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Embattled device maker Olympus Corp. posted a 14% increase in sales of medical scopes worldwide despite health officials linking its instruments to superbug outbreaks at U.S. hospitals. The Japanese company, which also makes cameras and microscopes, said Thursday that the strong performance of its gastrointestinal endoscopes led to record-breaking sales and profit for its medical business in the latest quarter ending June 30. The company's increased sales have sparked criticism from some federal lawmakers and patient advocates who say it's wrong for Olympus to benefit financially because design flaws in its duodenoscopes have contributed to the spread of deadly bacterial infections. (Terhune and Petersen, 8/7)

Twelve members of Congress sent a letter to the U.S. Government Accountability Office Friday asking the agency to investigate a controversial gynecological device that can spread cancer in women. ... A GAO investigation would heighten scrutiny of the Food and Drug Administration’s approval and monitoring of the power morcellator, which had been used in tens of thousands of minimally invasive procedures a year. The device is used primarily in hysterectomies, to slice up common benign uterine masses known as fibroids so the bulky tissue could be removed through tiny incisions. (Levitz, 8/7)

A federal judge said on Friday that the Food and Drug Administration could not prohibit the truthful promotion of a drug for unapproved uses because doing so would violate the protection of free speech. The decision, by a district judge in Manhattan, could inhibit the ability of the F.D.A. to regulate one aspect of pharmaceutical marketing. Pharmaceutical companies have collectively paid billions of dollars in fines in recent years after being accused of marketing drugs for unapproved uses. (Pollack, 8/7)

A federal judge barred the Food and Drug Administration from blocking a drug company’s efforts to promote an unapproved use for pills derived from fish oil, saying the firm’s claims are protected by the First Amendment. U.S. District Judge Paul Engelmayer granted Amarin Corp. preliminary relief. ... Amarin’s suit against the FDA will continue, but the company will be allowed to begin marketing the off-label use immediately, under the judge’s decision. (Johnson, 8/7)

A Maryland-based biotech company believes it can solve a riddle that has baffled Big Pharma for decades: how to protect against a virus that infects almost every American child. If mid-stage trial data proves positive, Novavax Inc will be closer than any drug developer to a vaccine for respiratory syncytial virus, or RSV, which affects those most with compromised immune systems - including young infants and the elderly. (Grover, 8/10)