The pharma also will assume responsibility for funding and clinical development beyond Phase II and for completing regulatory and commercialization activities...In addition to RA and Crohn's, the pharma may develop GLPG0634 in psoriasis, irritable bowel syndrome and lupus, mirroring the path by which the label on its blockbuster Humira (adalimumab) was expanded beyond RA. (See BioWorld Today, March 1, 2012, and Jan. 3, 2013...Prior to the reacquisition, GSK experienced manufacturing issues and delays

Mission Bay Capital committed to fund up to $500,000 per company...The company plans to use proceeds to repurchase common stock and for general corporate purposes, including the repayment of outstanding commercial paper borrowings and upcoming debt maturities

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

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...The product is marketed by Genentech Inc., a member of the Basel, Switzerland-based Roche Group, and Astellas Pharma Inc., of Tokyo...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 other news, closed its initial public offering (IPO) of 3.5 million American depository shares (ADSs) at $8.90 per share...Operating expenses for the quarter increased to $128.1 million compared to $66.8 million for the first quarter of 2012, with Jazz citing high cost of product sales due to a change in product mix and lower gross margin due to inclusion of products from the EUSA Pharma acquisition...PM01183 is designed to bind covalently to the minor groove of DNA to induce a specific degradation

Even after the news broke Monday – and the Theravance share price (NASDAQ:THRX) gained more than 14 percent to hit $40 – the entire company was still only valued at $3.94 billion...Editor's note: To obtain a CD of the webinar, "Royalty Financing for Biotech and Medical Device Companies: How to Determine Eligibility and Take Advantage of this Unique Financing Opportunity" or for a deeper dive, BioWorld's Biopharmaceutical Royalty Rates Analysis: Essential Benchmarks for Dealmaking, call 800-477-6307

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

Even after the news broke Monday – and the Theravance share price (NASDAQ:THRX) gained more than 14 percent to hit $40 – the entire company was still only valued at $3.94 billion...Editor's note: To obtain a CD of the webinar, "Royalty Financing for Biotech and Medical Device Companies: How to Determine Eligibility and Take Advantage of this Unique Financing Opportunity" or for a deeper dive, BioWorld's Biopharmaceutical Royalty Rates Analysis: Essential Benchmarks for Dealmaking, call 800-477-6307

The big pharma said no agreement has been reached and it does not intend to issue further comments...We note that an acquisition of Warner could potentially offer a tax strategy as Warner has a lower tax rate

Acceleron Pharma Inc., of Cambridge, Mass., said preclinical research conducted by Acceleron scientists on the ACE-536 program were presented at the 12th International Symposium on Myelodysplastic Syndromes in Berlin...Zhejiang Beta Pharma will own 51 percent of it and Amgen will own the remaining 49 percent...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

turned its attention to other candidates in its pipeline...continue to view shares as undervalued based on the >$1B potential of ISIS-SMN-Rx, as well as the promise of ISIS-TTR-Rx and Isis' 20+ other pipeline candidates," he wrote...In other earnings news

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

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

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

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

Like plasma, Kcentra is used in conjunction with the administration of vitamin K to reverse the anticoagulation effect and stop the bleeding...NextBio, of Santa Clara, Calif., said it inked a multiyear collaboration with Paris-based Sanofi SA aimed at using NextBio Clinical to incorporate patient omics and clinical data into Sanofi's drug R&D, as part of the big pharma's Translational Medicine for Patients program

Addex Therapeutics SA, of Geneva, said regulatory authorities in the Netherlands gave approval to start in the first half of this year a Phase I study of ADX71441, a GABA-B receptor positive allosteric modulator, for Charcot-Marie-Tooth1A (CMT1A) neuropathy and other disease indications...for the Brisbane, Australia-based company's Diversity Scanning Array (DSA) and Versatile Assembly on Stable Templates (VAST) technologies in a deal worth up to $240 million in milestones, plus other payments