October 14, 2013

The Food and Drug Administration has approved a new drug made by Antares Pharma for treating rheumatoid arthritis and psoriasis, the drug maker said Monday.

October 14, 2013

Johnson & Johnson on Monday announced that Mark McClellan, senior fellow in economic studies and director of the Initiative on Value and Innovation in Health Care at the Brookings Institution, will join the company's board of directors on Oct. 15. McClellan will serve on the regulatory, compliance and government affairs committee, as well as the science, technology and sustainability committee.

October 14, 2013

Allergy sufferers will have a new treatment option available to them by the spring allergy season. Sanofi on Friday announced that the Food and Drug Administration approved Nasacort Allergy 24HR nasal spray (triamcinolone intranasal) as an over-the-counter treatment for seasonal and year-round nasal allergies in adults and children 2 years of age and older.

October 11, 2013

A new law in Maine will allow the importation of drugs from abroad through mail-order from some pharmacies, formalizing a practice that has existed in many parts of the country for several years, and marking the first time a state government has, by law, gone against Food and Drug Administration regulations that bar importation of drugs.

Bloomberg columnist Megan McArdle said Maine was "going rogue" on drug importation, and that pretty much sums it up. The state, which has long had a close relationship with Canada — its governor, Paul LePage, is of French-Canadian descent and spoke Quebecois French as his first language — is openly defying federal law. And because federal law ultimately trumps state law, it's likely the federal government will crack down at some point.

October 10, 2013

Sales of Hyland’s oral analgesic products are up 23.5% to $15.4 million for the 52 weeks ended Aug. 11 across U.S. multi-outlets, according to IRI. Overall sales trends across the category are down by 1.7%, which suggests that what Hyland’s is doing is right — its products are safe, they work and they aren’t formulated with benzocaine.

October 10, 2013

When it comes to laws and regulations, what happens in Europe stays in Europe generally, and doesn’t have much bearing on the United States. But a recent win in Europe for U.S. drug maker Hospira could have some implications for the United States as well.

October 10, 2013

One of the Food and Drug Administration's top regulators is not retiring, contrary to rumors reported in news media Thursday.

October 10, 2013

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

October 10, 2013

While the boom in generic drugs now looks set to wane, another segment of the pharmaceutical industry is rapidly rising and presenting new growth opportunities for pharmacy retailers: specialty drugs.

October 9, 2013

The Food and Drug Administration today approved Adempas, also known as riociguat, to treat adults with two forms of pulmonary hypertension, which is caused by abnormally high blood pressure in the arteries of the lungs.

October 9, 2013

A new law in Maine will allow consumers to purchase drugs by mail order from some pharmacies overseas, according to published reports.

October 8, 2013

A Republican congressman from Alabama has proposed a stopgap bill that would fund the Food and Drug Administration through the middle of December or until the government shutdown ends, though it is unlikely to pass in the Senate.

October 8, 2013

The Food and Drug Administration has approved a new treatment for hot flashes and the prevention of osteoporosis, the agency said.

October 8, 2013

Sales of professional aesthetic products climbed 7.5% in 2012, and given the growth, aesthetic devices manufacturers are becoming increasingly interested in expanding their direct reach into the consumer market by launching devices for at-home use, according to recent research by consulting and research firm Kline & Co.

October 7, 2013

An analysis by the New York Times published over the weekend makes the case for generic drugs.

October 3, 2013

The Food and Drug Administration is requiring Johnson & Johnson to use long-lasting ink in the labeling and dosage strength of an opioid painkiller patch it markets in order to make it easier to see.

October 1, 2013

The Food and Drug Administration has approved a new drug developed by Takeda to treat major depressive disorder, the agency said.

September 30, 2013

Amneal Pharmaceuticals has bought rights to four generic drugs from Actavis, Amneal said Monday.

September 30, 2013

The Food and Drug Administration has approved a drug for treating early-stage breast cancer before surgery, the agency said Monday.

September 30, 2013

The Food and Drug Administration has approved a new usage for a drug made by UCB, the drug maker said Monday.

September 27, 2013

Congress is expected to pass the Drug Quality and Security Act, which would subject sterile compounding pharmacies to stronger federal regulations and has attracted support from an independent pharmacy trade group, compared with a previous effort at federal regulations of compounding, Senate Bill 959, which many pharmacists feared would threaten their businesses and patients' access to compounded drugs. The efforts to place compounding pharmacies under federal regulations stem from last year's scandal in which many patients died and more were sickened after taking injected steroids contaminated with fungus.

The bills' purpose is simple enough: protecting the safety of patients by preventing irresponsible pharmacies like the New England Compounding Center from slipping through the cracks. But the older bill attracted opposition from independent pharmacies because, despite its good intentions, forced them to make costly changes to their business models or force them out of compounding altogether.

September 26, 2013

Legislation to allow the Food and Drug Administration to strengthen its regulatory powers over compounding pharmacies is expected to pass both houses of Congress after committees agreed on it Thursday, according to published reports.

September 25, 2013

Foods must carry gluten content of less than 20 parts per million in order to carry the label "gluten-free," according to a new regulation issued by the Food and Drug Administration.

September 25, 2013

Mylan is challenging the patent protection on a drug used to treat fibromyalgia, prompting a lawsuit from the branded drug's manufacturers.