Author: Peter

... cells generally like having company, forming communities with other cell types to make complete tissues. However, quite often, researchers isolate cells from their 3-D environments, creating 2-D models that don’t always replicate complex biology...But now, an entire industry is emerging to recapitulate various tissues more realistically. 3-D bioprinting has the capacity to layer different cell types, creating more biologically accurate liver, kidney, skin and even tumor tissues. The hope is that more lifelike tissues will produce better scientific results...Organovo is the leader in 3-D bioprinting...The...company has been selling 3-D liver tissue to pharma companies for about 18 months and is about to expand into kidney tissue. The goal is to support drug development by using these 3-D models to gauge toxicity...Kidney and liver toxicology studies are required for every product before it goes into humans....The high costs of clinical trials could eventually make this a go-to technology for pharma and biotech, providing better data to spot toxicity early and avoid costly mistakes…

Physicians expect pharmaceutical companies to provide more beyond-the-pill services, as they face increasing pressure from empowered patients as well as accountable care organizations and integrated delivery networks...The report...found that 46% of the physicians it surveyed expect drugmakers to provide beyond-the-pill services, and 34% have used a beyond-the-pill service from a pharma company...Here are three key insights for pharma marketers to take note of:

1. Drugmakers should provide more than just product information on their websites.
2. Physicians are more likely to prescribe a product if it comes with beyond-the-pill services.
3. Sales reps should be leveraged to engage physicians.

Justin Gallagher, associate publisher of The American Journal of Managed Care. Welcome to This Week in Managed Care, From the Managed Markets News Network.

Chinese drugs and pharmaceutical ingredients are found in medicine cabinets as far away as New York and Chicago, and the country’s exports of pharmaceutical products and health supplements worldwide jumped 3 percent to $56 billion last year...Yet even as China’s drug industry has grown in global stature, so have questions about the safety of its products...about 700 Chinese firms were told by regulators in China to review their pending applications to sell new drugs and voluntarily withdraw any that were false or incomplete. Within months, about 75 percent had been retracted by the manufacturers or rejected by Chinese officials...Among those were some medicines that were separately approved for sale in the U.S. by the Food and Drug Administration. Some of the companies say their data in China were flawed because of faulty information by local research firms...

There is a real need for patients to have information about out-of-pocket costs and clinical tools being used when it comes to their coverage. A new prescription drug search tool that includes information about cost sharing, prior authorization and step therapy will be available to residents of Washington, D.C., shopping for coverage during the upcoming open enrollment period. These types of tools are important for patients, enabling them to find the best health care plan to meet their needs...DC Health Link’s new offering will allow patients in D.C. purchasing private health insurance to input up to 10 prescriptions and see which plans cover their drugs and the cost sharing that goes with them...The new DC Health Link tool also improves transparency and information about deductibles. One feature allows people to clearly see plan details, including whether available plans have a separate drug deductible, whether a medication is subject to a copayment or coinsurance and copayment amounts and coinsurance percentages...While progress continues to make marketplace websites more consumer friendly, additional improvements are still necessary to ensure consumers have a clear understanding of the choices in front of them when picking a health plan...

A top pharmaceutical lobbying group is launching an ad campaign to defend drugmakers that have been under fire for their pricing practices..."We’re under pressure and scrutiny like never before," said Jim Greenwood, chief executive officer of the Biotechnology Innovation Organization. The campaign, called "Innovation Saves," says new drugs can save both lives and costs to the health-care system...BIO is trying to reshape perceptions after a year of finger-pointing among insurers, drugmakers and health-care providers about why the medical system is so expensive..."This campaign is about defending the indefensible: astronomical price increases, drug pricing gimmicks, and massive cost increases," Clare Krusing, a spokeswoman for America’s Health Insurance Plans, said in a statement. "The way that the pharmaceutical industry can show real innovation is by embracing solutions that make treatments and cures affordable to every patient."...

Many patients haven’t heard of "biosimilars," generic versions of complex biotech drugs, and even some who say they’re familiar with these medicines may still be confused about them, a small European survey suggests...To see what patients know about biosimilars, researchers analyzed data from online surveys completed by 1,181 patients with irritable bowel disease or Crohn’s disease, chronic intestinal problems that are increasingly treated with biosimilars...just 38 percent (383) of the survey respondents had heard of biosimilars...researchers asked...more questions to see what they knew about these medicines, 47 percent said they worried about whether the copies were safe and 40 percent said they had concerns about whether the generics were effective…The study by Dr. Laurent Peyrin-Biroulet...found most patients were more concerned about the safety and effectiveness of biosimilars than whether they were a lower-priced alternative to brand name biotech drugs...the findings highlight the need for more patient education about biosimilars...

Celator Pharmaceuticals proudly displayed a large poster touting its experimental Vyxeos (CPX-351) medication as an effective salve for treating acute myeloid leukemia. The poster was, in fact, one of countless placards featured prominently on the exhibit floor at the American Society of Clinical Oncology meeting…the Celator poster managed to stick out...Vyxeos has not yet been approved to treat AML...Celator reported positive clinical trial results for the drug...But that’s not the same thing as having clearance to market a product. Unfortunately, that’s the impression regulators had after looking at the poster…As far as the Food and Drug Administration is concerned, Celator was, effectively, promoting a drug that was misbranded. And so the FDA sent the company (now Jazz Pharmaceuticals)...a letter to complain about its promotional behavior...From a public health perspective, these claims and presentations are concerning because they include representations in a promotional context regarding the safety and efficacy of an investigational new drug that has not been approved by the FDA...

Paul LeVine, vice president of Analytic Services at TrialCard, discusses how specialty pharmacies can best utilize data to improve patient outcomes.

Kelly Walsh, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.