The FDA yesterday said it won’t ban textured breast implants, which may be linked to a type of immune system cancer, after one of its advisory panels said there’s not enough evidence to support the move. In March the federal safety watchdog’s General & Plastic Surgery Devices panel held two days of hearings before reaching […]
Medtronic taps Lennon as CIO | Personnel Moves – April 9, 2018
Medtronic (NYSE:MDT) said that it named Sean Lennon as its new chief information officer, set to take effect April 29. The Fridley, Minn.-based medtech giant said that Lennon will take over for Mike Hedges, who is retiring from the position after 19 years with Medtronic, including 10 as CIO. Prior to joining Medtronic, Lennon served as […]
Health Canada notifies Allergan on intent to suspend Biocell breast implant license
Health Canada said yesterday that it plans to suspend Allergan‘s (NYSE: AGN) licenses to sell its Biocell breast implants in the region due to a possible association with a rare immune system-cancer. The move follows the agency’s completion of a scientific assessment of macro-textured implants, which it said is part of a larger safety review of […]
Number of cancer cases linked to breast implants soars
FDA said it has received reports of 457 unique cancer cases related to breast implants since 2010, including nine patient deaths. The agency identified those unique cases from a total of 660 adverse event reports in the U.S. from 2010 through September 2018, including 246 new adverse event reports since 2017. FDA began reporting on cases […]
Report: Pharma companies kick off new year with price hikes
Major pharmaceutical firms started the new year by hiking the prices of hundreds of drugs, according to a new study published by Rx Savings Solutions. First reported in The Wall Street Journal, the study found that the average price increase taken by more than three dozen companies was roughly 6.3%. Get the full story at our […]
Report: Despite settlement, patient seeks prosecution for off-label Seri scaffold breast surgery
A patient in Southern California who underwent breast reconstruction surgery using an off-label Seri surgical scaffold is pushing for the state to prosecute the operating plastic surgeon, despite having received $1 million in a settlement, over claims that he altered her medical records, according to a Pasadena Star News report. The patient, Wendy Knecht, underwent […]
Allergan pulls textured breast implants from the European market
Allergan (NYSE: AGN) has removed its textured breast implants from the market in Europe following a recall request from French regulators. France’s National Agency for the Safety of Medicines and Health Products said that it hasn’t “identified any immediate risk for the health of women carrying the implants,” and that it plans to convene an expert committee […]
FDA approves five-year hormonal contraceptive
Allergan (NYSE:AGN) and the nonprofit women’s health pharma company Medicines360 said today that the FDA approved an application to extend the duration of use for Liletta for the prevention of pregnancy for up to five years. Medicines360 first won approval for the levonorgestrel-releasing intrauterine device in February of 2015. The system’s latest FDA approval is based on a […]
FDA pushes back on silicone breast implant study
The FDA last week pushed back at a large study showing an association between silicone breast implants and some rare diseases, standing by its record of warning the public about their risks – despite granting approvals to a slew of the implants in recent years. The study, published Sept. 14 in the Annals of Surgery, […]
Oyster Point takes aim at the root of dry eye disease with intranasal drug-delivery technique
Large pharmaceutical companies dominate the dry eye disease space – Allergan (NYSE:AGN) rakes in more than a billion dollars every year for its Restasis eye drops. Eight-person Oyster Point Pharma wants in on that market. But it’s betting on a completely different approach. “What we’ve come up with is a very innovative nasal spray, which when sprayed into the […]
Tribe taking steps to ‘ramp up’ drug patent business
The Native American tribe wrapped up in litigation with generic pharmaceutical companies is trying to prove that its arrangement with Allergan (NYSE:AGN) reflects a legitimate move to boost its economy, according to court documents. The St. Regis Mohawk Tribe of New York found itself it the middle of a controversial deal this year after it agreed to […]
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