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Searching News Database:  enzyme replacement therapy 

 HSMN NewsFeed - 28 Jan 2026
REGENXBIO Announces Regulatory Update on Ultra Rare MPS Programs
Regenerative Medicine FDA
 HSMN NewsFeed - 19 Dec 2025
BioMarin to Acquire Amicus Therapeutics for $4.8 Billion, Expanding Position as a Leader in Rare Diseases, Accelerating Revenue Growth and Strengthening Financial Outlook
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 16 May 2025
BioMarin Strengthens Enzyme Therapy Business with Acquisition of Inozyme Pharma
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 20 Jan 2023
Astellas Announces Hold Lifted by FDA on FORTIS Clinical Trial of AT845 Investigational Treatment for Adult Patients with Late-Onset Pompe Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 31 Mar 2022
Sapience Therapeutics Expands Executive Team with Appointment of Gina Capiaux, Ph.D. as Vice President, Regulatory Affairs
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 18 Mar 2022
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of the BRIGHT Phase III Clinical Trial Evaluating PRX-102 for the Treatment of Fabry Disease
Biopharmaceuticals
 HSMN NewsFeed - 6 Aug 2021
FDA Approves New Treatment for Pompe Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Feb 2021
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Positive Topline Results from BRIGHT Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa 2 mg/kg every Four Weeks for Treatment of Fabry Disease
Biopharmaceuticals
 HSMN NewsFeed - 30 Dec 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease
Biopharmaceuticals
 HSMN NewsFeed - 11 May 2020
Protalix BioTherapeutics Announces Positive Topline Results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease
Biopharmaceuticals
 HSMN NewsFeed - 21 Oct 2019
SmartPharm Therapeutics Appoints John T. Potts, MD, DSc, to Board of Directors
Biopharmaceuticals Personnel
 HSMN NewsFeed - 25 Jun 2019
SmartPharm Therapeutics Appoints José Trevejo, MD, PhD, as Chief Executive Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 21 Mar 2019
Enzyvant's Investigational Farber Disease Enzyme Replacement Therapy, RVT-801, Receives FDA Fast Track and Rare Pediatric Disease Designations
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Feb 2019
Enzyvant Appoints Industry Veteran Rachelle Jacques as Chief Executive Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 30 Aug 2018
REGENXBIO Announces Pipeline Expansion with RGX-181 Gene Therapy for CLN2 Form of Batten Disease
Biopharmaceuticals
 HSMN NewsFeed - 30 Jul 2018
Enzyvant Expands Leadership Team with Appointments of Andrew Dawson and Alex Tracy
Biopharmaceuticals Personnel
 HSMN NewsFeed - 29 Jun 2018
Ultragenyx Announces Positive CHMP Opinion for Mepsevii(TM) (vestronidase alfa) For the Treatment of Mucopolysaccharidosis VII
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 23 Apr 2018
Amerigen and Dipharma Announce U.S. FDA Approval for Generic Miglustat 100 mg Capsules
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 17 Jan 2018
Pharming Announces FDA Acceptance for Review of Supplemental Biologics License Application for RUCONEST(R) for Prophylaxis of Hereditary Angioedema Attacks
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Nov 2017
Pharming Submits Supplemental Biologics License Application to FDA for RUCONEST(R) for Prophylaxis of Hereditary Angioedema Attacks
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 May 2017
Ultragenyx Announces Recombinant Human Beta-Glucuronidase Biologics License Application and Marketing Authorization Application Filed and Accepted for Review; FDA Grants Priority Review Status
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Apr 2017
PhaseRx Receives Positive Opinion for Orphan Drug Designation for PRX-OTC from European Medicines Agency
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 3 Mar 2017
Valerion Therapeutics Demonstrates a New Mechanism for Treating Pompe Disease
Biopharmaceuticals
 HSMN NewsFeed - 16 Jan 2017
European Commission Amends Marketing Authorisation for RUCONEST(R) to Include Self-Administration
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 8 Dec 2016
Pharming Announces Completion of Acquisition of All North American Commercialisation Rights for RUCONEST(R) From Valeant
Biopharmaceuticals Acquisitions
 HSMN NewsFeed - 11 Nov 2016
CHMP Adopts Positive Opinion to Include Self-administration for RUCONEST(R)
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 21 Jun 2016
PhaseRx Advances Product Pipeline for Treatment of Rare Genetic Liver Diseases
Biopharmaceuticals
 HSMN NewsFeed - 20 Jun 2016
Sangamo BioSciences Announces FDA Clearance of Investigational New Drug Application for ZFN-Mediated Genome Editing Treatment of MPS II
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Apr 2016
Allergan Receives CHMP Positive Opinion For ENZEPI(R) (Pancrelipase) For Patients With Exocrine Pancreatic Insufficiency (EPI)
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 7 Apr 2016
Pharming Announces Adoption by the European Commission of the CHMP Recommendation to Change the Terms of the Marketing Authorisation for Ruconest(R)
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 8 Feb 2016
Sangamo BioSciences Announces FDA Clearance Of Investigational New Drug Application For ZFN-Mediated Genome Editing Treatment Of MPS I
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Oct 2015
Amicus Therapeutics Provides U.S. Regulatory Update for Migalastat Monotherapy
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Jul 2015
Strensiq(R) (asfotase alfa) Receives Marketing Approval in Japan for Treatment of Patients with Hypophosphatasia (HPP)
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 8 Jun 2015
Amicus Therapeutics Strengthens Executive Leadership Team
Biopharmaceuticals Personnel
 HSMN NewsFeed - 3 Jun 2015
Amicus Therapeutics Submits Marketing Authorization Application (MAA) for Full Approval of Fabry Monotherapy Galafold(TM) (Migalastat) in European Union
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 27 Apr 2015
Amicus Therapeutics Appoints David Allsop as Senior Vice President, International
Biopharmaceuticals Personnel
 HSMN NewsFeed - 8 Apr 2015
ArmaGen Announces FDA Acceptance of IND Application for AGT-181 for the Treatment of Hurler Syndrome
Biopharmaceuticals Neurology
 HSMN NewsFeed - 3 Nov 2014
Salix and Pharming Announce the Launch of RUCONEST(R) in the U.S. for the Treatment of Acute Angioedema Attacks in Patients with Hereditary Angioedema (HAE)
Biopharmaceuticals Product Launch
 HSMN NewsFeed - 20 Aug 2014
Amicus Therapeutics Announces Positive Phase 3 Data From Fabry Monotherapy Study 012
Biopharmaceuticals
 HSMN NewsFeed - 23 Jul 2014
Shire Enters Strategic Licensing and Collaboration Agreement With ArmaGen
Biopharmaceuticals Neurology Licensing
 HSMN NewsFeed - 27 Jun 2014
Protalix Announces New Data on ELELYSO(TM) (taliglucerase alfa) Presented at the European Working Group on Gaucher Disease 2014 11th Meeting
Biopharmaceuticals
 HSMN NewsFeed - 12 May 2014
Lysosomal Therapeutics Inc. Receives $4.8 Million in Seed Funding
Biopharmaceuticals Neurology Venture Capital
 HSMN NewsFeed - 11 Dec 2013
FDA Grants Priority Review for Genzyme’s Cerdelga(TM) (eliglustat), an Investigational Oral Therapy for Gaucher Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Oct 2013
Molecular Templates Announces $8.5M Series C Financing and $10.6M Grant Funding
Biopharmaceuticals Oncology Venture Capital
 HSMN NewsFeed - 10 Sep 2013
Amicus Therapeutics Enters Collaboration With Biogen Idec for Parkinson's Disease
Biopharmaceuticals Neurology Licensing
 HSMN NewsFeed - 9 May 2013
Cornerstone Therapeutics Acquires Exclusive U.S. Marketing Rights to PERTZYE(R) (pancrelipase) for Treatment of Exocrine Pancreatic Insufficiency in Patients With Cystic Fibrosis
Biopharmaceuticals Acquisitions
 HSMN NewsFeed - 29 Apr 2013
UPLYSO(TM) (alfataliglicerase) Approved in Mexico and Chile for the Treatment of Gaucher Disease
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 15 Feb 2013
Genzyme Announces Positive New Data from Two Phase 3 Studies for Oral Eliglustat Tartrate for Gaucher Disease
Biopharmaceuticals
 HSMN NewsFeed - 6 Dec 2012
Protalix BioTherapeutics Signs Clinical Development Agreement With Pfizer for ELELYSO(TM) (taliglucerase alfa)
Biopharmaceuticals
 HSMN NewsFeed - 1 May 2012
Pfizer And Protalix BioTherapeutics Announce FDA Approval Of ELELYSO(TM) (taliglucerase alfa) For The Treatment Of Gaucher Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 9 Jan 2012
Gentium Appoints Swedish Orphan Biovitrum AB as Exclusive Distributor of Defibrotide in Nordic and Baltic Territories
Biopharmaceuticals Distribution
 HSMN NewsFeed - 29 Jun 2011
Amicus Therapeutics Announces John F. Crowley to Return as Chairman and Chief Executive Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 25 Feb 2011
FDA Issues Complete Response Letter for Taliglucerase Alfa New Drug Application
Biopharmaceuticals
 HSMN NewsFeed - 7 Sep 2010
Protalix BioTherapeutics Names Tzvi Palash Chief Operating Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 17 Aug 2010
BioMarin Acquires ZyStor Therapeutics, Inc.
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 2 Jul 2010
Lilly to Acquire Alnara Pharmaceuticals
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 3 May 2010
Abbott Receives FDA Approval for CREON(R) to Include Dosing Information for Patients With Chronic Pancreatitis and Pancreatectomy
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Feb 2010
Shire Provides Update on Biologics License Application (BLA) Filing for REPLAGAL(R) (agalsidase alfa) With the U.S. Food and Drug Administration (FDA)
Biopharmaceuticals
 HSMN NewsFeed - 28 Jan 2010
Alnara Pharmaceuticals Secures $35 Million in Series B Round
Biopharmaceuticals Venture Capital
 HSMN NewsFeed - 22 Dec 2009
Shire Submits Biologics License Application (BLA) for REPLAGAL(R) With the U.S. Food and Drug Administration (FDA)
Biopharmaceuticals
 HSMN NewsFeed - 17 Dec 2009
Protalix Names Sandra Lauterbach Vice President of Sales and Commercial Affairs
Biopharmaceuticals Personnel
 HSMN NewsFeed - 1 Dec 2009
Pfizer And Protalix Enter Into Agreement To Develop And Commercialize Gaucher's Disease Treatment
Biopharmaceuticals Licensing
 HSMN NewsFeed - 13 Nov 2009
Phase II/III Clinical Study Compares Safety and Efficacy of Two Doses of ZENPEP(TM) (Pancrelipase) Delayed-Release Capsules for Fat Absorption in Adult Chronic Pancreatitis Patients With Exocrine Pancreatic Insufficiency
Biopharmaceuticals
 HSMN NewsFeed - 3 Nov 2009
Alnara Pharmaceuticals Announces Appointment of Lee R. Brettman, M.D., FACP, to Chief Medical Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 8 Sep 2009
FDA Grants Protalix Orphan Drug Designation for prGCD
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Aug 2009
Eurand Granted FDA Approval for ZENPEP(TM)
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Aug 2009
Protalix Receives FDA Fast Track Designation for prGCD
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Aug 2009
Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Jul 2009
Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Jun 2009
FDA Extends Review Period for Eurand's ZENPEP(TM) Pancreatic Enzyme Replacement Therapy
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 9 Jun 2009
William Aliski Named FoldRx Chief Commercial Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 8 Apr 2009
The Journal of Cardiac Failure Publishes Results From Celladon Corporation's First-in-Human Phase 1/2 Clinical Trial in Advanced Heart Failure
Regenerative Medicine Cardiology
 HSMN NewsFeed - 22 Sep 2008
Enobia Pharma Appoints Industry Veterans with Commercial and Manufacturing Expertise to Expand Senior Management Team
Biopharmaceuticals Personnel
 HSMN NewsFeed - 27 May 2008
Shire Announces Approval of ELAPRASE(R) (idursulfase) in Brazil
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 31 Mar 2008
Naglazyme Approved by Japanese Ministry of Health
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 13 Feb 2008
Shire's ELAPRASE(R) (idursulfase) Approved in Mexico for Treatment of Hunter Syndrome
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 5 Dec 2007
Protalix BioTherapeutics Announces Resignation of Board Members
Biopharmaceuticals Personnel
 HSMN NewsFeed - 8 Nov 2007
Amicus Therapeutics and Shire plc Enter Into $440 Million ex-US Licensing Agreement to Develop and Commercialize Amigal(TM), Plicera(TM) and At2220
Biopharmaceuticals Licensing
 HSMN NewsFeed - 8 Nov 2007
Shire Expands its Human Genetic Therapies Pipeline Through In-Licensing Agreement With Amicus Therapeutics
Biopharmaceuticals Licensing
 HSMN NewsFeed - 19 Oct 2007
Actelion Ltd: Miglustat (Zavesca) Receives Negative Opinion From the European Committee For Medicinal Products For Human Use For Extension of Indication For Niemann Pick Type C
Biopharmaceuticals Neurology Regulatory
 HSMN NewsFeed - 4 Oct 2007
Genzyme Receives Approval to Market Elaprase(R) in Japan
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 4 Oct 2007
Shire's ELAPRASE(R) (idursulfase) Approved in Japan for the Treatment of Hunter Syndrome
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 11 Sep 2007
Enobia Pharma Raises $40.1 Million Series B Financing
Biopharmaceuticals Venture Capital
 HSMN NewsFeed - 27 Aug 2007
Protalix BioTherapeutics Treats First Patient in Phase III Clinical Trial of prGCD
Biopharmaceuticals
 HSMN NewsFeed - 8 Aug 2007
Paladin Expands Distribution Agreement with Shire HGT to Include ELAPRASE(TM) (Idursulfase)
Biopharmaceuticals Distribution
 HSMN NewsFeed - 2 Aug 2007
Axcan Pharma Submits Complete New Drug Application for ULTRASE
Biopharmaceuticals Gastroenterology
 HSMN NewsFeed - 14 Jun 2007
Shire's ELAPRASE(TM) (idursulfase) Approved by Health Canada for Treatment of Hunter Syndrome
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 11 Jun 2007
Altus Pharmaceuticals Reacquires European Development and Commercialization Rights to ALTU-135
Biopharmaceuticals Acquisitions
 HSMN NewsFeed - 22 May 2007
Shire Human Genetic Therapies AB Signs Exclusive Marketing and Distribution Deal With Samaritan to Launch REPLAGAL for Fabry Disease in Greece and Cyprus
Biopharmaceuticals Distribution
 HSMN NewsFeed - 9 May 2007
Altus Pharmaceuticals Initiates Phase III Clinical Trials of ALTU-135 for Cystic Fibrosis Patients with Pancreatic Insufficiency
Biopharmaceuticals
 HSMN NewsFeed - 15 Jan 2007
Genzyme Announces Publication of Study Showing Impact of Cerezyme on Bone Health for Patients With Type 1 Gaucher Disease
Biopharmaceuticals
 HSMN NewsFeed - 11 Jan 2007
ELAPRASE(R) for the Treatment of Hunter Syndrome Approved by the European Commission
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 11 Jan 2007
The European Commission Approves First and Only Enzyme Replacement Therapy for Hunter Syndrome
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 19 Dec 2006
Altus Pharmaceuticals Appoints Bruce A. Leicher General Counsel
Biopharmaceuticals Personnel
 HSMN NewsFeed - 21 Nov 2006
Altus Pharmaceuticals Appoints Shire Executive David Pendergast to Board of Directors
Biopharmaceuticals Personnel
 HSMN NewsFeed - 23 Jun 2006
Altus Pharmaceuticals Announces Positive Results from Phase II Study in Growth Hormone Deficient Patients with Once-Per-Week Growth Hormone
Biopharmaceuticals
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