November 17, 2014

DSN spoke with Neas in late October to mark the 30th anniversary of the landmark Drug Price Competition and Patent Term Restoration Act — better known as the Hatch-Waxman Act. 

November 17, 2014

Thirty years ago, Democratic and Republican members of Congress hammered out a rare and prescient bipartisan compromise bill that transformed the pharmaceutical landscape forever and unleashed the modern generic drug industry. That law, known as the Hatch-Waxman Act, has proven to be one of the most far-reaching and impactful pieces of legislation ever to shape the American healthcare system.

November 14, 2014

The Council for Responsible Nutrition has launched a tool that compiles Food and Drug Administration warning letters sent to dietary supplement companies into a searchable database.

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 22, 2014

A JAMA study noted that about two-thirds of dietary supplements recalled by the Food and Drug Administration still contained banned ingredients at least six months after being recalled.

October 17, 2014

The Congressional Dietary Supplement Caucus hosted an educational briefing and luncheon for congressional staffers on Oct. 14, the day before the 20th anniversary of the passage of the Dietary Supplement Health and Education Act.

October 17, 2014

A new study published Thursday by the Center for Healthcare Supply Chain Research identifies factors, based on an analysis of European models, that may affect the American launch of biosimilars and their marketplace potential in the United States.

October 15, 2014

Could the regulatory and scientific logjam that’s keeping copycat biotech medicines off the market and out of the hands of patients and health providers in the United States finally be breaking?

October 15, 2014

The U.S. Supreme Court on Wednesday heard arguments from Teva Pharmaceutical Industries in defense of the patent protecting its $4 billion multiple sclerosis drug Copaxone, according to a Reuters report. 

October 15, 2014

What’s in a name? A lot, apparently, if the name applies to a biosimilar medicine.

October 14, 2014

Twenty African-American and Hispanic community and health care organizations earlier this month submitted a letter to the Food and Drug Administration raising concerns that its Proposed Rule on Generic Labeling could jeopardize patient safety and access to affordable medicines. 

October 10, 2014

DSN examines chain pharmacy, including in-depth coverage of pharmacy technology, biosimilars and generics, in this multi-page report.

October 9, 2014

Congress and the sports nutrition industry independently called upon the Food and Drug Administration to act on removing an untested synthetic stimulant that was found in 12 products marketed as sports nutrition supplements.

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. 

October 6, 2014

Healthcare Distribution Management Association released a statement in support of the FDA’s “Know Your Source” campaign.

September 29, 2014

According to a report released Monday by Thomson Reuters BioWorld, currently there are 700 follow-on biologics therapies moving through pipelines with many already approved.

September 24, 2014

In celebration of the 30th anniversary of the enactment of the Drug Price Competition and Patent Term Restoration Act, also known as the “Hatch-Waxman” Act, the National Association of Chain Drug Stores issued a statement to reflect on the evolution of providing patient access to generic medications and noted that it is looking forward to further progress in the years ahead.

September 23, 2014

A bill has been introduced that lawmakers say would “close federal loopholes” and increase consumer access to generic drugs while boosting market competition.

September 18, 2014

The Generic Pharmaceutical Association on Thursday provided input on the Generic Drug User Fee Act process before the Food and Drug Administration. 

September 15, 2014

Mylan announced that its subsidiary, Mylan Labs Limited, has signed an agreement with Gilead Science under which Mylan has been licensed the non-exclusive rights to manufacture and distribute sofosbuvir and the investigational single-tablet regimen of ledipasvir/sofosbuvir in 91 developing countries. 

September 11, 2014

Medivation and Astellas Pharma on Wednesday announced that the Food and Drug Administration approved a new use of Xtandi (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer.

September 10, 2014

The Food and Drug Administration recently announced the availability of the “Purple Book,” which lists biological products in much the same way that the "Orange Book" lists pharmaceuticals. 

September 9, 2014

The Food and Drug Administration is on pace to match or exceed the 39 novel new medicines approved in 2012.