FDA issues cybersecurity guidance on medical devices

By Steven Ross Johnson  |  January 19, 2016

Concerns over the threat hackers pose to medical devices were the basis for draft guidance issued Friday by the U.S. Food and Drug Administration that would call on manufacturers to report to the agency cybersecurity vulnerabilities that endanger patient safety.

Pfizer-Allergan deal could reduce biosimilar cost savings

Pfizer-Allergan deal could reduce biosimilar cost savings

By Steven Ross Johnson  |  December 05, 2015

Pfizer's $160 billion deal to acquire Irish drugmaker Allergan got a lot of attention for the tax advantages Pfizer would enjoy from moving its New Jersey headquarters overseas to Dublin. There wasn't much talk, though, about how much the deal would expand Pfizer's footprint in biosimilars.

Pfizer completes $15B acquisition of Hospira

By Associated Press  |  September 03, 2015

Drugmaker Pfizer says it has completed its roughly $15 billion purchase of the injectable-drug maker and infusion-device manufacturer Hospira, expanding its product offerings in a growing medical market.

Pfizer says Hospira purchase will close in early September

By Associated Press  |  August 24, 2015

Drugmaker Pfizer says it's received the final regulatory approvals for its $15.23 billion purchase of the injectable drug and infusion devicemaker Hospira, and says the deal will close in early September. The FTC has ordered Pfizer to sell four drugs in order to preserve competition.

Emergency epinephrine syringes in short supply

By Adam Rubenfire  |  July 13, 2015

The Food and Drug Administration is reporting shortages of pre-filled syringes of epinephrine, which are most commonly used to treat individuals who are in cardiac arrest.

New meds help drugmakers weather strong dollar, other issues

By Associated Press  |  April 28, 2015

Revenue from important new medicines for various cancers, hepatitis C and more helped top U.S. drugmakers weather unfavorable currency exchange rates and other challenges. Pfizer, Merck & Co. and Bristol-Myers Squibb Co., which reported first-quarter results Tuesday, all derive at least half their...

FDA backs biosimilar; drugs could save billions

By Steven Ross Johnson  |  March 07, 2015

Federal regulators have approved the first biosimilar drug to be sold in the U.S., a move that could lower treatment costs as biosimilars compete with what historically had been more expensive medications.

Merck committed to Cubist after patent losses

By Associated Press  |  December 09, 2014

Merck remains committed to its $8.4 billion acquisition of Cubist Pharmaceuticals even though a federal court invalidated most of the patents protecting the company's top-selling antibiotic just hours after that deal was announced Monday.

FDA cites Hospira for drug manufacturing violations

By Bob Herman  |  October 01, 2014

Drugmaker Hospira said Wednesday that it received a warning letter from the Food and Drug Administration regarding poor manufacturing quality at one of its facilities in Australia.

Premier's TheraDoc deal boosts its clinical surveillance business

Premier's TheraDoc deal boosts its clinical surveillance business

By Bob Herman  |  August 05, 2014

Healthcare supply, analytics and consulting company Premier agreed Tuesday to acquire TheraDoc, a clinical surveillance software company, for $117 million, augmenting Premier's already sizable footprint in the clinical-safety solutions market.

AHA wants FDA to address IV fluids shortage

AHA wants FDA to address IV fluids shortage

By Virgil Dickson  |  March 21, 2014

The American Hospital Association is pushing the Food and Drug Administration to be more aggressive in getting manufacturers of saline and other IV fluids to increase production to alleviate shortages.

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