Tag:

Johnson & Johnson...was ordered...to pay $70 million to a male Tennessee teenager who claimed its Risperdal antipsychotic pill caused him to grow enlarged breasts. The finding by a Pennsylvania state court jury was not only the latest, but it is the biggest defeat to date in what has become another sprawling litigation over the drug....jury found that J&J failed to properly warn Risperdal could cause gynecomastia...also determined that the company "intentionally falsified, destroyed, or concealed records" that Risperdal could cause boys to develop breasts...J&J has a bad track record when it comes to marketing Risperdal...In 2013, the company paid more than $2.2 billion to resolve criminal and civil charges of illegally promoting the drug for unapproved uses...J&J reputation. The health care giant has portrayed itself as a trustworthy corporate brand, but has endured several episodes that have sullied its well-honed image...

Just after opening a refurbished manufacturing facility in Cape Town, South Africa earlier this year, pharma giant Johnson & Johnson recently opened the doors to its Global Public Health Africa Operations office there...The company has invested $21 million (300 million rand) in the facilities. The global public health facility will focus on HIV, tuberculosis and maternal, newborn and child health..."This (investment) tells us that South Africa has the capability to provide a facility for world-class manufacturing," Rob Davies, minister of the Department of Trade...

After a decade in which drug makers regularly paid huge fines for various fraudulent practices, there was a noticeable drop over the past two years, according to a new analysis by Public Citizen...Pharmaceutical companies paid approximately $2.8 billion to settle federal and state civil and criminal charges in 2014 and 2015, compared with $9.9 billion during 2012 and 2013. The most recent payments also amounted to the lowest two-year total since 2004 and 2005...Among the worst offenders in recent years were Johnson & Johnson, Pfizer, Novartis, and GlaxoSmithKline, although the report noted that nearly every large drug maker has paid fines to resolve some kind of infraction over the past two decades...A spokesman for the Pharmaceutical Research and Manufacturers of America...We are disappointed at the report’s misleading conclusions...Among its many methodological flaws, the report aggregates all settlements involving the pharmaceutical industry, with little regard as to whether the companies actually broke the law. Civil settlements rarely resolve the question of guilt. Yet the report glosses over its own finding that 88 percent of the settlements reported were civil, not criminal...

A medical advisory panel to the Food and Drug Administration...recommended approval of a cheaper biosimilar form of Johnson & Johnson's Remicade (infliximab) arthritis drug that could eventually batter sales of the branded product...The panel, by a vote of 21-3, supported use of the biosimilar from Celltrion Inc and Pfizer Inc, called Remsima. The FDA usually, but not always, follows the advice of its advisory panels...The independent panel determined that clinical trials of Remsima showed no clinically significant differences with Remicade in treatment of rheumatoid arthritis and a related condition called ankylosing spondylitis...Moreover, the panel agreed Remsima is likely as safe and effective for other conditions Remicade treats, including psoriasis and inflammatory bowel conditions like Crohn's disease and ulcerative colitis, even though Remsima was not tested against those conditions.

The U.S. Attorney's Office...is investigating contracts between drugmakers and companies that manage prescription benefits...Federal prosecutors have approached at least three companies, including Johnson & Johnson, Merck & Co and Endo International Plc, demanding information about their contracts with pharmacy benefit managers...Pharmacy benefit managers...which administer drug benefits for employers and health plans and also run large mail-order pharmacies, have been challenging the rising cost of new medications...When drugs are knocked off their formularies, patients may have to pay full price for them. PBMs often keep or dump a product depending on whether they can obtain favorable pricing.

If you thought drug makers might hunker down in the face of public outrage over pricing, think again...Given the clamor over the cost of prescription drugs, most manufacturers were expected to avoid drawing attention to themselves by boosting price tags. But several companies have been hiking prices for their medicines at a rate that one Wall Street analyst found surprising...Johnson & Johnson took cumulative price hikes on more than a dozen drugs ranging from 5 percent to 28 percent. The biggest boost was for Simponi, which is used to treat rheumatoid arthritis. Amgen raised prices on seven different drugs from 7.6 percent to 28 percent. The largest was for Enbrel, which is used to treat psoriasis and rheumatoid arthritis, among other ailments...Celgene increased price tags between 10.3 percent and 27.9 percent on four medicines, while Gilead Sciences raised prices between 10 percent and 16.5 percent on five drugs...Biogen boosted prices for five drugs anywhere from 9.8 percent to 18 percent; the biggest price hike was for the Tysabri multiple sclerosis treatment.

It is a startling accusation...Did two major pharmaceutical companies, in an effort to protect their blockbuster drug, mislead editors at one of the world’s most prestigious medical journals?...Lawyers for patients suing Johnson & Johnson and Bayer over the safety of the anticlotting drug Xarelto (rivaroxaban) say the answer is yes, claiming that a letter published in The New England Journal of Medicine and written...researchers at Duke University left out critical laboratory data. They claim the companies were complicit by staying silent, helping deceive the editors while the companies were in the midst of providing the very same data to regulators in the United States and Europe...The trial compared the number of strokes and bleeding events experienced by patients taking Xarelto with those of patients using warfarin. The concern is that the faulty results may have led doctors to give patients the wrong dose of warfarin, which could have favored Xarelto...Some experts say this case is reminiscent of other instances in which drug companies concealed or altered drug-trial data in medical journals...

Johnson & Johnson must pay $55 million to a 62-year-old South Dakota woman who blamed her ovarian cancer on the company’s talcum powder in the second such trial loss this year...State court jurors in St. Louis...awarded $5 million in compensation and $50 million in punitive damages to Gloria Ristesund, who was diagnosed with cancer in 2011 after using J&J’s talc-based feminine hygiene products for almost 40 years...J&J is accused in more than 1,000 lawsuits in state and federal courts of ignoring studies linking its Shower-to-Shower product and Johnson’s Baby Powder to ovarian cancer. Women contend the company knew the risk and failed to warn customers..."Unfortunately, the jury’s decision goes against 30 years of studies by medical experts around the word (world) that continue to support the safety of cosmetic talc,’’...Ristesund had several risk factors for ovarian cancer...That included a family history of cancer, having endometriosis and the fact she had no children...

The old process is slow and prone to errors...The process of biopharmaceutical drug manufacturing is stuck in the past. And the Food and Drug Administration is now openly calling for drugmakers to spring it forward into the 21st century..."batch" manufacturing technique used by the industry to an archaic relic...batch manufacturing in pharma involves regular breaks between spurts of production. Continuous manufacturing is usually a persistent, unbroken process wherein production plants keep humming... continuous manufacturing is more reliable...the (FDA) agency’s pioneering decision last week to approve Johnson & Johnson biotech arm Janssen’s request to switch over from batch to continuous manufacturing for the production of the HIV drug Prezista. And now, regulators are declaring outright that other biopharma players should "consider similar efforts."

Takeda is going behind closed doors with its first DTC campaign for Entyvio (vedolizumab), a new biologic treatment for inflammatory bowel diseases. Bathroom doors, that is...The Japanese drugmaker uses a series of bathroom doors in its ad campaign, asking if it's "time for a different perspective." A...TV spot launched Feb. 7...has racked up $2.9 million on more than 2,000 airings...This condition is such an isolating condition and such a stressful condition. Patients are kept from doing the important things they want to be doing in their lives and as a result they miss out on a lot...In testing many different creative ideas with Crohn's and ulcerative colitis patients...the bathroom doors resonated well because patients noted it is a view they are all too familiar with...But some patients even took it to the next level in saying that the doors metaphorically represent that barrier between their disease and being able to do all of the things they want to do. Emotionally, we've touched upon the reality of their disease in a very obvious bathroom door representation, but also a representation of just barriers in general...Analysts have projected blockbuster-level sales for Entyvio by 2020...Marketing will be key to gaining share in a crowded IBD space where it's up against established...brands such as AbbVie's Humira, Amgen's Enbrel, and Johnson & Johnson's Remicade...