@FiercePharma: FDA expands male age indication for Merck's Gardasil 9. More | Follow @FiercePharma
@EricPFierce: #EMA slams AstraZeneca for releasing APIs from India that repeatedly failed validation. Article | Follow @EricPFierce
@CarlyHFierce: J. Michael Pearson says it's a good thing everyone has TWO eyes - more available for cataract surgery. $VRX investor day so far. #pharma | Follow @CarlyHFierce
> Merck & Co. ($MRK) won an expanded indication for its HPV vaccine Gardasil 9 in boys and young men aged 16 to 26. Release
> In a lawsuit over "Low T" drug risks, a federal judge ordered AbbVie ($ABBV) and Besins Healthcare to produce documents withheld during discovery. Report
> Specialty drug costs blew a $438 million hole in the California Public Employees' Retirement System budget, a 32% increase year-over-year; the amount represented one-fourth of its drug spending, dollarwise, though specialty drugs accounted for only 1% of prescriptions. Report
> Johnson & Johnson's ($JNJ) "phantom recall" of Motrin products back in 2009 surfaced again in a state-court lawsuit in Oregon. Report
Medical Device News
@FierceMedDev: Jury deals J&J $80M payout as a result of an injury from its defective hemorrhoid stapler. Article | Follow @FierceMedDev
@EmilyWFierce: U.K. cost watchdog gives one-two punch to Roche's Kadcyla and BMS' Opdivo. More | Follow @EmilyWFierce
> Developer of simple, procedural solution to sleep apnea finds commercialization partner. Story
> VA contracts with DARPA-backed startup for real-time behavioral analytics, mental health app. Article
Biotech News
@FierceBiotech: Array's melanoma drug clears Phase III with an FDA filing in sight. More | Follow @FierceBiotech
@JohnCFierce: AstraZeneca spending hundreds of millions in China, blueprints new R&D hub. News | Follow @JohnCFierce
@DamianFierce: The 2015 Biotech IPO Boom, in Requiem. Watch | Follow @DamianFierce
> GlaxoSmithKline and J&J march toward the FDA with a new arthritis treatment. More
> Biogen inks a $100M hemophilia deal with a Polaris-backed startup. News
Biotech Research News
> Penn researchers highlight role of CAP2 gene in cardiac arrest. Item
> MS program identifies a new pathway for drug developers. Story
> Roche bags a preclinical next-gen prostate cancer program in $142M deal. News
> Penn State team IDs a candidate for liver disease, obesity. Story
> An experimental class of drugs alters cell metabolism and may prevent tumor growth. Article
Vaccines News
> TSRI-led team tracks antibody origin, development in HIV vaccine work. Report
> GSK partners with Australian scientists to make cheaper pediatric vaccines. Item
> FDA accepts PaxVax's BLA for cholera vaccine, grants it priority review. More
> FDA expands male age indication for Merck's Gardasil 9. Story
> NIAID combines MedImmune, Sanofi H7N9 jabs into promising prime-boost vaccine. Article
Pharma Marketing News
> NICE rebuffs Roche's Kadcyla, BMS' Opdivo in latest round of cancer rejections. Article
> Remicade biosim may face an uphill battle with U.S. docs, analyst says. News
> Mr. Mucus-repped cough meds get the most positive buzz online. Story
> GSW's year-ahead forecast includes pricing debates, changing script models and informed patients. Report
> Pharma brands need the human touch, and MS marketing offers some ideas. Article
And Finally... Johnson & Johnson's ($JNJ) atypical antipsychotic Risperdal appears to trigger a well-known side effect--weight gain--by interfering with gut microbes, a new study suggests. Report