It is unclear whether the potential issues leading to the European trial termination could impact timelines or the molecule's future development," RBC Capital Markets analyst Shibani Malhotra wrote in a research report...The news also adds to the growing fear that biosimilar drug development will prove trickier – and, perhaps costlier – than previously envisioned

That's all over now, and the handwriting was on the wall at the time of the recall, in the view of Christopher Raymond, analyst with Robert Baird & Co., who wrote in a research report that Omontys "appears to confer a 100-fold higher incidence of hypersensitivity and an 8.5-fold higher incidence of drug-related death," which were new data...PiperJaffray analyst Ian Somaiya pointed out in a research report Tuesday the "long road still facing the company before Omontys could potentially return to the

As Piper Jaffray analyst Ian Somaiya noted in a research report, "a safety setback of this magnitude early in the drug's launch could be challenging to recover from...Piper Jaffray's Somaiya said he estimates an incremental $300 million to $500 million per year in Epogen sales through 2016, and noted that the Omontys setback could keep other potential ESA competitors at bay...We believe the recall makes it less likely that dialysis centers and physicians will be inclined to try other ESA agents

plc to the blockbuster multiple sclerosis (MS) therapy Tysabri (natalizumab) didn't take long for analysts to applaud, though Wall Street traders spent time digesting the $3.25 billion deal, which includes contingent payments...In a research report, Yee wrote that "although $3.25 billion is a large chunk of cash, even for Biogen, and forgoes other business development opportunities for now, we view this as overall positive for the strong accretion...As others took the opportunity to note, Biogen's

plc to the blockbuster multiple sclerosis (MS) therapy Tysabri (natalizumab) didn't take long for analysts to applaud, though Wall Street traders spent time digesting the $3.25 billion deal, which includes contingent payments...In a research report, Yee wrote that "although $3.25 billion is a large chunk of cash, even for Biogen, and forgoes other business development opportunities for now, we view this as overall positive for the strong accretion...As others took the opportunity to note, Biogen's

Peregrine added that the discrepancies are specific to the Phase IIb trial and should not affect any other studies testing bavituximab, a phosphatidylserine-targeting monoclonal antibody...The news is a huge blow to Peregerine, which had been trading under $1 and facing a Nasdaq delisting at the start of summer before excitement began generating for bavituximab, culminating in a presentation at the Chicago Multidisciplinary Symposium in Thoracic Oncology earlier this month showing a statistically

The IQWiG assessment is only the first step to negotiating a drug's pricing in the European Union (EU) but Deutsche Bank analyst Robyn Karnauskas noted in a research report that it "could impact reimbursement in Germany, which could in turn impact reimbursement in the EU, since other EU nations use Germany as a reference

Revenues from other products were $28 million, compared to $13 million in the first quarter of 2011, while royalties were $29 million – a 13 percent increase over the same period last year...The humanized monoclonal antibody is expected to initiate a Phase II study by midyear in idiopathic pulmonary fibrosis. (See BioWorld Today, Feb. 15, 2012.) In other earnings news

Ltd., though Piper Jaffray analyst Ian Somaiya noted in a research report that the new agreement may be terminated at any time, and "Amgen likely had to increase the rate of discounts and rebates" since Epogen loses exclusivity in 2014

Ltd., the technology transfer arm of Hebrew University, to develop and commercialize BL-7040, a Phase II product for inflammatory bowel disease and other inflammatory diseases...In other news, Medivir signed an agreement with Daewoong Pharmaceutical Co...Other studies showed Victoza (liraglutide), a once-daily GLP-1 analogue for the treatment of Type II diabetes, could safely be added to insulin treatment and helped patients reach the ADA's HbA1C target, and that Victoza helped more patients achieve

Analyst Robyn Karnauskas, of Deutsche Bank, wrote in a research report that the label change should lead patients who are JCV-positive to discontinue treatment, but it should also help boost the number of JCV-negative patients taking Tysabri as well as lengthen their duration of treatment...Its shares will continue to be listed on the Toronto Stock Exchange...Ligand said it expects to report full results of a Phase II study in the fourth quarter, with a pivotal study targeted to begin by early 2012

Assistant Managing Editor After a three-day weekend to digest the news of Optimer Pharmaceuticals Inc.'s approval for macrolide antibiotic Dificid (fidaxomicin), investors jumped on the San Diego-based firm's stock (NASDAQ:OPTR) Tuesday, which, trading at seven times its average volume, gained $1.53, or 11.8 percent, to close at $14.51...Jefferies analyst Eun K. Yang wrote in a research note that existing cash could carry the company to profitability in 2014

Other soldiers get left at base camps to recover, which can take three days...To be fair, the company is developing human neural stem cells as a platform to treat other, less rare (though still qualifying as rare) diseases...Prize An astute reader forwarded the news that Johnson & Johnson admitted to bribing doctors in Greece, Poland and Romania and paying kickbacks in Iraq under the infamous UN "oil for food" program

The news sent shares of Biogen (NASDAQ:BIIB) up $5.26, to close Monday at $78.55...Based on other studies showing similar "p" values, Leerink Swann analyst Joshua Schimmer estimated an annualized relapse rate for BG-12 of "at least close to 35 percent," which would put it on par with other oral MS drugs, as well as the ABCR injectable or infused therapies: Biogen's Avonex (interferon beta-1a), Bayer AG's Betaseron (interferon beta-1b), Teva's Copaxone and EMD Serono Inc.'s Rebif (interferon beta-1a

Assistant Managing Editor Less than a month away from FDA advisory panels on hepatitis C virus (HCV) candidates telaprevir and boceprevir, the two protease inhibitors met up again at the European Association for the Study of the Liver meeting in Berlin, as analysts continued trying to figure out which one will have an edge over the other in the marketplace...Those analyses "continued to demonstrate telaprevir's advantages," Wells Fargo analyst Brian Abrahams wrote in a research note...Since both

As it relates to the approvability of ruxolitinib," Aschoff wrote in a March 16 note, "the argument about anemia and any relation of it to survival is overblown...Meanwhile, Roy said he believes Incyte should continue to invest in expanding potential indications for ruxolitinib outside of myelofibrosis, including other myeloproliferative disorders such as polycythemia vera (PV) and essential thrombocythemia (ET), and psoriasis

However, we believe that the recent attention drawn to cardiovascular safety profiles of other therapies for Type II diabetes" might have prompted "additional emphasis on the value" of a QTc study, Daniel Bradbury, Amylin's president and CEO, told investors on a late Tuesday conference call...allows competitors such as GSK/HGSI's Syncria to gain ground," Leerink Swann analyst Joshua Schimmer noted in a research report...wholly owned once-weekly GLP-1 begin to converge," analyst Thomas Russo, of Robert

Acorda plans to start Phase I studies in heart failure patients and is pursuing GGF2 in other cardiac and neurological applications...A blood-brain barrier research report from the University of British Columbia, in Vancouver, showed that p97, a delivery technology for neuroscience therapeutics being developed by biOasis Technologies Inc., crossed the blood-brain barrier more readily and to a greater degree than anti-amyloid and beta IgG...Phosphagenics plans to reformulate the oral compound into a

handed back rights to a midstage antibody program licensed from AVEO Pharmaceuticals Inc. — citing a shift in priorities in the wake of last year's mega-merger with Schering-Plough Corp. — the news had an unusual effect on the Cambridge, Mass.-based firm's stock...And, as last year's mega mergers continue to shake out and other big pharma firms focus efforts on building up near-term pipelines ahead of the patent cliff, there's little doubt the industry will see more projects handed back to biotechs