05/23/14 - 02:56 PM EDT
The FDA turned down Provectus BioPharmaceuticals' request to grant Breakthrough Therapy Designation (BTD) to its experimental skin cancer drug PV-10.READ FULL POST
05/23/14 - 08:46 AM EDT
PTC Therapeutics shares have doubled this morning on the surprising (I'd say shocking) news that European regulators recommended the conditional approval of Translarna as a new treatment for patients with Duchenne muscular dystrophy caused by so-called "nonsense" mutations.READ FULL POST
05/20/14 - 01:42 PM EDT
Provectus is supposed to hear back from the FDA this week about the request to grant PV-10 Breakthrough Therapy status for skin cancer. So far, Provectus has said nothing about the FDA's response.READ FULL POST
05/20/14 - 10:26 AM EDT
Japanese companies have a history of paying grossly inflated prices for U.S. assets, but the drug maker Eisai would have to be monumentally stupid -- and financially reckless -- to buy out its obesity drug partner Arena Pharmaceuticals.READ FULL POST
05/19/14 - 10:39 AM EDT
InterMune should have pirfenidone on the U.S. market in early 2015, but figuring out Boehringer's FDA strategy is more difficult.READ FULL POST
05/15/14 - 09:30 AM EDT
It's been five months since Northwest Biotherapeutics told investors that independent monitors were conducting an interim efficacy analysis of the phase III study of DC-Vax in patients with newly diagnosed glioblastoma multiforme (GBM.)READ FULL POST
05/14/14 - 03:35 PM EDT
Lion Bio received an SEC subpoena related to the Galena DreamTeam investigation.READ FULL POST
05/14/14 - 10:39 AM EDT
The phase I/II study will combine Bristol's PD-1 checkpoint inhibitor nivolumab with Celldex's CD27-targeted antibody varlilumab, also known as CDX-1127.READ FULL POST
05/12/14 - 06:24 PM EDT
Telik never recovered from hiding the premature deaths of ovarian cancer patients treated with its experimental drug Telcyta in 2007READ FULL POST
05/12/14 - 10:19 AM EDT
J.P. Morgan analyst Geoff Meacham issued a cautiously optimistic note about the biotech sector this morning. While investor sentiment remains "fragile," and volatility continues to be high, Meacham believes the worst of the selling is over.READ FULL POST
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