Content about Clinical research

September 28, 2012

Stiefel psoriasis drug gains additional FDA approval

The Food and Drug Administration has approved a treatment for psoriasis of the scalp made by a subsidiary of British drug maker GlaxoSmithKline.

RESEARCH TRIANGLE PARK, N.C. — The Food and Drug Administration has approved a treatment for psoriasis of the scalp made by a subsidiary of British drug maker GlaxoSmithKline.

Stiefel announced Friday the approval of Sorilux (calcipotriene) foam for psoriasis of the scalp in adults. The drug was already approved for psoriasis of other parts of the body in October 2010.

September 27, 2012

FDA approves new cancer drug

The Food and Drug Administration has approved a new drug for colorectal cancer developed by Bayer HealthCare.

SAN FRANCISCO — The Food and Drug Administration has approved a new drug for colorectal cancer developed by Bayer HealthCare.

Bayer and Onyx Pharmaceuticals announced the approval of Stivarga for colorectal cancer that has spread to other parts of the body, also known as metastatic CRC, specifically for those patients who have received treatment with currently available therapies.

Bayer developed the drug and will pay royalties to Onyx on future global net sales of the drug for cancer. The two companies will promote the drug together in the United States.

September 26, 2012

Depomed sues FDA over drug for shingles-related pain

A drug maker is suing the Food and Drug Administration to force the agency to give a special designation to one of its drugs.

MENLO PARK, Calif. — A drug maker is suing the Food and Drug Administration to force the agency to give a special designation to one of its drugs.

Depomed announced that it had filed suit against the FDA in federal district court for the District of Columbia seeking an order that would require the agency to grant the drug Gralise (gabapentin) orphan drug exclusivity for the management of post-herpetic neuralgia. The disease, also known as PHN, is a condition causing prolonged pain in people who have had shingles, a complication of chickenpox.

September 24, 2012

FDA approves Regeneron drug for macular edema

The Food and Drug Administration has approved a drug for treating a complication of a disease that results from vein blockages in the eye.

TARRYTOWN, N.Y. — The Food and Drug Administration has approved a drug for treating a complication of a disease that results from vein blockages in the eye.

Regeneron Pharmaceuticals announced the approval of Eylea (aflibercept) for treating macular edema following central retinal vein occlusion, or CRVO. Eylea already was approved for treating neovascular age-related macular degeneration, another eye disease.

September 24, 2012

FDA creates antibiotic development task force

The Food and Drug Administration is creating a new task force to support the development of new drugs for bacterial infections, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration is creating a new task force to support the development of new drugs for bacterial infections, the agency said Monday.

The FDA said the Antibacterial Drug Development Task Force would assist in developing and revising guidance related to development of antibiotics, as required by the Generating Antibiotic Incentives Now Title of the FDA Safety and Innovation Act, which president Barack Obama signed into law on July 9.

September 21, 2012

Amgen drug approved for osteoporosis in men

The Food and Drug Administration has approved a new usage for an Amgen drug, the drug maker said.

THOUSAND OAKS, Calif. — The Food and Drug Administration has approved a new usage for an Amgen drug, the drug maker said.

The biotech manufacturer announced the FDA approval of Prolia (denosumab) to increase bone mass in men with osteoporosis who are at high risk for fracture. The drug already was approved for osteoporosis in postmenopausal women.

September 21, 2012

FDA approves Mylan hypertension drug

The Food and Drug Administration has approved a blood pressure medication made by Mylan.

PITTSBURGH — The Food and Drug Administration has approved a blood pressure medication made by Mylan.

The drug maker announced Friday the approval of valsartan and hydrochlorothiazide tablets in the 80-mg/12.5-mg, 160-mg/12.5-mg, 160-mg/25-mg, 320-mg/12.5-mg and 320-mg/25-mg strengths.

The drug, a generic version of Novartis' Diovan HCT, is used to treat high blood pressure, or hypertension, in patients who can't control their blood pressure with one drug or who are starting therapy and need multiple drugs.

September 20, 2012

FDA approves Acton asthma drug

The Food and Drug Administration has approved a drug made by Acton Pharmaceuticals for asthma, the company said Thursday.

MARLBOROUGH, Mass. – The Food and Drug Administration has approved a drug made by Acton Pharmaceuticals for asthma, the company said Thursday.

The drug maker announced the approval of Aerospan (flunisolide HFA) inhalation aerosol as a maintenance treatment for asthma in patients aged 6 and older. The drug maker plans to launch the drug in early 2013.

September 19, 2012

J&J seeks FDA approval for intravenous Simponi

A subsidiary of Johnson & Johnson is hoping to gain Food and Drug Administration approval for a new formulation of one of its drugs.

HORSHAM, Pa. — A subsidiary of Johnson & Johnson is hoping to gain Food and Drug Administration approval for a new formulation of one of its drugs.

Janssen Biotech announced that it had filed an application with the FDA seeking approval for an intravenous formulation of Simponi (golimumab) in adults with moderately to severely active rheumatoid arthritis, which affects an estimated 1.5 million Americans.

September 18, 2012

FDA approves drug for brittle nails

The Food and Drug Administration has approved a treatment for a disease that causes brittle nails.

CHARLESTON, S.C. — The Food and Drug Administration has approved a treatment for a disease that causes brittle nails.

Innocutis announced the FDA approval of Nuvail (poly-ureaurethane) nail solution in the 16% strength. The drug is used to treat nail dystrophy, which causes fragile and brittle nails that crack and split.

One of the most common forms of nail dystrophy is brittle nail syndrome, which affects about 20% of the population, with women disproportionately affected. Patients with the condition report that their nails are painful and impair daily activities.

September 18, 2012

Generics saved U.S. $1 trillion in 9 years

A trillion of anything is difficult to wrap one’s head around, whether it’s the number of grains of sand on a beach or stars in the sky. It’s so much easier for the human mind to look at such a quantity as the sum of its parts rather than on the basis of its individual components. 

September 18, 2012

PDUFA, GDUFA make 2012 milestone year

2012 is turning out to be a pretty important year for generic drugs, important enough that some of the things happening over the past several months have begged comparison to 1984, probably the biggest milestone year for the industry. 

September 17, 2012

FDA approves Wockhardt generic ulcer drug

The Food and Drug Administration has approved a generic ulcer treatment made by Wockhardt, the Indian drug maker said Monday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic ulcer treatment made by Wockhardt, the Indian drug maker said Monday.

Wockhardt announced the approval and launch of lansoprazole delayed-release capsules in the 15-mg and 30-mg strengths. The drug is a generic version of Prevacid, which Takeda markets in the United States.

The drug has a market of about $700 million in the United States, according to IMS Health.

September 13, 2012

FDA approves Lupin depression, anxiety drug

The Food and Drug Administration has approved a generic psychiatric drug made by Lupin Pharmaceuticals, Lupin said Thursday.

BALTIMORE — The Food and Drug Administration has approved a generic psychiatric drug made by Lupin Pharmaceuticals, Lupin said Thursday.

The Indian drug maker announced the approval of escitalopram tablets in the 5-mg, 10-mg and 20-mg strengths, used for acute and maintenance treatment of major depressive disorder in adults and adolescents and for acute treatment of general anxiety disorder in adults.

September 13, 2012

FDA approves new MS drug

The Food and Drug Administration has approved a new drug for multiple sclerosis.

CAMBRIDGE, Mass. — The Food and Drug Administration has approved a new drug for multiple sclerosis.

Sanofi subsidiary Genzyme announced that the FDA had approved Aubagio (teriflunomide) as a once-daily, oral treatment for patients with relapsing MS.

September 13, 2012

Pfizer, Chinese drug maker ink branded generics deal

Pfizer has inked a deal with a Chinese drug maker to make branded-generic drugs for China and global markets, the companies said.

HANGZHOU, China — Pfizer has inked a deal with a Chinese drug maker to make branded-generic drugs for China and global markets, the companies said.

September 11, 2012

FDA: No matter that firms market concussion treatments as supplements; they're unapproved drugs

The Food and Drug Administration on Thursday issued warning letters to PruTect Rx, of Highlands Ranch, Colo., and Trinity Sports Group, of Plano, Texas, for promoting products labeled as dietary supplements with claims to treat concussions and prevent or treat post-concussion syndrome and other neurological disorders.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday issued warning letters to PruTect Rx, of Highlands Ranch, Colo., and Trinity Sports Group, of Plano, Texas, for promoting products labeled as dietary supplements with claims to treat concussions and prevent or treat post-concussion syndrome and other neurological disorders.

September 10, 2012

Patients who stop taking insomnia drug continue having sleeping problems, Merck study finds

A study of an experimental drug for insomnia indicated that patients who stop taking it continue having sleeping problems, according to results of a clinical trial announced Monday.

WHITEHOUSE STATION, N.J. — A study of an experimental drug for insomnia indicated that patients who stop taking it continue having sleeping problems, according to results of a clinical trial announced Monday.

Merck released data from a phase-3 trial of suvorexant in which patients who had been taking the drug daily for a year were switched to placebo for a two-month "discontinuation phase." Patients who were switched from the drug to placebo showed sleeping difficulties similar to those who had consistently taken placebo.

September 7, 2012

Perrigo seeks approval for generic bronchospasm drug

Perrigo is seeking regulatory approval for what it called the first generic version of a drug for treating bronchospasm.

ALLEGAN, Mich. — Perrigo is seeking regulatory approval for what it called the first generic version of a drug for treating bronchospasm.

September 6, 2012

Kalorama reports several new OTC categories under consideration by FDA

Kalorama Information on Thursday reported that a number of Rx-to-OTC switch applications currently are under review by the Food and Drug Administration across several new-to-self-care categories, including overactive bladder, bacterial infections, cholesterol and high blood pressure.

NEW YORK — Kalorama Information on Thursday reported that a number of Rx-to-OTC switch applications currently are under review by the Food and Drug Administration across several new-to-self-care categories, including overactive bladder, bacterial infections, cholesterol and high blood pressure.

September 5, 2012

FDA approves new drug for rare leukemia

The Food and Drug Administration has approved a new drug for treating a rare blood and marrow cancer that affects older adults, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare blood and marrow cancer that affects older adults, the agency said Tuesday.

The FDA announced the approval of Pfizer's Bosulif (bosutinib) for chronic myelogenous leukemia, or CML. According to the FDA, about 5,430 men and women will be diagnosed with CML this year.

The drug is designed for patients with chronic, accelerated or blast-phase Philadelphia chromosome-positive CML, who can't tolerate other therapies or for whom those therapies don't work.

September 5, 2012

FDA delays action on Salix drug

The Food and Drug Administration will not decide whether to approve a drug for diarrhea in HIV patients as it continues to review the regulatory approval application for it, the drug's manufacturer said.

RALEIGH, N.C. — The Food and Drug Administration will not decide whether to approve a drug for diarrhea in HIV patients as it continues to review the regulatory approval application for it, the drug's manufacturer said.

Salix Pharmaceuticals said the FDA was still reviewing its application for crofelemer in the 125-mg strength. The agency was originally expected to take action on the drug Wednesday. Crofelemer is meant for treating noninfectious diarrhea in HIV and AIDS patients taking antiretroviral therapy.

September 4, 2012

Astellas, Medivation cancer drug wins FDA approval

The Food and Drug Administration has approved a new drug made by Astellas Pharma U.S. and Medivation for treating prostate cancer, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Astellas Pharma U.S. and Medivation for treating prostate cancer, the agency said Friday.

The FDA announced the approval of Xtandi (enzalutamide) for castration-resistant prostate cancer that has spread or recurred despite medical or surgical therapy to minimize testosterone.

September 4, 2012

FDA approves smaller-dose Afinitor for rare brain tumor in children

The Food and Drug Administration has approved a new formulation of a cancer drug made by Novartis for a type of brain cancer in children, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new formulation of a cancer drug made by Novartis for a type of brain tumor in children, the agency said.

The FDA announced the approval of Afinitor Disperz (everolimus) tablets for oral suspension to treat a rare brain tumor called subependymal giant-cell astrocytoma, or SEGA. The agency said Afinitor Disperz, a new dosage form of the drug Afinitor, is the first pediatric-specific dosage form for a pediatric tumor to receive FDA approval.

September 4, 2012

FDA approves Wockhardt antidepressant

The Food and Drug Administration has approved a generic antidepressant made by Wockhardt, the Indian drug maker said Tuesday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic antidepressant made by Wockhardt, the Indian drug maker said Tuesday.

Wockhardt announced the FDA approval of its bupropion hydrochloride extended-release tablets in the 100 mg, 150 mg and 200 mg strengths.

The drug is a generic version of GlaxoSmithKline's Wellbutrin SR, various versions of which have a market of about $268 million, according to IMS Health.