Orwin out as CEO of Affymax; Sanofi and Regeneron advance RA drug in PhIII;

@FierceBiotech: $VVUS announces proposed offering of convertible senior notes. Release | Follow @FierceBiotech

@JohnCFierce: Quintiles joins Merck KGaA's R&D command post in 5-year exclusive. News | Follow @JohnCFierce

@RyanMFierce: Billionaires back Kite Pharma in $20M raise for cancer immunotherapies. Article | Follow @RyanMFierce

> John Orwin is out as CEO of Affymax ($AFFY), which is restructuring after its anemia drug Omontys was pulled from the market in February. Article

> Sanofi ($SNY) and Regeneron ($REGN) have begun recruitment for Phase III development of their experimental therapy sarilumab in rheumatoid arthritis. More

> Angry Elan ($ELN) shareholders have mounted a legal attack to get at least $549 million in damages from SAC Capital over insider trading allegations. Article

Medical Device News

@FierceMedDev: Elixir snags CE mark for dissolvable stent. News | Follow @FierceMedDev

@MarkHFierce: Roche won crucial FDA approval for a companion diagnostic for lung cancer. Goes with Astellas' Tarceva. Release | Follow @MarkHFierce

 @DamianFierce: Analogic is lopping off 140 jobs in Colorado and Vancouver. More | Follow @DamianFierce

> Daktari Diagnostics reels in $7M as it preps for Scotland expansion. Story

> Vermillion private placement comes through. Item

Pharma News

@FiercePharma: ICYMI - execs' bogeymen: Animal-rights extremists, disease activists and laid-off workers, security tells FAA. Report | Follow @FiercePharma

> Roche wins new targeted OK for Tarceva in EGFR-positive lung cancer. News

> U.K. saves £1 million a day, thanks to generic Lipitor. News

> Actavis nixed a $15B offer from Mylan to zero in on Warner Chilcott. Article

> Ranbaxy's rocky road ahead after $500M settlement. Story

Drug Delivery News

@MichaelGFierce: Israeli team spurs nerve healing with implant-released gel. More | Follow @MichaelGFierce

> New polymers shatter to release drugs at specific target. Report

> Marina platform to deliver first-ever miRNA cancer drug for Mirna PhI. News

> Scripps study reveals new RNA-drug targeting potential. Article

> FDA accepts Merck's sublingual allergy med license application. Item

Biomarkers News

> Genome mutations reveal acute myeloid leukemia risk, potential drug targets. Story

> Biomarker trio enables blood Dx to map heart attack risk. More

> Bristol-Myers Squibb, Adaptive Biotechnologies ally for cancer biomarker development. More

> Fetus secretes hormone that could flag preeclampsia risk. Article

> 9 blood-based biomarkers correspond to amyloid plaque in the brain. Item

And Finally… The New York Times analyzed the growing debate among medical experts about the implications of a highly publicized double mastectomy. Article