Daiichi Sankyo’s cancer drug wins the FDA’s coveted ‘breakthrough’ tag

Damian Garde Daiichi Sankyo picked up the FDA's breakthrough therapy designation for a Phase III cancer drug, putting it in line for preferential access to agency experts as it ...

Valeant cuts ties with shadowy pharmacy Philidor

Carly Helfand Valeant is severing all ties with specialty pharmacy Philidor–which a short seller recently claimed it used to inflate its top line–after reports that Philidor ...

Grifols bags €100M for Alzheimer’s R&D; Ipsen inks $137M cancer deal; Oryzon raises €17M

Nick Paul Taylor In this week's EuroBiotech Report, Catalan biotech Grifols secured a €100 million ($ 110 million) loan from the European Investment Bank's €315 billion ...

Allergan pays $125M to rid itself of marketing charges tied to Warner Chilcott

Eric Palmer Allergan has been trying for months to resolve bribery allegations that came with its $ 8.5 billion buyout of Warner Chilcott and now will do that with a plea deal ...

Witty insists GSK’s safe approach, backed by innovative pipeline, is the way to success

Eric Palmer GlaxoSmithKline CEO Andrew Witty continues to take heat for moving the U.K. drugmaker heavier into low-margin areas like consumer health and vaccines. But he continues ...

AstraZeneca’s gout drug wins faint praise from FDA advisers

Damian Garde A majority of independent FDA advisers recommended approval for AstraZeneca's new gout drug, but not without noting that the treatment's safety profile presents ...

GOP’s Rubio joins the pharma-bashing trend, slamming ‘profiteering’ on price hikes

Tracy Staton The drug-pricing debate has moved to the Republican side of the aisle. GOP candidate Sen. Marco Rubio joined the fray in New Hampshire over the weekend, by slamming "pure ...

With Opsumit launch rolling, Actelion doesn’t ‘need’ M&A: CEO

Carly Helfand Back in 2013, Actelion launched Opsumit, a new-and-improved pulmonary arterial hypertension drug it hoped would help make up sales for its aging Tracleer. And so far, ...

Kite nails down TCR IP in new licensing pact

John Carroll Kite Pharma has moved to cement its control of some of the IP behind its work on T cell receptor-based product candidates that zero in on MAGE A3 and A3/A6 antigens. FierceBiotech ...

FDA finds mystery ‘deficiencies’ with Neos’ long-acting Ritalin on the eve of approval

Damian Garde Neos Therapeutics got an ominous note from the FDA just weeks ahead of the expected approval date for its long-acting ADHD treatment, clouding the future of the company's ...

Valeant posts 36% growth amid pricing scrutiny; may sell neurology biz

Carly Helfand Valeant may be the subject of current government scrutiny, and it may have recently suffered a stock-price freefall. But the company gave investors some good news ...

In pharma M&A, 2015 trumps red-hot 2014 so far, report says

Carly Helfand Global activity in the pharma, medical and biotech spheres over the first three quarters of this year has hit its largest-to-date value since at least 2001, according ...
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