Merck nabs expanded use for Gardasil 9 in males; Judge orders AbbVie to hand over documents in Low-T case;

@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

Suggested Articles

Which rollouts might suffer most? Those that treat chronic diseases, require doctors to administer them or face current competition, analysts say.

Novartis and Incyte will put their blockbuster JAK inhibitor into phase 3 clinical trials as a possible treatment for COVID-19, the drugmakers said.

The Cannes Lions canceled its advertising creativity conference for 2020 after media reports that many large ad agencies planned to opt out.