FDA drops a hold on Halozyme study

The latest news sliced only 3% off the biotech's share price.

'Special K' once again wows investigators in small depression study

Yet another research team has pulled off a small study demonstrating the enormous potential of ketamine as a treatment for depression, highlighting again how difficult it has been to push beyond evidence of a rapid-acting treatment to develop a therapy with durable effects.

Novartis, NEA join $188M gamble on China biotech fund

BVCF, a Shanghai-based life sciences investor, has closed its third fund with $188 million to back upstart biotechs on both sides of the Pacific focused on the booming Asian market.

After burning up $349M, CymaBay aims for Nasdaq as IPOs get shaky

Three years ago, Sanofi walked away from a $375 million diabetes partnership with Metabolex, which had just salved the wound with a new pact with J&J. Now, operating under a new name--CymaBay--and armed with a fresh $38 million raise from late last year, the small biotech is floating plans for a $30 million IPO, looking to cash in on the lingering biotech boom.

GlaxoSmithKline joins a Big Pharma immuno-oncology R&D alliance

GlaxoSmithKline is taking a berth next to teams from AstraZeneca, Pfizer and Johnson & Johnson in an ambitious alliance of industry giants aimed at discovering some new products in the red-hot cancer R&D field.

Meet Spero, a biotech hopeful with Roche's blessing and a novel antibiotic

With seed funding from Atlas Venture and an early-stage partnership with Roche, startup Spero Therapeutics is striking out with a novel approach to drug-resistant bacteria amid an antibiotic sea change in the industry.

Low-profile Alios gets a roster of Big Pharma funds to back anti-RSV therapy

Even after out-licensing a pair of hepatitis C therapeutic candidates to Vertex, which was bidding on finding a contender as a new wave of transformational drugs approached the market, South San Francisco-based Alios BioPharma stubbornly maintained a very low profile.

Lilly preps a PhIII study as breast cancer drug race heats up

One of the big surprises at the annual meeting of the American Association for Cancer Research last weekend belonged to none other than Eli Lilly, which will soon be able to add another therapy to its list of Phase III assets in the clinic.

TetraLogic bags lymphoma therapy in $13M buyout

Malvern, PA-based TetraLogic is buying up Shape Pharmaceuticals and its Phase II-ready lymphoma gel treatment for $13 million in cash.

Versant gambles $12M on Swiss PI3K/mTOR cancer drug upstart

Versant Ventures is gambling $12 million on a spinoff of the University of Basel with an in-house drug program that is angling to come up behind one of Novartis's top mid-stage cancer assets.

Deerfield eyeing new biotech investments after launching $1.6B fund

Deerfield Management, one of the busiest institutional players in the biotech scene, has rounded up $1.6 billion to back a new wave of biopharma companies, a major niche for this big healthcare gambler.

UPDATED: Alkermes hits PhIII goal line with 'blockbuster' long-acting schizophrenia drug

Alkermes has crossed the finish line in a Phase III schizophrenia study of a long-acting version of Abilify, picking up the statistically significant results needed to back a new drug application later in the year.

Puma surges as neratinib beats Herceptin in head-to-head breast cancer study

Puma Biotechnology is boasting that its experimental cancer drug neratinib bested Herceptin in a head-to-head study of HER2-positive breast cancer when used ahead of surgery.

Little Deciphera raises its cancer R&D flag in Boston's bustling biotech hub

It's not often you find a little biotech company plugging away at new cancer drugs in out-of-the-way places like Lawrence, KS. But that's just what Deciphera Pharmaceuticals has been doing.

Agios shares spike on enthusiastic response to small, early-stage leukemia study

Agios Pharmaceuticals was the biotech canary in the coal mine when it went public last year. Not only did it survive its IPO, it thrived, helping lure dozens of other biotechs into the market with solid proof that investors would buy into a drug developer with no human data in the portfolio.

Biotech's breathless quarter of IPOs brings in $2.1B for R&D

Back in January, at the annual J.P. Morgan Healthcare Conference, across hotel lobbies and crowded hallways and standing-room-only cafes, one could hardly escape talk about the biotech IPO boom.

Roche's pRED jumps into epigenetics with $521M-plus cancer drug deal

John Reed's Basel-based pRED group at Roche has struck its first epigenetics deal, snapping up rights to Barcelona-based Oryzon's orphan cancer blocker ORY-1001, now being studied in the clinic for acute myeloid leukemia.

Sanofi decides to take a second shot on Lemtrada app

Sanofi is walking away from any plans to appeal the FDA's emphatic rejection of the multiple sclerosis drug Lemtrada, at least for now. But rather than launching the added trial that the FDA demanded ahead of any possible approval, the company thinks it has a shot at answering the FDA's concerns with a new application.

UPDATED: Pfizer's flagship palbociclib stymies cancer progression but falls short on survival

In the first detailed glimpse of palbociclib's impact on overall survival--a key feature to the future prospects of this flagship program--the therapy has failed to demonstrate a statistically significant improvement in extending patients' lives after an initial assessment.

UPDATED: Two deaths force MSK to hit the brakes on engineered T cell cancer study

Investigators are halting recruitment for a small study using T cells reengineered with chimeric antigen receptors against CD19-positive B cells for aggressive non-Hodgkin lymphoma, triggering concerns about the potential fallout at Juno Therapeutics, the biotech formed to commercialize the effort.