Analysts remained relatively unconcerned following Celgene Corp.'s news that it halted a Phase III study testing Revlimid (lenalidomide) in front-line elderly B-cell chronic lymphocytic leukemia (CLL) due to an imbalance in the number of deaths between the Revlimid and control arms, though up and coming competitors could benefit from the minor setback.
In a deal reminiscent of last year's acquisition of struggling Allos Therapeutics Inc., Spectrum Pharmaceuticals Inc. nabbed cash-strapped Talon Therapeutics Inc. for a mere $11.3 million in cash up front, gaining rights to Marqibo, a nanoparticle encapsulation version of microtubule inhibitor vincristine, which gained approval last year in a subset of acute lymphoblastic leukemia (ALL) patients.
Qiagen NV's Therascreen EGFR RGQ PCR Kit gained FDA approval alongside Boehringer Ingelheim GmbH's lung cancer drug Gilotrif (afatinib), putting another notch in the win column for the growing companion diagnostics space, though there are still challenges to overcome before the use of companion diagnostics becomes routine in the marketplace.
More than a year after filing an S-1 for an initial public offering (IPO), Oncomed Pharmaceuticals Inc. set proposed terms, seeking to sell 4 million shares priced between $14 and $16.
Heat Biologics, a firm founded in 2008 to develop an off-the-shelf allogeneic immunotherapy technology based on heat-shock proteins, is taking its place in biotech's bustling initial public offering (IPO) queue.
Shares of Onyx Pharmaceuticals Inc. jumped 51.3 percent Monday after it rejected over the weekend an unsolicited $10 billion bid from Amgen Inc. and said it would seek other potential offers.
Almost exactly a year after Remsima (infliximab) won approval in Korea as the first ever biosimilar monoclonal antibody (MAb), the Remicade copycat drug won a positive opinion from Europe's Committee for Medicinal Products for Human Use (CHMP), clearing the way for formal European approval within the next three months.
Following in the footsteps of upsized initial public offerings (IPOs) from PTC Therapeutics Inc. and Bluebird Bio, Plymouth, Mich.-based Esperion Therapeutics Inc. priced an IPO to raise $70 million – $80.5 million if underwriters exercise overallotments in full – to support midstage testing of its lead compound, ETC-1002, as an alternative to statin therapy in lowering LDL-cholesterol (LDL-C).
News of at least a three quarter delay in seeking regulatory approval for Fabry disease candidate migalastat unsurprisingly sent shares of Amicus Therapeutics Inc. falling 24 percent in Monday morning trading, but reports of the firm's recent meeting with the FDA left room for optimism for the Glaxosmithkline plc-partnered molecular chaperone.
