FDA accepts Novo Nordisk's request for a re-do on once-rejected insulin

Novo Nordisk's comeback plan for the long-acting insulin Tresiba took another step forward, as the FDA accepted the Danish drugmaker's resubmitted application and cleared the way for a potential approval this year.

Woodford to U.S.: You're in a bubble. We're not

Neil Woodford has weighed into the debate over whether biotech is in a bubble or sustainable bull market. The veteran fund manager drew a distinction between what he sees as the bubbly multiples of some publicly traded U.S. stocks and the bargain-basement valuations of unquoted British biotechs.

UPDATED: Merck (sort of) wins back 'breakthrough' boasting rights on hep C

The FDA notified Merck execs last January that it was stripping away its breakthrough therapy designation for their closely watched hepatitis C combo. But the agency has now relented and reversed itself, in part, and the pharma giant today notes that it's getting two new BTD titles in narrow patient subpopulations to replace the broader one that it lost.

Alzheimer's startup Alzheon bags $10M and beats a path to Phase III

The veteran Alzheimer's researchers at Alzheon believe their novel treatment for the disease has a chance to come through where so many others have failed, raising $10 million amid a "perfect storm" for the company's top prospect, the CEO said.

Regulus surges after AstraZeneca snags rights to NASH drug

Shares of Regulus spiked 10% Tuesday afternoon after its Big Pharma partner AstraZeneca stepped up to grab rights to a preclinical drug candidate for NASH with plans to steer it into clinical studies.

Clovis one-ups AstraZeneca with a 'breakthrough' tag for its cancer drug

Clovis Oncology picked up the FDA's coveted breakthrough therapy designation for its in-development ovarian cancer treatment, securing a speedy review and notching an honor denied to rival AstraZeneca and its similar drug.

UPDATED: CRISPR-Cas9 pioneer starts recruiting R&D group in Cambridge hub

CRISPR Therapeutics--which was founded in Switzerland by Emmanuelle Charpentier, one of the pioneers in the field--has hired Alexion vet Bill Lundberg to head up its R&D operations in Cambridge, MA.

Nabriva preps for PhIII antibiotic trial with a $120M VC commitment

A transatlantic group of venture investors crowded into a $120 million venture round for Vienna-based Nabriva Therapeutics, offering enough cash to get started with a Phase III study for a new antibiotic.

Fresh off a $76M raise, aTyr pilots an $86M IPO

San Diego-based aTyr Pharma wasn't just flirting with an IPO when it announced a big $76 million round a few days ago. It had its S-1 all ready to go.

Plotting a course for True North, biotech CEO steps up with a $35M round

Nancy Stagliano has a very clear idea of how to plot a course for True North. Eighteen months ago the biotech CEO raised $30 million for iPierian and split its assets with the newborn True North Therapeutics. Seven months later Bristol-Myers Squibb snapped up a reorganized iPierian in a $725 million deal. Then in swift succession Stagliano raised new funds, beefed up her staff with a key hire and is now banking $35 million in a fresh venture round that will take True North into the clinic with its lead therapy for rare diseases while positioning its follow-up program for human studies.

Merck wagers $434M on Arvinas and its protein-disposal system

Merck has partnered up with fast-moving upstart Arvinas to get its hands on technology that promises to give drug developers a crack at some previously untouchable targets, using the body's natural garbage system to dump troublesome proteins.

High-flying immuno-oncology player Adaptimmune pitches $150M IPO

Adaptimmune Therapeutics has become one of the brightest hopes in the U.K. biotech scene, scoring a $350 million collaboration pact with GlaxoSmithKline and a whopping $104 million venture round. Now Adaptimmune--a 2014 Fierce 15 company--will see if it can keep the hot streak rolling with a $150 million IPO pitch.

Ocular Therapeutix plunges as eye treatment blurs the line in PhIII

Ocular Therapeutix needed a clean sweep in its expansive Phase III program for a postoperative eye treatment in order to set itself up for a clear shot at an FDA approval. But it didn't get it.

Flexus founders regroup after $1.25B Bristol-Myers deal

Flexus Biosciences turned heads around the industry when Bristol-Myers Squibb signed a $1.25 billion deal to buy the fledgling biotech in February, but the company's founders aren't resting on their laurels, turning around with immediate plans for a new startup.

Woodford pours another $40M into Northwest Bio and its brain cancer vaccine

High-profile U.K. investor Neil Woodford is putting more chips on the controversial Northwest Biotherapeutics, betting another $40 million on the company as it works through Phase III with a cancer vaccine.

Alkermes heads to Phase III with a schizophrenia drug designed to spare the waistline

Alkermes unveiled more positive data for a schizophrenia drug the company believes can treat the disease without spurring weight gain, beating a path to late-stage development.

MorphoSys: That Celgene-abandoned cancer drug isn't dead yet

Germany's MorphoSys is moving on after the surprise cancelation of a Celgene partnership spooked investors and battered the company's share price, with CEO Simon Moroney preaching patience for an early-stage cancer candidate.

Juno and Novartis settle CAR-T patent fight with little fanfare

Novartis and Juno Therapeutics, pioneers in a promising new field of cancer treatment, have reached a settlement in their long-running patent dispute, clearing the way for each to advance rival therapies designed to weaponize the immune system.

Bristol-Myers bets big on gene therapy with a $1B uniQure deal

Bristol-Myers Squibb is the latest pharma heavyweight to buy into gene therapy's renaissance, signing a deal with uniQure worth as much as $1 billion and getting its hands a novel cardiovascular treatment.

UPDATED: GlaxoSmithKline to create new vaccines hub, uprooting R&D groups in Cambridge, Philly

GlaxoSmithKline is setting up a global vaccines hub in Rockville, MD, in the wake of its big asset swap with Novartis. And the move will force hundreds of staffers in Cambridge, MA, and Philadelphia to either look for a relocation package or exit the company.