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.
Regeneron Pharmaceuticals Inc.'s first-quarter earnings left consensus estimates in the dust, as higher-than-expected sales of age-related macular degeneration (AMD) drug Eylea (aflibercept ophthalmic solution) drove the company to profitability for the first time in its 24-year history.
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.
As the dust settled after the two-day Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting ended with a 17-6 vote in favor of requiring large cardiovascular outcomes trials (CVOTs) for all obesity drugs, regardless of cardiovascular risk or signal, analysts began scrambling to gauge whether the recommendations will affect the upcoming FDA decisions for Vivus Inc.'s Qnexa and Arena Pharmaceuticals Inc.'s Lorqess (lorcaserin).
Despite winning a reluctant yea vote from the Cardiovascular and Renal Drugs Advisory Committee last month, Chelsea Therapeutics International Inc.'s neurogenic orthostatic hypotension (NOH) candidate Northera (droxidopa) failed to win FDA approval, sending shares of the Charlotte, N.C.-based firm falling 28.6 percent.
