In the wake of a buying and selling frenzy, Irish drugmaker Allergan has been subpoenaed by the Department of Justice (DOJ) over antitrust concerns regarding the pricing of its generic drugs. Last week, the company announced a $40.5 billion selloff of its generics unit to the global generic market leader, Israeli-based Teva Pharmaceuticals. That deal
7/29/2015 Minnesota-based device giant Medtronic has issued letters to nearly 2,000 owners of the MiniMed 640 and 620 insulin pumps in Europe, warning them of a potential glitch in the reading mechanism. According to the letter, there is an error with the Bolus Wizard screen, causing it to not time-out and instead giving an outdated
7/28/2015 The global pharmaceutical landscape was significantly altered on Monday as Israeli drugmaker Teva announced that it will purchase the generic drug business of Dublin-based Allergan. The move will put a stranglehold on Teva’s top sales position in the generic drug market, acquiring its third-largest competitor. Teva will purchase the generics unit for $40.5 billion,
7/23/2015 Los Angeles Food and Drug Administration (FDA) compliance officer Dr. Raymond W. Brullo issued a scathing warning letter to Thomas Ring, the CEO of New Jersey-based device manufacturer C.R. Bard. The letter contained a litany of violations regarding several single-use devices for IVC and foreign body retrieval. The letter follows a series of inspections
7/18/2015 The Food and Drug Administration (FDA) has given the recall of Medtronic’s Shiley neonatal and pediatric tracheostomy tubes a Class I label, its most serious designation. Under a Class I label, the FDA believes that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” Last
7/15/2015 Biotech manufacturer Celgene is making an earnest push to become one of the industry’s leaders following a wave of transactions aimed at increasing long-term sustainability. Celgene’s current success is largely based on the popularity of its breakthrough cancer drug, Revlimid; however Celgene is attempting to set itself up for future growth when Revlimid’s patent
The U.S. Food and Drug Administration (FDA) is joining famous environmental and consumer activist Erin Brockovich in its skepticism of Bayer’s popular birth control device, Essure. Bayer claims that the coil-like device is the only non-surgical permanent form of birth control on the market. The FDA announced last month that it will be conducting a
7/8/2015 The U.S. Food and Drug Administration (FDA) released the results of a 1093-patient study on Tuesday of drugmaker, Eli Lilly’s experimental drug necitumumab, aimed at treating a certain form of lung cancer. The information comes as the FDA will be conducting a panel of outside experts on Thursday, July 9th that will review the
7/2/2015 In what may be the largest whistleblower lawsuit ever, the Justice Department, along with 11 states, are accusing Swiss pharmaceutical titan, Novartis, of running a massive kickback scheme through the U.S. Medicare and Medicaid programs. Specifically, the U.S. is accusing the drugmaker of referring patients to a handful of specialty pharmacies who sent in
7/1/2015 In a press release on Monday, Massachusetts-based medical device manufacturer, Abiomed, notified the public that the U.S. Department of Justice has dropped its investigation of the company’s Impella 2.5 heart pump. In the press release, Company CEO, Michael Minogue said, “We are pleased that the Department of Justice has chosen to close its investigation