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Stock Market & Financial Investment News

News Breaks
February 28, 2014
08:03 EDTACT, SNYActavis confirms generic Multaq patent challenge
Actavis (ACT) confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval to market Dronedarone Hydrochloride Tablets 400 mg. Actavis' ANDA product is a generic version of Sanofi's (SNY) Multaq, which is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent AF. Sanofi and Sanofi-Aventis U.S. filed suit against Actavis on February 26 in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA until Jan. 1, 2017, or final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
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October 20, 2014
06:28 EDTACTAllergan price target raised to $210 from $190 at Citigroup
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October 17, 2014
09:47 EDTACTValeant will not raise Allergan bid ahead of record date, CNBC reports
Valeant (VRX) will not raise its hostile takeover bid for Allergan (AGN) ahead of the record date for the vote, CNBC's David Faber reports. Allergan (AGN) is not currently in takeover talks with Actavis (ACT), Faber added.
09:45 EDTACTAllergan not in deal talks with Actavis, CNBC reports
09:06 EDTSNYAmgen files patent infringement lawsuit against Sanofi, Regeneron
Amgen (AMGN) announced that it filed a lawsuit in the United States District Court of Delaware against Sanofi (SNY), Aventisub, formerly doing business as Aventis Pharmaceuticals, and Regeneron Pharmaceuticals (REGN) for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. These patents, which are owned by Amgen, describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, or PCSK9. By its complaint, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron's alirocumab, a monoclonal antibody targeting PCSK9. Sanofi and Regeneron recently announced that they have completed Phase 3 clinical trials on alirocumab and intend to pursue regulatory approval to market alirocumab in the U.S. Amgen previously announced submission of a Biologics License Application to the FDA for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on Aug. 28.
October 16, 2014
17:27 EDTACTNoven files patent infringement suit against Actavis
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15:10 EDTACTAmerican College of Gastroenterology to hold annual meeting
ACG Annual Scientific Meeting 2014 to be held in Philadlephia, PA on October 17-22.
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 EDTACTActavis confirms generic Quillivant XR patent challenge
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08:02 EDTACTIronwood announces initiation of Phase II linaclotide trial
Ironwood Pharmaceuticals (IRWD) announced the initiation of a Phase II clinical trial evaluating linaclotide for the treatment of adults suffering from opioid-induced constipation. Data are expected in the second half of 2015. The clinical trial is being conducted jointly by Ironwood and Actavis plc (ACT), Ironwood’s co-development and co-promotion partner for linaclotide in the United States. Linaclotide is a guanylate cyclase-C agonist approved by the FDA for the treatment of adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Linaclotide is not currently approved for the treatment of OIC. The randomized, double-blind, placebo-controlled, multi-site Phase II clinical trial is expected to enroll approximately 240 adult patients with chronic, non-cancer pain who have been receiving a stable dose of an opioid analgesic and suffer from constipation, defined as fewer than three spontaneous bowel movements per week. Patients will be randomized to receive 145 mcg of linaclotide, 290 mcg of linaclotide, or placebo for eight weeks. The primary endpoint of the trial is an increase in SBM frequency. Additionally, a number of secondary endpoints and exploratory analyses intended to inform future development plans are included in the study design.
October 15, 2014
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 EDTSNYBIND 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.
07:46 EDTACTActavis should be able to mitigate Irish tax downside, says Leerink
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06:03 EDTACTMarket overreacted to new Irish tax rules, says BMO Capital
BMO Capital believes the market may have overreacted yesterday to the report that Ireland is eliminating the "Double Irish" tax loophole. The firm says Allergan (AGN) confirmed that it incorporated potential changes to Irish tax law in its recently raised earnings guidance while Mallinckrodt (MNK) said it does expect the new tax structure to have an immediate impact. BMO views yesterday's pullback in shares of Allergan, Mallinckrodt and Actavis (ACT) as an overreaction.
October 13, 2014
15:12 EDTACTActavis may see modest negative impact from Irish tax change, says BMO Capital
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October 10, 2014
10:20 EDTACTFidelity supports potential merger between Actavis and Allergan, Reuters reports
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07:37 EDTACTActavis more likely partner than Valeant if Allergan merges, says UBS
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