News

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.

Merck's new PhIII hep C program may help repair a damaged R&D rep

In a matter of weeks Merck plans to move a closely-watched combination treatment for hepatitis C into a Phase III trial. The move will boost Merck's late-stage pipeline to 13 programs, giving new R&D chief Roger Perlmutter some additional evidence to back up a case that the leviathan outfit has finally shaken off the lethargy that led to a years-long drought of significant approvals, focusing on pioneering therapies that can carve out badly needed revenue.

Seattle startup sets out with $5M, beer molecules and a plan to treat diabetes

KinDex Pharmaceuticals began in 2009 with a promising hypothesis: that the hops found in beer could be broken down and spun out into therapeutic molecules, regulating body weight and glucose metabolism. Now, after years of confirmatory lab work, the Seattle biotech is ready for a make-or-break Phase II trial, banking a $5 million round led by venture stalwart Polaris and planning to test whether its candidate can treat Type 2 diabetes.

High-flying biotech stocks take a dive, triggering a bad case of jitters

The Nasdaq Biotechnology Index took another nasty hit on Monday, dragging down the broader index and raising a simple question that pundits, investors and biotech execs chewed on all day: Is the biotech party finally over?

Who's going to win pharma's immunotherapy gold rush?

As Roche, Bristol-Myers Squibb and Merck race to the market with promising immunotherapies for advanced melanoma, analysts' sky-high sales estimates for the new drug class may soon have to reckon with revenue-slashing competition and pricing pressures.

Is the great biotech stock rally kaput?

While biotech IPOs continued strong last week as shares of Versartis climbed 49% on its opening day, analysts and investors were left chewing on a nasty drop in the Nasdaq Biotechnology Index on Friday.

Novartis chairman vows to preserve top R&D budget in retrenchment

At Novartis, only the top executives are allowed to discuss R&D strategy in any kind of a meaningful way. So when they talk, everyone--including the company's big research staff around the world--pays very, very close attention.

Gilead scrambles toward hep C cure-all with next-gen combo pill

Gilead won the race to be the first to market with an interferon-free oral therapy that can essentially wipe out all traces of the virus for a large group of patients. Now it's angling to follow up that big score with a single combo pill that can do the job for just about everyone in the megablockbuster market.

Eyeing rival mAb mob, Novartis touts PhIII secukinumab psoriasis data

Investigators for Novartis pumped out more positive Phase III data for its psoriasis therapy secukinumab over the weekend, adding some patient satisfaction scores on the self-injected treatment as the company positions this new product against a host of rivals that promise to quickly crowd the field.

Celgene wins FDA approval for its blockbuster arthritis contender apremilast

Celgene picked up the FDA's blessing for the much-debated apremilast, winning approval to market the oral drug as a treatment for psoriatic arthritis in step one of its blockbuster plan.

Boehringer's stumble is InterMune's gain in lung drug race

InterMune watched its shares jump more than 15% after Boehringer Ingelheim posted some mixed results for its rival idiopathic pulmonary fibrosis treatment, all while the biotech has nearly tripled in value over the past 30 days.

Versartis grabs $126M in an upsized IPO to fund its orphan drug

A month removed from raising $55 million in Series E cash, Versartis has hauled in $126 million more in an IPO, filling its coffers and planning to take its growth hormone deficiency treatment all the way to market.

EU smiles on Lilly and Boehringer's FDA-rejected diabetes drug

European regulators are recommending approval for Boehringer Ingelheim and Eli Lilly's latest diabetes offering, shrugging off a manufacturing issue that spiked the drug's FDA approval and putting the pair in line for third place in a new class of treatments.