(Reuters)—The U.S. Food & Drug Administration (FDA) is expected to announce a new warning on Johnson & Johnson’s (J&J’s) coronavirus vaccine related to a rare autoimmune disorder, The Washington Post reported on Monday, citing four people familiar with the matter.1 According to The Post, about 100 preliminary reports of Guillain-Barré syndrome have been detected in the…
FDA Names Drugmakers Potentially Acting to Delay Cheap Generics
(Reuters)—The U.S. Food and Drug Administration on Thursday listed drugmakers, including Celgene Corp, Johnson & Johnson, Gilead Sciences and Novartis AG, who the regulator says are potentially blocking access to samples of their drugs to delay generic competition. Generic drugmakers may not be able to develop alternatives without access to samples of branded products they…
Pfizer’s Second Biosimilar of J&J’s Remicade Wins U.S. FDA Approval
(Reuters)—The U.S. Food and Drug Administration approved Pfizer Inc’s second biosimilar to Johnson & Johnson’s blockbuster rheumatoid arthritis drug, Remicade, the company said on Wednesday. Pfizer’s Ixifi was approved for all eligible indications of Remicade, including the treatment of bowel disease Crohn’s disease and skin disorder plaque psoriasis, the drugmaker said. Biosimilars are medicines deemed…
Johnson & Johnson Discloses U.S. Probe Related to Arthritis Drugs
(Reuters) – Healthcare conglomerate Johnson & Johnson said on Monday the U.S. Department of Justice (DOJ) has opened an investigation concerning management and advisory services provided to rheumatology and gastroenterology practices that bought two of its drugs. The U.S. healthcare company said its Janssen Biotech Inc. unit received a civil investigative demand from the DOJ…
U.S. Senator Launches Probe into 5 Top Opioid Drugmakers
(Reuters)—U.S. Democratic Senator Claire McCaskill sought on Tuesday details from the nation’s top opioid drugmakers on their sales and marketing practices, as lawmakers step up efforts to tackle the country’s deadly opioid crisis. The Missouri senator’s investigation comes amid an epidemic of opioid addiction, with 91 Americans dying everyday as a result of overdose, according…
Verdict: Johnson & Johnson to Pay More Than $1 Billion for Defective Hip Implants
(Reuters)—A federal jury in Dallas on Thursday ordered Johnson & Johnson (J&J) and its DePuy Orthopaedics unit to pay more than $1 billion to six plaintiffs who said they were injured by Pinnacle hip implants. The jurors found that the metal-on-metal Pinnacle hip implants were defectively designed and that the companies failed to warn consumers…
U.S. Judge Cuts $500 Million Verdict over Johnson & Johnson Hip Implants
NEW YORK (Reuters)—A U.S. judge has slashed a $500 million verdict against Johnson and Johnson and its DePuy unit over allegedly defective metal-on-metal Pinnacle hip implants to approximately $151 million. On Tuesday, U.S. District Judge Ed Kinkeade in the Northern District of Texas says he was compelled to reduce the verdict under a Texas state…
Johnson & Johnson Hit with $500 Million Verdict in Trial over Hip Implants
NEW YORK (Reuters)—Johnson & Johnson and its DePuy unit were ordered by a Texas federal jury on Thursday to pay a total of about $500 million to five plaintiffs who said they were injured by Pinnacle metal-on-metal hip implants. Following a two-month trial, jurors found that the Pinnacle hips were defectively designed, and that the…