News

Cara's pain drug clears an abuse hurdle as it trots toward Phase III

Cara Therapeutics is touting positive data from a trial in which its in-development treatment proved significantly less abuse-friendly than a commonly used opiate, results the company believes could make the drug a standout on the market.

J&J partnering team now embedded in Shanghai hub, completing global network

J&J is officially cutting the ribbon on its new partnering office in Shanghai, completing the pharma giant's global plan to hit the ground running in all the world's top biotech hot spots. It's taking the wraps off of a lineup of new discovery deals with universities in the region. And it's spreading out feelers for more deals through satellite offices in Australia, Singapore and Japan.

Chimerix hammers out an emergency PhII Ebola study for antiviral

Chimerix has outlined plans for a small Phase II study of its powerful antiviral brincidofovir as a counterpunch to Ebola.

Daiichi Sankyo gains some in-house FDA support for a-fib drug edoxaban

Daiichi Sankyo's campaign to win approval for its atrial fibrillation drug edoxaban gained some support from regulators at the FDA who were clearly won over by the efficacy data in the NDA. But the internal review of the drug also includes recommendations for limiting its use to patients with abnormal kidney function. And they include a few cautionary notes on the competing drugs that have already made it to the market.

Advent joins the parade of new biotech funds with $235M war chest

Advent Life Sciences is joining the parade of new biotech funds debuting this year. Based in London with an investment strategy that reaches into Europe and the U.S., Advent's second dedicated life sciences fund has come up with $235 million to invest in about 15 early- to midstage companies in the next few years.

Amgen, Sanofi and Ono band together for open-source R&D

Biopharma giants Amgen, Sanofi and Ono have joined a group of international academics to flesh out a promising but underexplored field of drug development, planning to share their discoveries with the public in hopes of galvanizing global R&D.

UPDATED: Amgen will chop up to 1,100 more jobs in global restructuring

Amgen has concluded that its original plan to cut 12% to 15% of its global staff wasn't nearly as ambitious as it should have been. The big biotech put out the word today that it is now planning to chop 20% of its employee roster--a move that will shave up to 1,100 more jobs on top of the 2,900 layoffs already in the works.

Novartis chief Jimenez predicts 'multi-blockbuster' success for star heart drug

Novartis' pharma chief has hailed the company's forthcoming heart failure treatment as "the most exciting launch the company has ever had," and now the drugmaker's CEO has declared a "multi-blockbuster" in the making, joining a chorus of analysts who expect billions in annual sales from LCZ696.

Receptos' lead drug scores another promising PhII--this time for ulcerative colitis

San Diego-based Receptos is on a roll. After the markets closed on Monday, the biotech spread the word that its mid-stage trial for lead drug RCP1063 hit its primary endpoint for spurring remissions and clinical responses among patients suffering from ulcerative colitis in the trial. And the results quickly spurred a 37% spike in its share price, which follows a similar surge when the same drug hit its marks in a mid-stage trial for multiple sclerosis back in the summer.

Bristol-Myers nabs a HER2 cancer drug in $475M option deal with F-star

Late last year F-star spun out one of its early-stage drugs into a separate "asset-centric" company dubbed F-star Alpha. A group of venture players including Atlas and SR One chipped in $12 million to fund the clinical plans for the HER2-targeting antibody fragment FS102. And now Bristol-Myers Squibb has come along and seized the prize, nabbing a buyout option on the spinout as well as worldwide rights for an upfront and near-term milestone payment of $50 million in a deal that is worth up to $475 million.

Syros hauls in $53M to disrupt cancer's genetic roots

Watertown, MA's Syros Pharmaceuticals has banked a massive $53 million Series B to support its innovative approach to treating cancer, targeting the genetic switches responsible for tumor growth.

INC Research spells out details on $150M IPO

INC Research has spelled out its IPO plans, looking to raise $150 million through the sale of 8.1 million shares at $17 to $20 a share.

UPDATED: Akebia craters as adverse events cloud positive PhIIb anemia data

Procter & Gamble spinoff Akebia Therapeutics rolled out a batch of promising Phase IIb efficacy data for its experimental anemia drug today, but investors who came in early this year to back the biotech's IPO in the belief that it holds the key to a potential blockbuster were dinged with signs of safety issues.

Pfizer finally abandons all hope in Remoxy, and Durect/Pain Therapeutics feel the sting

Pfizer had hung on to high hopes for the drug Remoxy long after the tamper-resistant pain therapy endured its second rejection at the hands of the FDA in 2011. It even officially re-upped for the late-stage comeback try last fall, committing to see it through a third try. But today Pain Therapeutics says that the pharma giant has finally thrown in the towel, handing back rights to the long-delayed treatment and washing its hands of any further development work.

UPDATED: Sarepta plunges as CEO moves goal line on Duchenne MD drug downfield

Following a meeting with regulators in September, Sarepta spelled out a new set of data that the FDA is looking for in the application for its closely watched Duchenne muscular dystrophy drug eteplirsen, and the biotech says it will have to delay filing--another dramatic turning point for the company this year, which saw its shares plunge 30% on the news this morning.

Merck grabs another 'breakthrough' in PD-1 lung cancer race with Bristol-Myers

With the goal line for lung cancer in sight at the FDA as it races with an ambitious R&D team at Bristol-Myers Squibb, Merck has grabbed bragging rights to the agency's breakthrough drug designation for the checkpoint inhibitor pembrolizumab (Keytruda) for that golden market opportunity.

Baxter wins FDA approval for another hemophilia drug

Baxter widened its hemophilia franchise on the eve of its breakup, winning FDA approval for a drug that treats a rare form of the bleeding disorder.

GlaxoSmithKline cozies up to Five Prime for respiratory R&D

GlaxoSmithKline, facing widespread scrutiny for its underperforming respiratory business, has expanded its relationship with Five Prime Therapeutics, digging in to discover new treatments in the field.

AstraZeneca gets some EU encouragement for its $2B cancer hopeful

European regulators have recommended an early approval for AstraZeneca's new ovarian cancer treatment, welcome news for the company as it defends rosy sales estimates for its oncology pipeline.

Shire CFO to exit in wake of failed AbbVie deal

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)...