Current Events

A former technician at the New England Compounding Center testified Thursday about falsified cleaning logs, routine cleaning that was routinely missed and a dark, oil-leak stain that leaked from a hood in the Framingham compounding pharmacy’s supposedly sterile clean room.

“The priority was to get the drug made and sent out,” Nicholas Booth said on the stand. “That’s what we were told by (supervisory pharmacist Glenn) Chinn.”

Read more . . .

The prescribing label for Biogen Inc's big-selling oral multiple sclerosis drug Tecfidera has been updated to include a warning of potential liver injury that could require hospitalization, the company said on Wednesday.

However, the updated label says signs of liver injury resolved when those patients stopped taking the medicine.

Tecfidera, the world's top-selling oral MS treatment, accounts for about a third of Biogen revenue. It had sales of $1.03 billion in the third quarter.
Read more . . .

PG&E Corp. was ordered take out television and newspaper advertisements announcing that the company was found guilty of violating safety standards in the wake of a 2010 natural gas pipeline explosion that killed eight people.

A San Francisco federal judge on Thursday also directed “high-level personnel” at the utility to do 2,000 hours of community service and sentenced the company to a maximum-allowed fine of $3 million, saying the its crimes were “very serious and pose great risk to the public safety.” During a trial last year, prosecutors backed off a proposal to seek a penalty of as much as $562 million.

Read more . . .

(Reuters) - Volkswagen AG (VOWG_p.DE) is set to plead guilty on Feb. 24 in Detroit to three felony counts as part of a plea agreement with the U.S. Justice Department to resolve an excess diesel emissions investigation, a court filing shows.
Read more . . .

SEOUL, South Korea — Before a world audience watching online, Samsung on Monday offered details and schematics showing how its Galaxy Note 7 smartphone went from cutting-edge technology to a costly, combustible failure.

But for many of the company’s critics, the most interesting part of the presentation was what Samsung did not say: How could such a technologically advanced titan — a symbol of South Korea’s considerable industrial might — allow the problems to happen to begin with?

Read More

This past fall, an investment firm rattled the health care industry with unsubstantiated claims of multiple software vulnerabilities in internet-connected pacemakers and cardiac defibrillators.

But it took federal authorities who regulate medical devices four months to acknowledge only one of the alleged defects, and for the company, St. Jude Medical, to patch it.

Read more . . .

A man in Boston rolled several student loans into one, and his balance doubled overnight, with no explanation.

Near Chicago, a 39-year-old former graduate student who had a financial windfall sent in a $10,000 check to pay off his loans — and the payment was promptly lost.

Read more . . .

The Los Angeles County Board of Supervisors on Thursday appointed a longtime deputy in the coroner’s office to the role of acting chief medical examiner-coroner.

Dr. Christopher Rogers becomes the second interim leader to helm the troubled agency as it grapples with a staffing shortage, case backlog and an anticipated lapse in its professional accreditation.

Read more . . .

JPMorgan Chase agreed to a $55 million settlement with the government over allegations that it discriminated against "thousands" of African American and Latino mortgage borrowers, it was disclosed Wednesday.

The bank's independent brokers charged minority borrowers higher mortgage interest rates and fees during from 2006 to 2009, compared to "similarly situated white borrowers," according to a government lawsuit filed in a New York federal court.

Read More

General Motors Co. said Wednesday it will pay a $1 million civil penalty as part of a settlement with the U.S. Securities and Exchange Commission related to the regulator’s investigation into the automaker’s ignition switch recall.

The Detroit automaker said it is consenting to an administrative cease and desist order with the SEC and is doing so without admitting or denying wrongdoing.
Read more . . .

Can doctors and patients suss out misleading information in drug ads? That’s what the FDA wants to find out. In a proposed pair of studies, the agency will look at healthcare providers' and patients' responses to determine their ability to detect different levels and types of deception.

The proposal was posted in the Federal Register on Jan. 4 and is open for public comment until March 6, an FDA spokeswoman told FiercePharma via email.

Read more . . .