Merck: Regulatory Update on Cladribine Tablets
Merck KGaA announced that following feedback from regulatory authorities the company has decided to no longer pursue the global approval process of Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS). Based on discussions with the U.S. Food and Drug Administration (FDA) at the end-of-review meeting for the Cladribine Tablets new drug application, Merck believes that data from ongoing clinical trials are very unlikely to address the FDA requirements and will not provide a basis for approval. Overall the FDA feedback was consistent with the feedback previously received from the European Medicines Agency (EMA). 
Novo Nordisk is investing close to 1 billion Danish kroner (134 million euros) in a new factory in Kalundborg, Denmark, for the production of biopharmaceuticals such as haemophilia medicine, growth hormone and other current and future pharmaceuticals. The factory is expected to create 120–150 new jobs in Kalundborg over the next three years. The plans for the new factory have been underway since June of last year and were finally approved last week. Groundbreaking for the new factory will take place on 22 August. 
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that a pivotal Phase II study with vismodegib showed positive results in people with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate. Basal Cell Carcinoma is a form of skin cancer that can cause disfiguring and debilitating effects and can ultimately be life-threatening. Vismodegib is an investigational, oral medicine designed to selectively inhibit signalling in the Hedgehog pathway, which is implicated in more than 90 percent of BCC cases.[1] 
Novartis held a groundbreaking ceremony to announce the start of construction of a pharmaceutical manufacturing plant in St. Petersburg, Russia. The construction of this facility represents the most significant Novartis investment in Russia to date. This facility will further expand the company's capabilities to produce and deliver both innovative pharmaceuticals and high-quality generics to Russian patients. 
AstraZeneca announced today that it plans to establish a Predictive Science Centre in St. Petersburg over the coming year. The move strengthens AstraZeneca's investments in Russia and supports the Russian Government's strategy to modernise and develop the country's pharmaceutical sector. The new AstraZeneca Predictive Science Centre, the company's first in Russia, will leverage local scientific talent and focus on developing bioinformatics, data analysis methods, software and systems to better predict the safety and efficacy of potential new medicines. 
Bayer HealthCare and Regeneron Pharmaceuticals, Inc. announced that Bayer HealthCare has submitted an application for marketing authorization in Europe for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD). Bayer HealthCare and Regeneron are collaborating on the global development of VEGF Trap-Eye for the treatment of wet AMD, central retinal vein occlusion (CRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (mCNV). 
Pfizer Inc. is conducting the first-ever randomized clinical trial under an investigational new drug (IND) application that manages study participation entirely using electronic tools and allows patients to participate in the clinical trial regardless of their proximity to clinical sites. The pilot project, initiated following review from the U.S. Food and Drug Administration (FDA), uses mobile phone and web-based technology to collect necessary data for the trial without clinic visits.