FDA and hospitals are scrambling as the shortage of hydration products deepens

Eric Palmer The FDA has worked to face down shortages of important, sometimes life-saving, drugs that have sprung up in recent years. But occasionally something as mundane as saline ...

Aveo’s cancer drug circles the drain after a scuttled Phase II trial

Damian Garde Aveo Oncology and Astellas Pharma are shutting down a Phase II study of tivozanib in breast cancer after failing to enroll enough patients, the partners announced. FierceBiotech ...

As biosims win nods in Europe and India, debate over naming rights heats up

Alok Saboo What's in a name? In the pharmaceutical world, the answer to this question is no simple matter. Drugmakers, biotechs and their generic rivals are squabbling over the ...

Progenics tanks after two trial deaths cast doubt on its lead program

Damian Garde Two patients died of sepsis in a Phase II trial of Progenics Pharmaceuticals' in-development prostate cancer treatment, spurring concern that the drug is too toxic ...

Astellas, Medivation’s cancer drug Xtandi scores new upbeat PhIII results

Emily Mullin Medivation and Astellas Pharma unveiled final results on primary and secondary efficacy endpoints from their Phase III PREVAIL trial of Xtandi (enzalutamide), showing that ...

New data positions Astellas prostate cancer med Xtandi to grab market share from J&J’s Zytiga

Tracy Staton Some new data on the prostate cancer drug Xtandi promises to heat up competition with Johnson & Johnson's Zytiga. Medivation and its partner Astellas Pharma unveiled ...

AstraZeneca joins stepped-up antibiotic R&D action with FOB Synthesis deal

Tracy Staton AstraZeneca notched an antibiotics research deal with a licensing/option set-up with FOB Synthesis, covering combinations of the two companies' experimental drugs. FiercePharma ...

Indian clinical trials plummet 93% as local regs tighten up

Damian Garde Years of lax regulations helped India build a booming market for clinical trials, but a recent move to strengthen patient protections has deflated demand and last year ...

Medigene gambles on dendritic cell cancer vaccines in Trianta buyout

John Carroll Germany's Medigene AG has nabbed a small cancer vaccine developer in a buyout which will add a team of investigators from one of the country's top research institutes. ...

Ranbaxy will need new markets as FDA closes window on U.S., analysts predict

Eric Palmer What is a generic drugmaker going to do when the FDA finds flies filling its analytics laboratory and shuts down a yet another plant key to serving the U.S. market? Start ...

Teva stands by its MS pill after yet another setback

Damian Garde European regulators recommended against Teva Pharmaceutical's laquinimod, marring the Isreali company's odds of crossing the finish line with its once-promising ...

CHMP recommendation adds to Teva’s financial turmoil

Eric Palmer Regulators in Europe refused to give a favorable review to laquinimod, a potential successor treatment to Teva's multiple sclerosis drug Copaxone, which faces generic ...
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