News

Merck KGaA R&D chief exits, Sobi drug flops in PhIII, Adaptimmune gets full-time CEO

Welcome to our first edition of the weekly EuroBiotech Report, where FierceBiotech will go deeper into the news and events happening in Europe.

FDA panel throws dirt on Novartis' would-be cardio blockbuster serelaxin

After a daylong session heavy on scathing criticism, a panel of FDA advisers voted unanimously against approving Novartis' in-development heart drug serelaxin, casting serious doubts on the treatment's potential.

Genmab banks $22M from J&J as myeloma drug ticks forward

Denmark's Genmab is rolling right along with breakthrough-designated daratumumab for double refractory multiple myeloma, hitting a milestone in Phase II development and triggering a $22 million payout from collaborator Johnson & Johnson.

Pfizer says PCSK9 study was a winner, boosting its chances in hectic R&D race

Pfizer says the Phase IIb study for its closely-watched PCSK9 cholesterol drug bococizumab (RN316) scored the primary endpoint on all doses, which should help steer a massive Phase III program that started out last fall with 22,000 patients.

UPDATED: Baxter breaks in two, creating a $6B biotech business

Baxter International is the latest life sciences player to see better living through mitosis, unveiling a plan to separate its drug development arm from its sprawling med tech business in hopes of helping each grow faster.

RuiYi banks $15M from A-list backers to amp up Chinese R&D

As more and more drugmakers set sights on China through partnerships and acquisitions, Sino-American biotech RuiYi is taking a more direct approach, raising $15 million in venture cash to develop novel drugs in the country, for the country.

Novartis fuels drive for fast OK of LDK378 with new lung cancer data

Novartis has taken another step forward in its quest to win a fast approval for its lung cancer drug LDK378. The pharma giant says the ALK inhibitor demonstrated clear signs of activity in a majority of the non-small cell lung cancer patients enrolled in an early study, including a group already treated by the ALK inhibitor Xalkori (crizotinib).

GlaxoSmithKline joins a biotech brain trust to make R&D more efficient

Translating all the information from the genomics revolution into verifiable drug targets has proven to be no easy task. Now, in an effort to bend the curve toward R&D success, GlaxoSmithKline is teaming up with external experts, putting up money and brainpower to launch a collaborative research effort.

Exelixis' shares flogged after lead drug disappoints at interim PhIII point

Hell hath no fury as a disappointed investor who bet wrong on a biotech catalyst. The execs at Exelixis got a three-course serving of that anger this morning as its stock went into a 35% nose dive--after the biotech announced that its interim analysis was complete and the Phase III prostate cancer study for cabozantinib would go to its conclusion.

Kolltan banks $60M to hit the gas on its cancer drug

Fresh off starting up its first clinical trial, New Haven, CT's Kolltan Pharmaceuticals has wrapped up a $60 million D round, filling its coffers as it prepares for the developmental long haul with a cancer candidate.

Fierce readies a new weekly report on the European biotech scene

In order to make sure we're devoting the kind of attention the rest of the world deserves, we're launching a weekly EuroBiotech Report, a regional news roundup done Fierce-style, on Friday.

Merck snags rights to NanoBio's adjuvant vaccine tech

After collaborating with the University of Michigan-spinout NanoBio over the past three years, Merck has signed off on a new licensing pact for the biotech's nanoemulsion adjuvant technology.

Sanofi bets big on dengue with eyes on a blockbuster

After 20 years in the lab and $1.4 billion in R&D costs, Sanofi's in-development dengue fever vaccine is on the verge of regulatory applications, and, despite a few clinical hiccups, the drugmaker told Reuters it believes it has a blockbuster on its hands.

With FDA decision looming, GlaxoSmithKline nails EU OK for diabetes drug albiglutide

With its PDUFA date for the once-weekly diabetes drug albiglutide looming at the FDA next month, GlaxoSmithKline announced today that the European Commission has OK'd the GLP-1 drug for marketing.

Startup scPharmaceuticals snags $16M for self-dosed injectables

With its $16 million Series A, Lexington, MA's scPharmaceuticals has a plan to develop a wearable drug pump and succeed where its forebear failed.

UPDATED: Insmed faces another setback as lead therapy flunks PhII lung study

Insmed is once again hustling to put the best spin possible on a clinical study of its only therapy. But faced with a row of skeptical analysts, it's not likely to make much headway.

Wanna team with AstraZeneca? Post on its website

AstraZeneca has launched a website with hopes of opening up its R&D efforts to would-be collaborators, posting its compound bank and soliciting new ideas from academia, industry and government.

NeuroPhage adds a $17M round to back Alzheimer's drug program

Cambridge, MA-based NeuroPhage Pharmaceuticals has banked a $17 million venture round designed to fuel their early-stage work on a full slate of neurodegenerative disease targets like Alzheimer's and Parkinson's disease.

Biogen cozies up to MIT with a $5.3M drug discovery pact

George Scangos, CEO of biotech powerhouse Biogen Idec, and David Page, director of MIT's Whitehead Institute for Biomedical Research, have made a $5.3 million handshake, the Boston Globe reports, as the two institutions plan to collaborate on early-phase development.

FDA review slams Novartis's case for beleaguered heart drug serelaxin

One of Novartis's top late-stage drug prospects is in deep trouble. In advance of an upcoming advisory committee meeting, the FDA in-house review says point blank that the application for the heart drug serelaxin should be rejected as the pharma giant has yet to provide the decisive data on efficacy needed to green-light the therapy.