Tonix Pharmaceuticals Holding Corp., of New York, said it will start a study to compare the pharmacokinetic profile of TNX-102, its oral formulation of cyclobenzaprine, with the pharmacokinetics of a conventional immediate-release formulation and an intravenous injection

Chiasma Inc., of New York, presented data at ENDO 2012 in Houston showing that octreolin reduced pituitary growth hormone secretion in healthy volunteers as effectively as injectable octreotide, with similar safety, pharmacokinetic and pharmacodynamic properties

A total of 266 patients (85 percent) from the previous Phase II studies rolled over into the open-label portion, which was fully funded by partner Pfizer Inc., of New York

Bristol-Myers Squibb Co., of New York, formed a strategic partnership with Emory University in Atlanta to conduct clinical trials involving the pharma's investigational compounds...Forest Laboratories Inc., of New York, said it was notified that entities affiliated with Carl C. Icahn intend to nominate four individuals to Forest's 10-member board for election at the company's 2012 annual meeting

Pfizer Inc., of New York, said its ALK inhibitor Xalkori (crizotinib) met its primary endpoint in the PROFILE 1007 study, demonstrating significantly improved progression-free survival (PFS) when compared with pemetrexed or docetaxel, in previously treated patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC

Bristol-Myers Squibb Co., of New York, reported six-year follow-up results from a Phase III trial of Sprycel (dasatinib) in Philadelphia chromosome-positive chronic-phase chronic myeloid leukemia adult patients resistant or intolerant to Glivec (imatinib, Novartis AG), demonstrating a progression-free survival rate of 49.3 percent and an overall survival rate of 71 percent for patients receiving dasatinib, with 6 percent of patients progressing to accelerated or blast phase of the study at six

Ziopharm Oncology Inc., of New York, dosed its first patient in the Phase III MATISSE pivotal trial of palifosfamide for small-cell lung cancer

Bristol-Myers Squibb Co., of New York, reported four-year results from the long-term extensions of the BENEFIT and BENEFIT-EXT trials evaluating Nulojix (belatacept), its selective T-cell co-stimulation blocker indicated for the prophylaxis of organ rejection in adult Epstein-Barr virus-seropositive patients receiving a kidney transplant, in combination with basiliximab induction, mycophenolate mofetil and corticosteroids

Ziopharm Oncology Inc., of New York, said enrollment has been completed in the Phase III PICASSO 3 trial of palifosfamide in combination with doxorubicin, vs

Pfizer Inc., of New York, said the European Medicines Agency's Committee for Human Medicinal Products recommended marketing authorization for axitinib as a second-line treatment for adults with advanced renal cell carcinoma

Data were presented at the American Society of Hypertension meeting in New York

Celtic Pharmaceutical Holdings LP, of New York, said it completed a Phase I/II study of Xerecept (corticorelin acetate) in pediatric patients who are dependent on the steroid Decadron (dexamethasone) to treat peritumoral brain edema associated with cerebral tumors

Pfizer Inc., of New York, said the Phase III INTORSECT study testing Torisel (temsirolimus) in patients with advanced renal cell carcinoma whose disease had progressed on or after Sutent (sunitinib malate) therapy did not meet the primary endpoint of prolonging progression-free survival (PFS) when compared to Nexavar (sorafenib, Onyx Pharmaceuticals Inc. and Bayer AG

TG Therapeutics Inc., of New York, said the FDA cleared its investigational new drug application for TGTX-1101, also known as ublituximab, a third-generation chimeric monoclonal antibody targeting an epitope on the CD20 antigen found on B lymphocytes

Pfizer Inc., of New York, said its Pristiq (desvenlafaxine) extended-release tablets (50 mg/day) showed significant increases in time to relapse over six months compared to placebo in a trial in 548 patients with major depressive disorder

Pfizer Inc., of New York, said a Phase IIIb withdrawal design study for Lyrica (pregabalin) in patients with inadequately treated painful diabetic peripheral neuropathy did not meet its primary endpoint, defined as the change in mean pain score relative to baseline

Quark Pharmaceuticals Inc., of Fremont, Calif., said it amended its existing exclusive licensing agreement with Pfizer Inc., of New York, which enables Quark to perform a Phase IIa study assessing the effect of PF-655 on visual function in patients with moderate and advanced open-angle glaucoma

Ventrus Biosciences Inc., of New York, said it completed enrollment and randomization in its first Phase III trial of iferanserin (VEN 309), a selective peripheral 5-HT2A receptor antagonist, in patients with Grade 1, 2 and 3 hemorrhoids

Forest Laboratories Inc., of New York, reported positive top-line results from a Phase III trial of levomilnacipran for major depressive disorder