Amgen blocks Novartis' Neupogen biosim; NeuroDerm gets out from under FDA hold;

@FierceBiotech: La Jolla dumps its NASH drug and shifts its focus to rare disease. Report | Follow @FierceBiotech

@JohnCFierce: My thought: FDA panels lean on the side of approval, especially for a disease like CF. Any ??? can be answered post approval. $VRTX wins. | Follow @JohnCFierce

> Amgen ($AMGN) has successfully blocked Novartis ($NVS) from launching its Neupogen biosimilar in the U.S., at least for now. Story

> The FDA lifted its clinical hold on NeuroDerm's ($NDRM) Parkinson's disease treatments, allowing the biotech to get its development program back on track. More

> So-called safety switches could help the developers of CAR-T treatments make their cell therapies more tolerable. Feature

Medical Device News

@FierceMedDev: Adaptive Biotechnologies reels in $195M for immunosequencing tech. FierceDiagnostics story | Follow @FierceMedDev

@VarunSaxena2: ICYMI yesterday: Smith & Nephew boosts rep-less sales pilot by acquiring software assets that help automate training. Article | Follow @VarunSaxena2

@EmilyWFierce: ICYMI: RainDance shoots for long reads of whole genome with Pac Bio collaboration. Item | Follow @EmilyWFierce

> Mayo Clinic study finds digital health interventions reduce risk of cardiovascular disease. More

> Fitbit files for up to $100M IPO as it dominates fitness wearables and aims for corporate wellness. Story

> Smartphone-based diagnostic device detects parasitic worms via video. News

Pharma News

@FiercePharma: Japan's Eisai makes moves for Indian API manufacturing in further cost trimming. FiercePharmaAsia story | Follow @FiercePharma

@CarlyHFierce: ICYMI: Valeant chief Pearson the next Warren Buffett? Deal partner Ackman thinks so. Story | Follow @CarlyHFierce

> FDA staffers raise doubts over key Vertex combo. Item

> AdverseEvents: New generation of hep C meds bests older therapies in side-effect reports. More

> Amarin sues FDA over 'free speech' issue the agency says it is ready to hash out. Article

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