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Elite Announces Development and License Agreement with SunGen Pharma LLC

Lun, 08/29/2016 - 15:28
NORTHVALE, N.J., Aug. 29, 2016 -- (Healthcare Sales & Marketing Network) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (ELTP), a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, toda...
Biopharmaceuticals, Generics, Licensing
Elite Pharmaceuticals, SunGen Pharma

Fortimedix Surgical Announces 510(k) Clearance for Innovative Single-port Surgical Platform

Lun, 08/29/2016 - 15:25
NUTH, the Netherlands and SAN DIEGO, August 29, 2016 -- (Healthcare Sales & Marketing Network) -- Fortimedix Surgical today announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for FMX314, an innovative single-port pla...
Devices, Surgery, FDA
Fortimedix Surgical, single-port surgery

Leap Therapeutics and Macrocure Announce Definitive Merger Agreement

Lun, 08/29/2016 - 15:22
CAMBRIDGE, Massachusetts and PETACH TIKVA, Israel, August 29, 2016 -- (Healthcare Sales & Marketing Network) -- Leap Therapeutics, Inc., a clinical stage immuno-oncology company, and Macrocure Ltd. (MCUR) today announced the signing of a definitive merger...
Biopharmaceuticals, Wound Care, Mergers & Acquisitions
Leap Therapeutics, Macrocure

Regeneron and Sanofi Present Positive Phase 3 Investigational Data for Praluent(R) (alirocumab) Injection in Patients Undergoing LDL Apheresis Therapy at ESC Congress 2016

Lun, 08/29/2016 - 15:17
TARRYTOWN, N.Y. and PARIS, Aug. 29, 2016 -- (Healthcare Sales & Marketing Network) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced detailed positive results from ODYSSEY ESCAPE, a Phase 3 trial which evaluated Praluent® (a...
Biopharmaceuticals, Cardiology
Regeneron Pharmaceuticals, Sanofi, Praluent, alirocumab, PCSK9

New Repatha(R) (evolocumab) Analyses Show Efficacy and Safety Across Risk Groups in Results Presented at ESC Congress 2016

Lun, 08/29/2016 - 15:14
THOUSAND OAKS, Calif., Aug. 28, 2016 -- (Healthcare Sales & Marketing Network) -- Amgen (AMGN) today announced data presented at the European Society of Cardiology (ESC) Congress 2016 showing Repatha® (evolocumab) consistently reduced low-density lipo...
Biopharmaceuticals, Cardiology
Amgen, Repatha, evolocumab, heterozygous, hypercholesterolemia

Roche receives FDA Emergency Use Authorization for Zika PCR Test

Lun, 08/29/2016 - 15:07
PLEASANTON, Calif., Aug. 29, 2016 -- (Healthcare Sales & Marketing Network) -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the LightMix® Zika r...
Biopharmaceuticals, FDA
Roche Group, Zika PCR test, Zika virus

Alere Issues Statement

Ven, 08/26/2016 - 15:41
WALTHAM, Mass., Aug. 26, 2016 -- (Healthcare Sales & Marketing Network) -- Alere Inc. (ALR) (the "Company"), a global leader in rapid diagnostic tests, today issued the following statement in response to inquiries from its shareholders: On Au...
Diagnostics, Mergers & Acquisitions
Alere, Abbott

Advanced Wound Care Products PuraPly(TM) and PuraPly Antimicrobial(TM) Now Available for Medicare Reimbursement in 10 States

Ven, 08/26/2016 - 15:38
CANTON, Mass., Aug. 26, 2016 -- (Healthcare Sales & Marketing Network) -- Organogenesis Inc., a global leader in advanced wound care innovations and technologies, today announced that its PuraPly™ and PuraPly Antimicrobial (AM)™ wound management products ...
Devices, Wound Care, Reimbursement
Organogenesis, PuraPly

Portola Pharmaceuticals Announces Presentation of Interim Results from Phase 3b/4 ANNEXA(TM)-4 Study of AndexXa(TM) (andexanet alfa) at European Society of Cardiology 2016 Congress

Ven, 08/26/2016 - 15:33
SOUTH SAN FRANCISCO, Calif., Aug. 26, 2016 -- (Healthcare Sales & Marketing Network) -- Portola Pharmaceuticals Inc.® (PTLA) today announced that interim results from its ongoing Phase 3b/4 ANNEXA™-4 trial of AndexXa™ (andexanet alfa), a Factor Xa inhi...
Biopharmaceuticals
Portola Pharmaceuticals, AndexXa, andexanet alfa, Factor Xa

Theranos to Appeal CMS Sanctions

Ven, 08/26/2016 - 15:29
PALO ALTO, Calif., Aug. 25, 2016 -- (Healthcare Sales & Marketing Network) -- Theranos, a health technology company, said today that it has filed a notice of intent to appeal the sanctions that the Centers for Medicare and Medicaid Services (CMS) imposed ...
Diagnostics, Reimbursement
Theranos

Sirtex Medical Inc. Announces 19 Percent Dose Sales Growth of SIR-Spheres(R) Y-90 resin microspheres in Fiscal Year 2016

Gio, 08/25/2016 - 15:42
WOBURN, Mass.--(Healthcare Sales & Marketing Network)--Sirtex Medical Inc., a subsidiary of Sirtex Medical Limited (SRX.AX), a leading manufacturer of targeted liver cancer therapies, today announced dose sales of SIR-Spheres® Y-90 resin microspheres g...
Devices, Oncology
Sirtex Medical, SIR-Spheres, microspheres, SIRFLOX, radiotherapy

TapImmune Appoints Michael J. Loiacono as Chief Financial Officer

Gio, 08/25/2016 - 15:39
JACKSONVILLE, Florida, August 25, 2016 -- (Healthcare Sales & Marketing Network) -- TapImmune Inc. (TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for th...
Biopharmaceuticals, Oncology, Personnel
TapImmune, immunotherapy, naturally processed epitopes

Armetheon Announces Positive Results of Pharmacokinetics Study of Tecarfarin versus Warfarin

Gio, 08/25/2016 - 15:36
MILPITAS, Calif., Aug. 25, 2016 -- (Healthcare Sales & Marketing Network) -- Armetheon, Inc., a specialty pharmaceutical company developing novel small molecule drugs for cardiovascular diseases, today announced results from its Phase 1 clinical trial eva...
Biopharmaceuticals, Cardiology
Armetheon, tecarfarin, warfarin, anticoagulant

Teligent, Inc. Announces Health Canada Approval Of Three Baclofen Injection Products

Gio, 08/25/2016 - 15:34
BUENA, N.J., Aug. 25, 2016 -- (Healthcare Sales & Marketing Network) -- Teligent, Inc. (TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced that its Estonian subsidiary, Teligent OÜ, has received three Abbreviated New ...
Biopharmaceuticals, Generics, Regulatory
Teligent, Baclofen

Mallinckrodt Receives FDA Fast-Track Designation for Synacthen(R) Depot IND Application

Gio, 08/25/2016 - 15:30
CHESTERFIELD, United Kingdom, Aug. 25, 2016 -- (Healthcare Sales & Marketing Network) -- Mallinckrodt plc (MNK), a leading global specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has granted the company's reque...
Biopharmaceuticals, FDA
Mallinckrodt, Synacthen, tetracosactide, Duchenne muscular dystrophy

Mylan Taking Immediate Action to Further Enhance Access to EpiPen(R) (Epinephrine Injection, USP) Auto-Injector

Gio, 08/25/2016 - 15:27
HERTFORDSHIRE, England and PITTSBURGH, Aug. 25, 2016 -- (Healthcare Sales & Marketing Network) -- Mylan N.V. (NASDAQ, TASE: MYL) today announced it is taking immediate action to further enhance access to EpiPen® (epinephrine injection, USP) Auto-Injec...
Biopharmaceuticals, Devices, Drug Delivery, Reimbursement
Mylan, EpiPen, epinephrine

Pivotal Study Results Published in New England Journal of Medicine (NEJM) Confirm Safety and Efficacy of INSIGHTEC's Exablate Neuro System for the Treatment of Essential Tremor

Gio, 08/25/2016 - 15:22
HAIFA, Israel, Aug. 25, 2016 -- (Healthcare Sales & Marketing Network) -- INSIGHTEC, the leader in MR-guided Focused Ultrasound (MRgFUS) therapy, today announced that the New England Journal of Medicine (NEJM) has published the results of a pivotal study ...
Devices, Neurology
INSIGHTEC, Exablate, Exablate Neuro, essential tremor, ultrasound

Sunesis Announces Publication in "Drugs" Detailing Molecular and Pharmacologic Properties of Vosaroxin

Gio, 08/25/2016 - 15:19
SOUTH SAN FRANCISCO, Calif., Aug. 25, 2016 -- (Healthcare Sales & Marketing Network) -- Sunesis Pharmaceuticals, Inc. (SNSS) today announced the publication of an article detailing the molecular and pharmacologic properties of vosaroxin as a new therapeuti...
Biopharmaceuticals, Oncology
Sunesis Pharmaceuticals, vosaroxin, acute myeloid leukemia

Amgen Provides Update On Status Of Parsabiv(TM) (Etelcalcetide) New Drug Application (NDA) Submitted To The U.S. Food And Drug Administration (FDA)

Gio, 08/25/2016 - 15:15
THOUSAND OAKS, Calif., Aug. 24, 2016 -- (Healthcare Sales & Marketing Network) -- Amgen (AMGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the New Drug Application (NDA) for Parsabiv™ (etelcal...
Biopharmaceuticals, FDA
Amgen, Parsabiv, Etelcalcetide, hyperparathyroid

New Data Presentations Reinforce Clinical Value of Elekta’s Monaco Radiotherapy Treatment Planning Software

Mer, 08/24/2016 - 16:19
ATLANTA, Ga.--(Healthcare Sales & Marketing Network)--The latest version of Elekta’s Monaco® treatment planning software was recently highlighted in multiple presentations. The only treatment planning solution with gold-standard Monte Carlo accuracy an...
Devices, Oncology
Elekta, Monaco, Radiotherapy, Treatment Planning

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