May 8, 2013

There is as much as $10 billion in branded pharmaceutical sales that could make the switch from prescription-only to over-the counter in the next five years, suggested Joseph Papa, Perrigo chairman, CEO and president, to analysts on Tuesday.

May 6, 2013

Pfizer is attempting to stem the rise of counterfeit medicines by selling one of its most popular drugs — and one of the most popular targets for counterfeiters — online.

April 17, 2013

Food and Drug Administration commissioner Margaret Hamburg faced strong criticism Tuesday in a hearing before the House Committee on Energy and Commerce to investigate the nationwide outbreak of fungal meningitis linked to a Massachusetts compounding pharmacy, but she conceded the agency could have done more.

April 16, 2013

Taro Pharmaceutical Industries reported last week that it has received approval from the Food and Drug Administration for its new drug application Topicort (desoximetasone) topical spray, 0.25%.

April 12, 2013

The Food and Drug Administration is granting an expedited application process to a company that has developed a treatment for a condition related to Parkinson's disease, meaning that it can cancel a planned late-stage clinical trial, the company said.

April 9, 2013

The new world of targeted, specialized medicines — many of them bioengineered and many of them aimed at smaller and smaller segments of the population — isn’t just on its way. It’s here. And it’s going to radically change the practice of pharmacy.

Here’s an eye-opener: Specialty drugs will likely account for 50% of all drug costs by 2018, up from 28.7% of total prescription drug costs in 2012.

April 2, 2013

Specialty drugs are expected to account for 50% of all drug costs by 2018, according to two new studies.

March 25, 2013

More than 400 drugs are under development for the 10 most common chronic health conditions affecting elderly people, according to a new report by a drug industry trade group.

March 22, 2013

The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

March 21, 2013

A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said.

March 11, 2013

Nearly 1,000 biotech drugs and vaccines for more than 100 diseases are currently under development, according to a new report.

March 8, 2013

Just about every healthcare practitioner recommends over-the-counter medicines to their patients. And nearly 3-out-of-4 make that OTC recommendation as the first therapy option, according to a recent survey released by the Consumer Healthcare Products Association.

This is another proof point that OTC medicines play an important role in holding down cost.

March 4, 2013

The Food and Drug Administration has accepted a regulatory application for a new painkiller from Iroko Pharmaceuticals, the drug maker said.

February 28, 2013

Canadian generic drug makers expressed dismay over a new plan to reduce reimbursements for a half-dozen generic medications in most of the country's provinces. According to published reports, a group of premiers had reached a coordinated deal to reduce the prices their governments paid for six generic drugs, hoping to save the provinces nearly $100 million.

February 28, 2013

Has the explosion in generic utilization curbed pioneer-drug research and development? That's one concern floated by some pharmaceutical industry watchers, who claim that the stunning market share gains made by generic drug makers could reduce incentives for branded drug companies to spend to develop new molecular entities, conduct lengthy clinical trials, gain FDA approval and bring those new drugs to market.

February 28, 2013

Are doctors needlessly raising the costs of America's healthcare system through their prescribing habits? Absolutely, say researchers.

February 26, 2013

A newly conducted study of millions of Medicare Part D prescription drug event data has found that community pharmacies provide 90-day medication supplies at lower cost than mail-order pharmacies and that local pharmacists substitute lower-cost generic drugs more often when compared with mail-order pharmacies.

February 25, 2013

The Food and Drug Administration has approved a new drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the digestive system, the agency said Monday.

February 20, 2013

Lobbying groups for the retail pharmacy industry have a few suggestions for the Drug Enforcement Administration for drug take-back programs.

February 12, 2013

GlaxoSmithKline may be looking to buy a Brazilian drug maker for up to $4 billion, according to published reports.

February 8, 2013

A new switch paradigm could open the door to $35.7 billion in OTC opportunity, according to a new report recently released by Francesco International.

February 8, 2013

A new report by Francesco International identified $35.7 billion worth of potential Rx-to-OTC switches in a wide range of indications, from hypertension and chronic obstructive pulmonary disorder to high cholesterol and erectile dysfunction, and the Food and Drug Administration has been looking at ways technology and pharmacists could be employed to ensure that patients taking drugs new to the consumer health space take them appropriately.

With growth in traditional pharmaceuticals expected to slow down significantly, a growing number of drug makers — branded and generic alike — see specialty drugs as their main sources of revenue for the foreseeable future. At the same time, those drug makers not invested in specialty may be looking for growth opportunities in consumer health.

February 6, 2013

The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

January 28, 2013

U.S. generic drug maker Amneal Pharmaceuticals has entered a deal with South Korean drug maker Hanmi Pharmaceutical to acquire exclusive distribution rights for a Hanmi drug used for treating gastroesophageal reflux disease, Amneal said Monday.