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. […]
Miles White’s fearless strategy for growing Abbott
With strong leadership and a taste for risk-taking, outgoing CEO Miles White left no stone unturned as he grew Abbott into one of the world’s largest medical device companies. Few medical device companies have seen the growth and transformation that Abbott (NYSE:ABT) has seen under the leadership of Miles White. During his two decades as […]
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. […]
FDA approves J&J’s Tremfya self-injection pen for psoriasis
FDA has approved Johnson & Johnson’s patient-controlled injector for Tremfya, a treatment for adults with moderate to severe plaque psoriasis. The self-injection approval may help Tremfya compete with AbbVie’s (NYSE:ABBV) Humira pen, which was previously approved for self-injection by psoriasis patients. Get the full story on our sister site, Drug Delivery Business.
Pharma stocks fall as Rep. Cummings launches drug pricing investigation
Chairman of the House Oversight Committee Rep. Elijah Cummings (D-MD) launched an investigation today into the drug pricing practices of 12 pharmaceutical companies. A number of companies named in the investigation saw their stock prices fall, including Amgen (NSDQ:AMGN), AbbVie (NYSE:ABBV), AstraZeneca (NYSE:AZN), Eli Lilly (NYSE:LLY) and Novo Nordisk (NYSE:NVO). A hearing is reportedly set for Jan. 29 and will include patients affected by rising […]
EU approves fifth biosimilar for blockbuster Humira drug
Mylan (NSDQ:MYL) and Fujifilm Kyowa Kirin Biologics said today that the European Commission gave the companies marketing authorization for Hulio, a biosimilar to AbbVie‘s (NYSE:ABBV) billion-dollar Humira product. Mylan said it plans to launch Hulio across particular markets in Europe on or after Oct. 16. The drug is the fifth product authorized by the EC as a biosimilar for […]
Cerveau inks licensing deal with AbbVie for tau imaging agent
Cerveau Technologies has inked a deal to license and supply AbbVie (NYSE:ABBV) with its [F-18]MK-6240 investigational tau imaging agent, the company said today. After the FDA cleared the investigational new drug application for Cerveau’s imaging agent in June, the company said it planned to work with pharmaceutical partners to evaluate the product’s use in positron emission tomography scans to assess […]
Report finds pharma companies limited January list price hikes
Drug-makers didn’t raise list prices for as many drugs in January compared to last year and they initiated fewer hikes of 10% or more, according to analysis by Raymond James & Associates. Although 5.5% of price increases reached the 10% level in January this year, 15% did last year and 20% did 2 years ago. […]
Baxalta wants Shire to boost $30B takeover bid
(Reuters) — Baxalta (NYSE:BXLT), the spinout of Baxter‘s (NYSE:BAX) biopharmaceuticals division, wants Shire (NSDQ:SHPGY) to improve on its $30 billion bid significantly before it will engage in talks, while its Dublin-based rival could sweeten its offer if it gets to see the U.S. biotech company’s books, according to sources on both sides. Both camps are pushing hard behind […]
