Celltrion said it plans to submit the study application in the first half of this year, he added, which could allow for the trial to start in the second of this year...To date, Celltrion and Hospira have identified only two products from the alliance – Remsima, a biosimilar version of autoimmune drug Remicade (infliximab, Johnson & Johnson), which won approval as the first biosimilar monoclonal antibody last year in Korea, and a biosimilar version of breast cancer drug Herceptin (trastuzumab, Roche
headquarters in Plainsboro, N.J. The building is part of a $225 million public/private redevelopment project, which used an existing structure and sustainable materials to limit environmental impact
Addex said it plans to start a Phase IIa study of dipraglurant in a rare dystonia indication in the first half of this year...OPKO also said it is partnering with Pharmsynthez to develop and market several OPKO products for sale in Russia and certain other Eastern European countries...The assets are to be acquired in exchange for the satisfaction and discharge of $15 million outstanding under the secured notes
Eli Lilly and Co., of Indianapolis, said it acquired two positron emission tomography tracers from Siemens Medical Solutions intended to image tau tangles in the brain, one of two known hallmarks of Alzheimer's disease
Eddingpharm, of Hong Kong, said it inked a joint venture (JV) agreement with Chiesi Farmaceutici SpA, of Parma, Italy, to establish Chiesi Edding Hong Kong Ltd...The JV is controlled 51 percent by Eddingpharm and 49 percent by Chiesi and will leverage Eddingpharm's marketing platform to facilitate wide and quick commercialization of key products of Chiesi in the respiratory therapeutic area in China
Merck KGgA, of Darmstadt, Germany, reported that a collaboration agreement between its subsidiary, EMD Serono Inc., and Pfizer Inc., of New York, inked in July 2002 for the co-promotion of multiple sclerosis drug Rebif (interferon beta-1a) extends until Dec. 31, 2015, according to an appellate court ruling...EMD Serono had contended that the collaboration should end on Dec. 31, 2013, and has asked the court to reconsider its ruling...In separate news, Merck Serono SA, of Geneva, a division of Merck
According to Epivax Inc., of Providence, R.I., the new H7N9 flu virus has serious potential for rapid expansion on a global scale...To date, 60 people have been confirmed infected with H7N9 in China, with 13 deaths...The DSMB met every six months to review safety data from the trials, and will not now meet again until the data is locked and unblinded for a final assessment
Bristol-Myers Squibb Co., of New York, will invest $250 million to expand its large-scale biologics manufacturing facility in Devens, Mass., introducing biologics development and clinical trial manufacturing capabilities and adding about 350 employees...Work is expected to begin in late 2013
In the most recent action in the case, the mass torts law firm of Watts Guerra LLP, of San Antonio, has filed a motion to consolidate the incretins litigation nationally...Boehringer Ingelheim GmbH, of Ingelheim, Germany, is the target of a proposed national class-action lawsuit by the Toronto law firm of McPhadden Samac Tuovi LLP, relating to the blood thinner Pradax (dabigatran etexilate...Pradax is used to prevent clotting in patients who suffer from atrial fibrillation
Merck currently markets Noxafil oral suspension for prophylaxis of invasive Aspergillus and Candida infections in patients, 13 and older, at high risk of developing those infections due to being severely immunocompromised...PeptiDream Inc., of Tokyo, and Ipsen SA, of Paris, entered a research collaboration and license option agreement to discover, evaluate, potentially develop and launch therapeutic peptides to treat serious medical conditions in areas of therapeutic focus for Ipsen
The drug is expected to be available by the end of May...GlaxoSmithKline plc, of London, and A*STAR's Institute of Chemical and Engineering Sciences, of Singapore, signed a five-year agreement to develop new evidence-based formulations (EBFs) specifically for emerging markets...EBFs are medicines reformulated to provide additional patient benefit
AB103, a rationally designed short peptide designed to modulate the host's inflammatory response through binding to the CD28 dimmer interface, has orphan and fast-track status in the U.S...The company expects to see results from by late summer...The firms will aim to offer pharma and biotech companies a set of fully integrated nuclear receptor drug discovery capabilities by combining expertise in structural biology, medicinal chemistry, biology, DMPK, pharmacology and safety
In other news, Prana reported that it received a A$2.5 million (US$2.6 million) cash refund under the R&D Tax Incentive Program...The refund was received to support research and clinical development of PBT2 for Huntington's and Alzheimer's diseases, as well as for other Prana research activities into Parkinson's disease and other neurological indications
BioWorld International | Wednesday, April 10, 2013
Mallinckrodt International Finance SA (MIFSA), a wholly owned subsidiary of Covidien plc, of Dublin, Ireland, will become a wholly owned subsidiary of Mallinckrodt plc when Covidien's pharmaceuticals operation is separated from the company's other businesses, and said it plans a private offer of up to $900 million of senior unsecured notes...Subject to shareholder approval, at closing NovaDel will receive $400,000 in cash, 50 million shares of Suda common stock and 10 million options to purchase
Anacor also will create an expanded library of boron compounds to screen for additional potential drug candidates to treat neglected diseases and will provide access to the expanded library to the Gates Foundation and others, including academic, governmental and other nonprofit institutions or equivalent entities...The spinout is intended to split the clinical RVX-208 program from the epigenetics platform to create distinct corporate environments so Resverlogix is structurally ready for acquisition
Valeant has granted Actavis the exclusive right to co-promote Zovirax cream to obstetricians and gynecologists in the U.S., and Actavis has granted Valeant the exclusive right to co-promote Actavis Specialty Brands' Cordran Tape (flurandrenolide) product in the U.S...and, Kayexalate is prescribed to remove dangerously high levels of potassium in the blood
Covis Pharma Sarl, of Zug, Switzerland, inked a deal with affiliates of Paris-based Sanofi SA to acquire full commercial rights to Nilandron (nilutamide), Plaquenil (hydroxychloroquine), Rilutek (riluzole), Uroxatral (alfuzosin hydrochloride) and Kayexalate (sodium polystyrene sulfate) in the U.S. Sanofi will retain rights to the products outside of the U.S. Financial terms were not disclosed
ImmunoGen Inc., of Waltham, Mass., and Novartis AG, of Basel, Switzerland, amended their multitarget agreement inked in October 2010, allowing Novartis to take a license to develop and commercialize products directed at two pre-defined and related undisclosed targets – one licensed on an exclusive basis and the other on a nonexclusive basis...The refund was received to support research and clinical development of PBT2 for Huntington's and Alzheimer's diseases, as well as for other Prana research
Celltrion said it plans to submit the study application in the first half of this year, he added, which could allow for the trial to start in the second of this year...To date, Celltrion and Hospira have identified only two products from the alliance – Remsima, a biosimilar version of autoimmune drug Remicade (infliximab, Johnson & Johnson), which won approval as the first biosimilar monoclonal antibody last year in Korea, and a biosimilar version of breast cancer drug Herceptin (trastuzumab, Roche