News
Jun 5
2015
Beijing Bohui Innovation Technology Co., Ltd. (Bohui) Agrees to Acquire Advion, Inc.
Jun 5
2015
June 5, 2015 – Ithaca, NY – Advion, Inc., a leading systems and consumables developer for the life sciences industry, announces it has signed a definitive agreement to be acquired by Bohui with an expected close date on June 30, 2015. The acquisition is strategic for both companies and will enable Advion to broaden its investments in the areas of life science, clinical, and food safety applications. Advion will continue to trade under its current name and brand, with all employees and executives remaining with the company. All three (3) operations and locations in Ithaca, NY are expected to remain unchanged into the future.
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Jun 1
2015
TransEnterix Submits 510(k) Application to FDA for SurgiBot System
Jun 1
2015
-- First Patient-Side Robotically Enhanced Laparoscopic Surgery Platform --
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- TransEnterix, Inc. (NYSE MKT:TRXC), a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery, today announced the submission of its 510(k) application with the U.S. Food and Drug Administration (FDA) for clearance of the company's SurgiBot™ System.
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May 15
2015
FDA Approves TREXIMET (sumatriptan and naproxen sodium) for Use in Pediatric Patients
May 15
2015
Approval marks the First Approved Combination and First Approved Sumatriptan Migraine Product for Patients Age 12-17
MORRISTOWN, NJ – May 15, 2015 – Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX), a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved TREXIMET® (sumatriptan and naproxen sodium) for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura.
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May 14
2015
ZELTIQ(R) Aesthetics Reaches 2,000,000th CoolSculpting(R) Treatment Cycle Milestone
May 14
2015
CoolSculpting Procedure Continues to Grow Noninvasive Fat Reduction Market
PLEASANTON, CA -- (Marketwired) -- 05/14/15 -- ZELTIQ® Aesthetics, Inc. (NASDAQ: ZLTQ), a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, today announced it recently shipped its 2,000,000th CoolSculpting treatment cycle.
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May 11
2015
FDA Grants QIDP and Fast Track Designations to CD101 IV, Cidara Therapeutics’ Lead Antifungal Product Candidate
May 11
2015
-CD101 IV designated for treatment of serious or life-threatening Candida infections-
SAN DIEGO--(BUSINESS WIRE)--May 11, 2015-- Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today announced that the U.S. Food and Drug Administration (FDA) has designated the company’s lead antifungal product candidate, CD101 IV, as a Qualified Infectious Disease Product (QIDP) with Fast Track status. The QIDP and Fast Track designations are for the use of CD101 IV in the treatment of candidemia and invasive candidiasis.
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May 5
2015
Pernix Releases Pharmacokinetic Data for ZX007 Third Generation Zohydro ER on Track
May 5
2015
MORRISTOWN, NJ – (BUSINESS WIRE) – May 05, 2015 – Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX), a specialty pharmaceutical company, today announced the successful completion of a human pharmacokinetic equivalence study with ZX007, an innovative abuse deterrent tablet formulation of hydrocodone bitartrate. The clinical study evaluated the pharmacokinetics and safety of prototype formulations developed by Altus Formulation using its proprietary INTELLITAB™ technology, for comparison with Zohydro® ER, resulting in the selection of the final ZX007 prototype for pivotal clinical studies. Damon Smith, CEO of Altus Formulation said; “We are very happy that ZX007 is performing in the way we expected in human studies and we look forward to working with the Pernix team to complete development”.
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May 5
2015
Paratek Announces Closing of Common Stock Offering
May 5
2015
BOSTON, May 5, 2015 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a pharmaceutical company focused on the development and commercialization of innovative, antibacterial therapies based upon tetracycline chemistry, has completed its previously announced offering of 3,089,000 shares of common stock at a public offering price of $24.50, which includes 229,000 shares of common stock issued upon the exercise, in part, by the underwriters of an option to purchase additional shares from Paratek. The aggregate net proceeds before expenses to Paratek are approximately $71.1 million, after deducting underwriting discounts and commissions.
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May 4
2015
Pernix Launches Zohydro® ER with BeadTek™
May 4
2015
New Formulation Maintains 12-Hour Efficacy to Treat Patients Suffering from Chronic Pain
MORRISTOWN, NJ – (BUSINESS WIRE) – May 04, 2015 – Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX), a specialty pharmaceutical company, today announced that the new formulation of Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek™ is now available in U.S. pharmacies. On January 30, 2015, the U.S. Food and Drug Administration (FDA) approved this updated formulation that features BeadTek, a technology encompassing an indistinguishable mix of inactive beads, active immediate-release hydrocodone beads and active extended-release hydrocodone beads. Zohydro ER with BeadTek delivers an extended release of hydrocodone that provides 12-hour dose duration. When taken as directed, the inactive beads contained in Zohydro ER with BeadTek remain inert. The inactive beads dissolve independently of the active hydrocodone beads and are designed not to change the 12-hour release properties of the medication when taken as directed. However, when crushed and dissolved in liquids or solvents, the inactive beads are designed to immediately form a viscous gel.
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May 4
2015
Intersect ENT Announces Positive Coverage Decision by Health Care Service Corporation
May 4
2015
Policy Update Facilitates Access to Nearly 14.7 Million Members
MENLO PARK, Calif.--Intersect ENT, Inc. (NASDAQ:XENT), a company seeking to improve the quality of life for patients with ear, nose and throat conditions, today announced that Health Care Service Corporation (HCSC), the country’s largest customer owned health insurer, has updated its sinus surgery coverage policy. HCSC will now cover PROPEL® and PROPEL® mini, steroid releasing sinus implants, as “medically necessary” for patients meeting the criteria for endoscopic sinus surgery.
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Apr 24
2015
Pernix Therapeutics Closes Acquisition of Zohydro ER Franchise
Apr 24
2015
– Synergistic Fit Expands Commercial Footprint, Builds Strong Product Portfolio –
MORRISTOWN, N.J. – April 24, 2015 – Pernix Therapeutics Holdings, Inc. (Nasdaq: PTX) (the “Company” or “Pernix”), a specialty pharmaceutical company, announced today that it has closed its acquisition of the Zohydro® ER (hydrocodone bitartrate) franchise, comprising three extended release hydrocodone products, including an abuse-deterrent pipeline and all related intellectual property. Pernix first announced the agreement with Zogenix, Inc. to acquire this franchise on March 10th.
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