Aveo endures yet another FDA setback

Damian Garde An optimistic Aveo Oncology recently plotted a path back to Phase III with its thrice-failed cancer drug, but the FDA wants to see more data before signing off on that ...

Sanofi buys into NeuroVive’s cardio drug in Korea

Damian Garde Sanofi is betting on the promise of NeuroVive Pharmaceutical's top prospect, buying the South Korean rights to the biotech's Phase III cardiovascular drug. FierceBiotech ...

Hep C landscape shifts again as BMS combo nabs breakthrough tag

Eric Palmer Gilead Sciences and AbbVie caught a break for their hepatitis C treatments when the FDA rescinded breakthrough designations earlier this year for potential competitors being ...

Bellicum buys into CAR-T manufacturing amid a hot immuno-oncology race

Damian Garde Following the lead of Juno Therapeutics and Kite Pharma, CAR-T contender Bellicum Pharmaceuticals is splashing cash on an in-house manufacturing operation, speeding its ...

It’s getting mighty crowded in biotech’s hippest neighborhood

Damian Garde Biotech's extended hot streak has put loads of money in the pockets of drugmakers, and nowhere is that clearer than in Cambridge, MA, where the boom has created demand ...

Virtual biotechs a hit with investors and, increasingly, buyers

Damian Garde Biotech venture capitalists have increasingly embraced the virtual model, seeding companies with promising assets, tiny staffs and a willingness to outsource. Now, as Reuters ...

Plotting a course for True North, biotech CEO steps up with a $35M round

John Carroll Nancy Stagliano has a very clear idea of how to plot a course for True North. Eighteen months ago the biotech CEO raised $ 30 million for iPierian and split its assets ...

Geriatrics experts call for halt to Low-T consumer ads

Tracy Staton A couple of geriatrics experts have joined the chorus of recommendations against testosterone therapy. But they're going a step further. They say drugmakers' enthusiastic ...

Colorado lawmakers pass biosim substitution bill

Tracy Staton Colorado's house of representatives passed a bill allowing pharmacists to substitute biosimilar versions of biotech drugs, even when the brands are prescribed by name. ...

UPDATED: Endo aims to lure Salix from Valeant with $175-per-share offer

Carly Helfand Last month, some industry watchers speculated that the low price Valeant agreed to pay for North Carolina's Salix could leave room for other bids. And now, one has ...

Consumer group petitions FDA to pull generic antifungal med

Carly Helfand Currently, there are several generics on the U.S. market of oral antifungal agent ketoconazole. But consumer advocacy organization Public Citizen is trying to change that. FiercePharma ...

Ariad activists rabble for Berger’s job and mount a proxy fight

Damian Garde Activist investor Alex Denner has made the rumors official: He wants Ariad Pharmaceuticals CEO Harvey Berger out, and he's willing to mount a proxy fight to get his ...
© 2018 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS