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Titan Pharmaceuticals Announces FDA Advisory Committee Recommends Approval of Probuphine…
March 21 2013
"Titan Pharmaceuticals, Inc. (OTCBB:TTNP) today announced that the majority of Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) members recognized the favorable benefit-risk profile of Probuphine® and voted for approval (10 positive votes, 4 negative votes and 1 abstention)...."
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HeartWare International, Inc. Announces Pricing of Public Offering of Common Stock
March 12 2013
"HeartWare International, Inc. (Nasdaq: HTWR, ASX: HIN) ("HeartWare") announced today the pricing of a public offering of 1,500,000 shares of common stock at a price per share of $86.45 pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission ("SEC")...."
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HeartWare International, Inc. Announces Public Offering of Common Stock
March 11 2013
"HeartWare International, Inc. (Nasdaq: HTWR, ASX: HIN) ("HeartWare") announced today its intention to offer, subject to market and other conditions, 1,500,000 shares of common stock pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission ("SEC")...."
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Tokai Pharmaceuticals to Present Data on Galeterone in Advanced Prostate Cancer at 2013 International Congress on Targeted Anticancer Therapies (TAT)
March 4 2013
"Tokai Pharmaceuticals, Inc., a biopharmaceutical company focused on developing new treatments for prostate cancer, today announced that clinical data from the ARMOR1 Phase 1 study and preclinical data on the unique triple mechanism of action of galeterone (TOK-001) in patients with castration-resistant prostate cancer (CRPC),..."
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Titan announces date of FDA Advisory Committee Review of PROBUPHINE® for the Treatment of Opioid Dependence
February 27 2013
"Titan Pharmaceuticals, Inc. (OTCBB:TTNP) today announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) is scheduled to review the Company’s New Drug Application (NDA) for Probuphine® for the maintenance treatment of adult patients with opioid dependence on March 21, 2013...."
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Aileron Therapeutics to Highlight Stapled Peptide Pipeline at 2013 AsiaTIDES Meeting
February 26 2013
"Aileron Therapeutics, Inc. today announced the company will deliver two presentations on February 27, 2013 at the IBC’s 5th Annual 2013
AsiaTIDES meeting in Tokyo, Japan...."
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Aileron Therapeutics Secures $12 Million for First-Ever Stapled Peptide Clinical Trial
Jaunuary 14 2013
"Aileron Therapeutics, Inc. today announced that it secured the second tranche in its Series D financing, bringing the total round to $42 million. Current investors...."
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HeartWare International Announces Preliminary Fourth Quarter 2012 Revenues
January 7 2013
"HeartWare International, Inc. (NASDAQ: HTWR - ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that it expects total revenues for the fourth quarter of 2012 ...."
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Probuphine® Receives FDA Priority Review Designation for Adult Patients with Opioid Dependence
January 2 2013
"Titan Pharmaceuticals, Inc. (OTCBB:TTNP) today announced that the New Drug Application (NDA) for Probuphine® has been accepted for review and granted Priority Review designation...."
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Titan Pharmaceuticals Licenses Exclusive Probuphine® Commercialization Rights in U.S. and Canada to Braeburn Pharmaceuticals
December 17 2012
"Titan Pharmaceuticals, Inc. (OTCBB:TTNP) today announced the signing of a license agreement with Braeburn Pharmaceuticals Sprl, wholly owned by Apple Tree Partners IV, L.P., a partnership affiliated with Apple Tree Partners. The license grants Braeburn exclusive commercialization rights in the United States and Canada to the investigational product Probuphine®, a novel...."
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Tokai Pharmaceuticals Doses First Patient in a Phase 2 Study of Galeterone in Advanced Prostate Cancer
December 13 2012
"Tokai Pharmaceuticals, Inc., a biopharmaceutical company focused on developing new treatments for prostate cancer, today announced the treatment of the first patient in the ARMOR2 trial, a Phase 2 clinical study of...."
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HeartWare Receives FDA Approval for HeartWare Ventricular Assist System as a Bridge to Heart Transplantation for Patients with Advanced Heart Failure
November 20 2012
"HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that it has received approval from the United States Food and Drug Administration (FDA) for the HeartWare® Ventricular Assist System...."
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HeartWare Reports Third Quarter 2012 Results
November 9 2012
"HeartWare International, Inc. (NASDAQ: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced revenue of $22.9 million..."
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HeartWare Reports Second Quarter 2012 Results
August 7 2012
"HeartWare International, Inc. (NASDAQ: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced revenue of...."
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HeartWare Completes Acquisition Of World Heart Corporation
August 2 2012
"HeartWare International, Inc. (NASDAQ: HTWR, ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced the closing of the acquisition of World Heart Corporation...."
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Tokai Pharmaceuticals’ Galeterone Receives Fast Track Designation From the FDA for the Treatment of Advanced Prostate Cancer
June 12 2012
"Tokai Pharmaceuticals, Inc., a biopharmaceutical company focused on developing new treatments for prostate cancer, today announced that its lead candidate, galeterone (TOK-001), has received Fast Track designation...."
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FDA Advisory Committee Votes in Favor of HeartWare® Ventricular Assist System as Bridge to Transplant for Patients With End-Stage Heart Failure
April 25 2012
"HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration's...."
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Positive Phase 1 data presented
April 2 2012
"Tokai Pharmaceuticals, Inc., a biopharmaceutical company focused on developing new treatments for prostate cancer, today announced that its lead candidate galeterone...."
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HeartWare International Expands Intellectual Property and Technology Portfolio Through Definitive Agreement to Acquire World Heart Corporation for US$8 Million
March 29 2012
"HeartWare International, Inc. (NASDAQ: HTWR, ASX: HIN), which develops and manufactures miniaturized ventricular assist devices, and World Heart Corporation (NASDAQ: WHRT), which has been engaged in the development of...."
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10 Top Next-Gen Biotech Platforms
March 14 2012
"First-generation biologics took a long time to reach their commercial potential, with many setbacks along the way. The test of faith among biotech companies such as...."
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HeartWare International Reports Fourth Quarter 2011 Revenues of $23.1 Million; Full Year 2011 Revenues of $82.8 Million; 50% Increase From $55.2 Million in 2010
February 16 2012
"HeartWare International, Inc. (NASDAQ: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, announced revenue of $23.1 million for the fourth quarter ended...."
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Aileron expands stapled peptide drug collaboration with Roche
November 17 2011
"Aileron Therapeutics announced today that Roche will initiate a new program to expand its collaboration with Aileron to discover, develop and commercialize Stapled Peptide drugs...."
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Tokai lands new CEO, $23M venture round for PhIIb cancer study
September 20 2011
"Cambridge, MA-based Tokai Pharmaceuticals has rounded up a $23 million venture round to push its lead treatment for prostate cancer into mid-stage trials. And its board has tapped an experienced biotech business development hand to helm the company. Tokai turned to its two current investors--Novartis Venture Fund and Apple Tree Partners--for the fresh injection of cash...."
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Tokai Snaps Up $23M From Novartis and Apple Tree to Challenge Leaders in Prostate Cancer
September 20 2011
"The big bet at Cambridge, MA-based Tokai Pharmaceuticals is on prostate cancer, and now the size of that bet is getting a lot bigger. Tokai is announcing today it has raised $23 million in a Series D3 financing, which included its existing investors Novartis Venture Fund, Apple Tree Partners, and angel investors...."
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Tokai Pharmaceuticals Raises $23 Million in Funding
September 20 2011
"Tokai Pharmaceuticals, a biopharmaceutical company focused on developing new treatments for prostate cancer, today announced that it has raised $23 million in a Series D3 financing. The proceeds will be used to support the ongoing clinical development of galeterone (TOK-001), the company’s lead drug candidate, which has completed an initial proof-of-concept Phase 1 clinical trial for the treatment of patients with castration resistant prostate cancer (CRPC)...."
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FDA Grants Accelerated Approval of ISTODAX(R) As Treatment for Patients with Peripheral T-Cell Lymphoma Who Have Received at Least One Prior Therapy
June 16 2011
"Celgene Corporation (Nasdaq:CELG) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for its Supplemental New Drug Application (sNDA) for an additional indication for...."
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HeartWare International Reports First Quarter 2011 Revenues of $18.0 Million; 68% Increase From $10.7 Million in First Quarter 2010
May 5 2011
"HeartWare International, Inc. (NASDAQ: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced revenues of $18.0 million for the first quarter ended...."
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HeartWare Reports Additional Data from Bridge-to-Transplant Clinical Trial and Continued Access Patients
April 15 2011
"HeartWare International, Inc. (NASDAQ: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced the presentation of...."
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HeartWare International Receives Approval From the Therapeutic Goods Administration (TGA) in Australia
March 24 2011
"HeartWare International, Inc. (ASX: HIN; Nasdaq: HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the Therapeutic Goods...."
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FDA Grants Priority Review For ISTODAX(R) sNDA For Treatment of Progressive or Relapsed PTCL
February 28 2011
"Celgene Corporation (Nasdaq:CELG) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review classification to its Supplemental New Drug Application (sNDA) regarding ISTODAX (romidepsin) for...."
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HeartWare International Reports Fourth Quarter 2010 Revenues of $20.9 Million; 71% Increase From $12.2 Million In Fourth Quarter 2009
February 24 2011
"HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced revenues of $20.9 million for the...."
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HeartWare Receives Third Patient Allotment From FDA - Authorizing 94 Additional Patients - Under Continued Access Protocol for Pivotal U.S. Bridge-to-Transplant Clinical Trial
January 24 2011
"HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and...."
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HeartWare Files PMA Application for FDA Approval of the HeartWare(R) Ventricular Assist System for a Bridge-to-Transplant Indication
December 28 2010
"HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN) today announced that it has submitted a Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the HeartWare(R) Ventricular Assist System as a bridge to...."
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HeartWare International, Inc. Announces Completion of Concurrent Public Offerings of Convertible Senior Notes and Common Stock
December 15 2010
"HeartWare International, Inc. (Nasdaq: HTWR, ASX: HIN) ("HeartWare") announced today the completion of a public offering of $143.75 million principal amount of convertible senior notes due 2017 (the "notes"), pursuant to an effective shelf registration statement filed with the...."
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HeartWare International, Inc. Announces Pricing of Concurrent Public Offerings of Convertible Senior Notes and Common Stock
December 10 2010
"HeartWare International, Inc. (Nasdaq: HTWR, ASX: HIN) ("HeartWare") announced today the pricing of a public offering of $125 million principal amount of convertible senior notes due 2017 (the "notes") pursuant to an effective shelf registration statement filed with...."
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HeartWare International, Inc. Announces Concurrent Public Offerings of Convertible Senior Notes and Common Stock
December 9 2010
"HeartWare International, Inc. (Nasdaq: HTWR, ASX: HIN) ("HeartWare") announced today its intention to offer, subject to market and other conditions, $100 million principal amount of convertible senior notes due 2017 (the "notes") pursuant to...."
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New Clinical Data Evaluating ISTODAX(R) in Pivotal Open-Label Phase II Study for Patients with Peripheral T-Cell Lymphoma (PTCL)
December 5 2010
"Celgene International Sàrl (Nasdaq:CELG) today announced that data from a pivotal Phase II, multicenter, international, open-label study of romidepsin (ISTODAX(R)) in progressive or relapsed PTCL following prior systemic therapy were...."
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HeartWare Achieves Primary Endpoint with 92% Success in Pivotal Bridge-to-Transplant Clinical Trial
November 14 2010
"HeartWare International, Inc. (NASDAQ: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that data from its pivotal bridge to heart transplantation (BTT) study...."
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HeartWare 5-Ounce Pump Extends Lives in Heart Failure Patients
November 14 2010
"HeartWare International Inc.’s implantable pump extended the lives of heart-failure patients in a study that may help it compete against a similar device that weighs twice as much."
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Roche Enters $1.1B Deal With Aileron To Produce New Drugs
August 24 2010
"Roche Holding AG (ROG.VX) Tuesday entered into a partnership deal with U.S.-based biopharmaceutical firm Aileron Therapeutics to produce...."
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Roche Backs New Method for Drug Delivery to Cells
August 24 2010
"Roche agreed to pay up to $1.1 billion to Aileron Therapeutics, which is developing a new type of drug technology called stapled peptides."
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Stapled Peptides on the cover of the August issue of Nature Chemical Biology
August 1 2010
"Discovery of a stapled peptide inhibitor of Mcl-1. Stewart et al. screened a library of stapled peptides based on the BH3 domains of BCL-2 family...."
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HeartWare Announces Board Succession
June 24 2010
"HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that C. Raymond Larkin, Jr., who joined the Board in...."
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HeartWare Receives Conditional FDA Approval to Commence Pivotal Destination Therapy Clinical Trial in the U.S.
June 14 2010
"HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted...."
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HeartWare Data From First 100 Patients in International Clinical and Commercial Experience Shows 90% Survival at 180 Days
April 23 2010
"HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies revolutionizing the treatment of advanced heart failure, today announced that data from its international clinical trial and...."
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HeartWare Receives FDA Approval of Continued Access Protocol for Pivotal U.S. Bridge-to-Transplant Clinical Trial
April 7 2010
"HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration (FDA) has approved...."
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HeartWare Announces Early Conclusion of Enrollment for U.S. Bridge-to-Transplant Clinical Trial
February 22 2010
"HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies revolutionizing the treatment of advanced heart failure, today announced the conclusion of...."
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HeartWare International, Inc. Announces Completion of Public Offering of Common Stock
February 2 2010
"HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN) ("HeartWare") announced today the completion of a public offering of 1,767,900 shares of its common stock...."
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HeartWare International, Inc. Announces Commencement of Public Offering of Common Stock
January 26 2010
"HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN) ("HeartWare") announced today a public offering of 1,500,000 shares of its common stock."
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Celgene to Acquire Gloucester Pharmaceuticals
December 7 2009
"Celgene Corporation (NASDAQ:CELG) and Gloucester Pharmaceuticals Inc., a privately held pharmaceutical company, announced a definitive merger agreement under which Celgene Corporation will acquire Gloucester Pharmaceuticals...."
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Tokai eyes novel weapon to battle prostate cancer
November 27 2009
"Tokai Pharmaceuticals has begun a clinical trial for a new prostate cancer drug candidate after quietly raising cash over the...."
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Aileron Therapeutics Collaborators Publish In Vivo Research in Nature Showing Stapled Peptides Achieve the First Direct Inhibition of the Notch1 Transcription Factor Oncogene
November 11 2009
"Aileron Therapeutics, a biopharmaceutical company leading the development of a new class of drugs called Stapled Peptides...."
Link to Abstract
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Tokai Pharmaceuticals Initiates ARMOR Clinical Development Program for TOK-001; First Ever Multi-Target Investigational Drug for Prostate Cancer
November 10 2009
"Tokai Pharmaceuticals, Inc., today announced the initiation of a Phase 1/2 clinical trial of its lead candidate TOK-001 for the...."
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FDA Approves Gloucester Pharmaceuticals' ISTODAX® for Patients with Cutaneous T-cell Lymphoma
November 5 2009
"Gloucester Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved ISTODAX® (romidepsin)...."
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FDA Advisory Committee Recommends Gloucester Pharmaceuticals’ Romidepsin for Approval for Cutaneous T-cell Lymphoma
September 2 2009
"Gloucester Pharmaceuticals announced today that the Oncologic Drug Advisory Committee (ODAC) appointed by the...."
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Gloucester raises $29 million
August 25 2009
"Gloucester Pharmaceuticals Inc. (Cambridge, Mass.) raised $29 million in a series D round led by new investor Novo A/S. ...."
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HeartWare International Surpasses 50 Implants In The US
August 21 2009
"HeartWare International, Inc. (NASDAQ: HTWR) (ASX: HIN) today announced that HeartWare has surpassed 50 implants in the...."
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HeartWare International, Inc. Closes US$60 Million Financing
August 17 2009
"HeartWare International, Inc. (NASDAQ: HTWR) (ASX: HIN) announced today the completion of its offering of approximately...."
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Drug giants pump $40m into Aileron
June 9 2009
"Four global pharmaceutical companies have joined in a consortium to provide $40 million in financing to Aileron Therapeutics...."
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Aileron Therapeutics Closes $40M Financing To Advance Stapled Peptide Platform
June 8 2009
"Company Developing Novel Class of Stapled Peptide Drugs as Technology Platform for Historically Undruggable Targets...."
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"Emerging Drug Developer" Tokai Pharmaceuticals
June 1 2009
"Seth Harrison knows a thing or two about jump-starting a biotech company without breaking the bank...."
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Aileron Advances First Stapled Peptide Drug Candidate
that Targets Newly-Discovered BAX Activation Mechanism
October 22, 2008
"Aileron Therapeutics announced today that one
of its proprietary Stapled Peptide compounds, referred to as “BIM-SAHB” in an article published today in Nature..."
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