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

Suggested Articles

Q32 Bio raised $60 million to push its lead antibody through the clinic and bolster its pipeline and the technology behind it.

Sanofi is teaming up with Merck while AstraZeneca taps Arcus as the future of cancer work is very much made together.

The action follows the FDA’s decision to reject a filing for approval of the JAK1 inhibitor in rheumatoid arthritis due to toxicity concerns.