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FDA Issues Drug Safety Communication regarding Health Risks for Asthma Drug Xolair®

On September 26, the FDA issued a Drug Safety Communication regarding the health risks of the asmtha drug Xolair® (omalizumab). In particular, the FDA warned that a 5-year safety study suggests a slightly increased risk of cardiovascular and cerebrovascular serious adverse events (as a result of heart and brain blood vessel problems) for patients being […]

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Xarelto® Lawsuit Update: Bayer & Johnson & Johnson Aim to Expand Uses for Xarelto

The Wall Street Journal reports that Johnson & Johnson and Bayer AG recently announced plans to launch clinical trials of Xarelto® against new diseases in order to double the number of indications and widen the market for Xarelto®, which is already poised to exceed $1 billion in sales for 2014. In particular, Yahoo! Finance reports […]

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DePuy Executive Questioned regarding Safety Studies for DePuy Pinnacle™ Hips

Reuters reports that an executive at Johnson & Johnson’s DePuy Orthopaedics Inc. unit has testified in the first DePuy Pinnacle™ bellwether regarding the company’s assessment of safety risks associated with its Pinnacle™ hip implants. Pamela Plouhar, the DePuy executive and worldwide vice president of clinical research, was questioned about the studies DePuy performed on these […]

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Actos® Lawsuit Update: Jurors in Philadelphia Hear Evidence that Takeda Concealed Bladder Cancer Risks, Law 360 Reports

Law 360 reports that jurors in a Philadelphia state court case trial heard evidence from an expert witness who testified that Takeda worked to suppress information about the cancer risks associated with Actos®. Randall Tackett, an expert witness who testified on behalf of plaintiff Frances Wisniewski, testified that Takeda convinced one of its partners back […]

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Testosterone Lawsuit Update: FDA Advisory Committee Decides Further Study of Cardiovascular Risks Required

Bloomberg News reports that the members of a Food and Drug Administration (FDA) Advisory Committee unanimously agreed this week that manufacturers of testosterone drugs should further study the potential cardiovascular health risks of testosterone products and who should take these drugs. According to the FDA, the Advisory Committee Meeting was held on September 17, 2014 […]

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Transvaginal Mesh (TVM) Lawsuit Update: 3.25 Million Jury Verdict Against Ethicon

Yahoo! News reports that a federal jury in West Virginia has awarded a woman with $3.27 Million in damages for injuries due to Johnson & Johnson’s Ethicon transvaginal mesh product. The plaintiff, Jo Huskey, was implanted with a Gynecare TVT Obturator transvaginal mesh device in 2011 to treat stress urinary continence (SUI) and experienced problems […]

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FDA Warns of Risk of Allergic Reactions from Active Ingredients in Certain Acne Treatment Products

ABC News reports that the FDA has warned of rare, but serious, allergic reactions to some active ingredients in over-the-counter acne treatments, including benzoyl peroxide and salicylic acid. In particular, the FDA issued a statement notifying that such topical, over-the-counter acne products containing these active ingredients can cause dangerous side effects, including life-threatening allergic reactions […]

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Xarelto® Lawsuit Update: Bayer/Johnson & Johnson Plan to Further Expand Indications for Xarelto®

Yahoo! Finance reports that Bayer and its partner Johnson & Johnson plan to potentially expand Xarelto®’s use for the prevention of potentially deadly blood clots in patients at risk of arterial thromboembolism. The companies plan to evaluate Xarelto® for such a new indication in three clinical studies: (1) In a global phase III study (NAVIGATE […]

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Transvaginal Mesh (TVM) Lawsuit Update: $73 Million Jury Verdict Against Boston Scientific

Bloomberg reports that jurors in a Texas state court in Dallas found Boston Scientific liable and ordered the company to pay $73 Million in damages to a woman who was seriously injured by the company’s vaginal-mesh implant. In particular, the jury awarded the injured woman $23 Million in compensatory damages and $50 Million in punitive […]

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Actos® Lawsuit Update: Judge Denies Takeda’s Motion to Overturn $9 Billion Jury Verdict in First MDL Actos® Trial

Bloomberg reports that The Honorable Judge Rebecca Doherty has ruled against Defendants Takeda Pharmaceutical Co. and Eli Lilly in their motion to overturn the $9 Billion verdict decided by a jury earlier this year. In particular, Judge Doherty ruled that jurors properly considered evidence showing that the officials for the manufacturers of Actos® were aware […]

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