@FierceBiotech: Justice Roberts is a popular man in biotech today. Biosimilars pathway and 12 year market exclusivity appear intact. | Follow @FierceBiotech
@JohnCFierce: Quick snap on biopharma implications: Supreme Court upholds ACA, biotech threats disappear. News | Follow @JohnCFierce
> In a head-to-head study Shire says that its Gaucher's drug Vpriv bested Sanofi's Cerezyme in improving lumber spine bone density. Shire is out to help distinguish its therapy in the marketplace. Story
> Gilead Sciences ($GILD) has submitted a New Drug Application to the FDA for its HIV drug elvitegravir. Release
> Shionogo says the FDA has accepted its NDA for ospemifene, a new treatment of vulvar and vaginal atrophy. Release
Pharma News
@FiercePharma: Our quick take: With individual mandate upheld, pharma gets its new patients. More | Follow @FiercePharma
> Sandoz challenges Ranbaxy's 180-day lock on Nexium copies. Report
> Arena's next challenge: Build up Belviq sales. Story
> Purdue fights to extend OxyContin monopoly. Article
> Shire's Gaucher drug beats Cerezyme in bone study. News
Medical Devices News
@FierceMedDev: We have extended the nomination deadline for the 15 fiercest medical device developers to July 13. Spread the word. Survey | Follow @FierceMedDev
@MarkHFierce: SCOTUS upheld the whole national health reform law. The med device industry will keep opposing one of its major parts: the 2.3% industry tax. | Follow @MarkHFierce
@DamianFierce: Changing its tune, Medtronic will sit down with the man who figured out how to hack one of its insulin pumps. Article | Follow @DamianFierce
> India accelerates push for modern medical device regs. More
> Aptus Endosystems grabs $25M series BB for AAA device development. Story
> FDA slaps Class I recall status on Fresenius relabling. News
CRO News
@NesaNFierce: As an IU Hoosier, it's really nice to publish good news on Indiana biotech. News | Follow @NesaNFierce
> CROs or Pharma: The great innovation debate. Item
> CMO Shamrock hit with FDA warning over mislabeling. Story
> Top CRO executives predict industry's future. More
> NERI secures $18M pediatric clinical trial contract from NIH. News
Vaccines News
> Swine flu shots a success for Scotland. More
> BioDiem steps closer to a dengue vaccine. Story
> Sanofi's Hexaxim vax gets EMA thumbs up. News
> Cuban hepatitis B vax cuts disease. Item
Pharma Manufacturing News
> Daiichi Sankyo opens first U.S. manufacturing plant. News
> Merck closing Cherokee fermentation operations. More
> AMAG closing plant, moving to contract manufacturing. News
And Finally... Investigators at the University of Southampton believe that everyone signing up for a clinical trial should be better informed about possible placebo effects. "We believe the health changes associated with placebos should be better represented in the literature given to patients before they take part in a clinical trial. At the moment these effects are largely being ignored in the patient information leaflets," says lead researcher at Southampton and lecturer in psychology, Dr. Felicity Bishop. Release