Rise and shine. Another hectic day is on the way. Of course, busy is good, as they say, so no need to kvetch, yes? So time to dig in to the usual routine of deadlines and phone calls and whatnot. As always, we are helped along by a few cups of stimulation, which are especially comforting since a new study says they do not make our heart race any faster. So feel free to join us. Meanwhile, you have a splendid day and let us know if you hear anything interesting …
US Senator Joe Manchin (D-W.Va.) plans to filibuster the nomination of Dr. Robert Califf as Food and Drug Administration commissioner, making him the fourth senator to raise objections. “The FDA and Commissioner’s number one priority should be public health and it is inappropriate for the FDA Commissioner to have had such close financial ties with the pharmaceutical industry,” he said in a statement.
Artisan Partners, a major shareholder in Johnson & Johnson, urged several activist investors to pressure the company to consider separating its three product divisions, Reuters reports. Artisan, which manages nearly $100 billion, also suggested the health care giant should look at replacing board members and review standards for executive pay and financial reporting.
Roche CEO Severin Schwan believes drug makers should expect tough scrutiny on pricing ahead of the US presidential election and focus on more innovative products to avoid further pressure, The Financial Times writes. “If you have truly differentiated medicines … then I do believe that societies will continue to reward this innovation and this is particularly true in the US,” he said.
Johnson & Johnson is moving to settle thousands of lawsuits filed by women who blamed the company’s vaginal-mesh inserts for their injuries, according to Bloomberg News. The health care giant agreed to pay more than $120 million to resolve between 2,000 to 3,000 lawsuits that alleged women suffered organ damage and constant pain by mesh devices that that were surgically inserted but eroded in their bodies.
Chinese regulators halted drug imports from four drug makers for violating good manufacturing practices, and India’s Aurobindo Pharma was sanctioned for delaying an inspection, Regulatory Focus says.
Despite speculation, Biogen has not specifically ruled out raising prices again this year for its multiple sclerosis drugs, TheStreet tells us.
Novartis said US government and commercial insurers are taking longer to cover new medicines than in Europe, which contributed to weak sales of its new Entresto heart failure treatment, Reuters reports.
The FDA agreed to review a Merck drug that may prevent the recurrence of the Clostridium difficile superbug, The Wall Street Journal writes.
Vertex Pharmaceuticals hasn’t yet provided guidance on its newest cystic fibrosis drug, and The Boston Business Journal provides some reasons.