The FDA issued warning letters today to two breast implant manufacturers for failure to comply with regulatory requirements. One letter went to Allergan (now part of AbbVie) for failing to comply with requirements — under two separate premarket approval orders — to conduct post-approval studies to assess the long-term safety and risks of two models of […]
AbbVie gains U.S. nod for $63B Allergan takeover
Pharmaceutical giant AbbVie (NYSE:ABBV) has won U.S. antitrust approval for its purchase of Allergan (NYSE:AGN) for $63 billion in cash and stock. The purchase is seen as a hedge against the impending expiration of U.S. patents on AbbVie’s blockbuster drug, Humira. North Chicago-based AbbVie announced the deal in June 2019, but ran up against U.S. […]
Women accuse Allergan of dirty tricks in breast implant lawsuit
This article has been updated with comments from Allergan. A group of women who have had their recalled Allergan (NYSE:AGN) textured breast implants removed claim the company is trying to trick them and others into releasing the company from liability. Textured breast implants have been linked to BIA-ALCL, a type of non-Hodgkin’s lymphoma. The FDA asked […]
FDA approves expanded indication for Liletta 6-year IUD
Medicines360 and its partner Allergan (NYSE:AGN) said today that the FDA approved Medicines360’s supplemental new drug application to extend the duration use of the Liletta intrauterine device for up to six years. The Liletta levonorgestrel-releasing intrauterine system now has the longest approved duration of use for a hormonal intrauterine device in the U.S., according to a […]
Australia suspends sales of certain textured breast implants
Australian health officials have suspended sales of some textured breast implants for six months and recalled models of those implants already distributed due to concerns about an uncommon form of lymphoma. The Australian Therapeutic Goods Administration (TGA) temporarily halted import, export and supply of eight models of breast implants following reports of about 100 cases […]
Allergan sued over textured breast implants
Two women have filed a class-action lawsuit against Allergan (NYSE:AGN), alleging that the company’s textured breast implants gave them a rare form of cancer. Separately, a California judge dismissed two lawsuits against Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide over injuries allegedly caused by Mentor’s silicone breast implants. In the suit against Allergan, a woman […]
UPDATE: FDA asks Allergan to recall textured breast implants
UPDATED July 24, 2019, with new FDA statement. The FDA said today that it asked Allergan (NYSE: AGN) to recall its Biocell breast implants after concluding that they are six times as likely as other textured breast implants to cause an uncommon form of lymphoma. The federal safety watchdog said that nearly 84% of the 573 […]
AbbVie to buy Allergan for $6.3B
Pharmaceutical giant AbbVie (NYSE:ABBV) said today it will acquire Allergan (NYSE:AGN) for $63 billion in cash and stock. The purchase is seen as a hedge against the impending expiration of U.S. patents on AbbVie’s blockbuster drug, Humira. AbbVie will pay Allergan shareholders $188.24 per share of Allergan stock, a 45% premium to yesterday’s closing price. […]
Canada bans Allergan Biocell breast implants
Health Canada has suspended sales of Allergan’s Biocell breast implants due to a higher incidence of a rare breast cancer in patients with macro-textured breast implants than other implants. The Allergan (NYSE: AGN) Biocell breast implants are the only macro-textured implants available in Canada. The regulatory agency instituted the ban based on the results of a 2017 safety […]
FDA won’t ban textured breast implants
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 […]
- 1
- 2
- 3
- …
- 25
- Next Page »
