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

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

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

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

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

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

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

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

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

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

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

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