Esperion gets out from under the FDA and speeds toward Phase III

Ann Arbor, MI, biotech Esperion Therapeutics finally resolved the FDA snag standing in the way of its ambitious plans for a new cholesterol drug, clearing the company to begin late-stage trials with its potentially disruptive pill.

Chugai pours $374M into its Singapore R&D shop

Japanese drugmaker Chugai Pharmaceutical is planning a major expansion of its Singapore research outpost, laying out 476 million Singapore dollars ($374 million) over 7 years as it hits the gas on antibody research.

Mylan buys into Theravance's COPD contender in $265M deal

Generics giant Mylan is shouldering its way into the blockbuster market for COPD treatments, signing a $265 million deal with the respiratory experts at Theravance Biopharma to get its hands on a late-stage contender.

Lilly and Boehringer win FDA approval for a combo diabetes drug

Partners Eli Lilly and Boehringer Ingelheim picked up FDA approval for a first-of-its-kind diabetes treatment, combining two existing drugs into a single tablet.

UPDATED: AstraZeneca partner Ardelyx plunges after citing safety issue for lead drug

Four months after getting a promising readout on its lead drug in a Phase IIb study for irritable bowel syndrome, AstraZeneca-partnered Ardelyx reported another study win today, but investors zeroed in on a disturbing safety issue and ripped up the company's shares soon after the release went out.

Summit shoves rival Duchenne MD drug into public spotlight with $40M IPO

A biotech with scientific roots at the University of Oxford and a new approach to treating Duchenne muscular dystrophy is coming to America with a $40 million IPO.

Gene therapy pioneer bluebird bags a 'breakthrough' title for lead program

Bluebird bio nabbed the FDA's breakthrough drug title for LentiGlobin BB305 as a new treatment for beta-thalassemia major, putting one of the industry's top experimental gene therapies back squarely in a promising spotlight.

Biotech guru Gregory Verdine lands $18M round for new WaVe drug developer

A U.S./Japanese hybrid biotech chaired and co-founded by Gregory Verdine, the high-profile Harvard investigator now laboring as CEO of Warp Drive Bio, has gathered together $18 million in a transpacific venture round and set its sights on developing a "revolutionary" new class of nucleic acid drugs based on a potentially breakthrough approach to drug design.

Acorda cautiously steps forward with a drug to spur remyelination in MS

You can add another clinical stage program for remyelination to your watch list. Acorda's early-stage drug for targeting the root cause of multiple sclerosis has cleared its first hurdle in the clinic, passing its Phase I safety challenge with a set of patient cohorts that detected none of the preliminary toxicity issues or side effects that could derail it early on.

Valeant bids $296M on Dendreon; AstraZeneca pairs with MD Anderson;

@FierceBiotech: Obama wants $215M to kick off 'precision medicine' project. More | Follow @FierceBiotech @JohnCFierce: $ICPT up 38% this a.m., which is nuts. Article | Follow @JohnCFierce...

Tracon raises $36M in a downsized IPO

Cancer drug developer Tracon Pharmaceuticals pulled in $36 million in an IPO, pricing well below its expected range as it works to get its top drug into late-stage trials.

Obama wants $215M to kick off 'precision medicine' project

President Barack Obama is asking Congress for $215 million to sequence the genomes of 1 million Americans and help develop a new generation of medicines, part of a sweeping plan to accelerate biomedical R&D.

Pfizer bails on a $70M rare disease deal with Repligen

Pfizer is walking away from a $70 million collaboration with Waltham, MA's Repligen, handing back some early-stage treatments for the rare spinal muscular atrophy.

Alexion names David Hallal its next CEO

Welcome to this week's Chutes and Ladders, our roundup of hirings and retirings throughout the industry. Please send the good word--or the bad--from your shop to Michael Gibney (email | Twitter)...

Spark nails a $161M IPO to fund its 'breakthrough' gene therapy

Spark Therapeutics, at work on one-time treatments for rare diseases, pulled off a $161 million IPO, pricing above its range and keeping biotech's Wall Street hot streak rolling.

Astellas bets on Immunomic's allergy vaccine in a $75M deal

Astellas Pharma is teaming up with biotech Immunomic Therapeutics on a vaccine that could relieve a common allergy that affects millions in its native Japan.

Intercept Pharma soars after nabbing 'breakthrough' title for blockbuster NASH contender

Intercept Pharmaceuticals has nabbed the FDA's breakthrough therapy designation for obeticholic acid, a closely watched therapy in the pipeline for a blockbuster NASH indication.

Novartis pins weak Jetrea sales on PhIII, KDEV CEO leaves after 3 months, Cantargia plans IPO

In this week's EuroBiotech Report, Belgian biotech ThromboGenics, having seen its stock price peak at €45 two years ago, has experienced a series of share slides, the latest of which was triggered by its partner Novartis. And more.

One big reason why CNS drug development has foundered

When you want to develop a drug for, say, cancer, objective measures such as survival rate can tell regulators just how effective it is compared to a standard drug or placebo. But in diseases involving the brain, scientists often have to settle for crude measures for assessing how patients perform or feel after treatment. And the wild card here is a placebo effect that can be very difficult to factor into studies and has been fingered for the death of multiple development programs.

Buzz: Obama's 'precision' plan involves a major genomic database

President Barack Obama's plot to bolster personalized medicine research would lean heavily on a planned bank of patient genetic information, Science magazine reports, pooling existing databases to create a huge R&D utility. But the promise of a so-called Precision Medicine Initiative has left some scientists cold, hearkening back to overblown efforts past.