An apparent screw-up by organizers of the Society for Immunotherapy of Cancer (SITC) meeting led to trouble on Wall Street for Five Prime Therapeutics Inc., which spent time explaining not only the import of its phase Ia/Ib data in pancreatic cancer (PC) but also how the abstract related thereto appeared online unexpectedly. Read More

Transgenic skin stem cells combined with improved tissue engineering methods have enabled an almost total autologous skin transplant for a 7-year-old child with junctional epidermolysis bullosa (JEB), a rare genetic disease that causes the top layer of skin, the epidermis, to separate from the underlying dermis. Read More

The ends may justify the means after all, as Allergan plc's patent deal with the Saint Regis Mohawk Tribe has Congress addressing some of the unintended consequences of the America Invents Act (AIA). But the end may not be what Allergan was hoping for. Read More

Fortuna Fix Inc. is seeking to become the first company to advance a program into the clinic that uses autologous neural stem cells produced by direct reprogramming, dubbed drNPCs, to replace neuronal tissue lost to neurodegeneration or brain trauma. Read More

Immunomolecular (IM) Therapeutics LLC, a company created to develop small-molecule therapies for the treatment of genetically defined autoimmune diseases, has revealed its lead candidate, an immunotherapy for type 1 diabetes, IMT-002. The molecule, a proprietary formulation of the D enantiomer of methyldopa, already has FDA orphan status and could enter phase I testing next year after the company files an investigational new drug application (IND) in the second quarter of 2018. Read More

BERLIN – Omega-3 fatty acids have long been considered to have cardioprotective effects, but Berlin-based Omeicos Therapeutics GmbH has zeroed in on a short-lived metabolite which actually mediates the effect in an effort to develop a drug that can tackle chronic atrial fibrillation, a condition that affects millions of people. Read More

Fortress Biotech Inc., of New York, said the FDA granted subsidiary Cellvation Inc.'s CEVA-101 (autologous bone marrow-derived stem cells) regenerative medicine advanced therapy (RMAT) designation for the treatment of traumatic brain injury (TBI). Under terms of RMAT, the FDA will help facilitate the program's expedited development and review and provide guidance on generating the evidence needed to support approval of CEVA-101 for TBI. CEVA-101 is being assessed in phase II trials for severe TBI in children. Read More

Ohio Issue 2, the Drug Price Standards Initiative, was defeated by voters in the state Tuesday. On the Nov. 7 ballot as an indirect initiated state statute, it would have required the state and state agencies, including the Ohio Department of Medicaid, to pay the same or lower prices for prescription drugs as the U.S. Department of Veterans Affairs.  Read More

Vical Inc., of San Diego, priced its public offering of about 14.3 million shares at $1.75 apiece for gross proceeds of about $25 million. Vical granted sole underwriter H.C. Wainwright & Co. LLC a 30-day option to purchase up to an additional 2.14 million shares of common stock, which could add $3.7 million. The company, which works in the area of infectious disease, plans to use the net proceeds for general corporate purposes, including clinical trial expenses, R&D expenses, general and administrative expenses, manufacturing expenses and potential acquisitions. Shares of Vical (NASDAQ:VICL) closed Wednesday at $1.83, up 17 cents. Read More

Vanda Pharmaceuticals Inc., of Washington, reported total net product sales of $41.3 million for the third quarter. Sales of Hetlioz (tasimelteon) were $22.3 million, down 1 percent from the second quarter. Sales of Fanapt (iloperidone) were $19.1 million, down 3 percent from the prior quarter. Third-quarter non-GAAP net loss was $1.3 million, or 3 cents per share. The company had $22.5 million in cash and equivalents as of Sept. 30, with another $117.3 million in marketable securities. Shares of Vanda (NASDAQ:VNDA) closed Wednesday at $13.10, down $1.85. Read More

Biovie Inc., of Beverly, Mass., said a second patient has been dosed with orphan drug candidate BIV-201 (continuous infusion terlipressin) in a phase IIa trial in patients with refractory ascites due to advanced liver cirrhosis. The study is designed to enroll a total of six patients. In addition to evaluating safety, the trial will examine indicators of potential efficacy, including the degree of ascites fluid generation and the need for paracentesis procedures. It will also evaluate the steady-state pharmacokinetics of terlipressin and its active metabolite. Read More