The label now carries a boxed warning, advising patients that discontinuing treatment puts them at increased risk of stroke, and the postmarketing experience section was updated to include thrombocytopenia...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

Merck will continue to retain rights to its existing portfolio of sitagliptin-containing products...The first suit pertains to a previously disclosed investigation into discounts and rebates to specialty pharmacies for Myfortic

Novartis has worldwide rights to the drug, along with certain backup compounds in all indications, with Incyte retaining a co-development option to INC280 in the U.S...Due to third-party manufacturing issues, distribution of Janssen Products LP's Caelyx in Europe has been intermittently disrupted since 2011

Pfizer Inc., of New York, said the European Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion for Xeljanz (tofacitnib citrate) for the treatment of adults with moderate to severe active rheumatoid arthritis...Pfizer intends to appeal the opinion and seek a re-examination by CHMP

BioMarin Pharmaceutical Inc., of San Rafael, Calif., said it submitted a marketing authorization application to the European Medicines Agency for Vimizim (BMN-110, elosulfase alfa), an enzyme replacement therapy for patients with rare lysosomal storage disorder mucopolysaccharidosis Type IVA, also called Morquio A syndrome

It does not bind to blood coagulation factors or other blood proteins...The acquisition had been expected to be completed on Thursday, making Obagi a wholly owned subsidiary of Valeant

flutemetamol to help select patients for a Phase I trial testing Eisai's E2609, a BACE inhibitor for the potential treatment of Alzheimer's disease...Lambrolizumab is Merck's investigational antibody therapy targeting programmed death receptor that is currently being evaluated for the treatment of patients with advanced melanoma, and other tumor types...The Antimonopoly Committee of Ukraine gave approval to Valeant Pharmaceuticals International Inc., of Laval, Quebec, for its proposed acquisition of

Addex Therapeutics SA, of Geneva, reported preclinical data showing that its mGlu5 negative allosteric modulator oral small molecule, dipraglurant, dose-dependently prevented the abnormal excitatory effect observed on brain slices of transgenic primary generalized torsion dystonia 1 (DYT1) mice overexpressing the human mutant TOR1A gene by decreasing the paradoxical neuronal activity induced by the dopamine D2 receptor agonist quinpirole. DYT1 is a common and severe genetic form of dystonia

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...to conduct a review of merger and acquisition opportunities. (See BioWorld Today, Feb. 1, 2013...It expects to launch the product in Canada, and a number of Central American, South American and Asian countries in 2014 and 2015

BD Rx Inc., of Franklin Lakes, N.J., a wholly owned subsidiary of Becton, Dickinson and Co., reported that the FDA has approved its metoclopramide injection, the second drug to be offered in the recently launched BD Simplist line of prefilled generic injectables...The drug is in Phase III trials as an adjunctive therapy to levodopa...The two companies will collaborate on additional hit-to-lead and lead optimization for two new molecules, with the work taking place at AMRI's laboratories

Inc., of Whitehouse Station, N.J., entered into a nonexclusive deal with Bristol-Myers Squibb Co., of New York, to conduct a Phase II trial of a once-daily oral combination regimen consisting of BMS' NS5A replication complex inhibitor daclatasvir and Merck's NS3/4A protease inhibitor MK-5172 to treat chronic hepatitis C virus infection genotype 1

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

resulting in an estimated 20 percent increase in EMD Serono's employee base from last July to the end of 2014

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

to begin a Phase IIa trial of BL-8040, a selective antagonist of chemokine receptor CXCR4, in acute myeloid leukemia (AML...According to the terms, Shasun will be able to use the Debiopharm technology to manufacture synthetic Huperzine-A under GMP quality conditions and commercialize it in pharmaceutical and nutraceutical markets...In other news, GSK experienced manufacturing delays for manufacture and supply of Horizant (gabapentin enacarbil), partnered with XenoPort Inc., of Santa Clara, Calif

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