News

Daiichi Sankyo's new a-fib drug heads toward FDA approval and a crowded market

A panel of FDA advisers voted in favor of approving Daiichi Sankyo's irregular heartbeat treatment edoxaban, heralding its ability to break up blood clots and improving the company's odds of finally launching the drug in the U.S.

Big Pharma backs EU antibiotic R&D plan, Pfizer prompts Karo cuts, Advent closes £146M fund

In this week's EuroBiotech Report, a who's who of Big Pharma companies joined a European public-private consortium to develop and test new economic models of antibiotic R&D with the goal of making antibiotic R&D economically attractive again. And more.

Chris Viehbacher leaving Sanofi without a U.S.-style windfall

For the now-former chief of Sanofi, Chris Viehbacher, there's plenty of money for a cushion, but it won't be nearly as plump as the packages granted to his counterparts in the U.S.

Little Cortendo gains $11M for late-stage Cushing's study, hatches U.S. IPO plans

Cortendo is coming to America. Founded in Sweden, the little biotech has a new CEO who's building the executive team in the Philadelphia area. And he's dropping plans for a listing on the Oslo exchange in favor of a U.S. IPO after raising $11 million in bridge financing.

AstraZeneca wins another diabetes approval in a fast-crowding market

AstraZeneca won an FDA nod for a one-pill combination of its latest diabetes drug and the long-generic metformin, making it the second to market among a cadre of drugmakers developing similar cocktails.

Bristol-Myers' nivolumab impresses once again--this time in crucial lung cancer study

Bristol-Myers Squibb's closely watched checkpoint inhibitor nivolumab managed to wow analysts this morning with impressive survival results in a Phase II study of patients with advanced squamous cell non-small cell lung cancer. Of all the patients in the drug arm, 41% were alive at the one-year mark, while investigators tracked an overall response rate of 15%.

Novo Nordisk walks back some U.S. optimism for its next-gen insulin

Novo Nordisk is sounding a more cautious tone on Tresiba, its once-rejected new insulin. After hinting at an accelerated trip back to the FDA for the long-acting diabetes treatment, the Danish drugmaker now says it could be another few years before the injection is ready for another shot at approval.

Cleveland Clinic toasts Novartis, PCSK9ers and immuno-oncology in its R&D top 10

The Cleveland Clinic's annual list of the most promising medical innovations reads a bit like a biopharma yearbook, name-checking a slew of potential blockbuster treatments and affirming the potential of some of the biggest targets in drug development.

Scripps cancer spinout Xcovery grabs $20M from a pharma partner in China

Chris Liang had already forged a compelling profile in drug development when the newly formed Scripps Florida recruited him as head of chemistry back in 2004. Liang, who emigrated from China in 1984 to attend grad school at Princeton, had worked on Sutent early on in his career. He went on to found the first Scripps Florida spinout--Xcovery--with Genzyme founder Sheridan Snyder. And today, Liang put out the word that Xcovery has inked its first big deal for the little biotech with a virtual staff.

Xencor moves on without Amgen, ditching its hopes in arthritis

Xencor has reacquired the rights to an Amgen-optioned antibody, walking away from the Big Biotech and an arthritis indication with hopes of a new path in rare disease.

Sanofi CEO Chris Viehbacher gets the boot: What happens next in R&D?

Chris Viehbacher took the helm of Sanofi with one clear message about the future: R&D at the Big Pharma had to undergo a radical restructuring. The lost decade in drug development following 2000 proved that Sanofi and others had to mend their ways, he said, forcing the company to reach outside the organization for innovation and shed the dead wood that had accumulated in its research ops.

Armed with $48M bankroll, Aileron sets sights on p53 tumor target

Aileron Therapeutics has gone back to the well of investor cash and drawn up another $18 million in fresh support for its soon-to-launch, early-stage study of a p53 targeting cancer therapy.

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.