BioMarin’s rare disease drug gets so-so FDA review

Damian Garde BioMarin's drug for a rare enzyme deficiency resulted in a "modest" improvement for patients, according to an FDA staff review, possibly lowering expectations ...

Sanofi gets mixed FDA blessing for MS drug Lemtrada

Damian Garde After a scathing staff review, Sanofi walked away from an FDA panel with mixed messages on its long-delayed multiple sclerosis drug, as agency advisers said the injection ...

UCSD gets $100M for new stem cell research center

John Carroll UC San Diego is getting a whopping $ 100 million contribution to establish a new stem cell therapeutic development center.  FierceBiotech News

Booming Regeneron gets the dirt flying on big R&D expansion

John Carroll With blockbuster sales of Eylea spurring some gangbuster projections for Regeneron's future, the booming biotech today launched construction of a 300,000-square-foot ...

UPDATED: The ax drops at troubled Merck as big restructuring gets underway

John Carroll The pink slips are starting to fly at Merck R&D. The rumor mill was running full tilt on Monday morning, with comments flowing across Twitter that planned layoffs are ...

J&J gets FDA panel backing for simeprevir in hot race for hep C drug

Eric Palmer An FDA panel voted 19-0 to recommend its simeprevir, an NS3/4A protease inhibitor that promises to treat the most common genotype of chronic hepatitis C. FiercePharma News

Iroko gets a thumbs-up from FDA on lower-dose NSAID

John Carroll Iroko Pharmaceuticals failed to launch a $ 145 million IPO earlier in the year, but it has managed to win regulatory approval for a lower-dose, nonsteroidal anti-inflammatory ...

Actelion gets FDA approval for Opsumit, follow-up PAH drug to its Tracleer

Eric Palmer Actelion has been anxiously awaiting FDA approval of its new pulmonary arterial hypertension treatment Opsumit, a follow-up to its only significant product, Tracleer, which ...

PhIII antibiotic developer gets a new name, new CEO in makeover

John Carroll The New Haven, CT-based biotech Rib-X is undergoing a makeover. The biotech has a new name and is now being run by a new management team drawn in by a new lead investor. ...

Vivus president steps down, Bayer HealthCare gets new CEO

Alok Saboo FierceBiotech News

Bill Weldon gets new chairman title at Chase Bank

Eric Palmer William Weldon, who last year stepped down at Johnson & Johnson after running the company for years, has again added the title of chairman to his resume. In what The ...

Novartis COPD drug gets approvals in EU, Japan

Eric Palmer Novartis is launching the expected blockbuster into a rapidly expanding but increasingly competitive market as established players and newcomers vie for their piece of the ...
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