned almost every flavor of cigarette except menthol — including candy, fruit and clove flavors — but flavored cigars and pipe tobacco are still permitted.

August 13, 2013

The U.S. Food and Drug Administration this past weekend announced new fee rates for fiscal year 2014, including the abbreviated new drug application fee.

WASHINGTON — The U.S. Food and Drug Administration this past weekend announced new fee rates for fiscal year 2014, including the abbreviated new drug application fee.

August 12, 2013

Perrigo Co. announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug applications for fluocinolone acetonide scalp oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Scalp Oil, and fluocinolone acetonide topical oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Body Oil.

ALLEGAN, Mich. — Perrigo Co. today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for fluocinolone acetonide scalp oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Scalp Oil, and fluocinolone acetonide topical oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Body Oil. Perrigo expects to begin shipments of both products next month.

August 8, 2013

The world is turning generic. That's the takeaway from the latest trends in the drug industry, according to IMS Health.

The world is turning generic. That's the takeaway from the latest trends in the drug industry, according to IMS Health. In 2012, according to the healthcare industry analytics firm, dollar sales of drugs fell by 1% to $325.7 billion, but prescriptions grew by 1.2% as generic drugs' share of total drugs dispensed grew to nearly 83%.

August 8, 2013

The Supreme Court usually has a lot on its plate in any given year, but this year's term included a pretty big case for the pharmaceutical industry: the Federal Trade Commission v. Actavis, which concerned legal settlements between branded and generic drug makers that often occur when the latter attempts to market a generic drug before the former's patents have expired.

The Supreme Court usually has a lot on its plate in any given year, but this year's term included a pretty big case for the pharmaceutical industry: the Federal Trade Commission v. Actavis, which concerned legal settlements between branded and generic drug makers that often occur when the latter attempts to market a generic drug before the former's patents have expired.

August 8, 2013

Keryx Biopharmaceuticals announced the submission of a new drug application to the Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis.

NEW YORK — Keryx Biopharmaceuticals, Inc., today announced the submission of a new drug application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis.

August 6, 2013

The Food and Drug Administration has approved a generic heart disease drug made by Lupin, the Indian drug maker said.

BALTIMORE — The Food and Drug Administration has approved a generic heart disease drug made by Lupin, the Indian drug maker said.

Lupin said the FDA approved its ranolazine extended-release tablets in the 500-mg and 1,000-mg strengths. The drug is used to treat chronic angina.

Ranolazine extended-release tablets are a generic version of Gilead Sciences' Ranexa, which had sales of about $443.4 million during the 12-month period that ended in March, according to IMS Health.

 

August 1, 2013

Sanofi Wednesday evening announced that the Food and Drug Administration's Nonprescription Drugs Advisory Committee voted 10-6 in favor of its switch application of the nasal corticosteroid Nasacort AQ. Two committee members abstained.

SILVER SPRING, Md. — Sanofi Wednesday evening announced that the Food and Drug Administration's Nonprescription Drugs Advisory Committee voted 10-6 in favor of its switch application of the nasal corticosteroid Nasacort AQ. Two committee members abstained. 

July 31, 2013

The Food and Drug Administration has given Lupin Pharmaceuticals tentative approval to two of its products, the company said Wednesday.

BALTIMORE — The Food and Drug Administration has given Lupin Pharmaceuticals tentative approval to two of its products, the company said Wednesday.

Lupin announced the tentative approvals for armodafinil tablets in the 50-mg, 100-mg, 150-mg, 200-mg and 250-mg strengths and doxycycline capsules in the 40-mg strength. Tentative approval means that the drugs meet the FDA's conditions for approval, but can't be marketed yet due to patent or market exclusivity protection that has yet to expire.

July 29, 2013

Actavis hopes to become the first to market a generic drug for treating chronic pain, the company said.

PARSIPPANY, N.J. — Actavis hopes to become the first to market a generic drug for treating chronic pain, the company said Monday.

Actavis said it had filed with the Food and Drug Administration for approval of tapentadol extended-release tablets in the 50-mg, 100-mg, 150-mg and 200-mg strengths. The drug is a generic version of Johnson & Johnson subsidiary Janssen Pharmaceuticals' Nucynta ER. The drug is used as a continuous, around-the-clock analgesic over a long period of time.

July 23, 2013

The Food and Drug Administration on Tuesday took action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday took action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications. The agency recently issued letters warning 15 companies that the sale of their illegally marketed diabetes products violates federal law. The letters were sent to foreign and domestic companies whose products were sold online and in retail stores.

July 23, 2013

The Food and Drug Administration has approved a generic diabetes drug made by Lupin, the company said.

MUMBAI, India — The Food and Drug Administration has approved a generic diabetes drug made by Lupin, the company said.

Lupin, based in India, received approval for metformin hydrochloride extended-release tablets in the 500-mg and 1,000-mg strengths. The drug is a generic version of Santarus' Glumetza.

Glumetza had sales of about $144 million during the 12-month period that ended in March, according to IMS Health. The drug is an extended-release formulation of metformin hydrochloride, a widely prescribed drug used for treating Type 2 diabetes.

 

July 22, 2013

A new bill would exempt user fees paid by drug companies to the Food and Drug Administration — including those of generic drug makers — from the automatic federal budget cuts that went into effect in March, commonly known as the sequester.

WASHINGTON — A new bill would exempt user fees paid by drug companies to the Food and Drug Administration — including those of generic drug makers — from the automatic federal budget cuts that went into effect in March, commonly known as the sequester.

The bill, the FDA Safety Over Sequestration Act, received sponsorship from Reps. Leonard Lance, R-N.J.; Anna Eshoo, D-Calif.; Doris Matsui, D-Calif.; and Mike Rogers, R-Mich. Generic drug industry trade group the Generic Pharmaceutical Association heralded the bill.

July 22, 2013

Decisions on whether to bring new generic drugs to market depend significantly on companies' ability to settle patent lawsuits filed by branded drug companies, according to a new white paper.

WASHINGTON — Decisions on whether to bring new generic drugs to market depend significantly on companies' ability to settle patent lawsuits filed by branded drug companies, according to a new white paper.

July 19, 2013

The Council for Responsible Nutrition announced that Daniel Fabricant, director of the Division of Dietary Supplement Programs at the Food and Drug Administration, will be a keynote speaker at The Conference: CRN’s Annual Symposium for the Dietary Supplement Industry Sept. 18 to 21 in Park City, Utah.

WASHINGTON — The Council for Responsible Nutrition on Thursday announced that Daniel Fabricant, director of the Division of Dietary Supplement Programs at the Food and Drug Administration, will be a keynote speaker at The Conference: CRN’s Annual Symposium for the Dietary Supplement Industry Sept. 18 to 21 in Park City, Utah.

July 18, 2013

The Food and Drug Administration has approved a cholesterol drug made by Par Pharmaceutical Cos., the drug maker said Thursday.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a cholesterol drug made by Par Pharmaceutical Cos., the drug maker said Thursday.

Par announced the approval of generic fenofibric acid delayed-release capsules in the 45-mg and 135-mg strengths. The drug is used to reduce triglycerides and increase "good" high-density lipoprotein cholesterol.

The drug is a generic version of AbbVie's Trilipix, which has sales of about $554 million per year, according to IMS Health.