February 10, 2015

The Generic Pharmaceutical Association on Monday announced the election of its 2015 executive committee and board of directors.

February 6, 2015

The pharma industry praised outgoing Food and Drug Administration commissioner Margaret Hamburg and welcomed Stephen Ostroff, who will assume the role of acting commissioner.

February 5, 2015

Generic drug prices are going up. Spurred by market opportunities, short-term market exclusivity for some newly launched single-source generics and rising costs for manufacturing, quality control and raw materials, me-too drug manufacturers have escalated a series of price hikes, some of them significant.

February 4, 2015

DSN examines chain pharmacy, including in-depth coverage of telehealth, generic drug prices, and the GPhA CEO to step down, as well as Uhl appointed director of OGD, in this multi-page report.

February 3, 2015

Camber Pharmaceuticals on Tuesday announced the launch of rizatriptan benzoate tablets in 5- and 10-mg dosage strengths. 

 

January 28, 2015

The House Energy and Commerce Committee on Tuesday released a discussion document in the 21st Century Cures initiative.

January 27, 2015

Rep. Jason Chaffetz, R-Utah, last week introduced a bill that would extend to new combination drugs containing molecules already approved by the Food and Drug Administration the same five-year market exclusivity as a drug product containing an entirely new set of active ingredients.

January 27, 2015

Teva Pharmaceutical Industries announced that the Food and Drug Administration approved the company’s first generic Nexium delayed-release tablets in the United States.

January 22, 2015

Four House representatives on Thursday reintroduced legislation designed to help prevent prescription drug abuse and diversion and ensure patient access to necessary medications.

January 21, 2015

With specialty and biotech drugs claiming an ever-greater share of the pharmaceutical market and spawning a backlash from payers and patients over their high price tags, pharmacy operators are smack in the middle of a growing tug of war between the drug industry, the public and private health plans struggling to keep up with the new drug-cost paradigm.

January 20, 2015

Spurred by market opportunities, short-term market exclusivity for some newly launched single-source generics and rising costs for manufacturing, quality control and raw materials, me-too drug manufacturers have escalated a series of price hikes, some of them significant.

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.