News

Kura sheds stealth mode with $60M for PhII cancer drug licensed from J&J

Four years after executing a $310 million deal to sell Intellikine to Takeda, biotech entrepreneur Troy Wilson is back, springing out of stealth mode with a new company that has a full team, $60 million in financing, a cancer drug in-licensed from Johnson & Johnson and a plan to start mid-stage development with two Phase II studies launching later in the year. And he's done it while working out an OTC listing that puts him in a public market with an eye to moving up to one of the national exchanges.

Alcobra misses efficacy endpoint in ADHD trial

Alcobra's attention deficit hyperactivity disorder (ADHD) drug MDX has failed to statistically outperform the placebo in a Phase II trial. The outcome meant the trial missed its secondary efficacy endpoint, but Alcobra did its best to talk up the significance of the positive safety data.

Allergy Therapeutics raises £20M to bounce back from 5-year clinical hold

Allergy Therapeutics has turned to public investors for £20 million ($30 million) to move its subcutaneous immunotherapy allergy vaccine through late-phase development. The cash will fund Allergy Therapeutics' attempt to bounce back from the 5-year clinical hold of its U.S. trial program.

Acadia craters as takeover buzz is silenced by (another) NDA delay, CEO exit

San Diego-based Acadia Pharmaceuticals put out word on Wednesday evening that it is delaying its expected NDA for pimavanserin from Q1 back to some time in the second half of this year. And the company says its CEO is out the door.

Glaxo plants a flag in Singapore with CEO Witty on hand

GlaxoSmithKline planted its flag in Singapore to build on a close relationship with the government of the wealthy city-state where CEO Andrew Witty worked and lived earlier in his career with the U.K. drugmaker.

AgeneBio scouts deals and dollars ahead of Alzheimer's PhIII

AgeneBio, founded by Johns Hopkins investigator Michela Gallagher, says the numbers in a midstage study back up its case that its drug works against Alzheimer's--a story that the company hopes will deliver the support needed to pursue a Phase III study.

Intrexon partner AmpliPhi raises $13M for antibiotic R&D

AmpliPhi BioSciences has lined up $13 million in private placement cash, selling stock and warrants to fund its pipeline of treatments for drug-resistant bacterial infections.

The Fierce survey: Is this a biotech bubble or a sustainable bull market?

We here at Fierce are turning to the industry to get your opinion. Please register your vote on a sustainable bull market in biotech vs. a bubble. And we'd like to hear your thoughts on the subject. Final results will be revealed on Monday

Acadia's shifting calendar spurs market-moving takeout rumors

Acadia Pharmaceuticals' shares rocketed up nearly 20% on Tuesday based on some news tied to two investor conferences. But the market wasn't reacting to anything the company said, instead reading into a pair of cancellations and deducing that a buyout might be in the offing.

Sanofi backs pitch to turn Marseille into an immunotherapy R&D hub

The French city of Marseille has staked its claim for a corner of the booming immunotherapy R&D ecosystem. And the plan has some big-name backers, with Sanofi and Innate Pharma both signing up as founders of the MI-mAbs immunotherapy research center in the city.

U.K. academics move cell-gene lung cancer therapy into clinic

A team of London-based academics is set to trial a stem cell-delivered gene therapy in patients with lung cancer. The 56-person trial is the first time a stem cell-gene therapy combination has been tested in humans in the U.K.

UPDATED: Amgen is canning 300 Onyx staffers, abandoning campus in the latest biopharma purge

Days after Onyx Pharmaceuticals' banner drug came through in a big Phase III trial, Amgen is laying off about 40% of the subsidiary's staff, shedding roughly 300 workers amid widespread cuts around the industry.

Zafgen's obesity drug hits the mark in orphan disease trial

Zafgen's in-development obesity treatment led to significant weight loss in patients with obesity triggered by a brain injury, meeting its goals and sending the biotech's shares up nearly 8%.

United Therapeutics wins FDA OK for rare kids' cancer drug, plus a priority review voucher

The FDA has approved United Therapeutics' Unituxin (dinutuximab) to treat pediatric patients with high-risk cases of neuroblastoma. And the regulatory win comes with a priority review vouch that may well be worth tens of millions of dollars.

Apple's new ResearchKit: Disruptive force in R&D or flashy red herring?

ResearchKit, Apple's new health platform, promises to transform the world's hundreds of millions of iPhones into handheld gatherers of clinical data, which some say will usher in a new era of biomedical science but could well amount to more questions than answers.

What's the next big biotech target in the multibillion-dollar M&A game?

Now that AbbVie has managed to astonish just about everyone in the biopharma business with its $21 billion takeover of Pharmacyclics, there's been a deluge of speculation over the next big target in the M&A game. Yesterday, Bloomberg's restless team of deal-watchers proffered Bristol-Myers Squibb as a possibility, seeing as how the Big Biotech is now the clear leader in immuno-oncology, where it could be in line for $15 billion in peak sales.

Collegium bags $50M to get its abuse-deterrent painkiller through the FDA

Canton, MA's Collegium Pharmaceutical put together a $50 million D round to ferry its abuse-discouraging opioid drug onto the market.

Eyeing an FDA filing, Ocular Therapeutix drug hits PhIIIa goals

Ocular Therapeutix says that its lead eye therapy successfully wrapped the first of two Phase III studies, reducing inflammation and pain among a group of patients after cataract surgery. And with the second late-stage trial due to report out in a matter of weeks, the biotech says it remains on track to file for an approval in Q2.

FierceBiotech Radio with Express Scripts' Steve Miller

Steve Miller of Express Scripts, the nation's largest pharmacy benefit manager, joins FierceBiotech Radio to discuss the future of drug pricing, the impending debut of biosimilars in the U.S. and how he got into the PBM business.

FDA panel backs Kythera's double chin-fighting shot

Kythera won the unanimous support of an FDA advisory panel for its fat-busting injection, rolling toward approval with a first-of-its-kind treatment.