And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, as you know, our treasured signal to daydream about weekend plans. And our agenda is rather modest. We hope to spend time with our ancestors and indulge the shortest of short people. A little reading and a lot of napping is also on the horizon. And what about you? That big football game is coming up, which means a run to the store may be in order. You could make time to check in with someone special. Or perhaps contemplate what the future may hold. Whatever you do, have a grand time. But be safe. See you soon …
A surge of biosimilars is expected to be filed by drug makers, Food and Drug Administration official Janet Woodcock told a congressional committee, BioCentury reports. “What I’m concerned about is that this program is going to explode,” said Woodcock, who heads FDA’s Center for Drug Evaluation and Research. “I’m concerned that we will not have the staff because we’re always waiting to catch up.”
Obama administration officials insist they will not renegotiate the Trans-Pacific Partnership trade deal, which the pharmaceutical industry is lobbying against over concerns it would reduce 12 years of exclusivity for biologics, The Financial Times writes. Nonetheless, the administration has begun talks with members of Congress who object to shortening exclusivity, and those talks are expected to intensify.
The head of Pfizer operations in the UK claims that even cash-strapped Greece has better access to new medicines than his country, The Guardian reports. Erik Nordkamp warns that the UK system for approving new drugs, which relies on a government agency that measures cost effectiveness, needs “radical reform” or the UK runs the risk of not gaining access to specialty and personalized medicines.
FDA officials say the agency supports the controversial opioid prescribing guidelines proposed by the Centers for Disease Control and Prevention, according to this piece in The New England Journal of Medicine. The backing, which was mentioned in conjunction with a revamped agency approach to review opioids, follows recent debate over the guidelines, notably criticism from patient groups that receive backing from drug makers.
SciClone Pharmaceuticals agreed to pay $12.8 million to settle a US Securities and Exchange Commission investigation into potential violations of the Foreign Corrupt Practices Act, The Wall Street Journal reports.
FDA medical reviewers concluded that a Celltrion biosimilar version of the Remicade arthritis drug is “highly similar” to the brand-name drug, Reuters writes.
Johnson & Johnson and ViaCyte are working together to speed development of the first stem cell treatment for type 1 diabetes, the Associated Press informs us.
A UK report found that the Cancer Drugs Fund, which was created to promote access to new drugs, has failed to control costs and improve access to treatments for rarer cancers, Pharma Times tells us.
The risk for suicide and aggression in children and adolescents treated with antidepressants is twice as great compared with those who are not given the medicines, writes Medscape, citing results of a review 70 clinical trials.
An early-stage study suggests that statins may be used to treat dry age-related macular degeneration, which is a leading cause of blindness, Pharma Times says.