With $25 million pledged from a stock sale to institutional investors, rare-disease specialist Retrophin Inc. signed a deal with an unidentified pharma firm for an option to license its autism/schizophrenia drug and said plans for a potentially pivotal trial are on track for RE-021, the firm's dual-acting receptor antagonist of angiotensin and endothelin receptors, as a therapy for focal segmental glomerulosclerosis (FSG).
The falter by Forest Laboratories Inc. and Spanish partner Almirall SA in submitting a new drug application (NDA), originally planned for the first quarter of this year, pushes the duo back somewhat in the race by pharma and biotech firms to win approval of the magic potion, long-acting muscarinic antagonist with a long-acting beta agonist for chronic obstructive pulmonary disease.
Wall Street speculators once again began to mull Mannkind Corp.'s chances for partnering its inhaled insulin Afrezza, following news that the second-generation Dreamboat device proved just as good as the first gizmo, in terms of forced expiratory volume in 1 second – a matter questioned in the latest complete response letter from the FDA.
Osiris Pharmaceuticals Inc.'s latest data boost for already-marketed Grafix – a cell-repair matrix made of mesenchymal stem cells for diabetic foot ulcers (DFUs) that helped the company to $5.3 million in second-quarter biosurgery sales – likely will translate to a sizeable revenue hike, as reimbursement catches on.
Vical Inc.'s stock-bashing Phase III failure against metastatic melanoma with Allovectin (velimogene aliplasmid) caused at least one analyst to question the plasmid DNA platform that is the subject of another late-stage program with Astellas Pharma Inc. in a separate indication, as well as independent efforts.
“Once you obtain your genetic information, the knowledge is irrevocable,” warn the service terms at saliva-testing firm 23andMe.com. The news wasn’t so bad, except for Alzheimer’s. Also, I’m sort of related to Stephen Colbert. Of course, 23andMe, of Mountain View, Calif., can’t predict your medical future with certainty, but, using a saliva sample, does uncover a wealth of personalized data on predisposal to diseases – more than 240 health conditions and more than 40 inherited illnesses – along with likely drug responses and ancestry details that go back thousands of years. Here’s the process: You sign up online and pay...
Three months after Shire plc pulled the plug on their potential $498 million collaboration, Acceleron Pharma Inc. has filed for an initial public offering (IPO) that aims for about $74.7 million, and has extracted from its continuing partner Celgene Corp. a promise to buy more shares in an undisclosed amount at the IPO price, if the deal goes through.
The possibility of rebates attached to Regeneron Pharmaceuticals Inc.'s age-related macular degeneration (AMD) drug Eylea (aflibercept) – such as those offered by the maker of competitor Lucentis – was one of a handful of issues raised by analysts during the company's second quarter earnings call, but CEO Leonard Schleifer declined to tip his hand.
Zalicus Inc.'s shares gained ground the day after second-quarter earnings rolled out, as investors reawakened to the potential of Z160, the firm's Phase II oral, N-type calcium channel blocker for chronic pain.
Skittish investors seemed more worried than analysts about word from Halozyme Therapeutics Inc. and Viropharma Inc. that the Phase II study will be discontinued with subcutaneous Cinryze (C1 esterase inhibitor with recombinant hyaluronidase [rHuPH20]) for hereditary angioedema (HAE) because of high levels of non-neutralizing antibodies.
