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The government declined to intervene in 2011, so Mr. Streck and his counsel, Berger & Montague and Faruqi & Faruqi, litigated the case until settlement was reached. Despite the settlement, Mr. Streck's pursuit of alleged fraud is not over.  Mr. Streck's lawsuit alleged that a second category of defendants – specifically, nine pharmaceutical manufacturers – defrauded state Medicaid through a different scheme which also involved payments to wholesalers.  Yesterday, Judge Eduardo Robreno certified the final judgment against these defendants, thus paving the way for an appeal to the Third Circuit.  Those defendants include Allergan, Inc., Amgen, Inc., Bradley Pharmaceuticals, Inc., Eisai, Inc., Mallincrodt, Inc., Novo Nordisk, Inc., Reliant Pharmaceuticals, Inc., Sepracor, Inc., and Upsher-Smith Laboratories, Inc. The settlement with Genzyme marked the seventh previously-declined case in the past two years that Berger & Montague has successfully litigated on behalf of the federal and state governments. Dan Miller, lead counsel in the case against Genzyme and the co-chair of Berger & Montague's Qui Tam Practice Group, explained the changing landscape of FCA litigation: "Years ago, if the government declined a False Claims Act case brought by a whistleblower, the case would typically get dismissed.  But more recently, complex commercial litigation law firms like Berger & Montague have successfully litigated declined cases against many of the nation's largest companies. The results for the taxpayers speak for themselves." Berger & Montague shareholder Joy Clairmont, also an integral part of Mr. Streck's legal team, continued: "Our client's cases show that a single individual that steps forward as a whistleblower really can make a difference.  Mr. Streck has, literally, helped changed the drug pricing practices of an entire industry." The case is captioned U.S. ex rel. Ronald Streck v. Genzyme Corporation, et al., C.A. No. 08-5135. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/genzyme-corporation-pays-5885-million-to-resolve-false-claims-act-allegations-judgment-involving-cases-against-nine-other-pharmaceutical-manufacturers-certified-as-final-judgment-allowing-appeal-300452399.html


News Article | May 8, 2017
Site: www.businesswire.com

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Agilis Biotherapeutics, Inc. (Agilis), a biotechnology company advancing innovative gene therapy products for the treatment of rare genetic diseases that affect the central nervous system (CNS), announced today that the Company has expanded its commercial and medical teams, hiring Markus Peters, Ph.D., as Chief Commercial Officer, Kirsten Gruis, M.D. as Chief Medical Officer, and Anne Marie Conway, M.H.A, R.N., as Vice President Clinical Operations. “We are pleased to welcome these three talented individuals to our leadership team. Each brings a wealth of experience to Agilis that is directly aligned with our mission to help patients with rare CNS diseases, advance our clinical pipeline, and lay the foundation for future approval and commercialization of our promising gene therapy product candidates,” said Dr. Mark Pykett, President and CEO of Agilis. Dr. Markus Peters will lead Agilis’ commercial, business development and business analytics activities, and will spearhead market efforts for the company’s aromatic L-amino acid decarboxylase (AADC) deficiency gene therapy globally. He brings a significant background to Agilis in the commercialization of rare disease therapeutics and specialty pharmaceuticals. Most recently, he was an Associate Partner with the consulting group Alacrita. Dr. Peters was previously Vice President, Global Marketing/Commercial with Synageva, where he led the cross-functional global launch team for first-in-class enzyme replacement therapy Kanuma to develop and implement the global strategy and launch plan for the product in ultra-rare LAL deficiency. He was also responsible for the commercial assessment of the Synageva pipeline. Before Synageva, he was Head of Global Marketing Nephrology and Transplant Therapeutic Area at Alexion, leading the global launch of the ultra-orphan Soliris aHUS (atypical hemolytic uremic syndrome) franchise. Dr. Peters previously worked at Merck where he led the global launch of recombinant biologic Elonva, and at Sepracor, Wyeth, Bayer and Boehringer Ingelheim in the US, Japan and Europe in business and commercial roles of increasing responsibility. He holds a Ph.D. in Biochemistry from Heinrich-Heine Universität. Kirsten Gruis, M.D., is an accomplished physician scientist, board certified neurologist, and rare disease specialist, with a broad background in the development of innovative therapeutics. She has worked in Friedreich’s ataxia, Spinal Muscular Atrophy (SMA), Amyotrophic Lateral Sclerosis (ALS) and Duchenne Muscular Dystrophy (DMD), among others, across a range of development stages, including pre-clinical, Phase I, Phase II and Phase III programs. Dr. Gruis was most recently at WAVE Life Sciences leading their clinical development plans in DMD. Previously, she was at Idera Pharmaceuticals where she lead the team to initiate a global, phase II trial in dermatomyositis and, before that, she was at Alnylam Pharmaceuticals as the clinical lead of a global, phase III program of patisiran in the rare disease familial amyloidotic polyneuropathy and, before that, was with Pfizer managing pre-clinical and phase I-II assets in the Rare Disease Research Unit focused on Friedreich’s ataxia, SMA, ALS, and DMD. Dr. Gruis held academic appointments as an Associate Professor of Neurology at both the University of Michigan and SUNY Upstate Medical University. She received her MD from the University of Iowa and did her residency training at the University of Michigan, where she subsequently joined the faculty. While at SUNY Upstate Medical University, she served as the Director of the MDA clinic, Co-Director of the ALS Clinic, and prior to that was Director of the Motor Neuron Disease Center/ALS Clinic at the University of Michigan. Dr. Gruis is a member of the American Academy of Neurology and World Muscle Society, as well as a Fellow American Association of Neuromuscular & Electrodiagnostic Medicine with additional board certification in Neuromuscular Disorders. She has served on multiple NIH Scientific Review Panels for the NINDS and Neurotechnology study groups as well as a principal investigator of several clinical studies for ALS. Anne Marie Conway, M.H.A., R.N., brings extensive experience in clinical operations to Agilis’ clinical development programs. Most recently, she was Principal at AMC Consulting, providing clinical operations services to a range of drug development organizations including Rhythm Pharmaceuticals, bluebird bio and Lantheus Medical Imaging, among others. Before that, she worked at Ziopharm Oncology as head of Clinical Operations and Data Management. While there, she managed the start-up of the gene therapy program for high grade gliomas. Prior to that, she was at Shire Human Genetic Therapies (now integrated into Shire, plc) as Vice President, Development Operations, providing management oversight for the global filing and approval of VPRIV™ for Gaucher disease, running a global Phase III trial and subsequent approval of Firazyr™ for hereditary angioedema and, leading global clinical operations, data management and registry group for eight rare disease pipeline products in Phases I through IV studies. Prior to its acquisition by Shire, Ms. Conway worked at Transkaryotic Therapies and led the integrated development team for the clinical sections of the BLA/MAA filing and subsequent approval in the United States, European Union, and Japan for elaprase™. Before moving into industry, Ms. Conway worked at Tufts Medical Center as a Clinical Trials Manager, Outpatient Nurse Coordinator, and Staff Nurse. She has an M.H.A. from Suffolk University and a B.S. from Boston University, is a licensed nurse, and holds an adjunct faculty position at Suffolk University. Agilis is advancing innovative gene therapies designed to provide long-term efficacy for patients with debilitating, often fatal, rare genetic diseases that affect the central nervous system. Agilis’ gene therapies are engineered to impart sustainable clinical benefits by inducing persistent expression of a therapeutic gene through precise targeting and restoration of lost gene function to achieve long-term efficacy. Agilis’ rare disease programs are focused on gene therapy for AADC deficiency, Friedreich’s ataxia, and Angelman syndrome, all rare genetic diseases that include neurological deficits and result in physically debilitating conditions. We invite you to visit our website at www.agilisbio.com Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon our current expectations and projections about future events and generally relate to our plans, objectives and expectations for the development of our business. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and actual future results may be materially different from the plans, objectives and expectations expressed in this press release.


News Article | February 15, 2017
Site: www.marketwired.com

YONKERS, NY--(Marketwired - February 15, 2017) - ContraFect Corporation ( : CFRX), a biotechnology company focused on the discovery and development of protein and antibody therapeutics for life-threatening, drug-resistant infectious diseases, announced today that it has appointed Lisa Ricciardi to its Board of Directors. Ms. Ricciardi is a Life Sciences executive with deep business development and operational experience. She has worked for top pharmaceutical, payer, and molecular diagnostics firms including Pfizer, Inc., Medco Health Solutions, Inc., and Foundation Medicine, as well as for Essex Woodlands Health Ventures, a global venture capital partnership. She currently serves on the board of Chimerix, Inc, and United Drug Healthcare Group, PLC, and was a prior board member of Sepracor Inc., which was sold to Dainippon Sumitomo for $2.6 billion. "We are thrilled to have Lisa joining our board," said Steven C. Gilman, Ph.D., ContraFect's Chairman and CEO. "She has a proven ability to work in established companies as well as in early stage environments and her demonstrated success in executing global buy- and sell-side business development transactions will be invaluable to us as we continue to build the Company." Ms. Ricciardi commented, "I am excited to join the ContraFect Board of Directors and look forward to working closely with the board and the management team to continue to advance novel therapeutics which, if successful, may provide important solutions to patients with serious and often life-threatening infections due to drug-resistant organisms." ContraFect is a biotechnology company focused on discovering and developing therapeutic protein and antibody products for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. An estimated 700,000 deaths worldwide each year are attributed to drug-resistant bacterial infections. We intend to address life threatening infections using our therapeutic product candidates from our lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses (regions that are not prone to mutation). In addition to CF-301, the company's preclinical programs include potential novel lysins for the treatment of drug resistant gram-negative pathogens as well as a mononclonal antibody program targeted for the treatment of viral influenza. This press release contains, and our officers and representatives may make from time to time, "forward-looking statements" within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar references to future periods. Examples of forward-looking statements in this release include, without limitation, statements regarding our ability to discover and develop protein therapeutics and antibody products for life-threatening, drug resistant infectious diseases, whether Ms. Ricciardi's experience will be invaluable to the growth of the Company, whether the board and the management team can advance therapeutics which will provide important solutions to patients with serious and often life-threatening infections due to drug-resistant organisms, our ability to address life threatening infections using our therapeutic product candidates from our lysin and antibody platforms by targeting conserved regions of either bacteria or viruses, and our ability to discover and develop novel lysins for the treatment of drug-resistant gram-negative pathogens. Forward-looking statements are statements that are not historical facts, nor assurances of future performance. Instead, they are based on ContraFect's current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect's control, including those detailed in ContraFect's filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Important factors that could cause actual results to differ include, among others, our ability to develop treatments for drug-resistant infectious diseases. Any forward-looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.


Phenyl-substituted cyclohexylamine derivatives and method for their synthesis and characterization are disclosed. Use of these compounds to treat/prevent neurological disorders as well as methods for their synthesis are set forth herein. Exemplary compounds of the invention inhibit reuptake of endogenous monoamines, such as dopamine, serotonin and norepinephrine (e.g. from the synaptic cleft) and modulate one or more monoamine transporter. Pharmaceutical formulations incorporating compounds of the invention are also provided.


Coated tablets of (6-(5-chloro-2-pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazine) are provided. The tablets minimize the perceived bitterness of the medicament. A method for analyzing instantaneous dissolution of sub-microgram quantities of core material is also disclosed.


Provided herein are methods of treating a sleep-related breathing disorder, such as obstructive sleep apnea, comprising the administration of O-desmethylvenlafaxine or duloxetine.


Solid forms comprising a compound useful in the treatment, prevention and management of various conditions and diseases are provided herein. In particular, the invention provides solid forms comprising (-)-O-desmethylvenlafaxine, including salts thereof, having utility for the treatment, prevention and management of conditions and disorders including, but not limited to, affective disorders such as depression, bipolar and manic disorders, attention deficit disorder, attention deficit disorder with hyperactivity, Parkinsons disease, epilepsy, cerebral function disorders, obesity and weight gain, incontinence, dementia and related disorders.


One aspect of the present invention relates to pharmaceutical compositions containing two or more active agents that when taken together can be used to treat, e.g., menopause, mood disorders, anxiety disorders, or cognitive disorders. The first component of the pharmaceutical composition is a sedative eszopiclone. The second component of the pharmaceutical composition is trans 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-napthalenamine or trans 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-napthalenamine. The present invention also relates to a method of treating menopause, perimenopause, mood disorders, anxiety disorders, and cognitive disorders.


One aspect of the present invention relates to pharmaceutical compositions containing two or more active agents that when taken together can be used to treat, e.g., insomnia and/or depression. The first component of the pharmaceutical composition is a GABA receptor modulating compound. The second component of the pharmaceutical composition is a serotonin reuptake inhibitor, a norepinephrine reuptake inhibitor, a 5-HT_(2A) modulator, or dopamine reuptake inhibitor. In certain embodiments, the pharmaceutical composition comprises eszopiclone. In a preferred embodiment, the pharmaceutical composition comprises eszopiclone and fluoxetine. The present invention also relates to a method of treating a sleep abnormality, treating insomnia, treating depression, augmenting antidepressant therapy, eliciting a dose-sparing effect, reducing depression relapse, improving the efficacy of antidepressant therapy or improving the tolerability of antidepressant therapy, comprising co-administering to a patient in need thereof a GABA-receptor-modulating compound; and a SRI, NRI, 5-HT2_(A) modulator or DRI.


Patent
Sepracor | Date: 2011-04-06

A method of preparation of a highly pure salt of R,R-formoterol L-tartrate is disclosed. The process provides the most thermodynamically stable polymorph by recrystallization of a novel polymorph.

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