India and the European Union are taking steps to end a trade row sparked by an EU ban on Indian pharmaceutical products that New Delhi responded to by cancelling talks on a free trade accord with its largest trading partner, officials said. Indian Prime Minister Narendra Modi’s office wrote to the E.U. Trade Commissioner to […]

Redwood City, Calif.-based Relypsa Inc. (RLYP) announced yesterday that it had signed a two-year detailing deal with Sanofi for the commercialization of a kidney disease drug. It also announced today an exclusive partnership with St. Gallen, Switzerland-based Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP) for the same drug in Europe and additional territories.   […]

U.S. drugmaker Pfizer (PFE.N) gained European Union antitrust approval on Tuesday for its proposed $15 billion acquisition of U.S. rival Hospira (HSP.N) after pledging to sell some drugs to allay competition concerns. “The approval is conditional on Pfizer divesting certain sterile injectable drugs, as well as its infliximab biosimilar drug, which is currently under development,” […]

LAVAL, QUEBEC–(Marketwired – Aug. 4, 2015) – ProMetic Life Sciences Inc. (TSX:PLI)(OTCQX:PFSCF), (“ProMetic” or the “Corporation”) announced today that an orphan drug designation status has been granted for its human plasma derived plasminogen drug by the European Commission for the treatment of plasminogen deficiency. ProMetic is currently investigating the safety, tolerability and pharmacokinetics of its […]

OSAKA, Japan, July 30, 2015 /PRNewswire/ — Takeda Pharmaceutical Company Limited (“Takeda”) today announced the completion of the study to fulfill the post-marketing commitment and submissions of data to regulatory authorities from the Pan European Multi-Database Bladder Cancer Risk Characterization Study, a large (n= 112,674), multi-database retrospective matched cohort study, conducted in four European countries, for […]

Sunesis Pharmaceuticals Inc said the U.S. Food and Drug Administration called for more clinical evidence before considering approval for its cancer drug, sending the company’s shares down 60 percent in after-market trading. The drug, vosaroxin, failed a late-stage trial in October as it did not significantly improve the overall survival of patients compared with a […]

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for grazoprevir/elbasvir (100mg/50mg), an investigational, once-daily, single-tablet combination therapy for the treatment of adult patients with chronic hepatitis C (HCV) genotypes (GT) 1, 3, 4 or […]

Sanofi and Regeneron’s new cholesterol drug Praluent could be recommended for approval in Europe as early as this week, along with the world’s first malaria vaccine from GlaxoSmithKline. A European green light for Praluent would put the closely watched so-called PCSK9 drug two months behind Amgen’s rival product Repatha, which was formally approved by the […]

Amgen Inc’s cholesterol fighting drug was approved by the European Commission, giving the keenly anticipated treatment a head start over a rival drug being developed by Regeneron Pharmaceuticals Inc and Sanofi SA. This is the first approval by any regulator for PCSK9 inhibitors, a new class of biologic drugs that are injected. They are expected […]

The European Commission approval is based upon Phase III clinical trial – Reyataz®(atazanavir) and cobicistat combination demonstrated virologic failure rates as low as 6% at 48 weeks and 8% at 144 weeks [HIV-1 RNA ≥50 copies/mL: 6% Reyataz/cobicistat arm and 4% Reyataz/ritonavir arm at 48 weeks; 8% Reyataz/cobicistat arm and 5% Reyataz/ritonavir arm at 144 […]