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 26, 2014

Actavis on Friday confirmed that it has filed an abbreviated new drug application with the Food and Drug Administration to market buprenorphine transdermal system, a generic version of Butrans from Purdue Pharma. 

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 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 10, 2014

The Generic Pharmaceutical Association on Wednesday released a report showing that generic drugs saved the United States health system $239 billion in 2013.

September 2, 2014

More than 55% of people suffer from swallowing difficulties when taking tablets or capsules, which is likely to inhibit compliance, according to an international survey conducted by Spiegel Institute Mannheim on behalf of Hermes Pharma. 

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

Biotech company Roche will be acquiring research and pharmaceutical company InterMune for $8.3 billion, it announced over the weekend. 

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 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.

August 20, 2014

Excedrin relaunched in the United States in 2013 and is doing well. The brand generated $130 million between its Excedrin tablets and Excedrin Migraine tablets for the 52 weeks ended June 15 across total U.S. multi-outlets, according to IRI.

August 19, 2014

"The consumer healthcare market has experienced a steady stream of mergers and acquisitions in recent years. Some of this has created small ripples — like pebbles being gently tossed into still waters. Then there are the mega-mergers that have had a tsunami-like effect," writes Dave Wendland, Hamacher Resource Group VP, in his latest blog entry.

August 18, 2014

The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities. 

August 15, 2014

The second annual health survey by the Pharmaceutical Research and Manufacturers of America shows that Americans are more conscious of their health, and believe their own health is good.

August 13, 2014

The European Union is leading an international pilot project through which, upon request from a generic pharmaceutical company, it will share the assessment reports generated as part of the decentralized procedure in real time with collaborating regulatory agencies outside the EU.

July 31, 2014

The Food and Drug Administration on Friday will publish the fiscal year 2015 generic drug user fee rates as required under the Food Drug and Cosmetic Act as amended by the Generic Drug User Fee Amendments of 2012.

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 29, 2014

The Food and Drug Administration may have more generic drug applications than it does personnel to process them, according to a Wall Street Journal report published Tuesday.

July 23, 2014

Mylan on Wednesday announced that U.S. District Court for the district of New Jersey granted a temporary restraining order against Apotex Inc. and Apotex Corp. relating to Paroxetine CR.

July 21, 2014

The Food and Drug Administration’s Center for Drug Evaluation and Research is providing an update to key leadership positions within the Office of Generic Drugs, the agency announced.

July 17, 2014

Mylan on Thursday announced that the U.S. District Court for the district of New Jersey granted its motion for a permanent injunction against GlaxoSmithKline in relation to paroxetine CR, the generic version of GSK's Paxil CR.