AcelRx Pharmaceuticals Inc., of Redwood City, Calif., said it dosed its first patient in the second of three planned Phase III studies of Sufentanil NanoTab PCA System (ARX-01). The randomized, open-label, parallel-group trial will compare efficacy and safety of the drug to the standard of care, intravenous PCA with morphine. The primary objective of the study is noninferiority. Top-line data are expected in the second half of the year. Ampio Pharmaceuticals Inc., of Greenwood Village, Colo

Cerecor Inc., of Baltimore, said its investigational new drug application for FP01 for the treatment of cough cleared the FDA. The company plans to characterize the pharmacokinetics of FP01 lozenges in humans and then initiate an exploratory Phase II acute cough study in healthy subjects with upper respiratory tract infections. NeurogesX Inc., of San Mateo, Calif., said it will meet with the FDA for an end-of-Phase II meeting to discuss NGX-1998 for neuropathic pain, specifically Phase III

RedHill Biopharma Ltd., of Tel Aviv, Israel, said initial analysis of a pharmacokinetic study comparing its version of odansetron with Zofran (odansetron, GlaxoSmithKline plc) showed the trial met its objective of establishing bioequivalence. Assuming the final clinical study report supports the preliminary findings, RedHill said it will consider filing for U.S. marketing approval. RedHill licensed rights to the extended-release version of the anti-emetic drug, dubbed RHB-102, from Scolr Pharma

Arteriocyte Inc., of Cleveland, said it received FDA approval to start a Phase I trial using its Magellan MAR01 technology in the treatment of compartment syndrome. The company is moving forward under the FDA's investigational device exemption, which allows Arteriocyte and its clinical partners to initiate evaluation of concentrated marrow injections to mitigate ischemic damage due to compartment syndrome in extremity trauma patients. Magellan MAR01 is designed to enable the rapid operating

CSL Behring, of King of Prussia, Pa., reported the first in human dosing of recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP). The Phase I study will investigate in healthy volunteers the safety and pharmacokinetics of rVIIa-FP in comparison to placebo. CSL Behring is developing rVIIa-FP as a treatment for hemophilia A and hemophilia B patients who have inhibitors as part of the PROLONG 7- FP clinical study program. Shire plc, of Dublin, Ireland, said that

AlphaCore Pharma Inc., of Ann Arbor, Mich., initiated a Phase I trial of ACP-501 in patients with stable coronary arterial disease. The trial, to be conducted by the National Institutes of Health, will assess the safety, tolerability, pharmacokinetics and lipid effects of ACP-501. The drug is being developed as a treatment for high-risk atherosclerosis and serious lipid metabolism disorders. ImmunoGen Inc., of Waltham, Mass., initiated Phase II testing of IMGN901 as a first-line treatment of

Amsterdam Molecular Therapeutics (AMT) Holding NV, of Amsterdam, the Netherlands, published data demonstrating that one-time administration of gene therapy Glybera (alipogene tiparvovec) can improve metabolism of chylomicron (fat particles in the blood) following consumption of a low-fat meal, resulting in a reduced level of newly formed chylomicrons in the bloodstream. Chylomicrons are considered to be the cause of acute and recurring bouts of pancreatitis seen in the inherited disorder

AstraZeneca plc, of London, said subanalysis data from its VOYAGER study suggested that achieving an LDL-C goal of less than 70 mg/dL or a greater than 50 percent reduction in LDL-C levels in patients at high risk requires aggressive statin therapy. Results showed that a significantly greater percentage of patients achieved that goal with Crestor (rosuvastatin) than with equal or double doses of Lipitor (atorvastatin, Pfizer) or Zocor (simvastatin, Merck & Co. Inc.) Data were presented at the

Bionomics Ltd., of Adelaide, Australia, said it gained approval to proceed with a Phase I/II trial testing vascular disrupting agent BNC105 in women with ovarian cancer. The study, expected to start next quarter, is designed to evaluate BNC105 in combination with carboplatin and gemcitabine. China Biologic Products Inc., of Beijing, said subsidiary Shandong Taibang Biological Products Co. Ltd. received approval from Chinese regulators to begin clinical trials of its human fibrinogen to treat

Almirall SA, of Barcelona, Spain, said the European Respiratory Journal published full results of ATTAIN (Aclidinium To Treat Airway obstruction In COPD patieNts), a six-month pivotal study comparing the efficacy and safety of twice-daily inhaled aclidinium (200 mcg and 400 mcg) against placebo in patients with moderate to severe chronic obstructive pulmonary disease. The study showed improvement from baseline with aclidinium 200 mcg and 400 mcg vs. placebo, as well as improved health status

Galderma Laboratories LP, of Fort Worth, Texas, said it completed two Phase III trials of CD07805/47, a topical gel in development for adults with moderate to severe facial erythema of rosacea. Results from the two trials confirmed safety and efficacy seen in prior Phase II studies, and Galderma intends to submit marketing applications in the U.S. and Europe.

SK Biopharmaceuticals, of Seoul, South Korea, said it dosed the first patient in a Phase II trial of YKP10811, a selective partial agonist of serotonin Type 4 receptors, in chronic constipation. The goal of the program is to develop a drug with once-daily oral dosing and improved efficacy and safety for chronic constipation and other disorders related to reduced gastrointestinal motility.

CBT Development Ltd., a virtual company created by UK-based life science venture funds Avlar Bioventures and Excalibur Fund Managers, and drug development service firm Ergomed, said they completed enrollment of a 120-patient Phase II trial of oral BVT. 115959, an A2A agonist, in diabetic neuropathic pain. Data from the trial are expected in the middle of this year, and the parties plan to out-license the compound for further development and commercialization. Oncothyreon Inc., of Seattle

Forest Laboratories Inc., of New York, and Pierre Fabre Medicament, of Castres, France, reported top-line results in a Phase III trial showing that levomilnacipran significantly reduced depression symptoms in patients with major depressive disorder compared to placebo, as early as week one and at each subsequent visit, as measured by the Montgomery-Asberg Depression Rating Scale-Clinician Rated. Results from an additional Phase III study are expected this spring, and the companies anticipate

AcelRx Pharmaceuticals Inc., of Redwood City, Calif., said it dosed the first patient in a Phase III study of ARX-01, the Sufentanil NanoTab PCA System, its sublingual patient-controlled analgesia system. The first Phase III trial is expected to enroll about 150 adults, randomized 2-to-1 to active or placebo groups, who will be treated for postoperative pain following open abdominal surgery for a minimum of 48 hours and, as needed, up to 72 hours after randomization. AcelRx is planning

Shire plc, of Dublin, Ireland, began two Phase IV trials comparing Vyvanse (lisdexamfetamine dimesylate) capsules to Concerta (methylphenidate HCL) extended-release tablets. The randomized, double-blind trials will compare the two drugs in approximately 1,000 adolescents, between 13 and 17, with attention deficit hyperactivity disorder to determine efficacy via the ADHD-RS-IV Total Score. Results are anticipated in the second half of 2013.

CK Life Sciences International (Holdings) Inc., of Hong Kong, said the FDA cleared the investigational new drug application submitted by its subsidiary, Polynoma LLC, allowing it to proceed with Phase III testing of its melanoma vaccine, manufactured using a combination of antigens from three melanoma cell lines. The vaccine is designed to stimulate the body's immune system to fight disease. The company's Phase III trial is expected to begin enrolling patients within several months. Polynoma

Baxter International Inc., of Deerfield, Ill., reported long-term data supporting the clinical profile of HyQ, a combo product for use in patients with primary immunodeficiencies. Those and other results were presented at the American Academy of Allergy, Asthma and Immunology meeting in Orlando, Fla. Meda AB, of Goteborg, Sweden, reported data from three studies of MP29-02 (tentatively called Dymista), an intranasal formulation of azelastine hydrochloride and fluticasone propionate, at the

BioInvent International AB, of Lund, Sweden, and partner Genentech Inc., of South San Francisco, a member of the Roche Group, said they completed enrollment in the Phase IIa GLACIER study of BI-204, a monoclonal antibody targeting oxidized forms of low-density lipoprotein, in patients with stable atherosclerotic vascular disease. Top-line data are expected in the third quarter. Genentech Inc., of South San Francisco, a member of the Roche Group, said preliminary results from the ADACTA