December 12, 2014

DSN examines chain pharmacy, including in-depth coverage of pharmacy technology, biosimilars and generics, as well as a look at FDA reform and its potential impact on healthcare costs, in this multi-page report.

December 11, 2014

After a recent spike in the prices charged for some generic drugs led to outcries from pharmacists, patient advocates and federal lawmakers, a report issued last month suggests that drug costs can be controlled if the Food and Drug Administration changes the way it handles reviews and approvals.

 
December 5, 2014

The FDA issued a draft guidance that would provide generic companies a pathway to obtain samples of medicines requiring a Risk Evaluation and Mitigation Strategy (REMS) protocol for product testing.

November 20, 2014

Decision Resources Group found that sales of biosimilar versions of the granulocyte colony-stimulating factors (G-CSFs) filgrastim and pegfilgrastim could reach $1.8 billion in the United States by 2023. 

November 20, 2014

The Generic Pharmaceutical Association on Thursday emphasized the savings generic medicines bring to the table in light of rising brand prices. 

November 18, 2014

DSN examines chain pharmacy, including in-depth coverage of pharmacy technology, biosimilars and generics, as well as a look at the impact of the Hatch-Waxman act and Q&A's with industry leaders, in this multi-page report.

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 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 24, 2014

In the wake of an Oct. 21 blogpost on Health Affairs, “The $500 Billion Medicare Slowdown: A Story About Part D,” Ralph Neas, president and CEO of the Generic Pharmacuetical Association, issued the following statement.

October 22, 2014

Amneal Pharmaceuticals on Tuesday announced that the company has won the global “Company of the Year” Award from Generics bulletin.

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

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

October 8, 2014

Pending legislation in the Pennsylvania state legislature is raising the eyebrows of several industry members, including the National Community Pharmacists Association, which stated that the legislation in its current form would "severely limit access to more affordable medications, vastly increase overall healthcare costs to Pennsylvania businesses and citizens and add cumbersome reporting requirements on healthcare providers."

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 honor of the 30th anniversary of the Drug Price Competition and Patent Term Restoration Act — more commonly known as the Hatch Waxman Act — which enabled manufacturers to bring generic versions of pharmaceuticals to market more easily, GPHA president Ralph Neas issued a statement.

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 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. 

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 11, 2014

The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act, Bloomberg BNA reported.

July 29, 2014

The use of FDA drug safety programs to prevent generic competition is costing the American health care system and patients $5.4 billion in annual pharmaceutical spending.

July 28, 2014

The Food and Drug Administration has accepted a license application by Sandoz, Novartis' generics company, for a potential generic biologic drug, the company announced Monday.