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 13, 2014

 Janssen Pharmaceuticals announced that the Food and Drug Administration approved the company's supplemental new drug application for the once-monthly Invega Sustenna (paliperidone palmitate), an antipsychotic used to treat schizoaffective disorder as either monotherapy or adjunctive therapy. 

November 11, 2014

Dr. Reddy's Labs received approval from the Food and Drug Administration for a generic version of Roche Holding's antiviral medication Valcyte, according to a Reuters report

November 7, 2014

Janssen Therapeutics announced earlier this week that the Food and Drug Administration approved Olysio (simeprevir), a hepatitis C virus NS3/4A protease inhibitor, in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients as part of a combination antiviral treatment regimen. 

November 4, 2014

Rogaine brand on Tuesday announced the launch of Women's Rogaine 5% Minoxidil topical aerosol, the first and only once-daily treatment approved by the Food and Drug Administration for the treatment of female pattern hair loss, according to the brand. 

November 3, 2014

Protein Sciences Corp. last week announced that the Food and Drug Administration approved Flublok influenza vaccine for all adults ages 18 years and older.

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 30, 2014

AstraZeneca on Thursday announced that the Food and Drug Administration approved Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily drug for the treatment of adults with Type 2 diabetes. 

October 28, 2014

he Food and Drug Administration last week announced approval for Obizur for the treatment of bleeding episodes in adults with acquired hemophilia A. 

October 22, 2014

Pfizer last week announced that the Food and Drug Administration approved a revised label for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release capsules, for oral use, CII, to include abuse-deterrence studies. 

 

October 22, 2014

The Food and Drug Administration last week announced plans to survey pharmacists and patients about their experiences resulting from changes in generic drug pill appearance.

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

"The United States is in the midst of a prescription drug abuse epidemic as addiction, overdoses and deaths associated with non-medical drug use have risen dramatically over the last decade. In 2009, U.S. drug overdose deaths outnumbered motor vehicle accident deaths for the first time," writes Wendy Cloe, a director at Emdeon, in her latest blog.

October 16, 2014

The Food and Drug Administration has granted approval to Esbriet (pirfenidone), as well as Ofev (nintedanib), to treat idiopathic pulmonary fibrosis — a condition in which the lungs scar over time.

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 adoption of personal medical devices and healthcare kiosks that capture consumer health data — like blood pressure and glucose — coupled with data points with a patient’s health record at the pharmacy represents a significant opportunity to enhance disease state management programs.

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

As the Food and Drug Administration begins to explore ways to improve its user-fee program for generic drugs, the Generic Pharmaceutical Association and its members have weighed in with suggestions on how to shore up the law to ensure that it helps bring generics to market faster and provides benefits across the entire healthcare system.

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 10, 2014

The Food and Drug Administration on Friday approved Akynzeo (netupitant and palonosetron) for the treatment of nausea and vomiting in patients who are undergoing cancer chemotherapy.