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News Breaks
March 7, 2014
14:18 EDTREGN, SNY, AMGN, PFE, NVS, RHHBYConcerns with PCSK9 class not seen with Regeneron drug, says Citigroup
Citigroup said its talks with Regeneron (REGN) indicate that the issues the FDA has noted with PCSK9 drugs have not arisen in the ongoing Phase 3 studies of Regeneron and Sanofi's (SNY) Alirocumab. Citi suspects the events described in filings by Regeneron and Sanofi might have been seen with PCSK9 inhibitors being developed by Amgen (AMGN), Pfizer (PFE), Novartis (NVS) or Roche (RHHBY). Citi also notes that neurocognitive side effects are known to be caused by statins and it is unclear whether the effects were seen with PCSK9 inhibitors when used alone or when combined with statins.
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October 16, 2014
14:47 EDTRHHBYRoche in pact with Pharmacyclics to evaluate Imbruvica, Gazyva combo
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13:13 EDTRHHBYRoche considers submitting Ebola test for emergency use approval, WSJ says
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09:35 EDTRHHBYDiplomat announces contract to distribute Esbriet
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08:38 EDTPFEBaxter expects divestiture of vaccines business to Pfizer to close in Q4
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08:36 EDTREGNRegeneron Genetics Center announces new collaborations and appointments
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08:19 EDTSNYSanofi Pasteur, Immune Design enter collaboration HSV therapy
Immune Design (IMDZ) announced that it has entered into a broad collaboration for the development of a herpes simplex virus, or HSV, immune therapy with Sanofi Pasteur, the vaccines division of Sanofi (SNY). Sanofi Pasteur and Immune Design will each contribute product candidates to the collaboration: Sanofi Pasteur will contribute HSV-529, a clinical-stage replication-defective HSV vaccine product candidate, and Immune Design will contribute G103, its preclinical trivalent vaccine product candidate. The collaboration will explore the potential of various combinations of agents, including leveraging Immune Design's GLAASTM platform, with the goal to select the best potential immune therapy for patients. The two companies will develop the products jointly through Phase 2 clinical trials, at which point Sanofi Pasteur intends to continue development of the most promising candidate and be responsible for commercialization. Sanofi Pasteur will bear the costs of all preclinical and clinical development, with Immune Design providing a specific formulation of GLA from the GLAAS platform at its cost through Phase 2 studies. Immune Design will be eligible to receive future milestone and royalty payments on any product developed from the collaboration; other financial terms of the agreement have not been disclosed.
08:08 EDTPFEActavis confirms generic Quillivant XR patent challenge
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07:28 EDTPFEFDA to hold a joint advisory committee meeting on Chantix
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05:58 EDTRHHBYRoche sees FY14 core EPS targeted to grow ahead of sales
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05:56 EDTRHHBYRoche reports 9 month revenue CHF34.76B vs. CHF34.87B last year
Roche CEO Severin Schwan said: “Demand for our products is strong in both divisions and we are well on track to reach our full-year targets. We have had positive news from our product pipeline, including study results for Perjeta in breast cancer and a new combination therapy with Zelboraf in melanoma. The InterMune acquisition has also strengthened our portfolio with a new medicine, Esbriet for idiopathic pulmonary fibrosis, which has now been approved by the FDA. In Diagnostics, growth continues to be driven by the immunodiagnostics business and we have strengthened our molecular diagnostics portfolio with a new generation of testing systems.”
October 15, 2014
17:03 EDTNVSNovartis announces CTL019 data demonstrating efficacy in certain ALL patients
Novartis and the University of Pennsylvania's Perelman School of Medicine announced preliminary results from two pilot clinical trials published in The New England Journal of Medicine, or NEJM, evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia, or r/r ALL. The studies, conducted by Penn, demonstrated that 27 of 30 pediatric and adult patients, or 90%, experienced complete remissions with the investigational chimeric antigen receptor, or CAR, therapy CTL019. Largest published cohort to date for CTL019, which served as the basis for recent Breakthrough Therapy designation from the FDA. Sustained remissions of up to two years in r/r ALL patients with six-month event-free survival of 67% and overall survival of 78%.
15:45 EDTRHHBYFDA approves Esbriet to treat idiopathic pulmonary fibrosis
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15:00 EDTPFEShire-Allergan, AbbVie-Pfizer deals possible if merger scrapped, Bloomberg says
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10:02 EDTSNYOn The Fly: Analyst Upgrade Summary
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07:29 EDTSNYSelecta, JDRF, Sanofi extend collaboration for SVP immunotherapy
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05:26 EDTSNYSanofi upgraded to Outperform from Neutral at Credit Suisse
October 14, 2014
11:23 EDTRHHBY, NVS, PFE, SNY, AMGNBIND Therapeutics and The Conference Forum hold a conference
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09:00 EDTSNYSanofi rotavirus vaccine enters Phase III trials in India
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08:08 EDTSNYRegulus Therapeutics to present new preclinical data on multiple programs
Regulus Therapeutics (RGLS) announced that it will present new preclinical data on multiple programs and an overview of its clinical portfolio at the 10th Annual Oligonucleotide Therapeutics Society meeting being held October 12-October 15 at the Hilton San Diego Resort and Spa. In a poster titled "Anti-Diabetic Activity of miR-103/107 Anti-miRs", Regulus scientists will present preclinical data further demonstrating the potential benefit of a microRNA therapeutic for the treatment of metabolic disorders. In a poster titled "Inhibition of miR-21 with RG-012 Improves Renal Function and Survival in Multiple Strains of Col4A3 Deficient Mice", Regulus scientists, in collaboration with its strategic alliance partner Sanofi (SNY), will present new preclinical data demonstrating that weekly subcutaneous delivery of RG-012 has shown to provide both glomerular and tubule protection in the kidneys of Col4A3 deficient mice in an Alport syndrome model.
October 13, 2014
08:01 EDTPFEPfizer announces FDA acceptance of Palbociclib NDA with priority review
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