January 16, 2015

Kathleen "Cook" Uhl on Thursday was named director of the Food and Drug Administration's Office of Generic Drugs.

 

January 14, 2015

The Food and Drug Administration established the Office of Pharmaceutical Quality, a new division tasked with improving quality control at pharmaceutical manufacturing facilities.

 

January 12, 2015

Shire and NPS Pharmaceuticals have entered into a merger agreement for a total consideration of $5.2 billion.

 

January 7, 2015

With tens and possibly hundreds of billions of dollars in potential savings still snagged in a regulatory limbo, federal lawmakers and health industry stakeholders strongly urged the Food and Drug Administration last month to knock down the final barriers to review and approval of biosimilar drugs for marketing in the United States.

January 7, 2015

Lupin Pharmaceuticals on Tuesday launched its valsartan tablets USP in 40-, 80-, 160- and 320-mg dosage strengths. The drug is the generic version Novartis's Diovan tablets.

January 7, 2015

The pharmaceutical industry is back. Fueled by the launch of expensive, new biotech medicines, rising prices for both branded and generic drugs and a recent slowdown in branded-drug patent expirations and generic competition, the U.S. pharmaceutical market is staging a remarkable resurgence.

January 6, 2015

Aurobindo Pharma on Tuesday announced that the company has received final approval from the U.S. Food & Drug Administration to manufacture and market Valsartan Tablets.

January 6, 2015

Vermont Attorney General Bill Sorrell is investigating generic drug price inflation.

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.