November 19, 2014

The Food and Drug Administration opened a public docket and requested comments on proposed criteria for “first generic” abbreviated new drug application submissions.

 

November 7, 2014

Teva Pharmaceutical on Friday announced positive findings from a Phase III clinical study that examined the safety and efficacy of Qnasl.

November 3, 2014

The RAND Corp. projected that the introduction of biosimilar drugs in the United States will reduce direct spending on biologics by $44.2 billion from 2014 to 2024.

 

October 8, 2014

The Pharmaceutical Research and Manufacturers of America on Tuesday released a new report highlighting the number of investigational cancer medicines that did not succeed in clinical trials. 

June 23, 2014

America’s biopharmaceutical research companies are developing 435 innovative new medicines to target 15 leading chronic conditions affecting the Medicare population, according to a new report released by the Pharmaceutical Research and Manufacturers of America last week.

June 23, 2014

The Food and Drug Administration announced that it has approved Sivextro (tedizolid phosphate), an antibacterial drug.

June 12, 2014

Valeant Pharmaceuticals International announced that its subsidiary, Valeant Pharmaceuticals North America, received approval from the Food and Drug Administration for its new drug application for Jublia (efinaconazole 10% topical solution). The drug is the first topical triazole approved for the treatment of onychomycosis of the toenails, the company said.

June 9, 2014

A recently approved drug might make infusions for hemophiliacs fewer and further between. The Food and Drug Administration approved Biogen Idec's Eloctate, which clinical trials have shown works to treat bleeding episodes and to increase the time between prophylactic blood infusions for those with hemophilia A.

June 3, 2014

Asana BioSciences, a research and development company specializing in the discovery and development of new chemical and biological entities, on Tuesday announced that it has acquired an early stage branded pharmaceutical discovery platform from Endo Pharmaceuticals.

May 16, 2014

Pfizer announced plans to submit a new drug application with the Food and Drug Administration for palbociclib, which is used for the first-line systemic treatment of post-menopausal women with advanced or metastatic breast cancer.

May 6, 2014

Walgreens immunoglobulin home infusion patients reported health outcomes consistent with reported outcomes gathered by the patients’ physicians in the clinical setting, according to new Walgreens PartnerPoint Clinical Management platform data presented Friday at the American Academy of Neurology 2014 Annual Meeting in Philadelphia.

March 12, 2014

The Pharmaceutical Research and Manufacturers of America and the National Minority Quality Forum announced on Wednesday a first-of-its-kind national campaign to help increase diversity in clinical trials.

January 8, 2014

Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.

December 10, 2013

NEW YORK — Absorption Pharmaceuticals will be conducting clinical trials with Kaiser to measure the efficacy of the company's over-the-counter solution for PE Promescent, CNBC reported Tuesday.

December 9, 2013

The Food and Drug Administration's Office of Generic Drugs will be elevated to a "super office," a top official in the agency told staff members in a memo Monday.

November 11, 2013

AccentHealth collected data through an online survey conducted from Oct. 14 to 21. Participants responded via AccentHealth's national, online panel of network viewers, and the survey yielded 520 respondents who were at least 18 years of age, and either themselves or a household member have prediabetes, Type 1 diabetes or Type 2 diabetes.

November 5, 2013

A recently released clinical trial has found that patients taking a biotech drug for arthritis and those taking a biosimilar version had similar responses to both treatments.

September 12, 2013

AccentHealth collected data through an online survey conducted from Aug. 21 to 27, 2013. Participants responded via AccentHealth's national, online panel of network viewers, and the survey yielded 501 respondents who were at least 18 years of age.

August 14, 2013

AccentHealth collected data through an online survey conducted from July 10 to 16, 2013. Participants responded via AccentHealth's national, online panel of network viewers, and the survey yielded 512 respondents who were at least 18 years of age and have a child in school (i.e., elementary, middle or high school) or college.

June 25, 2013

Drug makers may be allowed to seek approval for a generic version of an eye drug made by Allergan based on lab tests rather than clinical trials, according to published reports.

May 9, 2013

AccentHealth collected data through an online survey conducted from Feb. 13 to 15, 2013. Participants responded via AccentHealth's national, online panel of network viewers, and the survey yielded 644 respondents who were at least 18 years of age and owned either a smartphone, cell phone with Internet access or a tablet.

April 23, 2013

The Food and Drug Administration has approved a new contraceptive drug made by Warner Chilcott, the drug maker said.

March 11, 2013

AccentHealth collected data through an online survey conducted from Feb. 13 to 15, 2013. Participants responded via AccentHealth's national, online panel of network viewers, and the survey yielded 644 respondents who were at least 18 years of age and owned either a smartphone, cell phone with Internet access or a tablet.

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.