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Enlivex Harnessing Apoptosis as a New Approach in GVHD
Several decades ago, scientists recognized that triggering the series of biochemical events that lead to changes in cell morphology, and ultimately cell death, could be applied in a therapeutic fashion, along with the clearance of apoptotic cells, which is essential to regulate inflammation and maintain immunotolerance. Since then, biotechs have used a variety of mechanisms to harness the process of apoptosis, or programmed cell death, in drug development. Enlivex Therapeutics Ltd. is focusingBy Marie Powers | BioWorld Today | Thursday, May 30, 2013 -
Volume of Industry Deal Making Will Continue its Robust Pace
While partnering strategies can provide access to essential products and technology, mergers and acquisitions can achieve the same goals and also provide greater leverage and control of the acquired assets. With a wide variety of biotech companies that have promising candidate products in late-stage clinical trials, and pharma companies still needing to tweak their product portfolios, the expectation is that the next big pharma acquisition of a biotech company is only just around the cornerBy Peter Winter | BioWorld Today | Thursday, May 30, 2013 -
Stock Movers
BioWorld Today | Thursday, May 30, 2013 -
Clinic Roundup
Euthymics Bioscience Inc., of Cambridge, Mass., reported top-line results from TRIADE (Triple Reuptake Inhibitor Anti-Depressant Effects), a Phase IIb/IIIa study designed to assess the safety and efficacy of amitifadine, a serotonin-preferring triple reuptake inhibitor antidepressant, in patients with major depressive disorder (MDD) failing to respond to one course of first-line antidepressants. Amitifadine efficacy at 50-mg or 100-mg doses did not show a statistically significant differenceBioWorld Today | Thursday, May 30, 2013 -
Pharma: Other News To Note
Bayer AG, of Leverkusen, Germany, said it has gained antitrust clearance from the U.S. Federal Trade Commission for the $1.1 billion acquisition of contraceptive device maker Conceptus Inc., of Mountain View, Calif. Janssen Inc., of Toronto, reported that Health Canada has approved the once-daily, oral medication Zytiga (abiraterone acetate) for use in combination with prednisone to treat metastatic castration-resistant prostate cancer in patients who are asymptomatic or mildly symptomaticBioWorld Today | Thursday, May 30, 2013 -
Other News To Note
Alethia Biotherapeutics Inc., of Montreal, partnered with International Biotechnology Center Generium to develop cancer therapy AB-16B5. The companies will collaborate on development of the product. When the initial clinical study is complete, they will share equally in profits in territories outside Russia and the Commonwealth of Independent States (CIS). Alethia will receive an up-front payment and research and development funding for the initial study, and milestones and royalties for RussiaBioWorld Today | Thursday, May 30, 2013 -
Financings Roundup
NPS Pharmaceuticals Inc., of Bedminster, N.J., closed a public offering of 6.9 million shares of common stock at $14.53 per share; 900,000 of the shares were sold pursuant to the underwriters' exercise of an overallotment option. Net proceeds were $93.4 million. J.P. Morgan Securities LLC and Morgan Stanley and Co. LLC were joint book-running managers for the offering. Canaccord Genuity Inc. and Leerink Swann LLC were lead co-managers. Oppenheimer and Co. Inc. and Wedbush PacGrow Life SciencesBioWorld Today | Thursday, May 30, 2013 -
Pharma: Clinic Roundup
Eli Lilly and Co., of Indianapolis, reported new data showing that Forteo significantly increased lumbar spine volumetric bone mineral density (vBMD) compared to risedronate in men with glucocorticoid-induced osteoporosis. Glucocorticoid-induced osteoporosis is caused by excess intake of glucocorticoids, a class of steroid hormones used to treat inflammatory, autoimmune and allergic disorders. Study results are published in the June 2013 issue of the Journal of Bone and Mineral ResearchBioWorld Today | Thursday, May 30, 2013 -
Trino Raises $12M for Indane Dimers in Ulcerative Colitis
DUBLIN, Ireland – Trino Therapeutics Ltd., a spinout from Trinity College Dublin (TCD), raised €9 million (US$11.6 million) in a Series A round to move PH46A, an oral, first-in-class indane dimer, into clinical trials in ulcerative colitis. The round was led by Dublin-based Fountain Healthcare Partners and the Wellcome Trust, a founding investor, which is funding the company through an equity-based Strategic Translation Award. Trino was founded in 2011 by two TCD scientists – pharmacologistBy Cormac Sheridan | BioWorld Today | Wednesday, May 29, 2013 -
Omthera Fish-Oil Drug Hooks AstraZeneca in $323M Buyout
AstraZeneca plc's planned buyout of Omthera Pharmaceuticals Inc. to gain Phase III-validated Epanova, the anti-triglyceride therapy based on ultra-pure fish oil, puts the firm at a "distinct commercial advantage" over Amarin Corp. plc, with its recently launched Vascepa (icosapent ethyl), said Decision Resources (DR) analyst Paramjit Narang. Agreeing to pay $12.70 per share for Omthera, London-based AstraZeneca pledges more potential upside that could value the deal as high as $443 million. TheBy Randy Osborne | BioWorld Today | Wednesday, May 29, 2013 -
Pharma: Other News To Note
Grunenthal Group, of Aachen, Germany, entered a licensing agreement with Purdue Pharma LP, of Stamford, Conn., regarding certain intellectual property rights for the development of an abuse-deterrent formulation technology for extended-release morphine sulfate. Specific financial terms were not disclosed. Valeant Pharmaceuticals International Inc., of Laval, Quebec, and Bausch & Lomb Holdings Inc., of Rochester, N.Y., entered a definitive agreement under which Valeant will acquire BauschBioWorld Today | Wednesday, May 29, 2013 -
Prosensa Leads More Biotechs into IPO Parade
The sizzling initial public offering (IPO) market gained two more biopharma contestants with a third moving carefully toward it, as Prosensa Therapeutics BV filed an F-1 registration statement, Evoke Pharma Inc. filed an S-1 and Oculus Innovative Sciences Inc. disclosed that subsidiary Ruthigen Inc. submitted a confidential draft registration statement to the SEC. Prosensa is seeking to raise up to $60 million and a listing on Nasdaq under the symbol "RNA." Evoke, a specialty pharma developingBy Marie Powers | BioWorld Today | Wednesday, May 29, 2013 -
Stock Movers
BioWorld Today | Wednesday, May 29, 2013 -
Clinical Failures Mark End for Agennix, Phytopharm
LONDON – Two of Europe's longest-standing public biotechs are leaving the stage following clinical trial failures, with Agennix AG going into liquidation and Phytopharm plc announcing a reverse merger. Agennix has been looking for a path forward since the bust in August 2012, when it reported negative results for the 742-patient Fortis-M Phase III trial of lead product Talactoferrin alfa in treating advanced non-small-cell lung cancer. The result was unequivocal, with median overall survival ofBy Nuala Moran | BioWorld Today | Wednesday, May 29, 2013 -
Clinic Roundup
Alkermes plc, of Dublin, Ireland, reported Phase I data showing that ALKS 3831, a drug candidate for treating schizophrenia, produced significantly less weight gain in subjects compared to olanzapine. ALKS 3831 combines olanzapine with the company's opioid modulator, ALKS 33, to treat schizophrenia without the associated weight gain usually seen with olanzapine treatment. Data showed the drug also was found to be safe and well tolerated. Those results were presented at the New Clinical DrugBioWorld Today | Wednesday, May 29, 2013 -
Pharma: Clinic Roundup
Ferring Pharmaceuticals SA, of Saint Prex, Switzerland, reported data from the EXPEDITE study at the First European Congress on Intrapartum Care in Amsterdam, the Netherlands, which demonstrated that use of a controlled-release misoprostol vaginal insert significantly reduced time (21.5 hours vs. 32.8 hours) to vaginal delivery compared to a dinoprostone vaginal insert. Misoprostol is a synthetic prostaglandin E1 analogue used for labor induction. The EXPEDITE study compared the efficacy andBioWorld Today | Wednesday, May 29, 2013 -
Other News To Note
Addex Therapeutics SA, of Geneva, is evaluating steps to reduce its operating costs and work force to conserve cash while ADX71149, its mGluR2 positive allosteric modulator, is being developed through a partnership with Janssen Pharmaceuticals Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson. The compound is in clinical development, funded by Janssen, for schizophrenia and anxious depression. In accordance with Swiss law, Addex has initiated a consultation process to determine itsBioWorld Today | Wednesday, May 29, 2013 -
Ophthotech Raises $175M for Solo Run in Phase III
At a time when a majority of biotech companies are partnering up with big pharma for Phase III trials, Ophthotech Corp., of Princeton, N.J., is building a war chest to go it alone. The company raised $175 million to support a global Phase III program for Fovista, an antiplatelet-derived growth factor (anti-PDGF) agent, in combination with anti-VEGF therapy for age-related macular degeneration (AMD). The $175 million breaks down into $125 million from Novo A/S, in exchange for royalties onBy Catherine Shaffer | BioWorld Today | Wednesday, May 29, 2013 -
Taking a Hollywood Cue, Will Congress Remake a Classic?
Revamping Medicare Part D, for some people, would be the health care equivalent of remaking Gone with the Wind. Some classics just shouldn't be messed with, they reason. When it comes to government programs, Part D, which covers prescription drug costs, is a classic. The long-running blockbuster hit boasts 90 percent participation and a 94 percent approval rating. And its costs continue to come in at 45 percent under budget. But despite its successful run of nearly a decade, Part D could be inBy Mari Serebrov | BioWorld Today | Wednesday, May 29, 2013 -
ImmuPharma Restarts Lupus Work; $76M Loan for Phase III
LONDON – Following an 18-month hiatus, ImmuPharma plc can now proceed with Phase III development of its lupus treatment, Lupuzor, after agreeing to a £50 million (US$75.7 million) loan to finance the trial. The product has been stalled since October 2011 when ImmuPharma took back rights following the acquisition of its partner Cephalon Inc. by Teva Pharmaceutical Industries Ltd. At that point, the London-based company expected it would rapidly find another partner and said it would not do anyBy Nuala Moran | BioWorld Today | Wednesday, May 29, 2013
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