Roche took a step forward in personalized medicine with the approval earlier this month of a new drug and related diagnostic to treat certain forms of metastatic melanoma. Roche’s strategy of developing drugs and related diagnostics shows the potential business and therapeutic value of personalized medicines. Read more »
The online sale of pharmaceutical products is a big headache for regulators. The Internet is the counterfeiter’s dream market stall, and virtually begs to be abused. Some surveys suggest that more than 60% of drugs purchased online are fake. But governments and regulators are fighting back. In July, the EMA welcomed a new directive on falsified medicines that had a strong focus on the sale of illegal medicinal products on the Internet—somewhat obscurely referred to as “sale at a distance to the public”—and the European Commission was charged with creating a cryptographic logo to identify legal sites.
Mistakes happen. In the pharma industry, these mistakes can lead to product recalls. Perhaps the medication is not the correct strength or maybe it became contaminated with metal fragments…
…and sometimes, entirely the wrong drug is found in the packet. In a case that has had UK media reports aflame, a prescription only antipsychotic drug was found in certain packets of a common pain medication that was manufactured by a completely different company. Is it a repackaging mistake? Or are more sinister intentions at work? Either way, it’s clear there are could be a few security holes in pharma’s distribution chains. Read more »
At least once a week, my spam inbox contains mail from one or more online pharmacies, promising me a great price on a particular drug that is not medically necessary, nor is it meant to be dispensed to someone of my gender. Hospital pharmacies, in the business of dispensing medically necessary drugs to hospital patients, receive email from distributors with lists of drugs and prices, and also receive offers from so-called gray market distributors, unofficial sellers who are now taking advantage of drug shortages to resell scarce products at inflated prices. Read more »
FDA released a strategic plan to advance regulatory science on Aug. 17, 2011, in an effort to “keep pace with and utilize…new scientific advances” and to promote public health. The plan is based on the agency’s 5-year strategic goals (see back story) and its October 2010 report on advancing regulatory science (see back story). The plan outlines eight priority areas that describe how FDA intends to gather and communicate information and advance tools and product quality. Priority 5 caught my eye. It aims to harness diverse data using information sciences. The idea is to integrate and analyze data from various sources, and one such program will involve opening product applications.
Stock prices have fluctuated wildly in response to factors such as persistently high unemployment, impending cuts in federal spending, and the downgrade of America’s credit rating. The already conservative pharmaceutical industry is hunkering down and socking away cash to be safe. Since January, Merck has saved $1 billion in cash, and Johnson & Johnson has saved $3 billion. The savings have come at the expense of R&D budgets, making observers wonder where the new drugs will come from.
There’s a lot of activity between the EMA and the FDA at the moment. Recently, reports have been published following two international pilot programmes regarding API inspections and good clinical practices (GCP). The outcome of the pilots? Success! Read more »
The reduction in the pharmaceutical R&D force has been in the news for the past several years, with well-publicized reductions by Pfizer and AstraZeneca, to name a few. However, the process of discovery has become, if anything, more complex over the years. Large pharma is no longer able to support stables of scientists that perform basic research but do not directly contribute to drug development. How to reconcile the need for information with the constraints of a reduced R&D force? Read more »
The International Conference on Harmonization (ICH) released a summary of its June 2011 meeting of the steering committee and expert working groups. The meeting was held in Cincinnati and chaired by FDA. Below is a recap of the key progress made regarding ICH’s quality and multidisciplinary working groups. Read more »
Good news on the drug-approval front. Through the end of July, FDA’s Center for Drug Evaluation and Research had approved 21 new drugs (new molecular entities and new biologics license applications), which equals the total number of new drugs approved in all of 2010. Although not enough to claim a reversal of the recent downward trend in drug R&D productivity, the numbers are a good sign for the industry. Read more »
From PharmTech.com