Good morning, everyone, and nice to see you again. We were absent Tuesday due to a commitment to moderate a panel at a conference, which was a welcome respite. However, the to-do list expanded enormously in just one day. So time to forge ahead with a few cups of stimulation. No doubt you may relate. So here is the usual menu of tidbits. Hope you have a wonderful day and do keep us in mind when something fascinating erupts …
Michael Pearson, the outgoing Valeant Pharmaceuticals chief executive, has changed his mind and will now be deposed on April 18 by the Senate Special Committee on Aging. Last week, the committee threatened to hold him in contempt for refusing to testify as part of its ongoing investigation into drug pricing. The company then issued a public statement urging Pearson to comply.
A federal appeals court revived a securities class action against Pfizer that accused the drug maker of hiding heart risks of the Celebrex and Bextra painkillers, according to this opinion. The panel decided a lower court improperly excluded testimony of an expert witness for the shareholders. Pfizer withdrew Bextra in 2004 and, in 2009, paid $2.3 billion to settle a US Department of Justice probe into illegal marketing of Bextra and other drugs.
A US Food and Drug Administration advisory panel voted against recommending accelerated approval for an experimental Clovis Oncology lung cancer treatment, TheStreet reports. The panel believes the treatment should not be approved until more data from an ongoing clinical trial that is expected to finish in 2019 is submitted to the FDA. The vote prompted speculation that further development work should be halted.
Medivation rejected a recent takeover offer from Sanofi, which is pursuing the drug maker to expand its lineup of cancer treatments, Bloomberg News reports. But Sanofi is not ruling out a hostile bid, and Medivation, which has hired advisers to thwart any unwanted overtures, wants a higher price than initial proposals have indicated. European regulators recently approved its Xtandi prostate cancer treatment.
A generic drug used for relieving allergy symptoms may help multiple sclerosis patients rebuild their eye nerves, Bloomberg News says. Clemastine fumarate may offer an over-the-counter option for tackling a disease now treated by more expensive drugs sold by companies such as Biogen. Patients saw the time it took to send a signal from the retina to the brain fall by 1.9 milliseconds per eye, a statistically significant difference from those on placebo.
Imprimis Pharmaceuticals, which makes a compounded version of Daraprim, said it registered as an outsourcing facility, which means it must comply with US Food and Drug Administration regulations. Daraprim is the life-saving medicine used mostly by HIV patients that Turing Pharmaceuticals bought last year and then jacked up the price by more than 5,000 percent. Martin Shrkeli ran Turing at the time. The move caused a firestorm of protest and outrage.
President Obama is expected to sign a bill that would provide financial incentives to companies developing treatments for the Zika virus, Reuters tells us.
Silicon Valley billionaire Sean Parker is making a $250 million grant to speed development of more effective cancer treatments by fostering collaboration among leading researchers, Reuters writes.
NIH Director Dr. Francis Collins recently told a congressional hearing the agency is reluctant to override patents in order to help address the rising cost of medicine, according to Bloomberg News.
The FDA will review an application for Merck to market a biologic that treats allergies caused by dust mites, Pharma Times reports.
A European chemical industry trade group argued that gelatin is safe after Indian regulators called for feedback on a plan to replace gelatin with cellulose in pharmaceutical capsules, InPharma Technologist says.
Johnson & Johnson faces its second state-court trial over allegations it hid the health risks of talcum powder, according to Reuters.
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