FDA panel dashes Merck’s hopes for broader use of Zetia, Vytorin

Tracy Staton In a blow for Merck & Co.'s cholesterol franchise, an FDA advisory panel shot down its bid to tout Vytorin and Zetia as preventives ...

Big Pharma pushes new migraine drugs into Phase III with blockbuster hopes

Damian Garde A cadre of drugmakers is pressing toward late-stage trials with new injectable treatments in the long-stagnant field of migraine therapy, racing to capitalize on what analysts ...

Novo hopes for European Saxenda launch this year after CHMP nod

Carly Helfand Novo Nordisk's obesity therapy Saxenda is on a roll. Just over a month after snagging FDA approval, the drug scored a positive recommendation on Thursday from Europe's ...

Xencor moves on without Amgen, ditching its hopes in arthritis

Damian Garde Xencor has reacquired the rights to an Amgen-optioned antibody, walking away from the Big Biotech and an arthritis indication with hopes of a new path in rare disease. FierceBiotech ...

Cyramza, key to Lilly’s oncology hopes, comes through in colorectal cancer

Damian Garde Eli Lilly's Cyramza (ramucirumab) met its primary endpoint in a study on metastatic colorectal cancer, good news for a key cog in the drugmaker's plans to capitalize ...

Tuberculosis cocktail stirs hopes for quick cures in patients with HIV

Damian Garde A new three-drug combo treatment for tuberculosis better eradicated the disease than standard therapy in a midstage trial, showing particular promise for patients with ...

Novartis hopes new COPD study data will draw patients from Glaxo’s Advair

Carly Helfand Novartis' generic of Advair in Europe is already a thorn in GlaxoSmithKline's side when it comes to sales of the declining blockbuster. Now, it says, another of ...

High court dashes Actelion’s hopes for $407M reprieve in Tracleer case

Arlene Weintraub Actelion has lost its fight against a $ 407 million court judgment. California's Supreme Court rebuffed the Swiss drugmaker's appeal in a lawsuit over competition ...

FDA staffers throw cold water on Sanofi’s Lemtrada hopes

Tracy Staton If you're a drug developer, which 6 words do you never, ever want to see in an FDA review of a potential new product? The 6 words applied to Sanofi's multiple sclerosis ...

Achillion shares crushed in a rout as hep C blockbuster hopes fade

John Carroll After the market closed on Friday, Achillion spread the word that the FDA is maintaining its clinical hold related to its once-hot hepatitis C drug sovaprevir, while distributing ...

Forest hits setback on new COPD drug, one of its key hopes for sales growth

Tracy Staton The delay could interfere with their plans to compete against rival drugs that could get to market first. FiercePharma News

New Vivus chief’s Qsymia marketing plans raise turnaround hopes

Carly Helfand Vivus announced second-quarter losses much worse than anyone expected. It took the first public comments from incoming CEO Tony Zook to sustain hopes for a turnaround. FiercePharma ...
© 2018 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS