January 5, 2015

Mylan announced the introduction of valsartan tablets USP in 40-, 80-, 160- and 320-mg dosage strengths. 

December 29, 2014

Telemedicine and a growing demand for biopharmaceutical medications were among the top trends in health care in 2014, according to Kalorama Information.

December 29, 2014

In a staff memo, the Office of Generics Drug’s acting director, Kathleen Uhl, vowed to take action on 90% of the abbreviated new drug application backlog before October 2017, and has appointed Ted Sherwood as acting director of OGD’s Office of Regulatory Operations to help with the improvements, FDANews.com has reported.

December 23, 2014

Specialty pharmaceutical company Actavis has hired Jonathon Kellerman as EVP, global chief compliance officer.

December 22, 2014

The Food and Drug Administration granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.

December 22, 2014

Sandoz has announced the U.S. market introduction of estradiol transdermal system, an authorized generic version of Vivelle-Dot, which is marketed by Novartis Pharmaceuticals.

December 19, 2014

The overwhelming majority of GlaxoSmithKline shareholders on Thursday approved the proposed transaction with Novartis.

December 18, 2014

The U.S. Senate Special Committee on Aging unveiled a new bipartisan report earlier this week that focuses on ways to increase the use of generic drugs within the Medicare Part D program.

December 17, 2014

The Generic Pharmaceutical Association on Wednesday expressed concerns that the current structure of the Trans-Pacific Partnership agreement (TPP) will impede generic utilization.

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 10, 2014

Teva Pharmaceutical Industries on Wednesday announced the launch of generic Celebrex (celecoxib) capsules in the United States. The company is offering the capsules in 50-,100-, 200- and 400-mg dosage strengths. 

 

December 9, 2014

Reps. Doug Collins, R-Ga., and Dave Loebsack, D-Iowa, introduced on Tuesday H.R. 5815 — the Generic Drug Pricing Fairness Act — which creates greater transparency in how PBMs reimburse pharmacies for generic prescription drugs under Medicare Part D, the military’s TRICARE program, and the Federal Employees Health Benefits Program.

December 9, 2014

Teva Canada, a subsidiary of Teva Pharmaceutical Industries, announced Tuesday that Health Canada has approved its application for the generic version of PrTarceva. 

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.

December 3, 2014

Health-and-wellness companies see increasing opportunity in the point-of-care channel to reach and engage with patients primed to receive information about their health.

 

December 2, 2014

The Generic Pharmaceutical Association on Tuesday announced that it has named Terry Bazyluk as VP communications, effective Dec. 1, 2014. Bazyluk has served in senior communications roles for trade associations, corporate CEOs and presidential cabinet secretaries Madeleine Albright, Colin Powell and Robert Reich.

December 1, 2014

GlaxoSmithKline last week announced that the Federal Trade Commission has approved GSK's acquisition of Novartis' vaccines business and the creation of a joint consumer care company between GSK and Novartis.

 

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 20, 2014

Moberg Pharma AB on Thursday announced that Jeff Vernimb has been named general manager for its U.S. operations and a member of Moberg's management team, effective Dec. 15.

 

November 19, 2014

The Food and Drug Administration opened a public docket and requested comments on proposed criteria for “first generic” abbreviated new drug application submissions.

 

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 17, 2014

Pharmaceutical sales through HDMA-member traditional primary distributors reached nearly $305 billion in 2013.

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.