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Allergan

The 18 most innovative medical devices of 2021

July 20, 2021 By Danielle Kirsh

The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards. The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition. “The Awards Committee is excited to introduce the nominees for the 2021 […]

Filed Under: Cardiac Implants, Cardiovascular, Catheters, Cosmetic/Aesthetic, Dental, Diagnostics, Digital Health, Endoscopic, Featured, Imaging, Implants, Optical/Ophthalmic, Pain Management, Patient Monitoring, Pharmaceutical, Replacement Heart Valves, Respiratory, Stents, Structural Heart, Structural Heart, Urology Tagged With: Allergan, baylismedical, BD, Biotronik, Boston Scientific, Cala Health, cvrx, Edwards Lifesciences, endomag, Galien Foundation, Glaukos, humanoptics, Pear Therapeutics, Prix Galien USA, Pulmonx, Sonendo, tevapharmaceuticals

Allergan must face breast implant class action

March 22, 2021 By Nancy Crotti

A federal judge in New Jersey has shut down part of a multi-district lawsuit against Allergan over its Biocell textured breast implants but kept most other parts of the litigation. Judge Brian Martinotti ruled on March 19 that some of the plaintiffs’ claims against Allergan (now part of AbbVie) were preempted by federal law while […]

Filed Under: Featured, Legal News, Product Liability, Women's Health Tagged With: Allergan, breast implants, FDA

FDA: Thousands of new breast-implant-related illnesses reported

August 20, 2020 By Nancy Crotti

The FDA today reported that it has received nearly 2,500 new reports globally of “breast implant illness” or BII. Reports of new breast implant-related cancer were also up. BII is not cancer, nor is it a term often found in medical literature, the agency said. But it is frequently used by patients and healthcare providers […]

Filed Under: Featured, Oncology, Women's Health Tagged With: AbbVie, Allergan, BIA-ALCL, FDA

Allergan, Ideal Implant targets of FDA warning letters

May 14, 2020 By Nancy Crotti

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 […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), Implants, Regulatory/Compliance, Women's Health Tagged With: AbbVie, Allergan, FDA, Ideal Implant

AbbVie gains U.S. nod for $63B Allergan takeover

May 6, 2020 By Nancy Crotti

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. […]

Filed Under: Business/Financial News, Featured, Mergers & Acquisitions, Pharmaceutical, Wall Street Beat Tagged With: AbbVie, Allergan, AstraZeneca plc, Eli Lilly & Co., Federal Trade Commission (FTC), Johnson & Johnson

Women accuse Allergan of dirty tricks in breast implant lawsuit

January 8, 2020 By Nancy Crotti

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 […]

Filed Under: Featured, Legal News Tagged With: Allergan

FDA approves expanded indication for Liletta 6-year IUD

October 28, 2019 By Sean Whooley

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 […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Gynecological Tagged With: Allergan, FDA, Medicines360

Australia suspends sales of certain textured breast implants

October 3, 2019 By Nancy Crotti

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 […]

Filed Under: News Well, Oncology, Recalls, Regulatory/Compliance, Women's Health Tagged With: AirXpanders, Allergan, Australia Therapeutic Goods Administration

Allergan sued over textured breast implants

September 4, 2019 By Nancy Crotti

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Implants, Legal News, Women's Health Tagged With: Allergan, Johnson and Johnson, Mentor Worldwide

UPDATE: FDA asks Allergan to recall textured breast implants

July 24, 2019 By Brad Perriello

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 […]

Filed Under: Cosmetic/Aesthetic, Featured, Recalls, Women's Health Tagged With: Allergan

AbbVie to buy Allergan for $6.3B

June 25, 2019 By Nancy Crotti

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. […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Mergers & Acquisitions, News Well, Wall Street Beat Tagged With: AbbVie, Allergan

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