Pharma Industry Archive

Last week’s press release from Immunomedics and partner UCB concerning lupus drug epratuzumab’s success in a Phase IIb trial seemed to be missing something. Despite claims of “positive” results and “clinically meaningful” data, the release didn’t actually say the trial achieved statistical significance, either in the overall population or in any of the subgroups. There were no...

More...

Merck and the FDA have agreed on new language in the precautions section of Singulair’s labelling. The warning states that using the asthma drug might be kind of, well … trippy: Neuropsychiatric events have been reported in adult, adolescent, and pediatric patients taking SINGULAIR. Post-marketing reports with SINGULAIR use include agitation, aggressive behavior or hostility,...

More...

Pfizer PR chief Ray Kerins blasted the FDA’s lack of guidance on social media as “a problem” at a recent conference. His speech came in July, but Ad Age just published a video of it. In it, Kerins says: There actually are no guidelines for corporations like Pfizer in what we can and cannot do in social media, and that’s a problem. On its own, that’s not a huge...

More...

Elan’s spat with Biogen over the rights to Tysabri seems likely to end up with Elan CEO Kelly Martin facing a deposition with Biogen’s lawyers, according to papers filed in litigation between the two companies. The case is about whether Elan’s financing deal with Johnson & Johnson breaks a joint venture agreement between Elan and Biogen over Tysabri, their MS drug. Biogen...

More...

A research paper in this month’s Bulletin of the World Health Organization suggests that, when it comes to disease funding, perception is reality. Some diseases get more than their fair share of government and nonprofit funding: HIV/AIDS received more than one-third of health donations in the early 2000s despite a mortality rate of about five percent, and severe acute respiratory syndrome...

More...

GlaxoSmithKline suggested that reports of liver failure associated with its diet drug Alli might be the fault of the patients, not the drug. In a press release responding to the FDA’s alert that it is probing 32 cases of liver damage associated with Alli, GSK said: … Liver changes can have many causes. People who are overweight and obese are predisposed to liver-related disorders....

More...

The relative efficacy of Optimer Pharma’s investigational antibiotic, fidaxomicin, compared to standard-of-care vancomycin (marketed as Vancocin by drugmaker ViroPharma), remains unclear. Published results show similar recurrence rates in a subset of patients infected with a life-threatening strain of the hospital-acquired gastrointestinal infection Clostridium difficile. In my opinion,...

More...

A doctor who wrote in an academic journal that preschoolers may suffer from depression and could be good candidates for atypical antipsychotics received funding from three drug companies that make mental health medicines. Dr. Joan Luby, a professor of child psychiatry at the Washington University School of Medicine in St. Louis, wrote that children as young as three years old may suffer from...

More...

Obesity cure for fruit flies! Merck looks for buddhism pill! Constipation drugs for dogs! It all happened in August … Om! Merck will examine brains of buddhists for new antidepressants Neuroscientists will stick meditators into MRIs to see what the brain looks like when it’s calm. Transcendence? There’s gonna be a pill for that … Pfizer sues supplier over bogus kosher...

More...

Back in November, BNET suggested we were about to see a media campaign full of scary stuff — anal cancer, anyone? — for which the prevention is Merck’s HPV vaccine, Gardasil. This week, it arrived. Spanish researchers reporting in the Journal of Clinical Pathology found that 46.9 percent of all penile cancers are caused by HPV. (And yes, penile cancer is located exactly where...

More...