Cytrx Corp.'s decision to stop in May its Phase IIb trial with the synthetic retinoid tamibarotene for non-small-cell lung cancer turned investor eyes to aldoxorubicin, an improved, albumin-binding form of the chemotherapy drug doxorubicin at the same stage of testing in first-line soft-tissue sarcoma (STS).
The regulatory system for drugs in China has improved since officials put the head of the country's FDA to death six years ago for accepting bribes, but the struggle is still uphill for drug developers inside the country and those trying to gain entry.
Last fall, when Biogen Idec Inc. and partner Swedish Orphan Biovitrum (Sobi) made public the Phase III from A-LONG, a trial testing their long-lasting recombinant factor VIII candidate – since branded Eloctate – in hemophilia A, most analysts were pleased but cautious about the treatment's chances anytime soon to dominate Advate, marketed by Baxter Healthcare Corp.
The regulatory system for drugs in China has improved since officials put the head of the country's FDA to death six years ago for accepting bribes, but the struggle is still uphill for drug developers inside the country and those trying to gain entry.
Another set of positive Phase III data with oritavancin, a semi-synthetic lipoglycopeptide antibiotic, in acute bacterial skin and skin structure infections (ABSSSIs) puts The Medicines Co. in line for a 2014 approval, and possibly a partnership to help commercialize the compound, which treats disorders caused by susceptible gram-positive bugs that include methicillin-resistant Staphylococcus aureus (MRSA).
Although hopes had not been high for the Phase II study in first-line non-small-cell lung cancer (NSCLC) to begin with, and the company – after talking with the FDA – still plans to go ahead with a Phase III trial, investors looked askance at Peregrine Pharmaceuticals Inc.'s latest snag with the cancer drug bavituximab.
Cytokinetics Inc.'s deal with Astellas Pharma Inc. to develop skeletal muscle activators for weakness-related disorders preserves rights to tirasemtiv for the biotech firm, and focuses on the follow-on compound, CK-212707 (or CK-107, as it's more often known), providing $40 million for Cytokinetics during the first two years, with potential milestone payments up to $450 million.
The death of a patient in trials with tosedostat for blood-related cancer cast a pall over Cell Therapeutics Inc.'s shares when investors learned of the partial clinical hold, placed on the compound June 17.
3-V Biosciences Inc.'s $20 million Series C financing will push the lead cancer product, a fatty acid synthase (FASN) inhibitor, through Phase I trials, while boosting preclinical studies with leads in virology – the research area on which the company was founded in 2007.
Plowing ahead with the second Phase III trial to evaluate Androxal (enclomiphene), the estrogen receptor antagonist for secondary hypogonadism, Repros Therapeutics Inc. priced an underwritten public offering of about 3.7 million shares at $19 each, grossing about $71.2 million.
