News

Proteon joins long IPO line with $69M offering

Another day, another biotech IPO. Waltham, MA-based Proteon Therapeutics has joined the queue of biotechs looking to make the leap into Nasdaq, looking to raise some $69 million.

Tokai pockets $97M in IPO cash to get its cancer drug into Phase III

Cambridge, MA, biotech Tokai Pharmaceuticals pulled off a $97.2 million Wall Street debut, raising the money it needs to get its three-in-one treatment for prostate cancer into late-stage development.

The 2014 Fierce 15 is about to debut in Boston

The 12th annual Fierce 15 report will be rolling out at the BioPharm America meeting in Boston on Monday just before we go live with the report on the website.

Novo Nordisk takes the plunge on obesity, eyeing Seattle for a huge R&D bet

In the midst of its first major foray into treating obesity, Novo Nordisk is liking what it sees in the space, and now the Danish giant plans to hire hundreds of researchers in a gambit to develop new treatments for the global scourge.

Sutro adds Merck KGaA to its roster of marquee 'armed antibody' partners

Sutro Biopharma has landed another marquee name for its list of development partners for antibody-drug conjugates. Merck KGaA, which has been struggling in the clinic for years, has signed on with the San Francisco-based biotech, offering a $300 million package of milestones along with some unspecified research support.

Gilead's oncology contender comes up short in pancreatic cancer

Gilead Sciences' simtuzumab failed to meet its main goal in a Phase II pancreatic cancer trial, denting the potential of a therapy the company hopes can treat a wide range of malignancies.

Sanofi partners with MyoKardia on a 'totally new' approach to heart disease

Sanofi has stepped up with a $45 million down payment on a potential $200 million early-stage deal to develop new drugs for heart muscle disease. The pharma giant inked one if its rare small-biotech collaboration pacts with MyoKardia, a South San Francisco-based biotech that was funded by Third Rock a couple of years ago.

UPDATED: Auxilium shares soar after Endo swoops in with a $2.2B buyout offer

Just a few days after Auxilium Pharmaceuticals put out the word that pressure on the sales side was forcing a restructuring and the elimination of about 200 jobs, Endo has come along with a proposal to buy out the company for about $2.2 billion worth of cash and stock.

AstraZeneca and Nektar win FDA OK for blockbuster-hopeful constipation drug

The FDA approved a new opioid-induced constipation treatment from partners AstraZeneca and Nektar Therapeutics, shaking off some safety concerns and green-lighting a drug the two hope can bring in billions.

UC looks for a piece of the biotech action with $250M venture fund

The University of California has been a rich source of innovative new medicines. It's outlicensed the IP behind such standout biotechs as Aragon and Seragon--twin biotech sisters bought out by pharma giants--as well as Kite Pharma, a recent IPO success focused on CAR-T. And now it wants a bigger piece of the action.

Smallpox biotech Siga files for bankruptcy over PharmAthene spat

A court ruling has saddled biodefense specialist Siga Technologies with debts it cannot pay, the company said, and the biotech is filing for bankruptcy in an effort to keep its doors open long enough for an appeal.

Novo's next-gen insulin clears a pediatric hurdle amid renewed U.S. hope

Novo Nordisk bolstered its better-late-than-never case to win FDA approval for a new long-acting insulin, as the drug, Tresiba, met its main goals in a study on children with Type 1 diabetes.

U.K. picks a controversial brain cancer vaccine as its first new 'innovative medicine'

Anxious to prove that U.K. drug regulators aren't as slow and stodgy as they're often accused of being, British officials today announced the first in a new category of experimental drugs to earn the title of "Promising Innovative Medicine."

Parkinson's biotech NeuroDerm joins the IPO queue with a $65M pitch

Israel's NeuroDerm is developing a wearable treatment solution for patients with Parkinson's disease, and the biotech is plotting a $65 million IPO to get its lead candidates across the finish line.

Eli Lilly takes the lead on AstraZeneca's Alzheimer's drug in $500M deal

Longtime Alzheimer's player Eli Lilly has agreed to pay $50 million in a near-term milestone and take charge of the development work in a collaboration package worth a total of up to $500 million.

Biotech R&D is changing. Don't get left behind

Over the last few years we've seen some big changes in the way some drugs are developed. What better time to host a new FierceBiotech executive panel discussion on current trends in late-stage development?

UPDATED: Safety concerns cloud odanacatib PhIII as Merck steps back from FDA filing

A growing buzz about potential safety issues has raised a cloud of doubt about Merck's osteoporosis drug odanacatib, which is likely to linger now that the pharma giant has released Phase III results and laid out plans for a delayed FDA filing.

Which body parts warrant the biggest biotech venture investments?

Dow Jones writer Brian Gormley set out to find out the answer to that question, reviewing the venture data for biotech and med tech in Dow Jones' VentureSource database.

Baxter and Halozyme sway the FDA after a painful rejection

Two years after safety concerns torpedoed their first pitch, partners Baxter and Halozyme Therapeutics have locked up FDA approval for HyQvia, a treatment for immunodeficiency.

NPS slides as faint panel praise puts FDA approval in jeopardy

NPS Pharmaceuticals walked away from an FDA panel meeting with a recommendation to approve its orphan drug, but a lukewarm reception and nagging safety concerns have investors fearing the worst.