Drug Development: To Sue or Not to sue?

Guest blog written by Dr Nicholas Jones, partner and patent attorney at Withers & Rogers LLP.

While it may not happen often, clinical trials can sometimes be halted by patent disputes, leading to costly delays in bringing new drugs to market. At last, the UK Government has decided to do something about this in a bid to make UK patent law more consistent with that in some other parts of the world. Read more »

Scientist Jailed for Falsifying Research Data

Steven Eaton, a scientist working for Aptuit, a US pharmaceutical company, has been jailed three months for falsifying preclinical safety data on experimental anticancer drugs due for clinical evaluation. Eaton, 47, who worked at the company’s drug discovery and development site in Riccarton, near Edinburgh, Scotland, is the first person in the UK to be jailed under the country’s scientific safety laws. Read more »

Towards Greater Transparency of Clinical Trials Data

As an industry that is constantly being scrutinised, pharma is now under pressure to openly publish all data from clinical trials, including negative results such as failures of medicines during phase I–III evaluation. From January onwards, the British Medical Journal (BMJ) will only publish studies on drugs and devices, whether industry funded or not, where there is a commitment to “make the relevant anonymised patient level data available on reasonable request.” The move was fully supported by GlaxoSmithKline (GSK), who is already posting results from all its clinical trials on the company’s website. In a press release, Patrick Vallance, the president of pharmaceuticals R&D at GSK, said, “Moves like this should help medical research by allowing scientists to study the detailed results of clinical trials and increase understanding of current and new medicines.” Read more »

Study ‘Confirms Economic Viability’ of Orphan Drugs

Julian Upton Pharm Exec EuropeOrphan drugs achieved blockbuster status in 2011, generating over $50 billion, and have the potential to generate as much lifetime revenue as drugs used for more common health conditions, according to a report from Thomson Reuters’ IP & Science division. Read more »

GSK in Spotlight for Alleged Unethical Trials

Stephanie Sutton Pharm Tech EuropeGlaxoSmithKline has faced intense media scrutiny this week after being fined approximately 72 650 Euros by a court in Argentina for allegedly conducting unethical clinical trials on children for the company’s pneumococcal vaccine, Synflorix.

I always seem to be writing about GSK in my blogs but this is a much more sombre subject compared with the recent news of GSK CEO Andrew Witty’s knighthood. This week’s attention on GSK is focused on the COMPAS (Clinical Otitis Media and PneumoniA Study) study, which involved almost 24 000 children and was completed in Argentina in June 2011. The fine issued by the Argentinean National Administration of Medicines, Food and Medical Technology (ANMAT) related to administrative procedures in place for the study in 2007 and 2008. According to media reports (Sky News, CNN), some consent forms were signed by illiterate parents or people who did not have custody of the children. Claims have also been made that some children feeling unwell after vaccination were not seen by doctors. Read more »

Two Early Cancer Studies Show Promise

Erik Greb PharmTech editorThe coming patent cliff and the nation’s continuing economic problems have tightened many drugmakers’ R&D budgets. Cancer research has remained a priority, however, as GE Healthcare’s recent $1-billion investment in oncology demonstrates. Two recent studies show the importance of this research by offering glimmers of hope. Read more »

Accelerated Approvals Could Raise Risks for Patients

Erik Greb PharmTech editorFDA approved 35 innovative drugs in fiscal 2011, including treatments for hepatitis C, prostate cancer, Hodgkin’s lymphoma, and lupus. This number of approvals is among the highest in the past 10 years, and it reflects the agency’s efforts to hasten patients’ access to new drugs. In the past two years, the agency’s lower levels of approvals—21 drugs in 2010 and 25 in 2009—caused concern throughout the industry and in Congress. We may feel grateful to FDA, but we also should ask how the agency achieved this high number of approvals.

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A Call for Clarity about Vaccines

Erik Greb PharmTech editorAs I wrote last week, the market for vaccines is expanding, and the newswires have stories about these products almost daily. Sanofi and GlaxoSmithKline, to name just two major players, are increasing investments in research and manufacturing capacity for these therapies. Kalorama Information predicts that sales of pediatric vaccines will grow even more quickly than sales for adult vaccines. Yet drugmakers have surely noticed that not all publicity about vaccines has been positive. Read more »

FDA Follows EMA toward Follow-On Biologics

Erik Greb PharmTech editorDuring this cost-conscious time, many patients and other healthcare payors are opting for generic versions of branded pharmaceuticals. Biopharmaceuticals have claimed a place in the spotlight, but the US currently has no regulatory pathway for biosimilars. That could change after FDA releases its final guidance on follow-on biologics later this year. Read more »

A Rat Is Not A Human!

Stephanie Sutton Pharm Tech EuropeIt’s common knowledge that many of our medicines are tested in rats. It’s also common knowledge that a rat is not a human, so it should come as no surprise that animal studies can only predict a medicine’s effects in humans with an accuracy of 50% at best — no better than the toss of a coin, argue scientists in a recent letter. Read more »

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