Common stock in Fibrocell Science Inc., of Exton, Pa., has been approved for listing on the NYSE Market, to commence trading on May 17, under the ticker symbol FCSC...Genfit SA, of Lille, France, said GFT505 reduced a new component of cardiovascular risk, remnant cholesterol, contained in lipid particles other than LDL and HDL...In the GFT505-209-4 study, the effect of GFT505 on measured remnant cholesterol was -24 percent (p = 0.0046) compared to the placebo group after 28 days of treatment

Quintiles will also contribute to Merck Serono's future trial design process

Prior to the approval of Nymalize, nimodipine was available only in gel capsule form...The company expects to complete the trial in the first half of 2014. (See BioWorld Today, Dec. 20, 2012...distribution rights to the drug, a next-generation micellar diblock co-polymeric paclitaxel formulation, from Samyang

Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA granted priority review to its new drug application for simeprevir (TMC435), an NS3/4A protease inhibitor for once-daily administration with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease...Valeant Pharmaceuticals International Inc., of Laval, Quebec, has provided additional information related to the proposal to continue

Kinnovata plans to develop, manufacture and commercialize respiratory products for China and other regional Asian markets, initially exploiting Vectura's Clickhaler and Duohaler dry powder inhaler (DPI) technology platforms in asthma and chronic obstructive pulmonary disease...KingYork is expected to hold a 50 percent equity share, with Vectura holding 35 percent and Zendex and partners holding 15 percent

We note that an acquisition of Warner could potentially offer a tax strategy as Warner has a lower tax rate...Regeneron waived its right to opt in on canakinumab and, instead, is entitled to sales royalties

formed a joint venture to commercialize Vectibix (panitumumab) in China...The split is intended to increase the per-share trading price of the common stock to satisfy the $1 minimum bid price requirement for continued listing on the Nasdaq Capital Market

Under the terms, Adaptive will use its immune profiling assay, immunoSEQ, to identify potential biomarkers that may inform about drug response

Merck expects the review for this BLA, as well as a BLA for its Timothy grass pollen (Phleum pretense) sublingual allergy immunotherapy tablet, to be completed in the first half of 2014

To date, 130 laboratory-confirmed cases of human infection with the H7N9 virus, resulting in 31 deaths, have been reported to the World Health Organization...To date the company is known for its biodegradable and low toxicity DNA and RNA delivery reagents for cell-based research and therapeutics

He allegedly permitted a trader, dubbed John Doe in the affidavit, to purchase 20,000 shares of an initial public offering of stock for GeneMedicine Inc., of The Woodlands, Texas, in exchange for which John Doe agreed to purchase 5,000 shares of stock issued by two other companies, Hemisphere and Ecogen Inc...Public Information Officer Marvin Smilon, of the U.S. Attorney's Office, told BioWorld Today that a hearing is set for May 14 before Judge Kevin Thomas Duffy, in Manhattan District Court

Eisai Inc., of Woodcliff Lake, N.J., said the European Commission granted orphan drug designation to multityrosine kinase inhibitor lenvatinib for the treatment of follicular and papillary thyroid cancer...In separate news, Eisai said it filed a Type II variation application with the European Medicines Agency for Halaven (eribuln), requesting an indication extension to include treatment of earlier-line metastatic breast cancer patients

Sagent expects to close the transaction over the next several months...Addition of Vaxfectin to the influenza vaccines substantially increased both antibody and T-cell responses compared with nonadjuvanted vaccines in mice and guinea pigs, according to Vical

BIO's Special 301 Submission encouraged the USTR to perform out-of-cycle reviews of patent systems in these countries. (See BioWorld Today, April 2, 2013...The company said it plans to file an investigational new drug application for ES414 next year...The team designed the vaccine to elicit antibodies against not only heroin, but also 6-acetylmorphine and morphine

Bristol-Myers Squibb Co., of New York, said the FDA approved a supplemental new drug application for the HIV-1 therapy Sustiva (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg...Inc., of Whitehouse Station, N.J., said the FDA has approved Liptruzet (ezetimibe and atorvastatin) tablets to treat elevated low-density lipoprotein cholesterol in patients with primary or mixed hyperlipidemia as adjunctive

to sell shares of common stock 4/19/13 Navidea Biopharma-ceuticals Inc. (Dublin, Ohio) At-the-market common stock offering 2.1S $5.1 Navidea raised $5.1M in an offering of 2.1M shares at $2.43 per share...StemCells issued SVB a warrant to purchase 293,531 shares of common stock at $1.7034 per share 4/10/13 Unigene Laboratories Inc. (Boonton, N.J.) Amended financing agreement N/A $0.75 Unigene entered a second amendment to a financing agreement with affiliates of Victory Park Capital Advisors LLC

Allergan licensed rights to the Darpin technology from Molecular Partners AG for development in AMD and other eye diseases. (See BioWorld Today, Aug. 22, 2012.) And Eylea has fared well so far against Roche AG's Lucentis (ranibizumab), due to its lower cost and a label that calls for less frequent dosing, and even to cancer drug Avastin (bevacizumab), a cheaper, off-label alternative

ChemRar Ventures, of Moscow, said it signed a scouting agreement, for a period of 18 months, with Sanofi SA to source a venture investment in Russia...In granting the motion, the judge ruled that the plaintiffs failed to offer any reliable evidence that Mr. Cooper's disease was caused by Actos (pioglitazone HC1)," said Kenneth D. Greisman, senior vice president, general counsel, Takeda Pharmaceuticals U.S.A. Inc...Actos is prescribed for use with diet and exercise to improve blood sugar control in

It's the second oncology compound within the Janssen pipeline to receive the designation in the last three months...The company expects to repurchase about $7.5 billion of common stock over the next 12 months, financed through a combination of debt issuance and operating cash flows, with the remainder to be repurchased over time with no time limit