Content about Experimental drug

December 10, 2013

An expert panel at the Food and Drug Administration has given a thumbs-up to an experimental drug made by Takeda Pharmaceutical Co. for treating ulcerative colitis and Crohn's disease, the drug maker said.

DEERFIELD, Ill. — An expert panel at the Food and Drug Administration has given a thumbs-up to an experimental drug made by Takeda Pharmaceutical Co. for treating ulcerative colitis and Crohn's disease, the drug maker said.

October 24, 2013

The Food and Drug Administration has granted breakthrough therapy designation to an experimental drug made by Merck for hepatitis C, the drug maker said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has granted breakthrough therapy designation to an experimental drug made by Merck for hepatitis C, the drug maker said.

March 25, 2013

Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said.

RIDGEFIELD, Conn. — Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said Monday.

BI and Lilly announced the submission of a regulatory application to the Food and Drug Administration for empagliflozin. The drug belongs to a new drug class known as SGLT2 inhibitors, which work by removing excess glucose through the urine by blocking its reabsorption in the kidneys. The companies are testing the drug in a late-stage clinical trial for which they plan to enroll 14,500 patients.

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 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.

January 30, 2013

A panel of Food and Drug Administration experts has recommended approval for an experimental drug made by Boehringer Ingelheim for chronic obstructive pulmonary disease, the drug maker said.

RIDGEFIELD, Conn. — A panel of Food and Drug Administration experts has recommended approval for an experimental drug made by Boehringer Ingelheim for chronic obstructive pulmonary disease, the drug maker said.

January 3, 2013

An experimental drug for Lou Gehrig's disease made by Biogen Idec has failed in a late-stage clinical trial, the drug maker said.

WESTON, Mass. — An experimental drug for Lou Gehrig's disease made by Biogen Idec has failed in a late-stage clinical trial, the drug maker said Thursday.

Biogen announced results of its phase-3 trial of dexpramipexole in patients with the disease, known technically as amyotrophic lateral sclerosis, or ALS. The drug failed to improve functioning and survival in patients and failed to show efficacy in key secondary endpoints as well, the company said.

December 12, 2012

The Food and Drug Administration has accepted a regulatory approval application from Takeda and Lundbeck for an experimental drug to treat depression, the companies said Wednesday.

DEERFIELD, Ill. — The Food and Drug Administration has accepted a regulatory approval application from Takeda and Lundbeck for an experimental drug to treat depression, the companies said Wednesday.

The FDA will review the companies' application for vortioxetine for the treatment of major depressive disorder in adults. The agency expects to finish reviewing the application by Oct. 2, 2013.

December 12, 2012

A subsidiary of Johnson & Johnson is seeking regulatory approval for a new Type 2 diabetes drug.

RARITAN, N.J. — A subsidiary of Johnson & Johnson is seeking regulatory approval for a new Type 2 diabetes drug.

J&J division Janssen Research & Development announced Wednesday that it had filed with the Food and Drug Administration for a drug combining the experimental drug canagliflozin and immediate-release metformin, a common generic drug for diabetes.

The company also submitted a regulatory approval application to the FDA for canagliflozin in May 2012.

November 8, 2012

The Food and Drug Administration has accepted an application from Merck for an experimental drug for insomnia, the drug maker said Thursday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted an application from Merck for an experimental drug for insomnia, the drug maker said Thursday.

Merck announced the the FDA's acceptance of its regulatory filing for suvorexant, which the FDA's Controlled Substances Staff will review while the agency is reviewing the application.

September 6, 2012

A panel of Food and Drug Administration experts is recommending that the agency approve an experimental drug for cystic fibrosis made by Novartis, the Swiss drug maker said.

EAST HANOVER, N.J. — A panel of Food and Drug Administration experts is recommending that the agency approve an experimental drug for cystic fibrosis made by Novartis, the Swiss drug maker said.

May 29, 2012

An experimental drug made by Pfizer for a rare and fatal neurodegenerative disease got a favorable vote from a Food and Drug Administration expert panel.

NEW YORK — An experimental drug made by Pfizer for a rare and fatal neurodegenerative disease got a favorable vote from a Food and Drug Administration expert panel.

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 13-4 that the drug tafamidis meglumine would provide certain clinical benefits to patients with transthyretin familial amyloid polyneuropathy, or TTR-FAP, a hereditary disease that affects about 8,000 people worldwide. The FDA is not required to follow the recommendations of FDA advisory committees, but usually does.

May 24, 2012

Two drug makers are looking to win approval for an experimental drug in patients with colorectal cancer that has spread to other parts of the body.

SOUTH SAN FRANCISCO, Calif. — Two drug makers are looking to win approval for an experimental drug in patients with colorectal cancer that has spread to other parts of the body.

Onyx Pharmaceuticals announced that Bayer HealthCare had submitted a regulatory approval application to the Food and Drug Administration for regorafenib in patients with metastatic colorectal cancer.

April 30, 2012

An online plea for help from a mother dying of breast cancer prompted the manufacturer of an experimental drug to release it early, according to published reports.

NEW YORK — An online plea for help from a mother dying of breast cancer prompted the manufacturer of an experimental drug to release it early, according to published reports.

In an article posted on its website, CNN told the story of 46-year-old Darlene Gant, a woman with stage-four breast cancer, as she wrote letters to be given to her 11-year-old son on his upcoming birthday, and at future events, such as his high school and college graduations and marriage.

April 26, 2012

The Food and Drug Administration declined to approve a drug made by Takeda Pharmaceutical, the drug maker said.

DEERFIELD, Ill. — The Food and Drug Administration declined to approve a drug made by Takeda Pharmaceutical, the drug maker said.

Takeda announced that the FDA issued a complete response letter for its regulatory applications for the Type 2 diabetes drug alogliptin and a combination pill that includes alogliptin and pioglitazone, the active ingredient in the drug Actos.

April 16, 2012

Two drug makers have signed a deal to develop an experimental drug for treating two types of cancer.

WHITEHOUSE STATION, N.J. — Two drug makers have signed a deal to develop an experimental drug for treating two types of cancer.

Merck and Endocyte announced that they would develop and commercialize the latter's drug EC145 (vintafolide), currently in a phase-3 trial, as a treatment for platinum-resistant ovarian cancer and a phase-2 trial for non-small cell lung cancer. Both studies are also using Endocyte's experimental diagnostic agent, EC20 (etarfolatide).

June 13, 2010

An advisory committee of the Food and Drug Administration unanimously recommended approval for an investigational...