Microdosing To Make Medicines For Infants

Stephanie Sutton Pharm Tech EuropeChildren are not just small adults, which is part of the reason why developing paediatric drugs is not easy. Most medicines are designed for and tested in adults, and then prescribed to children off-label. In particular, there is a lack of medicines for infants aged 0–2 years. There are a variety of reasons for this shortage — mostly relating to the ethical, regulatory and practical issues associated with testing new drugs in infants. Most parents, for instance, would not want new drugs to be tested on their children! Read more »

Bugbear Turned Booster

Erik Greb PharmTech editorPharmaceutical companies can no longer take strong growth for granted, and CEOs and shareholders are lowering their expectations about future performance. The industry’s global sales growth likely will be limited to 1.3% until 2015, according to Joe Dixon, a spokesperson for Datamonitor. Compare this anemic figure to the 7.1% growth rate that manufacturers enjoyed from 2003 to 2009, and you’ll see little reason for joy in drugville. Read more »

Pharma Accused Of Misleading Regulators

Stephanie Sutton Pharm Tech Europe“The pharmaceutical industry is a ‘market for lemons’; a market in which the seller knows much more than the buyer about the product and can profit from selling products less effective and less safe than consumers are led to believe”. Read more »

AIDS Vaccine Trial Planned by IAVI, Crucell, Harvard, Ragon Institute

Alexis Brekke Pellek PharmTech editorA new clinical trial for an AIDS vaccine will take place in Africa and the United States. The program, announced this week, is a collaboration between the International AIDS Vaccine Initiative (IAVI), which will lead the trial, biopharmaceutical company Crucell (Leiden, Netherlands), Harvard Medical School’s Beth Israel Deaconess Medical Center, and the Ragon Institute, an organization dedicated to HIV/AIDS research. Read more »

Clinical Trials: Can the EU Backtrack Fast Enough?

They may be well-meaning, but sometimes the EU’s decisions can have harmful effects, as is the case with its much criticized clinical trials directive. Read more »

A Difficult Balance

Patricia Van Arnum PharmTech editor The Office of the Inspector General at the US Department of Health and Human Services (HHS) issued a report this month citing the US Food and Drug Administration’s need to improve its oversight of foreign clinical trials. The report raises questions over the effectiveness of federal regulatory practices and resources to keep pace with an increasingly global pharmaceutical industry, and in doing so, also engenders larger policy considerations on how to best address this problem. Read more »

Transparency and Safety

Jill Wechsler Washington EditorThe US Food and Drug Administration’s transparency task force promises to raise questions about why certain manufacturer information on drug products is kept secret. Read more »

Trials without Tribulations

Erik Greb PharmTech editorPfizer (New York) has apparently agreed to settle allegations that it conducted an illegal clinical trial of its meningitis drug trovafloxacin in Nigeria. Eleven children died during the trial that prosecutors say was unlicensed. It would be impossible to establish drugs’ safety without clinical trials in humans, but the settlement agreement is more grist for those who say that trial patients’ rights and health are not sufficiently protected. How will regulators respond? Read more »

Eye on Genentech

Alexis Brekke Pellek PharmTech editorKey results from a colon cancer study of Genentech’s Avastin (bevacizumab) could be available in April, according to a Securities and Exchange Commission filing. Genentech previously said results would be available mid-year. The drug is currently approved to treat breast and lung cancer, and it’s a first- and second-line treatment for metastatic colorectal cancer. Read more »

The Right to a Safe Trial

Erik Greb PharmTech editorNormally, I don’t think much about research and development. I usually leave that subject to our sister magazine, Applied Clinical Trials. I do think about patient safety, though, and today an announcement on the website of the US Department of Health and Human Services (DHHS) got my attention.DHHS’s Office for Human Research Protections (OHRP) is soliciting public comment about a proposal to issue guidance recommending training for personnel who conduct, review, or oversee human clinical trials. I was surprised that such training was not already formalized.When I read a little more, I was even more surprised. Read more »

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