Merck's Keytruda beats Yervoy in skin cancer study; FDA keeps the pace with speedy approvals;

@FierceBiotech: Video: Is this a biotech bubble? Watch | Follow @FierceBiotech

@JohnCFierce: Daiichi Sankyo starts layoff drive with 16% cuts at HQ. FiercePharma report | Follow @JohnCFierce

@DamianFierce: We asked @FierceBiotech readers whether biotech is in a bubble or a sustainable boom. Here's what they said | Follow @DamianFierce

> Merck's ($MRK) melanoma immunotherapy Keytruda beat out rival Bristol-Myers' Squibb's ($BMY) Yervoy in a head-to-head study, the company said, performing so well that investigators halted the trial early. News

> The FDA is approving drugs faster and faster, following through on some promises to Congress and stirring optimism among drugmakers and investors. News

> Germany's Rigontec raised €4.8 million ($5.2 million) in a second closing of its Series A round, bringing its haul to €14.25 million ($15.5 million) as it moves forward with a pipeline of RNA immunotherapies. More

Medical Device News

@FierceMedDev: ICYMI yesterday: Foundation Medicine reveals C-suite and board metamorphosis. FierceDiagnostics story | Follow @FierceMedDev

@VarunSaxena2: Does the FDA overregulate devices? Experts weigh in. Report | Follow @VarunSaxena2

@EmilyWFierce: ICYMI: French researchers harness wireless monitors to track drug-resistant bacteria. Story | Follow @EmilyWFierce

> Nearly 10,000 GE, Siemens MRI machines under FDA recall. Story

> Abiomed gains after FDA finally approves tiny heart pump. Report

> Startup raises Series A to launch interactive, holographic surgical imaging software. News

Pharma News

@FiercePharma: ICYMI yesterday: Regeneron chief nabs $42M, but he'll have to pay his own club fees this year. Article | Follow @FiercePharma

@EricPFierce: ICYMI: When it comes to Big Pharma revenues, who's the biggest of them all? Special report | Follow @EricPFierce

@CarlyHFierce: GSK, U.K. 'hopeful' they can strike a Bexsero price deal soon. FierceVaccines story | Follow @CarlyHFierce

> GlaxoSmithKline tags 180 sales-and-admin jobs for cutting in NC. Report

> AbbVie's $21B buyout puts Pharmacyclics execs in line for $4B payoff. Story

> FDA lets Lilly's long-acting Zyprexa off the hook in patient deaths. Article

Drug Delivery News

> Bacteria deliver molecule to gut to suppress hunger and ward off weight gain. Report

> Clearside's novel eye drug delivery tech shows promise in latest clinical trial. More

> 3D printing will enable creation of delivery devices on demand. Item

> Developer of men's health drug with novel delivery tech secures $1M+ in seed financing. Story

> Maker of microspheres for local delivery of radiation suffers clinical trial setback. Article

Pharma Manufacturing News

> India to invest in infrastructure that drugmakers can share. Item

> Deals for Actavis, Teva plants put G&W in the spotlight; CEO says its culture is its beacon. Editor's corner

> Cypriot company targets Vietnam for generic expansion. More

> Norway's Weifa bets growth on separate API biz. Story

> Chinese company balks on reopening Boehringer plant. Report

Pharma Asia News

> South Korea tells Bayer to divest oral contraceptives business. Report

> China FDA approves first proton carbon ion therapy for Siemens device. Item

> Sun winds up Ranbaxy deal. More

> Daiichi Sankyo starts layoff drive with 16% cuts at HQ. Article

> China FDA approves first proton carbon ion therapy for Siemens device. Item