Though FDA reviewers highlighted concerns of renal impairment in briefing documents disclosed ahead of Friday's advisory panel meeting on Gilead Sciences Inc.'s HIV drug Quad, analysts continue to expect a thumbs-up for the single-tablet regimen, comprising the active ingredients of Truvada (emtricitabine/tenofovir disoproxil fumarate) plus elvitegravir and boosting agent cobicistat.

Capitalizing on a wealth of biologics expertise, 2010 start-up Coherus BioSciences Inc. is moving into the global biosimilars space, kicking off its efforts with an Asian partnership with Daiichi Sankyo Co. Ltd. to develop and commercialize biosimilar versions of Enbrel (etanercept, Amgen Inc.) and Rituxan (rituximab, Biogen Idec Inc. and Roche AG).

For companies working in orphan diseases, support from patient advocacy groups and foundations is critical, both in terms of providing much-needed funding and building relationships with the small patient communities. But 2011 start-up Halo Therapeutics LLC credits its connection to patient groups to the company's actual formation.

Gilead Sciences Inc. beat revenue estimates for the first quarter, but missed earnings-per-share consensus by 2 cents, as it reported solid sales for its antiviral franchise, including impressive uptake of recently launched triple-drug, single-tablet HIV drug Complera.

Seattle-based Cell Therapeutics Inc. nabbed worldwide rights to Phase III-ready JAK2 inhibitor pacritinib from S*Bio Pte Ltd., of Singapore, for a relatively modest up-front payment of $30 million – half of that in convertible preferred stock – and up to $132.5 million in regulatory and sales milestones if the drug lives up to its full potential.

Hyperion Therapeutics Inc. joined the initial public offering (IPO) queue Friday, filing an S-1 aiming to raise as much as $57 million to advance pivotal studies, and possible commercial launch, of lead drug Ravicti (glycerol phenylbutyrate) in two orphan indications: urea cycle disorders (UCD) and hepatic encephalopathy.

Amylin Pharmaceuticals Inc.’s board dodged a dissident shareholder bullet three years ago, but the San Diego-based biotech is back in the crosshairs of billionaire investor and activist shareholder Carl Icahn, who again is seeking to nominate a new slate of board members to pull the trigger on a company sale. Given Icahn’s personal track record in the sector over the past few years – ImClone Systems Inc., MedImmune Inc. and Genzyme Corp. all landed acquisitions, though he was unsuccessful in facilitating a sale of Biogen Idec Inc. – Amylin’s days as an independent firm could be numbered. Certainly there are...

A venture capital firm with a reputation for supporting early stage innovation, Flagship Ventures is teaming up with Merck & Co. Inc. in an unusual partnership that brings Merck closer to early stage discoveries while allowing young companies the chance to tap into the big pharma's expertise.

Despite high hopes for oral Akt inhibitor perifosine, the drug failed to improve overall survival in a Phase III colorectal cancer (CRC) trial, sending shares of partners Keryx Pharmaceuticals Inc. and Aeterna Zentaris Inc. tumbling Monday and shifting investor attention to each firm's other late-stage programs.