French biosimilar substitution plan alarms pharma; FDA green-lights Vanda's Hetlioz; Novartis sends malaria treatments to Zambia;

@FiercePharma: Top-read special report: The top 10 pharma companies by 2013 revenue. Feature | Follow @FiercePharma

@TracyStaton: FiercePharma's best-read marketing story: Sanofi aims for outcomes with new Chief Patient Officer. Article | Follow @TracyStaton

@EricPFierce: Sources tell Economic Times that Sun will phase out Ranbaxy brand in U.S. Sun doesn't deny it. More | Follow @EricPFierce

@CarlyHFierce: Hamburg to pharma at PhRMA 14, on improving applications: "One message, and I maybe will come to regret it, is really do reach out and engage with us." | Follow @CarlyHFierce

> France has worried pharma with a measure allowing pharmacists to substitute prescribed brand-name biologic drugs with biosimilars. Report

> The FDA has approved Hetlioz, Vanda Pharmaceuticals' ($VNDA) treatment for non-24-hour sleep-wake disorder. Release

> A Florida federal jury has decided that Novartis ($NVS) didn't fail to sufficiently warn a prescribing physician of the risk of jaw injuries supposedly caused by bone drugs Aredia and Zometa. More (sub. req.)

> Two New Jersey men who made hundreds of thousands of dollars trading with insider info on Celgene ($CELG) are headed to federal prison. Story

> An FDA advisory committee recently looked favorably on two competitors to Pfizer's ($PFE) Zyvox, which boasts a $1.4 billion market. More

> Novartis ($NVS) plans to provide two million pediatric antimalarials to Zambia. News

Medical Device News

@FierceMedDev: Boston Scientific eyes Israel in global marketing push. News | Follow @FierceMedDev

@VarunSaxena2: ICYMI: Adaptive Biotechnologies raises $120M to bolster its immune Dx. Article | Follow @VarunSaxena2

@EmilyWFierce: U.S. and European docs want to put the kibosh on renal denervation devices. Story | Follow @EmilyWFierce

@MichaelGFierce: ICYMI from FierceDrugDelivery: Nanoballoons 'pop' open to deliver cancer drugs when hit with a red laser. Story | Follow @MichaelGFierce

> Abbott creeps toward the FDA with its dissolvable stent. More

> Tendyne raises $25M in Series C financing for mitral valve device. Article

Biotech News

@FierceBiotech: Biogen's hemophilia hopeful scores a PhIII win as FDA awaits. News | Follow @FierceBiotech

@JohnCFierce: Celladon's heart drug grabs 'breakthrough' status at FDA. Item | Follow @JohnCFierce

@DamianFierce: As $GILD gets pilloried over pricing, $BMY (Article) and $MRK (Story) creep up in hep C. | Follow @DamianFierce

@EmilyMFierce: WHO offers road map for new vaccine introduction. Article | Follow @EmilyMFierce

> Soon after media storm fades, Chimerix CEO Moch is out the door. More

Pharma Manufacturing News

> Neuland opens API plant as part of its partnership with Mitsubishi. More

> Kyowa Hakko Kirin finishes $60M biologics API plant. Story

> Sources: Sun has blueprint for turning Ranbaxy around. Article

> AbbVie partners with Arabio for production in Saudi Arabia. More

> Novartis' government-backed vaccine plant should be operational by 2017. Item

Vaccines News

> Merck KGaA lung cancer vaccine gets a second shot with start of PhIII trial. Story

> Colorado Senate hears vaccine bill testimony. Item

> Report: Emergency flu vaccine manufacturing site will be online by 2017. Article

> Novartis' Bexsero wins FDA 'breakthrough' status. More

And Finally... Eye doctors say their profits are smaller than Medicare makes them look. Report (sub. req.)

 

 

Suggested Articles

Look out, diabetes market: Novo Nordisk won its FDA nod for highly anticipated Rybelsus to control blood sugar in patients with Type 2 diabetes.

Insys is in fire sale mode as part of its bankruptcy plan, and now it’s been given the go-ahead to sell the opioid that helped get it there.

GSK CEO Emma Walmsley could soon have a new title: Microsoft board member. The software giant has nominated her to its board of directors.