Bayer (ETR:BAYN) said yesterday that it won FDA approval for its hormonal contraceptive device, Kyleena, to prevent pregnancy for up to 5 years. The German company said the long-acting reversible contraceptive (LARC) is due to hit the market next month. LARCs are an increasingly popular form of birth control, including intrauterine devices like Kyleena. Bayer’s […]
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FDA: No evidence of data manipulation in clinical trials for Bayer’s Essure
The FDA said it completed a review of a trade complaint which alleged that Bayer (ETR:BAYN) was engaged in clinical trial misconduct and altering data, saying it found no signs of manipulation. The agency set out to review the allegations, which accused Bayer of clinical trial misconduct, “notably that clinical trial participants’ medical records were altered […]
Bayer can’t dodge Essure lawsuits in California
Bayer (ETR:BAYN) can’t dodge a clutch of lawsuits filed by patients alleging their injuries were caused by its Essure female sterilization device, a California state judge ruled last week. Three cases, covering claims from 14 women and 11 separate suits, were given the go-ahead to proceed by the Superior Court of California in Alameda County in […]
Bayer launches over-the-counter Aleve TENS pain device
Bayer (ETR:BAYN) said today it launched the Aleve direct therapy targeted transcutaneous electrical nerve stimulation pain relief device in the U.S. The device is designed as a non-invasive, drug-free method of pain control, specifically targeted at lower back pain, according to the company. “Aleve Direct Therapy puts controllable TENS technology in consumers hands without having to […]
Dozens sue Bayer over Essure permanent contraceptive implants
UPDATED March 23, 2016, with comment from Bayer. More than 30 women are suing Bayer (ETR:BAYN) over injuries allegedly related to its Essure permanent birth control device, claiming the device led to severe health problems including abdominal cramping, migraines and abnormal menstrual bleeding, according to a law firm’s press release. The lawsuit was filed March 17 in the […]
UPDATE: FDA mandates new study, ‘black box’ label for Bayer’s Essure
Updated with comment from Bayer The FDA today said it would put a pair of measures in place for the controversial Essure permanent contraception device made by Bayer (ETR:BAYN), mandating a new clinical study and new guidance on using the device. Essure is a small metal coil that’s placed in the fallopian tubes via catheter. The FDA said […]
Bayer taps strategy head Baumann for CEO | Personnel Moves
Bayer (ETR:BAYN) named strategy chief Werner Baumann to replace Marijn Dekkers as CEO today, prompting some industry watchers to speculate that there’s more deal-making ahead for the German firm’s non-pharma markets. Baumann, who’s slated to succeed Dekkers May 1, joined Bayer in 1988 and made a name for himself with the successful integration of rival drugmaker […]
Panasonic closes $1B Bayer diabetes biz buy
Panasonic (NYSE:PC) said today it closed its $1 billion buy of Bayer‘s (ETR:BAYN) diabetes care business. The diabetes care business will operate as a stand alone company, named Ascensia Diabetes Care and will develop, manufacture, market and sell blood glucose monitoring meters and strips across 125 countries, according to Panasonic. “Our goal is to ensure high-quality […]
Johnson & Johnson, Medtronic make BCG’s most innovative list
Johnson & Johnson (NYSE:JNJ) and Medtronic (NYSE:MDT) were named in the Boston Consulting Group’s list of the 50 most innovative companies this year at the 20 and 42 spot, respectively. Apple (NSDQ:AAPL) and Google (NSDQ:GOOG) took the top 2 spots on the list. Other notable entries were Gilead at number 8, Bayer‘s (ETR:BAYN) at 11, Biogen (NSDQ:BIIB) at […]
FDA plans Essure action for February
The FDA said today it will issue an evidence-based review of information on Bayer‘s (ETR:BAYN) controversial Essure permanent birth control for women in February next year. The agency said patient health and well-being was its 1st priority regarding the device, and named the issues with Essure specifically as a high-priority issue for it. The federal watchdog […]
House bill would ban Bayer’s Essure
A bill introduced by Rep. Mike Fitzpatrick (R-Pa.) would ban U.S. sales of the Essure female sterilization implant made by Bayer (ETR:BAYN). The “E-Free Act” or H.R. 3920 was introduced Nov. 4 and has 3 co-sponsors: Reps. Marsha Blackburn (R-Tenn.), Gregorio Sablan (I-N. Mariana Islands) and Christoper Smith (R-N.J.). It would direct the FDA commissioner to withdraw approval for the Essure device, the only approved permanent […]