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.

August 27, 2014

The International Society for Pharmaceutical Engineering on Wednesday announced that it has released a preview of its Drug Shortages Prevention Plan aimed at helping the pharmaceutical industry avoid drug shortages and maintain a reliable supply of medications. 

August 25, 2014

Pharmaceutical company Iroko announced today that a new version its anti-inflammatory drug Zorvolex had been approved by the Food and Drug Administration.

August 21, 2014

The generic drug industry — and by extension, patients across the United States — is being adversely impacted by what some are calling branded drug makers’ abuse of risk evaluation and mitigation strategies, or REMS.

August 21, 2014

Restricting access to samples of generic biological drugs would lead to nearly $140 million in lost savings for every $1 billion in biologics sales, Matrix Global Advisors said.

August 21, 2014

The Food and Drug Administration cleared South Korean company Philosys’ Gmate blood-sugar monitoring device for U.S. marketing on Aug. 15.

August 20, 2014

Despite creating a detailed plan to speed up the rate at which generic drug applications are reviewed, experts say a backlog has developed at the Food and Drug Administration’s Office of Generic Drugs.