Santen Pharmaceutical

Harrow Announces Appointment of Mark Mannebach, Ph.D., R.Ph. as Head of Regulatory Affairs and Pharmacovigilance

Retrieved on: 
Monday, March 6, 2023
Biotechnology, Health, Pharmaceutical, Optical, Clinical Trials, Santen Pharmaceutical, Acquisition, Baxter, Patient, Mallinckrodt, Pharmacia, Regulatory affairs, FDA, Ophthalmology, Mannebach, Pharmaceutical industry, Pharmacovigilance, Sanofi, Pfizer

Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced the appointment of Mark Mannebach, Ph.D., R.Ph.

Key Points: 
  • Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced the appointment of Mark Mannebach, Ph.D., R.Ph.
  • as Head of Regulatory Affairs and Pharmacovigilance, responsible for overseeing and managing all regulatory related submissions and strategy related to the Company’s portfolio of new and existing products.
  • Dr. Mannebach’s successful 30-year career in the pharmaceutical industry, much of which was focused in ophthalmology, includes leadership roles in regulatory affairs, quality assurance, program management and pharmaceutical product development.
  • Earlier in his career, Dr. Mannebach held roles of increasing responsibility at Sanofi, Pharmacia, Baxter, and Pfizer.

Outlook Therapeutics® Strengthens Medical Affairs and Commercial Expertise with Appointments of Surendra Sharma, MD, Senior Vice President of Medical Affairs and Glen Olsheim, Executive Director of Commercial Excellence

Retrieved on: 
Thursday, January 19, 2023
Hospital, Santen Pharmaceutical, Bevacizumab, Ophthalmology, SVP, Therapy, FDA, Surender Sharma, Medical Affairs Bureau, Outlook, Marketing, Patient, Sale, Biogen, Business, Pharmaceutical industry, Medical device, Retina, MD

“Outlook Therapeutics is very happy to welcome Surendra and Glen to our growing executive leadership team.

Key Points: 
  • “Outlook Therapeutics is very happy to welcome Surendra and Glen to our growing executive leadership team.
  • Dr. Sharma has more than 15 years of experience in the pharmaceutical and biotechnology industries leading corporate alliances among R&D, commercial, marketing and business stakeholders.
  • In his new role as SVP of Medical Affairs, Dr. Sharma will report to Russ Trenary, President and Chief Executive Officer of Outlook Therapeutics.
  • In his new role as Executive Director of Commercial Excellence, Mr. Olsheim will report to Jeff Evanson, Chief Commercial Officer of Outlook Therapeutics, to help deliver an industry-leading customer experience.

Xequel Bio Expands Leadership Team with Appointments of Dr. Michael J. Brubaker as Chief Scientific Officer and Tony C. Tipton as Chief Operating Officer

Retrieved on: 
Tuesday, July 26, 2022
DNA-binding protein, Psychiatry, University, GLOBE, Corporate development, Abbott Laboratories, Physician, Medical device, Research, Dermatology, Tissue, Commercial, VP, Development, Cell biology, Santen Pharmaceutical, Marketing, Fibrosis, Ophthalmology, Degenerative disease, Wichita State University, Rice University, Leadership, Inflammation, Technology, Company, Granulation tissue, Alcon, Department, Therapy, Neurology, Health, Regulatory affairs, Fine chemical, Chemistry, Education

The addition of these two key executives to our team comes at an important time as we continue to build momentum, said Jerry St. Peter, Chief Executive Officer and Board Member.

Key Points: 
  • The addition of these two key executives to our team comes at an important time as we continue to build momentum, said Jerry St. Peter, Chief Executive Officer and Board Member.
  • Mike and Tony bring proven leadership, extensive global clinical development and commercial expertise, especially in ophthalmology and dermatology.
  • Prior to joining Xequel, Mr. Tipton served as Vice President of Market Access and Trade Channels at Santen Pharmaceuticals, USA, formerly Eyevance Pharmaceuticals.
  • in Education and Health from the University of Tennessee, and he completed the Executive Leadership Certification Program from Rice University.

Capricor Therapeutics Appoints Xavier Avat as Chief Business Officer

Retrieved on: 
Wednesday, May 25, 2022
Linda, Senior, Corporate development, Organic acid, CEO, RNA transfection, Company, General manager, EDHEC Business School, Private Securities Litigation Reform Act, Medicine, U.S. Securities and Exchange Commission, GM, Leadership, Duchenne muscular dystrophy, Patient, Goal, NASDAQ, Vaccine, Therapy, Master of Science in Health Informatics, Exosome, DMD, Ownership, Schering-Plough, Research, Industry, Biotechnology, Intellectual property, Drug discovery, Instagram, Santen Pharmaceutical, Genentech, Technology, Safety, Edwards Lifesciences, Business administration, Protein, Twitter, Growth, Master of Business Administration, Security (finance), Annual report, Gilead Sciences, GLOBE, Pharmaceutical industry, Merck, Facebook

SAN DIEGO, May 25, 2022 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ:CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of a broad spectrum of diseases, today announced that it has appointed Xavier Avat as Chief Business Officer. In this role, Mr. Avat will oversee Capricor’s strategic priorities, the commercialization of its pipeline products and business development activities.

Key Points: 
  • In this role, Mr. Avat will oversee Capricors strategic priorities, the commercialization of its pipeline products and business development activities.
  • Mr. Avat obtained his Master of Business Administration degree from Edhec Business School and a Master of Science degree in bioengineering from Polytech Lille in France.
  • What separates Capricor from other biotechnology companies of its size in the industry is its innovative pipeline and differentiated technology platform, added Mr. Avat.
  • Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a biotechnology company focused on developing transformative cell and exosome-based therapeutics and vaccines for treating and preventing a broad spectrum of diseases.

Nanoscope Therapeutics Appoints Two Pharmaceutical Industry Veterans as Scientific and Clinical Advisors

Retrieved on: 
Wednesday, May 25, 2022
Department, Chemistry, Retinitis pigmentosa, MBA, Company, University, Dow Medical College, Retina, Doctor of Philosophy, Geographic atrophy, Patient, Genetic testing, Spark Therapeutics, Tufts University School of Medicine, GA, Therapy, BA, Retinal degeneration, MCO, Faculty, D Grubu, ProQR, Corneal transplantation, Novartis, University of California, FDA, AMD, Industry, Harvard University, RP, Medical school, Santen Pharmaceutical, Board, Genentech, Wound healing, Harvard Medical School, Eye, MD, CEO, Pharmaceutical industry, Medical device, Atomic de Broglie microscope, Stargardt disease, Indiana University, Ophthalmology

"We are extremely pleased to have these distinguished leaders join our team of advisors.

Key Points: 
  • "We are extremely pleased to have these distinguished leaders join our team of advisors.
  • "Nanoscope has already begun to demonstrate the tremendous potential of this approach, including extraordinary efficacy and good tolerability in severely visually impaired individuals.
  • At Genentech, Dr. Shams helped to establish the Ophthalmic Clinical R&D Group and led the development of Lucentis through approval.
  • Nanoscope Therapeutics is developing gene-agnostic, sight restoring optogenetic therapies for the millions of patients blinded by retinal degenerative diseases, for which no cure exists.

jCyte Announces Appointment of Victor Chao as Vice President of CMC Operations

Retrieved on: 
Thursday, September 9, 2021
Engineering, Transport, Chemicals, Plastics, Manufacturing, Biotechnology, Health, Pharmaceutical, Logistics, Supply Chain Management, Optical

jCyte, Inc. , a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, announced the continued expansion of the Companys leadership team with the appointment of Victor Chao as Vice President of Chemistry, Manufacturing and Controls (CMC) Operations.

Key Points: 
  • jCyte, Inc. , a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, announced the continued expansion of the Companys leadership team with the appointment of Victor Chao as Vice President of Chemistry, Manufacturing and Controls (CMC) Operations.
  • Mr. Chao joins jCyte with over 25 years of industry experience across numerous corporate operational leadership roles in CMC operations, cGMP global manufacturing, distribution, and supply chain management for multiple blockbuster biological therapies and commercial and corporate operations for ophthalmology prescription medicines, surgical devices, and biosimilars.
  • Victor holds a BS in chemical engineering from Brigham Young University and earned his MBA from The Wharton School with a dual major in strategy and entrepreneurship.
  • In addition to RMAT designation, jCell has received Orphan Drug designation from the FDA and the European Medicines Agency (EMA).

Santen and IAPB Taking Action to Implement the First Ever UN General Assembly Resolution Recognizing the Link Between Eye Health and Sustainable Development

Retrieved on: 
Monday, July 26, 2021
Health, Science, Pharmaceutical, Research, Optical, Optometry, The International Agency for the Prevention of Blindness, Health, Santen Pharmaceutical, Organizations

Santen Pharmaceutical Co., Ltd. (Santen) announced today that Santen, in partnership with the International Agency for the Prevention of Blindness (IAPB), will take action to implement United Nations General Assembly Resolution A/75/L.108 on eye health.

Key Points: 
  • Santen Pharmaceutical Co., Ltd. (Santen) announced today that Santen, in partnership with the International Agency for the Prevention of Blindness (IAPB), will take action to implement United Nations General Assembly Resolution A/75/L.108 on eye health.
  • This comes after several months of collaboration with the IAPB, advocating for global action to improve access to basic eye health services.
  • International financial institutions and donors will be urged to include eye health priorities in their funding programs.
  • The eye health sector has believed for a long time that quality eye care is critical to the world achieving the Sustainable Development Goals said Peter Holland, CEO of IAPB.

Glaukos Announces Australia’s TGA Regulatory Approval for PRESERFLO™ MicroShunt

Retrieved on: 
Tuesday, June 8, 2021
Surgery, Medical devices, Health, Pharmaceutical, Optical, Blindness, Glaucoma, Santen Pharmaceutical, Medication, Articles, Commercialization, Product, Health sciences, Glaukos, Santen, GLAUKOS, SANTEN

We are delighted to receive regulatory approval from Australias TGA for the MicroShunt, marking a notable milestone in advancing our goal to bring this important late-stage glaucoma technology to ophthalmic surgeons and patients, said Thomas Burns, Glaukos president and chief executive officer.

Key Points: 
  • We are delighted to receive regulatory approval from Australias TGA for the MicroShunt, marking a notable milestone in advancing our goal to bring this important late-stage glaucoma technology to ophthalmic surgeons and patients, said Thomas Burns, Glaukos president and chief executive officer.
  • We are excited for the opportunity to leverage our best-in-class sales organization to bring this novel technology to patients in Australia.
  • Glaukos plans to commence initial commercial launch activities for the MicroShunt in Australia in late 2021, with a full commercial launch targeted in mid-2022 following the establishment of formal reimbursement.
  • Under its current development and commercialization license agreement with Santen Pharmaceutical Co., Ltd. (Santen), Glaukos has exclusive commercialization and development rights for the MicroShunt in Australia.

Santen and Aerie Conclude Exclusive License Agreement for Rhopressa® and Rocklatan® in Japan and Several Other Asian Countries

Retrieved on: 
Wednesday, October 28, 2020
General Health, Health, Genetics, Pharmaceutical, Optical, Chemical compounds, Drugs, Organic compounds, Prostaglandins, Santen Pharmaceutical, Aerie Pharmaceuticals, Netarsudil, Latanoprost, Ophthalmic, Aerie, Medication, Pharmaceutical industry in China

Santen Pharmaceutical Co., Ltd. (Santen) and Aerie Pharmaceuticals, Inc. (NASDAQ: AERI, Aerie) announced that Santen and Aerie have entered into an exclusive development and commercialization agreement for Rhopressa and Rocklatan in Japan, along with rights for several other Asian countries.

Key Points: 
  • Santen Pharmaceutical Co., Ltd. (Santen) and Aerie Pharmaceuticals, Inc. (NASDAQ: AERI, Aerie) announced that Santen and Aerie have entered into an exclusive development and commercialization agreement for Rhopressa and Rocklatan in Japan, along with rights for several other Asian countries.
  • Rhopressa (netarsudil ophthalmic solution) 0.02% and Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% are approved and being sold in the United States by Aerie.
  • We are delighted to partner with Santen, which is a leading global ophthalmology company and the largest in Japan.
  • Santen is the market leader for prescription ophthalmic pharmaceuticals in Japan and its products now reach patients in over 60 countries.

Santen Announces U.S. FDA Acceptance of Premarket Approval (PMA) Application for DE-128 (MicroShunt) for Review

Retrieved on: 
Tuesday, July 7, 2020
Health, Articles, Pharmaceuticals policy, Santen Pharmaceutical, Food and Drug Administration, Medical device, Pharmaceutical industry in China, Pharmaceutical industry

OSAKA, Japan, July 6, 2020 /PRNewswire/ -- Santen Pharmaceutical Co., Ltd. (hereinafter, Santen) today announced that the United States Food and Drug Administration (FDA) has accepted the Premarket Approval (PMA) application for DE-128 (MicroShunt) for review.

Key Points: 
  • OSAKA, Japan, July 6, 2020 /PRNewswire/ -- Santen Pharmaceutical Co., Ltd. (hereinafter, Santen) today announced that the United States Food and Drug Administration (FDA) has accepted the Premarket Approval (PMA) application for DE-128 (MicroShunt) for review.
  • The substantive review, which traditionally spans 180 days from the FDA's receipt of the PMA final module, is an in-depth review following which the FDA will make a decision as to whether the PMA is approved.
  • As a specialized company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices.
  • Santen is the market leader for prescription ophthalmic pharmaceuticals in Japan and its products now reach patients in over 60 countries.