Given the hoopla surrounding data for Plexxikon Inc.'s targeted melanoma candidate Zelboraf (vemurafenib) earlier this year, a sooner-than-expected FDA nod for the drug and its companion diagnostic in patients with a specific BRAF mutation came as little surprise. Read More
As the biosimilar road trip gets under way, the FDA is mapping out three distinct routes – follow-ons, biosimilars and interchangeable biologics. Read More
Cytos Biotechnology Ltd. is taking drastic measures to keep the company afloat ahead of the looming maturity of its convertible bond in February 2012. Although its product, CYT003-QbG10, has shown positive results in three Phase II trials for allergic asthma and allergic rhinitis, the company has been unable to fund its earlier stage programs, and may face a financing gap of more than $21.5 million even after it slashes its staff and programs. Read More
While its planned merger with AMAG Pharmaceuticals Inc. and a rival offer for AMAG from hedge fund MSMB Capital Management swirled in the background, Allos Therapeutics Inc. enrolled the first patient in its Phase III randomized trial (PDX-017) evaluating Folotyn (pralatrexate injection) in patients with previously undiagnosed peripheral T-cell lymphoma (PTCL). The post-approval study is open to newly diagnosed patients with PTCL who have achieved an objective response following initial treatment with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) or a CHOP-like regimen. Read More
Inhibitex Inc., of Atlanta, filed a shelf registration statement to raise, from time to time, up to $130 million in common stock, preferred stock, warrants, debt and/or rights. Read More
Cynapsus Therapeutics Inc., of Toronto, said it plans to proceed with its all-stock acquisition of Hamilton, Ontario-based Adagio Pharmaceuticals Ltd., its partner on APL-130277, a reformulation of an approved Parkinson's drug. Read More
