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The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities.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

July 16, 2014

RetireSafe, a grassroots organization advocating on behalf of America’s seniors on Tuesday released a survey finding that seniors overwhelmingly support strong patient safeguards for biosimilar medications. 

July 15, 2014

Current programs to dispose of unused medicines in the home are sufficient, argued representatives of industry in appealing a provision put into place by a San Francisco-area county that would place the burden of recapturing these medicines on the manufacturer.

July 14, 2014

Sandoz on Monday announced the introduction of tobramycin inhalation solution, USP into the U.S. market. The drug is an authorized generic version of Tobi from Novartis.

July 10, 2014

As lifetime earnings for pharmaceuticals decrease, commercialization expenses increase and payers tighten their belts on reimbursement, life science companies will be faced with shrinking margins over the next few years. In order to maintain basic operating margin levels and continue investing in research and development at current levels, life science manufacturers will be forced to reduce costs by more than $35 billion by 2017, according to results from a new survey of 70 life science organizations from the IMS Institute for Healthcare Informatics.

July 10, 2014

The Food and Drug Administration on Wednesday shut down a company for noncompliance of the dietary supplement current good manufacturing practice requirements. 

July 3, 2014

Roche on Wednesday announced that Genentech, a member of the Roche Group, has entered into a definitive agreement to acquire Seragon Pharmaceuticals, a privately held biotechnology company based in San Diego. 

July 2, 2014

The Food and Drug Administration on Tuesday issued several policy documents regarding compounding as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act enacted in November 2013. 

July 1, 2014

Actavis and Forest Labs. on Monday announced that the U.S. Federal Trade Commission has voted to approve Actavis' proposed acquisition of Forest.

June 25, 2014

Worldwide prescription drug sales are expected to exceed the trillion dollar mark by 2020, according to Evaluate's "World Preview 2014, Outlook to 2020" report released Wednesday.

June 24, 2014

The Federal Trade Commission is stepping up probes of pay-for-delay settlements — pharmaceutical deals that delay the sale of generic drugs — according to a report published Monday by Bloomberg.

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.